| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
Phase 3 topline data readout example | Phase 3 | — | Subscribe to access the data. | Biologics | Infectious Diseases | ||
Phase 3 topline data readout example | Phase 3 | — | Subscribe to access the data. | Biologics | Infectious Diseases | ||
Phase 3 topline data readout example | Phase 3 | — | Subscribe to access the data. | Biologics | Infectious Diseases |
Recent Updates
Recently added Catalysts
Invivyd, Inc.$0.78
-0.02 (-2.35%)
C 53Pipeline Score Undervalued Biotech · Clinical
Market Cap
324.07 M
EPS
-0.36
P/E Ratio
-
Value Trade
3.17 M
SEC Financials
Q1 2026Dilution Risk
40%Revenue
13.74 M
R&D Expenses
30.73 M
Operating CF
-41.71 M
Total Assets
241.74 M
Total Liabilities
38.69 M
Equity
203.05 M
D/E Ratio
12,345
-5.17 %
Week
-31.25 %
1 Month
-30.82 %
3 Month
-55.1 %
6 Month
-94.76 %
5 Year
-94.76 %
All Time
Cash Data
Cash Position
184.15 M
Monthly Burn
13.90 M
Runway
11.5 mo
Burn Trend
SEC Filing
May 14, 2026
Overview
Volume
2.01 M
52 Week Range
0.48 - 3.07
% held by Insiders
10.77 %
% held by Institutions
76.04 %
Enterprise Value
148.54 M
Total Shares
233.19 M
Short %
17.64 %
Float Shares
155.54 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Invivyd, Inc.
352Total events
8Upcoming
71Tier-1 (high impact)
2021 – 2027Coverage
Upcoming catalysts 8
2026
T2IND Submission
IND-enablement and regulatory outreach for VMS063; target IND readiness in late 2026
Event history 344
Jul 6, 2026
▼Drug WithdrawalPEMGARDADiscontinuedFDA Decision
FDA Notice of Termination of PEMGARDA EUA received
COVID-19 pre-exposure prophylaxissource ↗
Q3 2026
◆Topline ReadoutVYD2311Clinical Data
Top-line results expected in Q3 2026 (shifted from mid-year)
COVID-19source ↗
Jun 16, 2026
▲Enrollment CompleteVYD2311Trial
Enrollment completed in Phase 3 LIBERTY trial comparing VYD2311 vs mRNA COVID-19 vaccine
COVID-19 preventionsource ↗
Jun 9, 2026
▲First Patient DosedVYD2311Trial
First participants dosed in LIBERTY Phase 3 trial of VYD2311
COVID-19 preventionsource ↗
Jun 3, 2026
Jun 1, 2026
▲Enrollment CompleteVYD2311Trial
Completion of enrollment in upsized DECLARATION trial
COVID-19source ↗
Jun 2026
Jun 2026
◆Trial InitiationVYD2311Trial
Phase 2 clinical trial evaluating VYD2311 in Long COVID or COVID vaccine injury expected to be initiated mid-2026
Long COVID or COVID vaccine injurysource ↗
May 14, 2026
▲Biomarker DatapemivibartClinical Data
In vitro neutralizing activity of pemivibart against SARS-CoV-2 variant BA.3.2.2 (Cicada)
COVID-19 preventionsource ↗
Drug Pipeline Intelligence
C53
Pipeline Score $1.6B
Pipeline ValueUndervalued
Valuation Signal4
Drugs Scored4.8x
rNPV / MCap Top 81%
Micro Cap (rank 174 of 911)
Percentile RankInvivyd, Inc. carries a moderate pipeline score (53/100), with $5.2B risk-adjusted pipeline value, led by VYD2311-SD in COVID-19 (Phase 3).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VYD2311-SD Small molecule | COVID-19 | Phase 3 | NCT07298434 | 56% | $1.6B | ACTIVE NOT_RECRUITING | 1,770 | AVERAGE | B (73) | Aug 1, 2026 | MODERATE_RISK | MEDIUM Jun 10, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
adintrevimab | COVID-19 | Phase 2/3 | 2026-05-11 | In the EVADE trial, adintrevimab demonstrated a significantly lower incidence of Grade 2/3 systemic adverse events at 2% compared to 91.6% for mRNA vaccines and 83.6% for protein vaccines within the first seven days post-dosing. Read More | Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination Read More | |
adintrevimab | COVID-19 | Phase 2/3 | 2026-05-11 | In the EVADE trial, adintrevimab demonstrated a significantly lower incidence of Grade 2/3 systemic adverse events at 2% compared to 91.6% for mRNA vaccines and 83.6% for protein vaccines within the first seven days post-dosing. Read More | Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination Read More | |
adintrevimab | COVID-19 | Phase 2/3 | 2026-05-11 | In the EVADE trial, adintrevimab demonstrated a significantly lower incidence of Grade 2/3 systemic adverse events at 2% compared to 91.6% for mRNA vaccines and 83.6% for protein vaccines within the first seven days post-dosing. Read More | Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in IVVD
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
IVVD Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
IVVD▼ -6.7%on this news
Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA
Invivyd has received a Notice of Termination for the Emergency Use Authorization (EUA) of PEMGARDA, effective June 29, 2027. The company is in discussions with the FDA regarding next steps to secure permanent approval for this monoclonal antibody, which has shown strong efficacy in clinical trials. Despite the termination notice, Invivyd remains committed to providing protection for vulnerable populations against COVID-19.
Read more →IVVDInvivyd Announces Completion of Enrollment in Phase 3 LIBERTY Trial Evaluating VYD2311 Antibody Versus mRNA COVID-19 Vaccine
Invivyd has completed participant enrollment in its Phase 3 LIBERTY trial, which compares the monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The trial aims to assess safety, tolerability, and immune response. Initial results are anticipated in Q3 2026, potentially alongside data from the DECLARATION trial, as Invivyd seeks to establish VYD2311 as a viable alternative for COVID-19 prevention.
Read more →IVVDInvivyd Announces First Participants Dosed in LIBERTY, a Phase 3 Clinical Trial to Evaluate the Safety and Tolerability of VYD2311 Antibody Versus mRNA COVID Vaccine and to Characterize the Safety and Immunology of Antibody and mRNA Vaccine Co-Administration
Invivyd has commenced dosing participants in its LIBERTY Phase 3 clinical trial, which aims to evaluate the safety and tolerability of its monoclonal antibody VYD2311 compared to an mRNA COVID-19 vaccine. The trial will also explore the effects of co-administering VYD2311 with the vaccine. Topline data is expected in Q3 2026, alongside results from the DECLARATION trial.
Read more →IVVDInvivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Invivyd, Inc. announced the granting of stock options to 17 newly hired non-executive employees under Nasdaq Listing Rule 5635(c)(4) as an inducement for their employment. The options, totaling 513,500 shares, have an exercise price of $1.22 and will vest over four years. This move reflects Invivyd's strategy to enhance its workforce while maintaining a focus on developing therapies for viral infectious diseases.
Read more →IVVD▲ +7%on this newsshared move
Invivyd Announces Completion of Enrollment in Upsized DECLARATION Clinical Trial, a Phase 3 Pivotal Study of VYD2311, an Investigational Antibody to Prevent COVID
Invivyd has completed enrollment in its DECLARATION trial, a Phase 3 study evaluating VYD2311, an investigational monoclonal antibody for preventing symptomatic COVID-19. The trial includes both single and monthly dosing arms, with top-line results expected in late Q3 2026. The study aims to provide data on the safety and efficacy of VYD2311 in a broad population.
Read more →IVVDInvivyd to Participate in Upcoming Investor Events
Invivyd, Inc. has announced its participation in several upcoming investor events in June 2026, including the Jefferies Global Healthcare Conference and H.C. Wainwright's 'HCW @ Home' series. The management team will also host investor meetings during these events. The company focuses on developing innovative antibodies for viral infectious diseases, having received FDA emergency use authorization for one of its monoclonal antibodies.
Read more →IVVD▼ -21.1%on this news
Invivyd Reports First Quarter 2026 Financial Results and Recent Business Highlights
Invivyd, Inc. reported its Q1 2026 financial results, showcasing a 22% increase in net product revenue from PEMGARDA, amounting to $13.7 million. The company confirmed the effectiveness of its monoclonal antibody VYD2311 against the SARS-CoV-2 variant BA.3.2.2. Despite a significant increase in operating expenses linked to clinical trials, Invivyd maintains a robust cash position of $184.2 million.
Read more →IVVDInvivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination
Invivyd has released a preprint manuscript evaluating the tolerability of its investigational monoclonal antibody adintrevimab in comparison to COVID-19 vaccines. The study indicates that adintrevimab has minimal side effects, suggesting a significant difference in tolerability compared to vaccines. The upcoming LIBERTY trial will further investigate the safety of VYD2311 against mRNA vaccines.
Read more →IVVDInvivyd to Host First Quarter 2026 Financial Results and Corporate Update Call on May 14, 2026
Invivyd, Inc. has announced a conference call scheduled for May 14, 2026, to discuss its first quarter financial results and provide a corporate update. The call will begin at 8:30 a.m. ET, with a registration link available for interested parties. The company is known for its focus on developing antibodies for viral infectious diseases.
Read more →IVVDInvivyd Announces Chairman Marc Elia to Speak at POLITICO Health Care Summit
Invivyd's Chairman, Marc Elia, will speak at the POLITICO Health Care Summit on April 21, discussing the role of monoclonal antibodies in viral disease prevention. The event aims to connect policymakers and health experts to explore the future of American health care. Elia emphasizes the importance of advanced monoclonal antibodies beyond vaccines for improving health outcomes.
Read more →IVVD▲ +31.9%on this news
Invivyd Announces REVOLUTION Program Progress and Advancement of Novel, Potential First- and Best-in-Class Measles Monoclonal Antibody Candidate VMS063 for Treatment and Prevention of Measles
Invivyd has announced advancements in its REVOLUTION program, including the development of VMS063, a novel monoclonal antibody for measles. The company is also progressing in the DECLARATION Phase 3 study for VYD2311, with a recent upsizing to enhance statistical power. The FDA has aligned with Invivyd on a pediatric study plan, indicating a pathway for future development.
Read more →IVVDInvivyd Launches “Antibodies for Any Body” in Partnership with World Champion Skier Lindsey Vonn to Inspire Actions that Help Support Immune Health
Invivyd, Inc. has launched a national education campaign titled 'Antibodies for Any Body' in collaboration with skier Lindsey Vonn. The initiative aims to enhance public understanding of antibodies and their importance in immune health. The campaign features an interactive website providing resources and assessments to help individuals improve their immune wellness. Vonn emphasizes the significance of understanding how antibodies contribute to overall health.
Read more →IVVD▼ -13.1%on this news
Invivyd Announces Presentation at the World Vaccine Congress Washington
Invivyd, Inc. announced that its Chief Scientific Officer, Robert Allen, Ph.D., presented at the World Vaccine Congress Washington. His presentation focused on developing monoclonal antibody therapies to address rapidly evolving viral threats. The company emphasized the importance of diversifying prophylaxis methods to mitigate public health risks. Challenges such as scalability and economic factors were also discussed.
Read more →IVVDInvivyd Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Recent Business Highlights and DECLARATION Clinical Trial Updates
Invivyd reported a strong financial performance for Q4 and full-year 2025, with a 25% increase in net product revenue for PEMGARDA. The company has successfully completed full enrollment for the DECLARATION Phase 3 trial of VYD2311, which has received Fast Track designation from the FDA. Despite a net loss of $52.5 million, Invivyd remains optimistic about its pipeline and ongoing clinical trials.
Read more →IVVDInvivyd Appoints Distinguished Physician and Scientist, Michael Mina, M.D., Ph.D. as Chief Medical Officer
Invivyd has appointed Dr. Michael Mina as Chief Medical Officer, bringing his expertise in infectious diseases, particularly COVID-19. Dr. Mina's background includes significant research and public health contributions, which are expected to accelerate Invivyd's efforts in developing monoclonal antibodies. His appointment comes at a crucial time for advancing infectious disease prevention.
Read more →IVVD▼ -5.8%on this newsshared move
Invivyd Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 2, 2026
Invivyd, Inc. announced the grant of stock options to four new non-executive employees as an inducement for their employment. The options, totaling 192,000 shares, have an exercise price of $1.69 and will vest over four years. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to enhance employee retention.
Read more →IVVD▼ -5.8%on this newsshared move
Invivyd to Host Fourth Quarter and Full-Year 2025 Financial Results and Corporate Update Conference Call on March 5, 2026
Invivyd, Inc. will hold a conference call on March 5, 2026, to discuss its fourth quarter and full-year 2025 financial results, along with a corporate update. The call is scheduled for 8:30 a.m. ET, and interested parties can join via a live webcast. A recording will be available afterward on the company's investor relations website.
Read more →IVVDNew Publication Demonstrates Variant-Agnostic Correlate of Protection from COVID-19 for Invivyd Monoclonal Antibody, Useful for Understanding of and Confidence in COVID-19 Antibodies
Invivyd, Inc. announced a peer-reviewed publication demonstrating a correlate of protection from COVID-19 using their monoclonal antibody, pemivibart. This analysis, based on data from the CANOPY Phase 3 trial, indicates that clinical protection can be predicted from laboratory-determined antibody activity levels, regardless of virus variation. The findings support the use of monoclonal antibodies in clinical decision-making and public health strategies.
Read more →IVVD▲ +8%on this news
Invivyd Aligns with the U.S. FDA on LIBERTY, a Phase 3 Trial to Evaluate the Safety of VYD2311 Antibody Versus mRNA COVID Vaccine, and to Characterize the Safety and Immunology of Antibody and Vaccine Co-Administration
Invivyd has aligned with the FDA on its LIBERTY Phase 3 trial, which will evaluate the safety and immunologic profile of its monoclonal antibody VYD2311 against mRNA COVID vaccines. The trial will also assess the simultaneous administration of both VYD2311 and mRNA vaccines. The FDA has requested monitoring for specific adverse events, including myocarditis and pericarditis, during the trial.
Read more →IVVDInvivyd Announces Partnership with World Champion Skier Lindsey Vonn to Educate Americans on Antibodies and Disease Prevention
Invivyd, Inc. has partnered with Olympic skier Lindsey Vonn to launch a multimedia educational campaign aimed at improving public understanding of antibodies and their role in disease prevention. The campaign is set to begin in Spring 2026, with Vonn serving as the spokesperson. This initiative reflects a commitment to enhancing health literacy in the context of infectious disease prevention.
Read more →IVVD▼ -8.6%on this newsshared move
Invivyd and SPEAR Study Group Announce Plan for Phase 2 Study of VYD2311 for Treatment of Long COVID and COVID Vaccine-Injured Individuals to Commence Mid-2026
Invivyd, Inc. and the SPEAR Study Group announced plans to initiate a Phase 2 clinical trial for VYD2311, a monoclonal antibody aimed at treating individuals suffering from Long COVID and COVID vaccine injuries. The trial is set to begin by mid-2026 and aims to explore the therapeutic potential of VYD2311, which has shown promising antiviral activity. This collaboration seeks to address the growing health crisis associated with Long COVID.
Read more →IVVDInvivyd Reports Preliminary Fourth Quarter 2025 Revenue and Recent Business Highlights Preliminary Q4 2025 PEMGARDA (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth
Invivyd, Inc. has announced preliminary revenue for Q4 2025, revealing a 25% increase in net product revenue from PEMGARDA (pemivibart). The company highlighted its preparations for the potential launch of VYD2311, a new prophylactic treatment for COVID-19. While there are positive prospects for revenue growth and pipeline expansion, PEMGARDA remains investigational, and its efficacy may be affected by new SARS-CoV-2 variants. Overall, 2026 is seen as a critical year for Invivyd in addressing the ongoing challenges of COVID-19.
Read more →IVVDInvivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent
Invivyd, Inc. announced that the FDA has granted Fast Track designation for its monoclonal antibody candidate VYD2311, aimed at preventing COVID-19. This designation will expedite its development and review processes, potentially leading to quicker access for patients with underlying risk factors. The company is set to conduct a Phase 3 clinical trial named DECLARATION, which will assess the safety and efficacy of VYD2311 in a broad participant group. This trial is expected to provide top-line data by mid-2026, contributing to the ongoing fight against COVID-19.
Read more →IVVDInvivyd Announces Initiation of DECLARATION Clinical Trial, a Phase 3 Placebo-Controlled Pivotal Study of VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
Invivyd, Inc. has announced the initiation of the DECLARATION clinical trial, a Phase 3 study to evaluate the safety and efficacy of VYD2311, a vaccine-alternative monoclonal antibody intended to prevent COVID-19. The trial will compare different dosing regimens with placebo, aiming to enroll approximately 1,770 participants. Results from this pivotal study are anticipated to support the development of a potential prophylactic treatment against COVID. If successful, VYD2311 could provide a flexible option for individuals seeking additional COVID protection in various circumstances.
Read more →IVVD▼ -5.4%on this news
Invivyd to Participate at the 8th Annual Evercore Healthcare Conference
Invivyd, Inc. has announced its participation in the upcoming 8th Annual Evercore Healthcare Conference scheduled for December 2, 2025. The company's management will engage in a fireside chat at the event, which will also be available via a live webcast. This appearance highlights Invivyd's commitment to transparency and communication with investors. The biopharmaceutical company is known for its focus on developing innovative solutions for viral infectious diseases, having received emergency use authorization for a monoclonal antibody from the U.S. FDA in March 2024.
Read more →IVVDInvivyd Announces Selection of Potential Best-In-Class RSV Antibody Candidate VBY329; Targeting 2H 2026 IND Readiness
Invivyd has nominated VBY329, a monoclonal antibody candidate for RSV prevention, for preclinical development. This candidate shows promising in vitro properties and improved potency compared to existing treatments like nirsevimab. Invivyd aims for IND readiness by the second half of 2026, targeting a significant market for RSV prophylaxis among infants and children.
Read more →IVVD▼ -10.9%on this news
Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants
Invivyd, Inc. has announced a public offering of 44 million shares at a price of $2.50 each, along with pre-funded warrants for an additional 6 million shares. This offering is projected to raise approximately $125 million, which will be used for commercial preparedness for the potential launch of VYD2311 and for research on respiratory syncytial virus and other initiatives. The closing is expected on or around November 19, 2025, pending fulfillment of customary closing conditions.
Read more →IVVD▲ +20.9%on this newsshared move
Invivyd Announces Proposed Public Offering of Common Stock
Invivyd, Inc. has announced a proposed underwritten public offering of its common stock, with an option for underwriters to purchase additional shares. The offering is intended to fund commercial readiness for the potential launch of VYD2311 and support ongoing R&D programs. The company emphasizes that the success of the offering is uncertain and is contingent on market conditions. Key management and regulatory approvals also pose potential risks to the offering's completion.
Read more →IVVDInvivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Invivyd, Inc. reported its financial results for Q3 2025, highlighting a strengthened balance sheet and progress on its monoclonal antibody VYD2311, which has received IND clearance and FDA alignment. The company is preparing for pivotal studies and a potential commercial launch, aiming to provide antibody protection against COVID-19. However, challenges remain regarding the efficacy of its existing product, PEMGARDA, against emerging variants.
Read more →IVVD▼ -13%on this newsshared move
Invivyd to Host Third Quarter 2025 Financial Results and Corporate Update Call on November 6, 2025
Invivyd, Inc. will host a conference call on November 6, 2025, to discuss its third quarter financial results and provide a corporate update. The call is scheduled for 8:30 a.m. ET, and interested parties can join via a live webcast. A recording will be available after the event.
Read more →IVVDLife can only be understood backwards; but it must be lived forwards KIERKEGAARD Invivyd 1
Invivyd, Inc. presented its vision for developing monoclonal antibodies to combat various viral threats, including COVID-19 and RSV. The company highlighted the importance of understanding the limitations of current immune responses to SARS-CoV-2 and emphasized the challenges in achieving consistent vaccine efficacy amidst evolving variants. Concerns were noted regarding public mistrust in vaccines and the potential impact on overall vaccine uptake. The company's future endeavors depend on navigating regulatory pathways, which pose additional uncertainties.
Read more →IVVDInvivyd to Host Webcast on the REVOLUTION Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
Invivyd, Inc. is hosting a live webcast on October 30, 2025, to discuss its REVOLUTION clinical program for VYD2311, a monoclonal antibody aimed at preventing COVID-19. The session will feature key team members and provide an overview of the ongoing clinical trials. VYD2311 is designed to deliver effective antiviral protection through a patient-friendly administration route.
Read more →IVVD▲ +22.4%on this news· ran to +63% by day 3
Invivyd Announces U.S. IND Clearance and Alignment with U.S. FDA on Pivotal Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
Invivyd, Inc. has received FDA clearance for its IND application for VYD2311, a monoclonal antibody intended as a vaccine alternative for COVID prevention. The company plans to initiate two pivotal clinical trials, DECLARATION and LIBERTY, aimed at evaluating the safety and efficacy of VYD2311 compared to existing vaccines. These trials are expected to start by the end of 2025, with results anticipated in mid-2026.
Read more →IVVD▼ -6.6%on this news
Invivyd Appoints Paul B. Bolno, M.D. to Its Board of Directors
Invivyd, Inc. has appointed Dr. Paul B. Bolno to its Board of Directors, enhancing its leadership team. Dr. Bolno, who is currently the President and CEO of Wave Life Sciences, brings extensive experience in biotechnology and product development. His appointment is expected to support Invivyd's mission to advance its pipeline and address major viral infectious diseases.
Read more →IVVD▲ +5.2%on this newsshared move
INVIVYD APPOINTS PAUL B. BOLNO
Invivyd, Inc. has appointed Dr. Paul B. Bolno to its Board of Directors. Dr. Bolno, the current President and CEO of Wave Life Sciences, is expected to leverage his experience in pipeline development to aid Invivyd’s goals. The company aims to focus on preventing major viral infectious diseases, including COVID-19. This appointment comes at a crucial moment as Invivyd transitions to enhance its capabilities in addressing public health challenges.
Read more →IVVD▼ -8.7%on this news
Invivyd Announces Appointment of Kristie Kuhl as Chief Communications Officer
Invivyd, Inc. has appointed Kristie Kuhl as Chief Communications Officer to lead its communications and patient advocacy efforts. Kuhl, recognized for her influence in health communications, aims to enhance stakeholder trust and support the company's growth. Invivyd focuses on providing monoclonal antibodies for viral diseases, including SARS-CoV-2.
Read more →IVVDSPEAR Study Group to Present its Recommended Long COVID Antibody Study Design Featuring Invivyd’s VYD2311 At RECOVER-TLC Workshop September 9-10, 2025
Invivyd, Inc. announced that the SPEAR Study Group will present a recommended clinical study design for evaluating monoclonal antibody therapy for Long COVID at the RECOVER-TLC Workshop on September 9-10, 2025. The proposed study focuses on the effects of broadly neutralizing antibodies, including VYD2311, on patients suffering from Long COVID. This initiative aims to advance understanding of the underlying biology of the condition.
Read more →IVVD▼ -15.4%on this news
Invivyd to Participate in Upcoming Investor Conferences
Invivyd, Inc. announced its participation in two upcoming investor conferences, including the Cantor Global Healthcare Conference and the H.C. Wainwright Annual Global Investment Conference. The company will host fireside chats and investor meetings, providing opportunities for engagement. Live webcasts of the events will be available for those unable to attend in person.
Read more →IVVDInvivyd Announces Closing of $57.5 Million Public Offering and Full Exercise of the Underwriter’s Option to Purchase Additional Shares
Invivyd, Inc. has successfully closed a public offering, raising approximately $57.5 million. This includes the full exercise of an underwriter's option for additional shares. The proceeds will be utilized for clinical program advancements, particularly in areas like RSV and Long COVID therapies. The offering was managed by Cantor and involved multiple healthcare investors.
Read more →IVVD▼ -16.7%on this news· ran to +63% by day 3shared move
Invivyd Announces Pricing of $50 Million Public Offering of Common Stock and Pre-Funded Warrants
Invivyd, Inc. has announced a public offering priced at $50 million, involving 74.8 million shares of common stock and pre-funded warrants. The offering is expected to close around August 22, 2025, pending customary conditions. Proceeds will be allocated to clinical program advancements and general corporate purposes. The offering is facilitated by Cantor as the sole book-running manager.
Read more →IVVD▼ -17.8%on this newsshared move
Invivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) and VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG (“Stratus”)
Invivyd announced continued effective neutralizing activity of PEMGARDA (pemivibart) and VYD2311 against the XFG variant of SARS-CoV-2. Ongoing wastewater surveillance indicates a surge in COVID-19 cases across the U.S., emphasizing the need for robust treatments. The company's data demonstrate stable efficacy across various SARS-CoV-2 variants, indicating the durability of target epitopes. Data will soon be presented to the FDA for consideration in addressing the needs of immunocompromised patients.
Read more →IVVDInvivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19
Invivyd, Inc. has received alignment from the U.S. FDA for a rapid pathway towards a Biologics License Application (BLA) for its monoclonal antibody candidate VYD2311. This treatment aims to provide an alternative prophylactic option against COVID-19, particularly for adults and adolescents. The FDA recommends a single Phase 2/3 clinical trial focusing on symptomatic COVID-19 prevention, estimated to enable quick patient enrollment. If successful, VYD2311 could offer a viable option in the face of declining public confidence in traditional vaccines.
Read more →IVVDInvivyd Reports Second Quarter 2025 Financial Results and Recent Business Highlights PEMGARDA (pemivibart) net product revenue of $11.8 million reported for Q2 2025, representing 413% growth year-over-year Invivyd s targ
Invivyd, Inc. announced its financial results for Q2 2025, showing significant growth with PEMGARDA net product revenue reaching $11.8 million, a 413% increase from the previous year. The company is focused on advancing its lead candidate VYD2311 for COVID-19 protection and is actively refining its clinical and market strategies. Despite the promising figures, PEMGARDA's growth is described as modest, underlining the competitive landscape for COVID-19 therapies. Looking ahead, Invivyd plans to identify candidates for RSV and measles, further expanding its pipeline in infectious diseases.
Read more →IVVDInvivyd and Leading Researchers Form SPEAR (Spike Protein Elimination and Recovery) Study Group to Assess the Effects of Monoclonal Antibody Therapy for Long COVID and COVID-19 Post-Vaccination Syndrome
Invivyd has established the SPEAR Study Group, collaborating with leading researchers to evaluate the efficacy of monoclonal antibody therapy for treating Long COVID and Post-Vaccination Syndrome. Following reports of substantial clinical benefits from PEMGARDA (pemivibart), a monoclonal antibody currently FDA-authorized for COVID-19 prevention, the group aims to rigorously assess its safety and effectiveness. The initiative responds to the significant medical burden of Long COVID, with efforts to conduct clinical trials and further explore monoclonal antibodies as a treatment option.
Read more →IVVDInvivyd and Leading Researchers Form SPEAR ( S pike P rotein E limination a nd R ecovery) Study Group to Assess the Effects of Monoclonal Antibody Therapy for Long COVID and COVID-19 Post-Vaccination Syndrome - SPEAR Stu
Invivyd has launched the SPEAR Study Group to explore the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome. This initiative follows encouraging independent reports indicating clinical benefits from its monoclonal antibody PEMGARDA. The study aims to evaluate monoclonal antibody safety and efficacy among patients experiencing persistent symptoms. Notably, this effort is led by recognized experts in the field, emphasizing the importance of rigorous clinical research in understanding these complex health challenges.
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Invivyd Announces Positive Full Phase 1/2 Clinical Data for VYD2311, a Next Generation COVID-19 Monoclonal Antibody for Potential Use as a Non-Vaccine Preventative and for Treatment of Active Infection • Attractiv
Invivyd has released positive findings from the Phase 1/2 clinical trials for its monoclonal antibody candidate VYD2311, which is designed for COVID-19 prevention and treatment. The trial reported an attractive safety profile, with all adverse events classified as mild to moderate and primarily related to injection reactions. Notably, VYD2311 exhibited a long half-life, maintaining high serum concentrations for up to six months, potentially allowing for long-term protection against COVID-19. Invivyd plans to meet with the FDA in early Q3 2025 to discuss the approval pathway for VYD2311.
Read more →IVVD▲ +20.1%on this news
Invivyd Announces Publication of Landmark CANOPY Phase 3 PEMGARDA (pemivibart) Clinical Trial; Results Underscore Strong Efficacy of Monoclonal Antibodies in Preventing COVID-19 in a Modern U.S. Population Against Relevant, Immune-Evasive SARS-CoV-2 Virus
Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial for pemivibart (PEMGARDA), demonstrating significant efficacy in reducing symptomatic COVID-19 among both immunocompromised and at-risk individuals. The trial showcased an 84% relative risk reduction and met all primary endpoints. The findings highlight the importance of monoclonal antibodies alongside traditional vaccines, particularly in modern populations facing evolving SARS-CoV-2 variants. Overall, the study reaffirms pemivibart's potential as a pre-exposure prophylaxis against COVID-19.
Read more →IVVDInvivyd Announces Inclusion of PEMGARDA (pemivibart) in National Comprehensive Cancer Network (NCCN ) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas
Invivyd announced that its investigational monoclonal antibody, PEMGARDA (pemivibart), has been included in the NCCN Clinical Practice Guidelines for B-Cell Lymphomas. This recognition highlights PEMGARDA's potential role in protecting immunocompromised patients from COVID-19, particularly those unable to mount adequate immune responses to vaccination. The NCCN guidelines reflect the urgent need for effective prophylactic options in patients with B-cell malignancies. Despite its advantages, the emergency use authorization of PEMGARDA is subject to the presence of SARS-CoV-2 variants and their susceptibility.
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Invivyd Commends FDA Focus on Contemporary Evidence In Evaluating Medical Interventions To Prevent COVID-19
Invivyd, Inc. has praised the FDA's recent steps to tackle uncertainty regarding COVID-19 vaccine booster efficacy. The Agency's updated framework aligns with Invivyd's Citizen Petition and emphasizes the need for randomized trials involving contemporary populations. Furthermore, Invivyd is advancing its monoclonal antibody pemivibart, which showed an 84% reduction in symptomatic COVID-19 risk in a Phase 3 trial. The company anticipates further progress with its next-generation mAb VYD2311 and plans to engage with the FDA for expedited development pathways.
Read more →IVVD▼ -15.8%on this news
Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights PEMGARDA (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contr
Invivyd, Inc. reported its Q1 2025 financial results, highlighting a net product revenue of $11.3 million for PEMGARDA. The company has shifted to an internal sales force, which initially posed challenges, but is starting to show positive growth signs as they advance into Q2 2025. With a robust financial backing, Invivyd is aiming for profitability by mid-2025, despite PEMGARDA still being categorized as investigational and authorized only for emergency use under specific conditions.
Read more →IVVDInvivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy
Invivyd, Inc. has submitted a Citizen Petition to the FDA advocating for a re-evaluation of COVID-19 vaccines and monoclonal antibodies (mAbs) in light of evolving virus strains. This petition urges the FDA to conduct long-term efficacy studies involving seropositive populations and modern variants like Omicron. Invivyd believes this updated approach will enhance vaccine effectiveness and restore public trust in health measures. The company is focused on providing alternative preventative treatments as a part of its commitment to combat serious viral infectious diseases.
Read more →IVVDInvivyd to Participate at the H.C. Wainwright 3rd Annual BioConnect Investor Conference
Invivyd, Inc. will participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025. The company's management will engage in a fireside chat and conduct investor meetings during the event. Additionally, a live webcast of the discussion will be accessible on their website, providing an opportunity for broader investor engagement. Invivyd focuses on developing innovative antibody therapies for serious viral infections and recently received FDA emergency use authorization for one of its monoclonal antibodies.
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Invivyd Announces New Pipeline Discovery Program Focused on Monoclonal Antibody Treatment for Measles • Multiple HCPs have requested from Invivyd a monoclonal antibody (mAb) for treatment of active measles infecti
Invivyd has launched a discovery program to develop a monoclonal antibody treatment for measles, addressing inquiries from healthcare providers about needed therapies. With over 20 million unvaccinated individuals in the U.S., the company aims to identify a preclinical candidate by 2025. Existing treatments for measles are limited, making this research critical as vaccination rates decline. Updates on progress are expected by the end of the year.
Read more →IVVDInvivyd to Host First Quarter 2025 Financial Results and Corporate Update Conference Call on May 15, 2025
Invivyd, Inc. has announced it will host a conference call on May 15, 2025, to discuss its financial results for the first quarter of 2025 and provide updates on recent business developments. The company, focused on protecting against serious viral infectious diseases, highlights its dedication to transparency and communication with stakeholders. This call will also offer analysts an opportunity to engage during a question-and-answer session. Invivyd is known for its integrated technology platform and received emergency use authorization for a monoclonal antibody in March 2024.
Read more →IVVD▲ +10%on this news· ran to +31% by day 3
Invivyd Announces $30M Non-dilutive Loan Facility with Silicon Valley Bank
Invivyd, Inc. has announced the signing of a $30 million non-dilutive loan facility with Silicon Valley Bank, which allows for future capital drawdown based on certain conditions. This financing is expected to support the company's regulatory efforts related to VYD2311, its monoclonal antibody candidate for COVID-19. The company emphasizes that this non-dilutive financing will help focus on enhancing shareholder value. However, there are inherent risks, including the potential need to meet specific milestones and the uncertain effectiveness of related therapies against emerging viral variants.
Read more →IVVD▼ -6.7%on this news
Invivyd Appoints Ajay Royan, Founder of Mithril Capital, to its Board of Directors
Invivyd, Inc. has appointed Ajay Royan, founder of Mithril Capital, to its Board of Directors. Royan, a venture capitalist, has previously led initiatives to support Invivyd's mission in addressing viral infectious diseases, starting with COVID-19. The appointment aims to leverage Royan's expertise as Invivyd prepares to enhance its monoclonal antibody therapies, aiming to address urgent medical needs for vulnerable populations. The company's innovative platform positions it uniquely in the biopharmaceutical landscape, promising scalable and impactful therapies.
Read more →IVVDInvivyd Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Recent Business Highlights • Achieved Q4 2024 PEMGARDA (pemivibart) net product revenue of $13.8 million, representing 48% growth ov
Invivyd reported significant growth in revenues for Q4 2024, with PEMGARDA generating $13.8 million, a 48% increase from the previous quarter. The company aims to achieve profitability by mid-2025, supported by cash reserves of $69.3 million. Positive clinical data for VYD2311 was also announced, highlighting its potential against SARS-CoV-2 variants. However, FDA declined a request to expand PEMGARDA’s emergency use authorization, indicating regulatory hurdles ahead.
Read more →IVVDInvivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1 • New in vitro neutralization data show continued, consistent neutralizing activity o
Invivyd has announced that its monoclonal antibody PEMGARDA (pemivibart) maintains its neutralizing activity against the currently prevalent SARS-CoV-2 variant LP.8.1, along with other variants. The data provided to the FDA suggests continued efficacy for vulnerable populations, particularly in preventing COVID-19 in immunocompromised individuals. Moreover, VYD2311, another monoclonal antibody candidate, has demonstrated stability against these variants. However, there are noted concerns regarding anaphylaxis and the possibilities of emerging variants reducing susceptibility to PEMGARDA.
Read more →IVVD▼ -29.9%on this news
FDA Declined Invivyd's Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic O
The FDA has declined Invivyd's request to expand the Emergency Use Authorization (EUA) of PEMGARDA (pemivibart) to include treatment for mild-to-moderate COVID-19 in immunocompromised patients. Despite demonstrating comparable antiviral activity to previously authorized treatments, the FDA believes it must provide superior efficacy to justify broadening PEMGARDA's use. The existing EUA for pre-exposure prophylaxis remains unchanged, leaving many patients without effective options for COVID-19 treatment. Invivyd plans to continue working with the FDA to address this shortage and also advance its other treatment candidate, VYD2311.
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Invivyd to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025
Invivyd, Inc. will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025. Marc Elia, the Chairman of the Board, will lead the presentation at 1:20 PM ET. The event will be accessible via a live webcast on the company's investor relations website. Invivyd focuses on developing antibodies to combat serious viral infectious diseases and has received emergency use authorization for one of its monoclonal antibody candidates.
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Invivyd Announces Partnership with Pro Football Coach Jim Harbaugh to Elevate Awareness and Ongoing Impact of COVID-19: Common, Not A Cold
Invivyd, Inc. announced a strategic partnership with football coach Jim Harbaugh to increase awareness about the long-term risks associated with COVID-19, especially for immunocompromised individuals. The collaboration will focus on educating the public regarding the ongoing health toll of COVID-19, which continues to cause significant deaths and hospitalizations in the U.S. despite high vaccination rates. Coach Harbaugh's efforts aim to promote alternate options for managing COVID-19 risks. The initiative is set to feature live and social media campaigns to improve public engagement.
Read more →IVVD▲ +196.3%on this news· ran to +454% by day 3shared move
Invivyd Announces Positive Phase 1/2 Clinical Data for VYD2311, a Monoclonal Antibody Designed to be a Superior Alternative to COVID-19 Vaccination for the Broad Population
Invivyd, Inc. has announced encouraging Phase 1/2 clinical trial results for VYD2311, a monoclonal antibody aimed at providing an alternative to COVID-19 vaccination. Data indicate VYD2311 is safe with favorable pharmacokinetics, exhibiting a significantly higher neutralization potency against SARS-CoV-2 variants. This monoclonal antibody could facilitate less frequent dosing and offers a promising option for treating COVID-19 effectively. The results underscore its potential effectiveness for broader population coverage while avoiding vaccine-related immune activation.
Read more →IVVD▲ +196.3%on this news· ran to +454% by day 3shared move
Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability • Preliminary Q4 2024 PEMGARDA (pemivibart) net product revenue of $13.8 m
Invivyd, Inc. has announced its preliminary fourth quarter 2024 financial results, highlighting a strong revenue growth of 48% with net product revenue reaching $13.8 million. This success is accompanied by a significant reduction in operating costs by 55%, resulting in a total of approximately $32 million in expenses. The company aims to achieve near-term profitability by the end of the first half of 2025, bolstered by its financial position, which includes $69.3 million in cash and equivalents. Further updates are expected during the Q4 earnings call in late March 2025.
Read more →IVVD▼ -12.9%on this news
Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA's Gating Request for Completing Its Review of EUA Request for PEMGARDA (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in
Invivyd has announced the submission of an updated treatment immunobridging analysis of its investigational monoclonal antibody, pemivibart, to the FDA as part of its amendment request for Emergency Use Authorization (EUA) to treat mild-to-moderate COVID-19 in certain immunocompromised patients. This latest analysis demonstrates that pemivibart exhibits higher antiviral activity compared to its predecessor, adintrevimab, particularly in the critical early days of treatment. No new cases of anaphylaxis have been reported during the post-authorization use of PEMGARDA, reinforcing the drug's safety profile. The company's ongoing data submissions reflect a commitment to providing effective treatment options amidst evolving SARS-CoV-2 variants.
Read more →IVVDinvivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) Against Dominant SARS-CoV-2 Variant XEC • New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA (p
Invivyd announced that new in vitro data demonstrates the continued effectiveness of its monoclonal antibody PEMGARDA (pemivibart) against the dominant SARS-CoV-2 variant XEC. Recent findings indicate that PEMGARDA maintains strong neutralization activity for a broad range of circulating variants, supporting its role as a critical option for pre-exposure prophylaxis in moderately to severely immunocompromised patients. The U.S. FDA is also expected to receive an updated Fact Sheet reflecting this data. Overall, the consistency in PEMGARDA's performance over the past three years reflects its potential to withstand ongoing viral mutations.
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Invivyd Announces New England Journal of Medicine Publishes Letter to the Editor Highlighting Immunobridging Pathway Leading to PEMGARDA™ (pemivibart) Emergency Use Authorization; Comments on Adjacent Third-Party Letter to the Editor
Invivyd, Inc. announced that the New England Journal of Medicine published a Letter to the Editor regarding its PEMGARDA (pemivibart) immunobridging pathway for Emergency Use Authorization. The letter includes an updated correlate of protection analysis, suggesting that PEMGARDA may provide strong protection against symptomatic COVID-19. Invivyd expressed disappointment over a separate letter from a third-party institution that presented conflicting data, which could confuse healthcare professionals regarding the drug's effectiveness. Despite the controversy, the company continues to assert that PEMGARDA retains efficacy against current SARS-CoV-2 variants.
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Invivyd Reports Third Quarter 2024 Financial Results and Recent Business Highlights Q3 2024 PEMGARDA (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalent
Invivyd, Inc. announced its financial results for Q3 2024, reporting $9.3 million in net product revenue from PEMGARDA, increasing from $2.3 million in the previous quarter. The company updated its Fact Sheet for healthcare providers, showcasing PEMGARDA's neutralization activity against circulating COVID-19 variants and reflecting positive efficacy data from the CANOPY Phase 3 clinical trial. Despite the revenue growth, it remains below initial projections, and the company acknowledged potential risks associated with variant susceptibility and the limitations of existing data.
Read more →IVVDInvivyd Announces Preprints Conveying CANOPY Phase 3 Clinical Trial Data Including Long-Term Protection Versus Recent JN.1 Sublineages at Low Residual Titers, and Describing a Novel Approach for Predicting Monoclonal Antibody Activity Were Uploaded to MedRxiv and BioRxiv, Respectively
Invivyd, Inc. has released preprints detailing the CANOPY Phase 3 trial results for its investigational monoclonal antibody, pemivibart. The data showcases pemivibart's capacity to provide long-term protection against symptomatic COVID-19, particularly during significant viral waves, with noteworthy efficacy even at low residual titers. Additionally, a novel approach for predicting antibody activity against evolving variants has been described, further reinforcing the potential of pemivibart in combating SARS-CoV-2.
Read more →IVVD▲ +12.6%on this news
Invivyd to Host Third Quarter 2024 Financial Results and Corporate Update Conference Call on November 14, 2024
Invivyd, Inc. has announced it will host a conference call on November 14, 2024, to discuss its financial results for Q3 2024 and recent business highlights. This follows the preliminary results reported on October 29, 2024. The company is focused on developing antibodies to combat viral infectious diseases, supported by its proprietary INVYMAB platform. Invivyd has already received emergency use authorization for its first monoclonal antibody from the U.S. FDA in March 2024.
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Invivyd to Participate in the Guggenheim Securities Healthcare Innovation Conference
Invivyd, Inc. has announced its participation in the Guggenheim Securities Healthcare Innovation Conference scheduled for November 11-13, 2024. Management will take part in a fireside chat and hold one-on-one meetings with investors. The company is recognized for its efforts in combating serious viral infectious diseases through its proprietary INVYMAB platform, which has already garnered emergency use authorization for its first monoclonal antibody from the U.S. FDA.
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Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection from Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent Participants
Invivyd, Inc. announced positive results from the CANOPY Phase 3 clinical trial of pemivibart, revealing a 76% overall risk reduction in symptomatic COVID-19 over a 12-month period after two doses. The long-term efficacy data indicated a significant 64% risk reduction during the months 7-12 follow-up, showcasing the continued protective effect of the monoclonal antibody without the need for additional doses. Importantly, no new safety concerns emerged during this follow-up, reinforcing the drug's favorable safety profile.
Read more →IVVD▼ -12.8%on this news
Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term Profitability • Preliminary Q3 2024 PEMGARDA (pemivibart) net product revenue of $9.3 million; Invi
Invivyd announced preliminary financial results for Q3 2024, reporting a net product revenue of $9.3 million for its monoclonal antibody PEMGARDA. The company also withdrew its previous revenue guidance following FDA warnings related to reduced effectiveness against current SARS-CoV-2 variants. Despite these challenges, Invivyd ended the quarter with approximately $107 million in cash and aims to achieve profitability by mid-2025. The company continues to engage with healthcare professionals to clarify doubts regarding PEMGARDA's antiviral activity.
Read more →IVVDInvivyd to Present PEMGARDA™ (pemivibart) Data at Infectious Disease Week (IDWeek) 2024
Invivyd, Inc. announced it will present data on the investigational monoclonal antibody, PEMGARDA (pemivibart), at IDWeek 2024 in Los Angeles. The presentations include findings from Phase 1 and Phase 3 clinical trials, highlighting PEMGARDA's efficacy and safety profile. While PEMGARDA is authorized for emergency use in certain high-risk populations, it remains investigational and subject to limitations, particularly regarding the emergence of SARS-CoV-2 variants.
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Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity Data
Invivyd, Inc. announced that the FDA has updated the Emergency Use Authorization Fact Sheet for its monoclonal antibody PEMGARDA, providing corrected data on its neutralization effectiveness against SARS-CoV-2 variants, including KP.3.1.1 and LB.1. This update aims to resolve discrepancies regarding the drug's susceptibility and efficacy. The company continues its monitoring efforts to ensure the treatment remains effective against circulating variants. However, concerns regarding misleading data from competing laboratories and the potential emergence of resistant variants pose ongoing challenges.
Read more →IVVDInvivyd Provides Detailed Virology Data and Analysis of SARS-CoV-2 Structural Biology Predicting Anticipated Neutralization Activity for PEMGARDA (pemivibart) • Independent evaluation of KP.3.1.1 and LB.1 variants
Invivyd has released detailed virology data supporting the neutralization activity of its investigational monoclonal antibody PEMGARDA (pemivibart) against various SARS-CoV-2 variants. Independent evaluations have confirmed the in vitro effectiveness of PEMGARDA against contemporary variants KP.3.1.1 and LB.1, with ongoing stability of its binding site since the Omicron shift. However, the antibody is only authorized for emergency use in pre-exposure prophylaxis, and cases of anaphylaxis and hypersensitivity have been reported. Continuous monitoring of SARS-CoV-2 evolution remains crucial to ensure the efficacy of PEMGARDA.
Read more →IVVD▲ +12.7%on this news
Invivyd at the Ready for Upcoming Respiratory Virus Season with PEMGARDA™ (pemivibart) to Help Protect Vulnerable Immunocompromised Persons from COVID-19
Invivyd, Inc. has announced its preparedness for the upcoming respiratory virus season with its investigational monoclonal antibody PEMGARDA, designed to protect immunocompromised individuals from COVID-19. The antibody has received Emergency Use Authorization and is covered by Medicare and Medicaid, ensuring its accessibility. The CDC reports an increase in COVID-19 mortality rates, emphasizing the necessity for effective preventive measures for high-risk populations. While PEMGARDA shows continued efficacy against major variants, safety concerns such as the potential for anaphylaxis must be acknowledged.
Read more →IVVDCorporate Overview September 2024 2024 Invivyd, Inc. Invivy , Pemgar , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE
Invivyd, Inc. has outlined its corporate overview and forward-looking statements regarding the potential launch and commercialization of PEMGARD, a monoclonal antibody intended for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. The company is pursuing a unique immunobridging pathway with the FDA to enhance regulatory acceptance for their therapies. While there are optimistic projections for PEMGARD, significant risks remain, including the uncertainty of regulatory approvals and the company's ability to effectively navigate the competitive landscape.
Read more →IVVDInvivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of
Invivyd, Inc. has commenced dosing the first participants in a Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody candidate for COVID-19. This trial aims to assess the safety and efficacy of VYD2311 against recent virus variants, with results anticipated in late 2024. The antibody candidate aims to build on the prior success of PEMGARDA, which has received Emergency Use Authorization for immunocompromised patients. VYD2311 may offer a more patient-friendly administration method through intramuscular delivery, enhancing therapeutic options for vulnerable populations.
Read more →IVVDInvivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) Against Dominant SARS-CoV-2 Variants KP.3.1.1 and LB.1, and Other Variants of Interest • New pseudovirus in vitro neutralization data show
Invivyd has announced that PEMGARDA (pemivibart) continues to demonstrate effectiveness against predominant SARS-CoV-2 variants, including KP.3.1.1 and LB.1, based on recent in vitro neutralization data. The company has submitted these findings to the FDA for timely updates to the PEMGARDA Healthcare Providers Fact Sheet. Additionally, another monoclonal antibody candidate, VYD2311, shows promising neutralization potency against contemporary variants. While the data is encouraging, PEMGARDA remains under emergency use authorization and presents some safety concerns, including anaphylaxis and variable effectiveness against certain SARS-CoV-2 variants.
Read more →IVVD▼ -28.7%on this news
Invivyd Announces PEMGARDA (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical Trial In all-comer cohort of im
Invivyd, Inc. announced positive findings from the CANOPY Phase 3 clinical trial for their monoclonal antibody, PEMGARDA (pemivibart). The study showed that PEMGARDA reduced symptomatic COVID-19 risk by 84% compared to placebo over a 180-day period, with no related hospitalizations or deaths. Safety data revealed some instances of anaphylaxis and mild adverse events among participants. The ongoing research aims to further highlight the potential of this treatment for immunocompromised populations.
Read more →IVVD▼ -7.5%on this news
INVIVYD REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS PEMGARDA launched commercially in Q2 2024 with $2.3 million of net product revenue Notable acceleration of commercial results in early
Invivyd, Inc. reported its financial results for the second quarter of 2024, highlighting $2.3 million in net product revenue from PEMGARDA, which was launched commercially after receiving Emergency Use Authorization. The company is transitioning its commercial strategy to enhance awareness and education about PEMGARDA, particularly among healthcare professionals and medical institutions. Additionally, Invivyd expects to initiate a first-in-human clinical trial for a next-generation monoclonal antibody, VYD2311, by late August. Despite positive growth, there are challenges regarding data limitations and safety concerns associated with PEMGARDA.
Read more →IVVD▼ -6.3%on this newsshared move
Invivyd to Host Conference Call Discussing Second Quarter 2024 Financial Results and Business Highlights
Invivyd, Inc. will host a conference call on August 14, 2024, to discuss its second quarter 2024 financial results and business highlights. This comes after the company received emergency use authorization from the FDA for its first monoclonal antibody. Invivyd focuses on addressing serious viral infectious diseases through its proprietary INVYMAB platform, which combines viral surveillance with advanced antibody engineering. A replay of the webcast will be made available shortly after the call concludes.
Read more →IVVD▲ +9.1%on this news
Invivyd Announces its Addition to the Russell 2000 and Russell 3000 Indexes
Invivyd, Inc. has been added to the Russell 2000 and Russell 3000 Indexes as part of their annual reconstitution process, effective July 1, 2024. This inclusion provides the company with enhanced visibility among institutional investors and positions it well for future opportunities in the market. The Russell indexes are important benchmarks used by investment managers, which could lead to increased interest in Invivyd's stock. This move aligns with Invivyd's mission to combat viral infectious diseases through innovative monoclonal antibody treatments.
Read more →IVVD▼ -7.1%on this news· ran to -23% by day 3
Invivyd Announces Antiviral Activity of VYD222 (pemivibart) Against SARS-CoV-2 KP.1.1 FLiRT & KP.3 Variants • Pseudovirus in vitro neutralization data show continued neutralizing activity of VYD222 (pemivibart) ag
Invivyd announced that its monoclonal antibody candidate VYD222 (pemivibart) demonstrates continued in vitro neutralization activity against the KP.1.1 FLiRT and KP.3 SARS-CoV-2 variants, which represent currently dominant strains. This aligns with preliminary data from an independent academic lab. Additionally, Invivyd's next mAb candidate, VYD2311, also shows effective neutralization in tests against these prevalent variants. The stability of the VYD222 binding interface contributes to its potential efficacy in treating and preventing COVID-19.
Read more →IVVDInvivyd to Participate at the Jefferies Global Healthcare Conference
Invivyd, Inc. will participate in the Jefferies Global Healthcare Conference on June 6, 2024, where its management team will engage in a fireside chat and hold investor meetings. The conference presents an opportunity for potential investors to connect directly with the company's leadership. Invivyd recently received emergency use authorization from the U.S. FDA for its first monoclonal antibody targeting serious viral diseases, showcasing its innovative approach in the biopharmaceutical sector.
Read more →IVVDInvivyd Announces the Appointment of Timothy Lee as Chief Commercial Officer Mr. Lee joins Invivyd with a history of high-quality commercial execution at Alexion, Biohaven and Amylyx Appointment intended to accelerate th
Invivyd, Inc. has appointed Timothy Lee as the Chief Commercial Officer to lead their commercial strategy. This move comes as the company seeks to enhance its operations following the departure of the Chief Operating Officer, Jeremy Gowler. The appointment aligns with Invivyd's plans to launch PEMGARDA, a monoclonal antibody designed to provide protection for vulnerable populations against COVID-19. Lee's experience in driving sales growth and product launches is expected to accelerate Invivyd's growth trajectory.
Read more →IVVDInvivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Serial Monoclonal Antibodies
Invivyd, Inc. announced a general alignment with the U.S. FDA on a repeatable immunobridging pathway aimed at facilitating emergency use authorizations for its monoclonal antibodies targeting symptomatic COVID-19. This new framework is designed to streamline the registration process, enabling quick evaluation of multiple new mAbs under a single master protocol. The company plans to enter registrational trials for its candidate VYD2311, potentially improving the treatment landscape for COVID-19 amid the challenges posed by viral evolution.
Read more →IVVDInvivyd to Present Data at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and 2024 American Transplant Congress (ATC)
Invivyd, Inc. announced its upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the American Transplant Congress (ATC). The company will share preliminary findings from its CANOPY Phase 3 trial of the monoclonal antibody VYD222, aimed at providing pre-exposure prophylaxis for COVID-19. Presentations will address subsets of patients with significant immune compromise and solid organ transplant patients, showcasing the antibody's potential efficacy and safety. This advancement follows Invivyd's receipt of FDA emergency use authorization for VYD222 in March 2024.
Read more →IVVDInvivyd Elects Two New Independent Members to its Board of Directors
Invivyd, Inc. announced the election of two independent directors, Dr. Srishti Gupta and Kevin F. McLaughlin, to its Board of Directors during the annual stockholders' meeting on May 21, 2024. Dr. Gupta will chair the Compensation Committee and Mr. McLaughlin will chair the Audit Committee. Their appointments come as Invivyd moves towards commercializing its first product, having received emergency use authorization for pre-exposure prophylaxis against COVID-19. The company aims to leverage its proprietary technology for continually developing antibody candidates.
Read more →IVVDInvivyd to Participate at the H.C. Wainwright 2nd Annual BioConnect Investor Conference
Invivyd, Inc. is set to present at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024. The company's Chairman of the Board, Marc Elia, will participate in a fireside chat, followed by management-hosted investor meetings. The presentation will also feature a live webcast available on their investor website. Invivyd focuses on combating viral infectious diseases and has received FDA emergency use authorization for its first monoclonal antibody developed using their proprietary INVYMAB platform.
Read more →IVVDInvivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback Pathway leverages immunobridging approach via serum
Invivyd, Inc. has announced plans to submit an emergency use authorization application to the FDA for pemivibart, aimed at treating COVID-19 in moderately to severely immunocompromised individuals. This initiative leverages an immunobridging pathway, building on prior FDA collaboration for the drug's pre-exposure prophylaxis approval. The company aims to address a critical unmet medical need, with an anticipated manufacturing capacity of approximately 100,000 doses by late 2024. However, the effectiveness and safety of the treatment remain contingent upon positive clinical trial results and regulatory approval.
Read more →IVVDInvivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights Launched PEMGARDA in the U.S. for COVID-19 pre-exposure prophylaxis (PrEP) in certain adults and adolescents with moderate-to-severe imm
Invivyd, Inc. reported its financial results for Q1 2024, highlighting recent business developments and the launch of PEMGARDA for COVID-19 pre-exposure prophylaxis. PEMGARDA, an investigational monoclonal antibody, aims to protect certain adults and adolescents with moderate-to-severe immune compromise. The company expressed optimism about its innovative engine delivering advancements in viral protection. However, PEMGARDA remains under emergency use authorization due to the ongoing pandemic.
Read more →IVVD▲ +6.4%on this newsshared move
Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback
Invivyd, Inc. announced plans to pursue an emergency use authorization (EUA) from the FDA for its monoclonal antibody pemivibart, targeting treatment for COVID-19 in immunocompromised patients. This initiative is built on prior clinical trial data and aims to leverage a rapid immunobridging pathway to address urgent medical needs. The company expects to remain on target with its existing revenue forecast, despite not factoring in potential revenues from this new treatment. The submission represents a significant step in providing additional therapeutic options for those at high risk from COVID-19 complications.
Read more →IVVDInvivyd to Host Conference Call Discussing First Quarter 2024 Financial Results and Business Highlights
Invivyd, Inc. will host a conference call on May 9, 2024, to discuss its Q1 2024 financial results and recent business developments. The biopharmaceutical company's innovative INVYMAB platform aims to provide protection against serious viral diseases, starting with SARS-CoV-2. Recently, Invivyd received emergency use authorization from the FDA for its first monoclonal antibody. The call will be accessible via a webcast for interested analysts and investors.
Read more →IVVD▲ +6.7%on this newsshared move
Invivyd Announces $20 Million to $25 Million Improvement in Projected 2024 Year-End Cash Position
Invivyd, Inc. has announced an improvement of $20 million to $25 million in its projected cash position for the end of 2024, now estimating at least $75 million in cash and equivalents. This update follows a comprehensive strategic review aimed at optimizing resources for the launch of PEMGARDA, an investigational monoclonal antibody. The company expects 2024 net revenue from PEMGARDA to be between $150 million and $200 million, signaling optimistic growth prospects. Details regarding financial performance will be shared during the Q1 report in May 2024.
Read more →IVVDInvivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™
Invivyd, Inc. announced that it has received Healthcare Common Procedure Coding System (HCPCS) reimbursement codes from CMS for PEMGARDA, its investigational monoclonal antibody for COVID-19 prevention. The Q code (Q0224) covers product reimbursement, while the M code (M0224) pertains to administration costs. With Medicare and Medicaid covering approximately 50% of the target population, the approval marks a significant milestone in making PEMGARDA accessible. Early interest from both patients and prescribers has been reported, indicating a favorable commercial outlook.
Read more →IVVDInvivyd Announces CEO Transition Jeremy Gowler appointed Interim
Invivyd, Inc. has announced the appointment of Jeremy Gowler as Interim CEO, following Dave Hering's departure. The Board of Directors believes this leadership change positions the company for its next growth phase, particularly in the development of novel monoclonal antibody therapies like PEMGARDA for COVID-19 pre-exposure prophylaxis. The interim leadership aims to enhance company operations while focusing on the successful launch of their investigational drug, which has recently received emergency use authorization from the FDA. However, challenges and uncertainties related to drug efficacy and ongoing management transitions remain pertinent.
Read more →IVVDInvivyd Announces CEO Transition
Invivyd, Inc. has appointed Jeremy Gowler as Interim CEO following Dave Hering's departure. The Board aims to position the company for its next phase of growth, with a focus on launching PEMGARDA, a monoclonal antibody designed for COVID-19 pre-exposure prophylaxis. The company highlights its strong balance sheet and innovative therapies in development, while navigating potential challenges related to management transition and regulatory authorizations. PEMGARDA has shown promising neutralizing activity against prevalent SARS-CoV-2 variants but remains investigational with an emergency use authorization currently in effect.
Read more →IVVD▼ -8.9%on this news· ran to -23% by day 3
Invivyd Provides PEMGARDA™ Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million
Invivyd, Inc. has announced the commercial availability of PEMGARDA™ in the U.S. for pre-exposure prophylaxis of COVID-19 in immunocompromised patients. Following its emergency use authorization from the FDA, the company expects net product revenue to reach between $150 million and $200 million in 2024. The company is also expecting to end the year with a stable cash position of at least $55 million. However, warnings regarding potential anaphylactic reactions have been noted, along with concerns about the efficacy data limitations.
Read more →IVVD▼ -8.9%on this news· ran to -23% by day 3
Invivyd Provides PEMGARDA TM Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million PEMGARDA now commercially available in the U.S. for pre-exposure prophylaxis (PrEP)
Invivyd, Inc. has launched PEMGARDA (pemivibart) injection for pre-exposure prophylaxis against COVID-19 following its emergency use authorization by the FDA. The product is intended for adults and adolescents with moderate-to-severe immune compromise who cannot adequately respond to COVID-19 vaccination. Invivyd projects 2024 net product revenue between $150 million and $200 million, showcasing the product's commercial potential. However, the treatment is still investigational with noted risks such as anaphylaxis.
Read more →IVVD▲ +11%on this news
Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights Received emergency use authorization for PEMGARDA , a monoclonal antibody (mAb) authorized in the U.S. for pre-exposure prophylaxis (PrEP) o
Invivyd, Inc. announced the financial results for the year ending December 31, 2023, alongside significant business developments, including the emergency use authorization (EUA) of its monoclonal antibody, PEMGARDA, for pre-exposure prophylaxis against COVID-19 in certain immunocompromised individuals. This marks a notable milestone as it is the first mAb authorized using a rapid immunobridging trial design. The company is focused on executing its commercial launch plan for PEMGARDA, which is expected to be available imminently.
Read more →IVVD▼ -25.9%on this newsshared move
Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19 PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults a
Invivyd has announced that PEMGARDA (pemivibart), formerly known as VYD222, has received emergency use authorization from the FDA for the pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals. This authorization, targeted at adults and adolescents who are unlikely to respond effectively to vaccinations, marks a significant milestone for the company and provides a new preventive option for a vulnerable group. Invivyd plans to further explore the use of monoclonal antibodies for symptomatic COVID-19 in future studies and anticipates making PEMGARDA available shortly.
Read more →IVVD▲ +41.1%on this newsshared move
Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial
Invivyd, Inc. has announced interim data from the CANOPY clinical trial for its monoclonal antibody candidate VYD222, indicating potential clinical protection against symptomatic COVID-19. The update, based on secondary exploratory endpoints, suggests the need for further analysis correlating serum virus neutralizing antibody titers with clinical protection. Future data updates are anticipated, particularly after Day 180 of the trial, highlighting the investigational nature of this information. The results may offer insights for future studies on pre-exposure prophylaxis in vulnerable populations.
Read more →IVVD▲ +41.1%on this newsshared move
Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19
Invivyd announced that PEMGARDA (pemivibart), formerly known as VYD222, has received emergency use authorization from the FDA for pre-exposure prophylaxis against COVID-19 in certain immunocompromised adults and adolescents. This marks the first monoclonal antibody to receive such authorization based on a novel trial design. The company expects to make the product available imminently, supported by positive clinical data and significant funding to bolster its operations. The development aims to provide vulnerable populations with effective preventive options against COVID-19.
Read more →IVVDINDEX TO CONSOLI DATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID 238) F- 2 Consolidated Balance Sheets F- 3 Consolidated Statements of Operations and Comprehensive Loss F
The report from PricewaterhouseCoopers outlines Invivyd, Inc.'s consolidated financial statements for the years ending December 31, 2022, and 2021. It highlights ongoing financial struggles, including recurring operational losses and substantial doubt regarding the company's ability to continue as a going concern. The report indicates that the company will need to secure additional funding to support its future operations.
Read more →IVVDInvivyd to Participate at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference
Invivyd, Inc. will participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference, with CEO David Hering scheduled for a fireside chat on February 8, 2024. Investor meetings will also take place, allowing for direct engagement between the management team and investors. A live webcast of the discussion will be available on the company's investor website, maximizing accessibility for interested stakeholders. Invivyd focuses on developing antibody therapies for serious viral infections, starting with SARS-CoV-2.
Read more →IVVD▲ +6.6%on this news
CORPORATE OVERVIEW
Invivyd has submitted a request for Emergency Use Authorization (EUA) for its mAb candidate VYD222, targeting the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. This move follows positive preliminary results from the CANOPY Phase 3 pivotal clinical trial and ongoing neutralization activity against significant SARS-CoV-2 variants. The company is preparing for a potential commercial launch of VYD222 if the EUA is granted, indicating a commitment to addressing the needs of vulnerable populations facing viral threats.
Read more →IVVDInvivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents EUA submission is based on positive initial res
Invivyd has submitted a request for Emergency Use Authorization (EUA) from the FDA for VYD222, a monoclonal antibody aimed at preventing COVID-19 in immunocompromised adults and adolescents. This submission is based on positive initial results from the CANOPY Phase 3 trial, which indicated strong neutralizing activity against the virus and early signals of clinical protection. VYD222 is designed to target conserved viral epitopes and hold potential for significant impact on the at-risk population. If authorized, Invivyd plans to make VYD222 available commercially shortly after.
Read more →IVVD▲ +120.2%on this news
Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19 VYD222 produced high serum virus neutralizing antibody titer levels in imm
Invivyd announced promising initial results from its CANOPY Phase 3 clinical trial for VYD222, a monoclonal antibody aimed at preventing symptomatic COVID-19. The trial showed high serum virus neutralizing antibody levels, particularly in immunocompromised individuals. The company plans to seek Emergency Use Authorization based on these results and reports a favorable safety profile with no serious adverse events. VYD222 demonstrates efficacy against multiple circulating strains of SARS-CoV-2, further supporting its potential as a key preventative therapy.
Read more →IVVD▼ -7.9%on this news
Invivyd Reports Third Quarter 2023 Financial Results and Recent Business Highlights Enrollment completed in CANOPY Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19 Company ex
Invivyd, Inc. reported its third quarter 2023 financial results, highlighting significant progress in its clinical development, particularly the completion of enrollment in the CANOPY Phase 3 trial for VYD222 aimed at preventing symptomatic COVID-19. The company anticipates initial primary endpoint data by late 2023 or early 2024 and is preparing for a possible EUA submission to the FDA. VYD222 is set to target over 9 million immunocompromised individuals in the U.S., with a commercial launch expected in 2024, pending regulatory approval. The company emphasizes its proactive approach in addressing viral threats through its INVYMAB platform.
Read more →IVVD▲ +5.4%on this news
Invivyd to Host Conference Call Discussing Third Quarter 2023 Financial Results and Business Highlights
Invivyd, Inc. announced a conference call scheduled for November 9, 2023, to discuss its third-quarter 2023 financial results and recent business developments. The company is focused on developing antibody-based therapies targeting viral infectious diseases, including COVID-19 and others. Their approach includes using advanced technology in virology and antibody engineering aimed at creating effective therapies. Details about the call, including registration options for analysts and listeners, were provided in the announcement.
Read more →IVVDInvivyd Announces Dosing of First Participant in CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of Symptomatic COVID-19
Invivyd Inc. has initiated dosing of the first participant in its CANOPY Phase 3 clinical trial for VYD222, a monoclonal antibody aimed at preventing symptomatic COVID-19. This trial is set to enroll approximately 750 participants, focusing on immunocompromised individuals who have limited preventive options against COVID-19. The company anticipates that the trial will generate critical data to support an emergency use authorization. Initial data is expected by late 2023 or early 2024, highlighting the urgent need for therapeutic advancements amid rising COVID-19 cases in vulnerable populations.
Read more →IVVDCORPORATE OVERVIEW September 2023 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING
Invivyd, Inc. focuses on rapidly developing monoclonal antibodies to protect vulnerable populations from viral threats, particularly COVID-19. The company is exploring a streamlined path towards Emergency Use Authorization for its mAb product candidates, including VYD222. This presentation outlines the ongoing research, upcoming CANOPY clinical trials, and the importance of addressing the reduced efficacy of vaccines in immunocompromised individuals. Despite the promising strategies, Invivyd acknowledges the inherent risks and uncertainties in executing its plans.
Read more →IVVDInvivyd Appoints William Duke as Chief Financial Officer
Invivyd, Inc. has appointed William Duke as its new Chief Financial Officer, who possesses over 25 years of experience in finance and accounting, particularly in the biotechnology sector. In his new role, Duke will lead the company's financial strategy as Invivyd plans to initiate a pivotal clinical study and possibly submit for Emergency Use Authorization for its candidate VYD222. Duke expressed enthusiasm for joining Invivyd, citing his desire to leverage his experience in supporting the development of novel therapeutics aimed at providing protection against viral diseases.
Read more →IVVDINVIVYD INVESTIGATION INITIATED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Invivyd, Inc. – IVVD, ADGI
Kahn Swick & Foti, LLC has initiated an investigation into Invivyd, Inc. regarding potential breaches of fiduciary duties by its officers and directors. This follows a securities class action lawsuit that alleges the company failed to disclose critical information about its lead product candidate ADG20. The investigation focuses on compliance with state and federal laws amidst these ongoing legal challenges. Invivyd, formerly known as Adagio Therapeutics, has faced scrutiny over its COVID-19 treatment efficacy claims.
Read more →IVVDInvivyd Reports Second Quarter 2023 Financial Results and Business Highlights Reported positive initial Phase 1 VYD222 clinical trial data, including favorable safety data and robust serum neutralizing titers from all th
Invivyd, Inc. announced its financial results for Q2 2023, highlighting encouraging initial data from the Phase 1 clinical trial of VYD222. The company is gearing up to initiate the CANOPY trial, which targets the prevention of symptomatic COVID-19 by leveraging positive serum neutralizing titers. CEO Dave Hering expressed optimism about the rapid pathway to a potential EUA as Invivyd anticipates enrolling approximately 450 participants. The company aims to have initial data from the CANOPY trial by the end of 2023.
Read more →IVVDInvivyd to Host Conference Call Discussing Second Quarter 2023 Financial Results and Business Highlights
Invivyd, Inc. will hold a conference call on August 10, 2023, to review its financial results for Q2 2023 and discuss recent business highlights. The call aims to inform stakeholders about the company's developments in antibody-based therapies targeting viral diseases, including COVID-19. Interested participants can register for the webcast and a replay will be available shortly following the call.
Read more →IVVDINVIVYD ANNOUNCES APPOINTMENT OF SARA COTTER TO BOARD OF DIRECTORS WALTHAM, Mass., JULY 27, 2023 Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from seriou
Invivyd, Inc. announced the appointment of Sara Cotter to its board of directors, bringing extensive healthcare investment and drug development experience. Cotter's expertise is anticipated to aid in advancing Invivyd's lead candidate, VYD222, which has shown positive initial Phase 1 clinical data. The company aims to rapidly progress VYD222 into a pivotal clinical trial to support a potential emergency use authorization for COVID-19 prevention in immunocompromised individuals.
Read more →IVVDInvivyd Announces Additional Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People
Invivyd, Inc. has reported additional positive initial data from its Phase 1 clinical trial of VYD222, a monoclonal antibody candidate aimed at preventing symptomatic COVID-19 in immunocompromised individuals. The results indicate favorable tolerability and robust neutralization against the Omicron XBB.1.5 variant across all dose levels tested. Ongoing analyses of serum neutralizing activity and pharmacokinetic data are expected to facilitate a transition to pivotal trials. The company’s CEO expressed optimism regarding VYD222's potential to offer protection where conventional vaccines may fall short.
Read more →IVVD▼ -5%on this news
Corporate Overview June 2023 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORW
Invivyd, Inc. provides a corporate overview detailing forward-looking statements regarding the development of its monoclonal antibody, VYD222. The company is focused on addressing the therapeutic needs of immunocompromised individuals amidst diminishing effective COVID-19 treatments. However, the potential success of VYD222 is subject to regulatory approval and may be impacted by evolving viral variants. The overview emphasizes ongoing research and the urgency for new therapeutics given the current COVID-19 landscape.
Read more →IVVDInvivyd Announces General Alignment with FDA on Pathway to Potential EUA for VYD222 and Anticipated Follow-On Monoclonal Antibody Candidates Designed to Prevent COVID-19
Invivyd, Inc. has announced its alignment with the FDA regarding the pathway for potential emergency use authorization of its monoclonal antibody candidate VYD222, aimed at preventing symptomatic COVID-19. Leveraging prior clinical trial data from its prototype, ADG20, Invivyd plans to initiate a pivotal clinical trial using serum neutralizing titers for efficacy evaluation. The company is also progressing towards a rapid initiation of this clinical trial to support the EUA submission, demonstrating its commitment to combat COVID-19 in vulnerable populations.
Read more →IVVD▼ -6.2%on this newsshared move
Invivyd Announces Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People
Invivyd, Inc. has announced positive initial data from the Phase 1 clinical trial of its monoclonal antibody candidate VYD222, which is designed to prevent symptomatic COVID-19 in immunocompromised individuals. The trial demonstrated VYD222's strong neutralization efficacy against the Omicron XBB.1.5 variant and good tolerability across all tested doses, with no serious adverse events reported. Initial results are expected to facilitate a swift transition to a pivotal clinical trial, addressing an identified need for effective protection in vulnerable populations. The company plans to further analyze the data and present additional results at an upcoming medical meeting.
Read more →IVVD▼ -16.7%on this news
Invivyd to Participate at the Jefferies Healthcare Conference
Invivyd, Inc. will present at the Jefferies Healthcare Conference on June 9, 2023, as announced by CEO David Hering. The company aims to engage with investors and showcase its innovative antibody-based therapies designed to combat viral diseases, including COVID-19. A live webcast of the presentation will be available on their investor website.
Read more →IVVDInvivyd Reports First Quarter 2023 Financial Results and Business Highlights Completed dosing of the Phase 1 clinical trial of VYD222, a broadly neutralizing monoclonal antibody (mAb) candidate being developed to protect
Invivyd has reported its financial results for Q1 2023, showcasing positive developments in its clinical trials for VYD222, a monoclonal antibody aimed at protecting immunocompromised individuals from COVID-19. The company has successfully completed dosing in the Phase 1 trial, with initial data expected to be available in Q2. It holds a strong financial position with $333.4 million in resources, which will support its operations through mid-2024. Invivyd aims to continuously innovate and adjust their strategies concerning the evolving SARS-CoV-2 virus.
Read more →IVVDInvivyd to Host Conference Call Discussing First Quarter 2023 Financial Results and Business Highlights
Invivyd, Inc. announced it will host a conference call on May 11, 2023, to discuss its financial results for the first quarter of 2023 and highlight recent business developments. The biopharmaceutical company specializes in creating antibody-based therapies for viral diseases, including COVID-19 and influenza. Their innovative technology and strong pipeline suggest a commitment to addressing pressing public health needs. A replay of the call will be accessible on their website shortly after it concludes.
Read more →IVVD▼ -7.3%on this newsshared move
Corporate Overview May 2023 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Stat
Invivyd, Inc. presents a cautious outlook in its May 2023 corporate overview, emphasizing potential risks tied to forward-looking statements regarding its monoclonal antibody program, VYD222. The document highlights the urgent need for new COVID-19 therapeutics aimed at protecting immunocompromised patients, particularly as existing options dwindle. Despite promising research trajectories, the company acknowledges challenges in regulatory approval and the impact of evolving COVID-19 variants on trial outcomes. The potential market for these therapeutics remains significant, but the firm must navigate uncertainties to achieve its objectives.
Read more →IVVDInvivyd to Participate at H.C. Wainwright’s BioConnect Investor Conference
Invivyd, Inc. is set to participate in the H.C. Wainwright BioConnect Investor Conference on May 2, 2023. The company's CEO, David Hering, will present in a fireside chat at the event held at the Nasdaq World Headquarters in New York. Invivyd emphasizes its commitment to delivering antibody-based therapies to combat serious viral diseases, including COVID-19. A live webcast of the presentation will be available on the company's investor website and archived for 90 days.
Read more →IVVDInvivyd Announces the FDA Has Cleared Its IND Application for VYD222, a Monoclonal Antibody Candidate for Prevention of COVID-19, and Provides Phase 1 VYD222 Clinical Trial Update
Invivyd, Inc. has received FDA clearance for its Investigational New Drug application for VYD222, a monoclonal antibody aimed at preventing COVID-19 in vulnerable populations. The company reports that the Phase 1 clinical trial in Australia is progressing well, with dosing of the first cohort completed and initial data readouts anticipated in Q2 2023. VYD222 has shown in vitro effectiveness against prevalent SARS-CoV-2 variants, addressing an urgent need for alternatives to vaccines for those who may not respond adequately.
Read more →IVVDInvivyd Appoints Robert Allen as Chief Scientific Officer and Stacy Price as Chief Technology and Manufacturing Officer
Invivyd, Inc. has announced the appointment of Robert Allen as Chief Scientific Officer and Stacy Price as Chief Technology and Manufacturing Officer. Both leaders bring extensive experience in their fields, with Allen focusing on overseeing the scientific direction and supporting the discovery of new therapies, and Price managing the chemistry, manufacturing, and controls programs. This leadership expansion is aimed at enhancing Invivyd's efforts to deliver antibody-based therapies designed to protect vulnerable populations against viral diseases, starting with COVID-19.
Read more →IVVD▼ -8.1%on this news
Invivyd Doses First Participants in Phase 1 Trial of VYD222, a Novel Monoclonal Antibody Candidate for COVID-19
Invivyd, Inc. has initiated dosing for the first participants in a Phase 1 trial of their monoclonal antibody candidate, VYD222, aimed at treating COVID-19. This trial, which is randomized, blinded, and placebo-controlled, will assess the safety and efficacy of VYD222, particularly for immunocompromised individuals who may not respond well to vaccinations. Preliminary data is expected in the second quarter of 2023, with additional clinical updates planned for the remainder of the year.
Read more →IVVDINVIVYD SHAREHOLDER ALERT: CLAIMSFILER REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Invivyd, Inc. – IVVD, ADGI
ClaimsFiler has alerted investors of Invivyd, Inc. about a class action lawsuit deadline for lead plaintiff applications. Investors who purchased shares between November 29 and December 14, 2021, are reminded to file by April 3, 2023. The lawsuit follows the disclosure by the company, then known as Adagio, that its COVID-19 treatment was significantly less effective against the Omicron variant. This revelation led to a sharp decline in the company’s stock price.
Read more →IVVD▼ -8.4%on this newsshared move
Invivyd, Inc. (IVVD) Investor Alert: Robbins LLP Reminds Investors of Pending Lead Plaintiff Deadline in Invivyd, Inc. Class Action
Invivyd, Inc. (NASDAQ: IVVD) faces a class action lawsuit regarding misleading statements about its monoclonal antibody therapy, ADG20, during a specific period in late 2021. The lawsuit claims that the company falsely asserted that ADG20 would effectively neutralize the Omicron variant of COVID-19. Following a December 2021 announcement revealing significant ineffectiveness of ADG20 against Omicron, the company's stock experienced a dramatic decline of nearly 80%. Investors are reminded of the April 3, 2023 deadline to file for lead plaintiff status in the case.
Read more →IVVDInvivyd Reports Full Year 2022 Financial Results and Business Highlights Advancing VYD222 into clinical development based on in vitro data demonstrating neutralizing activity against multiple important variants of concer
Invivyd, Inc. has reported its financial results for the year ended December 31, 2022, and highlighted its strategic shift towards developing SARS-CoV-2 monoclonal antibody candidates. The company is advancing VYD222 into clinical development, backed by promising neutralizing activity against various SARS-CoV-2 variants. Invivyd has sufficient capital to sustain its operations through the second half of 2024, and plans to initiate a Phase 1 clinical trial for VYD222 soon, with potential for expedited Phase 3 trials based on positive results.
Read more →IVVD▼ -9.6%on this newsshared move
INVIVYD SHAREHOLDER ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: KAHN SWICK & FOTI, LLC REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Invivyd, Inc. – IVVD, ADGI
Kahn Swick & Foti, LLC has issued a reminder to investors of Invivyd, Inc. (formerly known as Adagio Therapeutics) that they have until April 3, 2023, to file lead plaintiff applications in a class action lawsuit. This lawsuit stems from allegations that Invivyd failed to disclose critical information about its lead product candidate, ADG20, which was found to be significantly less effective against the Omicron variant of COVID-19. Following these revelations, the company's stock plummeted nearly 80% in a single day. Investors who purchased shares during the class period are encouraged to consider their legal rights and options.
Read more →IVVD▼ -9.6%on this newsshared move
Invivyd Publishes Model for Evaluating Biomarker Correlates of Protection for Monoclonal Antibodies Against Symptomatic COVID-19
Invivyd, Inc. announced the publication of research that presents a model for evaluating biomarker correlates of protection for monoclonal antibodies against COVID-19. The study indicates that low levels of neutralizing antibodies can confer significant protection against symptomatic COVID-19, potentially leading to revised regulatory frameworks for antibody therapies. The findings build on existing vaccine studies and highlight the importance of neutralizing antibody titers. Invivyd plans to advance its investigational mAb, VYD222, into clinical trials soon, aiming for a swift regulatory response.
Read more →IVVDINVIVYD, INC. (NASDAQ: IVVD) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Invivyd, Inc. f/k/a Adagio Therapeutics, Inc. (NASDAQ: IVVD)
Invivyd, Inc., previously known as Adagio Therapeutics, is facing a class action lawsuit after its key product candidate, ADG20, was found to be significantly less effective against the Omicron variant of COVID-19 than initially claimed. The lawsuit alleges that the company made false and misleading statements regarding the therapy's efficacy, which led to a substantial drop in stock price. Affected investors are reminded of the April 3, 2023 deadline to file motions to serve as lead plaintiff in the case. The situation underscores significant concerns about the credibility of the company's previous announcements regarding ADG20.
Read more →IVVDInvivyd to Host Conference Call Discussing Full Year 2022 Financial Results and Business Highlights
Invivyd, Inc. announced a conference call scheduled for March 23, 2023, to discuss its financial results for the year 2022 and key business developments. The call underscores the company's commitment to transparency with investors and stakeholders. Invivyd's mission centers on developing therapies to combat serious viral infections, leveraging advanced technology in antibody engineering. The event will provide insights into their progress and pipeline aimed at addressing high-need indications, including COVID-19 and influenza.
Read more →IVVDINVIVYD OPTIMIZES DEVELOPMENT EFFICIENCY WITH ELECTION OF VYD222 FOR NEAR-TERM CLINICAL ADVANCEMENT TO ADDRESS URGENT UNMET NEED FOR COVID-19 MONOCLONAL ANTIBODIES Company seeks to utilize emerging global COVID-19 regula
Invivyd, Inc. has elected VYD222 for near-term clinical advancement as a novel monoclonal antibody for COVID-19, focusing on immunocompromised individuals. The company aims to utilize evolving global regulatory frameworks to accelerate the development process. VYD222 has demonstrated neutralizing activity against significant variants and is expected to enter clinical trials in Q1 2023. This development addresses a pressing need, as there are currently no authorized monoclonal antibodies in the U.S. for COVID-19 prevention or treatment.
Read more →IVVDInvivyd to Participate at Cowen’s 43rd Annual Healthcare Conference
Invivyd, Inc. will participate in Cowen's 43rd Annual Healthcare Conference on March 6, 2023, where CEO David Hering will present. The event aims to showcase the company’s mission of developing innovative antibodies that improve protection against viral respiratory diseases. A live webcast of the presentation will be available, and it will be archived for 90 days. Invivyd, previously known as Adagio Therapeutics, is leveraging advanced technology in antibody engineering to enhance immunity against viral threats.
Read more →IVVDInvivyd, Inc. (IVVD) Class Action Notice: Contact Robbins LLP for Information About Filing a Lead Plaintiff Motion in Class Action Against Invivyd, Inc.
Robbins LLP has announced a class action lawsuit against Invivyd, Inc. (NASDAQ: IVVD) on behalf of shareholders who purchased stock between November 29, 2021, and December 14, 2021. The lawsuit alleges that Invivyd misrepresented the effectiveness of its monoclonal antibody therapy ADG20 against the COVID-19 Omicron variant, leading to significant losses when the truth was revealed. Investors are invited to participate in the lawsuit, with a deadline to file as lead plaintiff set for April 3, 2023. The company’s stock saw a sharp decline following the disclosure of ineffective results against Omicron, impacting investor confidence.
Read more →IVVDInvivyd, Inc. (IVVD) Class Action Alert: Robbins LLP Urges Shareholders to Contact the Firm Regarding Representation in the Class Action Against Invivyd, Inc.
Robbins LLP has announced a class action against Invivyd, Inc. on behalf of shareholders who purchased stock during a specific period in late 2021. The lawsuit claims that Invivyd misrepresented the efficacy of its monoclonal antibody therapy, ADG20, particularly against the COVID-19 Omicron variant. Following revelations of its ineffectiveness, the company's stock price plummeted, leading to significant losses for investors. Shareholders may participate in the class action by filing their papers by April 3, 2023.
Read more →IVVDInvivyd, Inc. (IVVD) f/k/a Adagio Therapeutics, Inc. Shareholder Notice: Robbins LLP Informs Investors of Class Action Against Invivyd, Inc. f/k/a Adagio Therapeutics, Inc.
Robbins LLP has announced a class action on behalf of shareholders of Invivyd, Inc. (f/k/a Adagio Therapeutics, Inc.) for alleged violations of the Securities Exchange Act of 1934. The lawsuit arises from claims that Invivyd misled investors regarding the effectiveness of its COVID-19 treatment, ADG20, particularly against the Omicron variant. Following the disclosure of ADG20's poor performance against Omicron, Invivyd's stock experienced a drastic decline, losing nearly 80% of its value. Shareholders wishing to act as lead plaintiffs must file by April 3, 2023.
Read more →IVVD▼ -7.9%on this newsshared move
Invivyd Announces Changes to Executive Team
Invivyd, Inc. has announced that its Chief Scientific Officer, Laura Walker, Ph.D., is leaving the company to pursue other opportunities. The company has initiated a search for her successor and appointed Lukas Dillinger, Ph.D., as interim Head of Discovery. Despite Walker's departure, Invivyd remains focused on advancing its pipeline of antibody candidates aimed at addressing serious infectious diseases like COVID-19.
Read more →IVVDINVIVYD, INC. (NASDAQ: IVVD) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Invivyd, Inc. f/k/a Adagio Therapeutics, Inc. (NASDAQ: IVVD)
A securities class action lawsuit has been filed against Invivyd, Inc. (formerly Adagio Therapeutics) for alleged violations of the Securities Exchange Act. Investors claim that the company misrepresented the efficacy of its monoclonal antibody drug, ADG20, against the Omicron variant of COVID-19. Specifically, the lawsuit states that ADG20 was shown to be 300 times less effective against Omicron than earlier variants, a fact that was revealed shortly after the company assured investors of its efficacy. This led to a significant decline in Invivyd's stock price, falling nearly 80% following the announcement.
Read more →IVVD▲ +7.8%on this news· ran to +37% by day 3
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of
Invivyd is preparing to advance its clinical programs focusing on COVID-19 and its variants through the development of monoclonal antibodies. A key product candidate, NVD200, which targets distinct epitopes, is set to enter a Phase 1 trial in early 2023. The company is furthermore leveraging its discovery platform to expand into other viral diseases, while navigating regulatory challenges and market competition. However, the unpredictability surrounding clinical trial outcomes and regulatory approvals poses significant risks.
Read more →IVVDInvivyd Presented Joint Industry Rationale on Potential Expedited Development Pathways for Monoclonal Antibodies at FDA-EMA Workshop
WALTHAM, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, was invited to participate in an FDA-EMA workshop on SARS-CoV-2 monoclonal antibodi
Read more →IVVD▼ -8.5%on this news
INVIVYD APPOINTS JEREMY GOWLER AS CHIEF OPERATING AND COMMERCIAL OFFICER, PROMOTES PETE SCHMIDT, M.D., TO CHIEF MEDICAL OFFICER WALTHAM, MASS
INVIVYD APPOINTS JEREMY GOWLER AS CHIEF OPERATING AND COMMERCIAL OFFICER, PROMOTES PETE SCHMIDT, M.D., TO CHIEF MEDICAL OFFICER WALTHAM, MASS; December 06, 2022 Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect humanity from serio
Read more →IVVDINVIVYD ANNOUNCES PARTNERSHIP WITH POPULATION HEALTH PARTNERS TO ACCELERATE CLINICAL DEVELOPMENT IN INFECTIOUS DISEASES INCLUDING COVID-19 -Broad partnership will strengthen Invivyd s development platform and organizatio
INVIVYD ANNOUNCES PARTNERSHIP WITH POPULATION HEALTH PARTNERS TO ACCELERATE CLINICAL DEVELOPMENT IN INFECTIOUS DISEASES INCLUDING COVID-19 -Broad partnership will strengthen Invivyd s development platform and organizational capabilities towards acceleration of NVD200 clinical p
Read more →IVVD▲ +7.6%on this news
Invivyd Reports Third Quarter 2022 Financial Results and Business Highlights Novel monoclonal antibody combination candidate (NVD200) on track to advance into clinical trials in Q1 2023 $419 million in cash, cash equival
Invivyd Reports Third Quarter 2022 Financial Results and Business Highlights Novel monoclonal antibody combination candidate (NVD200) on track to advance into clinical trials in Q1 2023 $419 million in cash, cash equivalents and marketable securities expected to support operati
Read more →IVVD▼ -9.1%on this newsshared move
Invivyd to Participate in Fireside Chat at the Jefferies London Healthcare Conference
WALTHAM, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced David Hering, chief executive officer of Invivyd, is scheduled to pa
Read more →IVVD▼ -9.9%on this news
Invivyd to Host Conference Call on November 10 to Discuss Third Quarter 2022 Financial Results and Recent Business Highlights
WALTHAM, Mass., Nov. 02, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced that it will host a conference call on Thursday, November 10, 2022,
Read more →IVVDINVIVYD ANNOUNCES THE APPOINTMENT OF CHRISTINE LINDENBOOM TO BOARD OF DIRECTORS WALTHAM, MASS
INVIVYD ANNOUNCES THE APPOINTMENT OF CHRISTINE LINDENBOOM TO BOARD OF DIRECTORS WALTHAM, MASS; October 24, 2022 Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, today announced the
Read more →IVVD▲ +5.4%on this news
Invivyd Appoints Fred Driscoll as Interim Chief Financial Officer and Announces Resource Reallocation to Maximize Integrated Discovery Platform WALTHAM, MASS
Invivyd Appoints Fred Driscoll as Interim Chief Financial Officer and Announces Resource Reallocation to Maximize Integrated Discovery October 13, 2022 Invivyd, (Nasdaq: IVVD) a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respira
Read more →IVVDInvivyd to Present Multiple Posters Highlighting Clinical Data from Adintrevimab During ID Week 2022
WALTHAM, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Invivyd, (Nasdaq: IVVD), formerly Adagio Therapeutics (Nasdaq: ADGI), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases announced today that it will have four poste
Read more →IVVDAdagio Therapeutics Announces Corporate Name Change to Invivyd New name reflects Company focus on leveraging its integrated discovery platform to generate anti-viral antibodies that transcend the limits of naturally occu
Adagio Therapeutics Announces Corporate Name Change to Invivyd WALTHAM, MASS; September 12, 2022 Adagio Therapeutics, (Nasdaq: ADGI), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases, announced today that the Co
Read more →IVVDInvivyd Announces Multiple Next Generation COVID-19 Antibody Candidates and Selects Combination for Clinical Advancement Based on Positive in vitro Data Against Omicron Variants
Integrated discovery platform is producing a stream of candidate antibodies demonstrating broad in vitro neutralization against past variants of concern (e.g., D614G, beta, delta) and Omicron sublineages BA.1, BA.2, BA.4, BA.5 and BA.2.75, as well as SARS-CoV-1 Antibodies target
Read more →IVVDAdagio Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights $475 Million in Cash and Cash Equivalents to Support Operating Runway into Second Quarter of 2024 Integrated Discovery Platform Id
Adagio Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights $475 Million in Cash and Cash Equivalents to Support Operating Runway into Second Quarter of 2024 Integrated Discovery Platform Identifies Multiple New Candidates for COVID-19 Prevention a
Read more →IVVDAdagio Announces Results of Annual Meeting of Stockholders and Evolution of the Board of Directors Marc Elia Named Chair of the Board of Directors Waltham, MA
Adagio Announces Results of Annual Meeting of Stockholders and Evolution of the Board of Directors Marc Elia Named Chair of the Board of Directors Waltham, MA July 01, 2022 Adagio Therapeutics, Inc. (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the disco
Read more →IVVDAdagio Therapeutics Reports First Quarter 2022 Financial Results $532.2 Million in Total Cash at Quarter End; Strong Balance Sheet Expected to Support Operations into Second Half of 2024 Additional Data from Adintrevimab
Adagio Therapeutics Reports First Quarter 2022 Financial Results $532.2 Million in Total Cash at Quarter End; Strong Balance Sheet Expected to Support Operations into Second Half of 2024 Additional Data from Adintrevimab Phase 2/3 STAMP Treatment Trial to be Presented at ASM An
Read more →IVVDAdagio Therapeutics Announces ADG20 (adintrevimab) is the First Monoclonal Antibody to Meet Primary Endpoints with Statistical Significance Across Pre- and Post-exposure Prophylaxis and Treatment for COVID-19 and Plans t
Adagio Therapeutics Announces ADG20 (adintrevimab) is the First Monoclonal Antibody to Meet Primary Endpoints with Statistical Significance Across Pre- and Post-exposure Prophylaxis and Treatment for COVID-19 and Plans to Seek U.S. Emergency Use Authorization Risk of symptomat
Read more →IVVDAMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement ( Agreement ) is made between Adagio Therapeutics, Inc., a Delaware corporation (the Company ), and Jane Henderson (the Executive )
AMENDED AND RESTATED EMPLOYMENT AGREEMENT Amended and Restated Employment Agreement ( Agreement ) is made between Adagio Therapeutics, Inc., a Delaware corporation (the Company ), and Jane Henderson (the Executive ), this 5th day of August 2021. This Agreement amends, restates
Read more →IVVDCONFIDENTIAL: NOT FOR RELEASE Adagio Therapeutics Announces David Hering Appointed Interim Chief Executive Officer Waltham, MA
Adagio Therapeutics Announces David Hering Appointed Interim Chief Executive Officer Waltham, MA February 23, 2022 Adagio Therapeutics, Inc., (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based
Read more →IVVDAdagio Therapeutics Announces CEO Succession Plan Waltham, MA
Adagio Therapeutics Announces CEO Succession Plan Waltham, MA February 18, 2022 Adagio Therapeutics, Inc., (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases
Read more →IVVDAdagio Therapeutics Summarizes ADG20 Neutralizing Activity Against SARS-CoV-2 Variants and Outlines Initiatives to Address Omicron Recent Publications by Several Independent Laboratories Show ADG20 Has Neutralizing Activ
Adagio Therapeutics Summarizes ADG20 Neutralizing Activity Against SARS-CoV-2 Variants and Outlines Initiatives to Address Omicron Recent Publications by Several Independent Laboratories Show ADG20 Has Neutralizing Activity with Potency Comparable to Other Antibodies that Retai
Read more →IVVDAdagio Therapeutics Reports Reduction in In Vitro Neutralizing Activity of ADG20 Against Omicron SARS-CoV-2 Variant Previously Reported In Vitro Data Demonstrating that Individual Omicron Mutations Were Not Associated wi
Adagio Therapeutics Reports Reduction in In Vitro Neutralizing Activity of ADG20 Against Omicron SARS-CoV-2 Variant Reported In Vitro Data Demonstrating that Individual Omicron Mutations Were Not Associated with ADG20 Escape Do Not Translate to Omicron Authentic and Pseudovirus
Read more →IVVDAdagio Therapeutics Reports That None of the Mutations Present in SARS-CoV-2 Variant, Omicron, Are Associated with Escape from ADG20 Neutralization In Vitro Additional in vitro studies to determine neutralization activit
Adagio Therapeutics Reports That None of the Mutations Present in SARS-CoV-2 Variant, Omicron, Are Associated with Escape from ADG20 Neutralization In Vitro Additional in vitro studies to determine neutralization activity of ADG20 against Omicron are ongoing ADG20 EUA submissi
Read more →IVVDAdagio Therapeutics Announces Expansion of Management Team and Board of Directors to Support Rapid Advancement and Commercial Readiness of ADG20 for COVID-19 Waltham, MA
Adagio Therapeutics Announces Expansion of Management Team and Board of Directors to Support Rapid Advancement and Commercial Readiness of ADG20 for COVID-19 Waltham, MA Nov. 22, 2021 Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused o
Read more →IVVDAdagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention
Adagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention of COVID-19; Interim Clinical Data Package from EVADE Pr
Read more →IVVDAdagio Therapeutics Announces New In Vitro Data Highlighting Broad and Potent Neutralization of ADG20 Against All Known SARS-CoV-2 Variants Data to be presented at the 2021 ISIRV-WHO Virtual Conference Waltham, MA
Adagio Therapeutics Announces New In Vitro Data Highlighting Broad and Potent Neutralization of ADG20 Against All Known SARS-CoV-2 Variants Data to be presented at the 2021 ISIRV-WHO Virtual Conference Waltham, MA Oct. 19, 2021 Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clini
Read more →IVVDAdagio Therapeutics Announces New Data Highlighting the Potential of ADG20 for Treatment and Prevention of COVID-19 ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neut
Adagio Therapeutics Announces New Data Highlighting the Potential of ADG20 for Treatment and Prevention ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Stud
Read more →IVVDAdagio Therapeutics Provides COVID-19 Antibody Program Updates as well as Business Highlights and Second Quarter 2021 Financial Results New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVI
Adagio Therapeutics Provides COVID-19 Antibody Program Updates as Highlights and Second Quarter 2021 Financial Results New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVID-19 to be Presented at IDWeek 2021 Patient Population in Global EVADE Ph
Read more →IVVDAdagio Therapeutics Announces Expansion of Patient Population in Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19 Independent Data Monitoring Committee Supports Expansion to Adolescents and Pregnan
Adagio Therapeutics Announces Expansion of Patient Population in Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19 Independent Data Monitoring Committee Supports Expansion to Adolescents and Pregnant and Nursing Women Based on Safety and Tolerability Data
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