MRNA (Moderna, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jun 3, 2026

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ASCO wins from RevMed, Akeso/Summit, more; plus more Lilly and more China; ADA on deck

At the recent ASCO annual meeting, RevMed and Summit Therapeutics garnered attention with promising developments in oncology. Moderna reported positive results for its melanoma vaccine and secured $50 million for its Ebola vaccine amid ongoing outbreaks. Additionally, Eli Lilly continues to expand its partnerships, signaling a robust pipeline in obesity and other indications.

Jun 2, 2026

ASCO: Moderna’s mRNA-based melanoma vaccine shows ‘encouraging’ 5-year survival

Moderna's mRNA-based melanoma vaccine, intismeran autogene, combined with Merck's Keytruda, showed promising 5-year survival data at the ASCO meeting. The Phase 2b KEYNOTE-942 trial demonstrated a 49% reduction in recurrence or death risk and a 59% reduction in distant metastasis. Despite some skepticism surrounding mRNA technology, the results are seen as encouraging for future studies.

May 28, 2026

11 companies hiring in New Jersey now

New Jersey's life sciences sector is thriving, with over 3,000 companies and 3,100 active clinical trials. Job postings have surged by 73% year over year, indicating strong demand for talent. Several prominent companies, including AbbVie, Moderna, and Regeneron, are currently hiring for various positions across the state.

May 27, 2026

Lilly wheels and deals, Moderna gets boost on hantavirus scare, ASCO excitement builds

Eli Lilly has made significant strides in vaccine development through multiple acquisitions, including Curevo and LimmaTech Biologics. The company also reported impressive results for its weight-loss drug retatrutide. Meanwhile, Moderna's share price has risen due to concerns over hantavirus, and its mRNA flu shot is set for FDA review. The upcoming ASCO conference will showcase critical cancer treatment data.

May 22, 2026

Moderna’s once-rebuffed mRNA flu shot to face scrutiny from FDA adcomm

The FDA's advisory committee will review Moderna's mRNA flu vaccine application next month, following an earlier refusal to file. The meeting will assess the vaccine's safety and efficacy for older adults. Despite initial rejection due to concerns over trial standards, a compromise has been reached for review. A decision is anticipated in August.

Moderna Recognized by TIME as One of the World’s Most Impactful Companies

Moderna, Inc. has been recognized as the top company on TIME's 2026 list of the World's Most Impactful Companies, highlighting its advancements in mRNA technology and commitment to addressing significant health needs. CEO Stéphane Bancel emphasized the company's focus on innovative medicines and pandemic preparedness. Additionally, Moderna's recent approval for its flu and COVID combination vaccine marks a significant milestone in its product offerings.

May 1, 2026

Moderna Reports First Quarter 2026 Financial Results and Provides Business Updates Reports first quarter revenue of $0.4 billion, with approximately 80% of revenue from international markets Reports first quarter GAAP ne

Moderna, Inc. reported its financial results for the first quarter of 2026, revealing a revenue of $0.4 billion, driven significantly by international markets. Despite the strong revenue growth, the company faced a net loss of $(1.3) billion, largely due to a litigation settlement expense of $0.9 billion. Key progress included the approval of its combination flu and COVID vaccine in Europe, alongside the initiation of a Phase 3 trial for intismeran in treating high-risk Stage 1 non-small cell lung cancer. Management remains optimistic about future revenue growth and additional regulatory approvals.

Apr 28, 2026

AACR 2026: Combo therapies by Moderna, Marengo show promise in skin, breast cancer

At the AACR annual meeting, companies like Moderna and Marengo presented promising data on combination therapies for cancer. Moderna's mRNA-4359 in combination with Keytruda showed an 83% overall response rate in melanoma patients. Marengo's invikafusp alfa combined with Trodelvy demonstrated significant responses in metastatic breast cancer. However, some therapies, like Agenus's, faced challenges with response rates.

Apr 7, 2026

Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026

Moderna, Inc. will present late-breaking data on its investigational seasonal influenza vaccine, mRNA-1010, and its RSV vaccine, mRESVIA, at the ESCMID 2026 Global Congress. The studies indicate that mRNA-1010 is safe and effective for older adults, while mRESVIA shows promise for revaccination. Both vaccines are under regulatory review in several countries.

Apr 2, 2026

Pfizer, BioNTech Halt Large US COVID-19 Vaccine Trial Over Slow Enrollment

Pfizer and BioNTech have ceased enrollment in a significant U.S. trial for their updated COVID-19 vaccine due to slow participant recruitment. The study aimed to enroll 25,000 to 30,000 healthy adults aged 50 to 64 but faced challenges as many potential participants did not meet health criteria. This decision follows new FDA requirements for data from placebo-controlled trials for vaccines in this age group.

Moderna Notches Much-Needed Win in COVID-19 Patent Spat With Roivant

Moderna has settled its patent dispute with Roivant and Arbutus Therapeutics for up to $2.25 billion, alleviating investor concerns. The settlement includes an immediate payment of $950 million and a potential additional $1.3 billion if an appeal is unsuccessful. Following the announcement, Moderna's shares rose by 6.5%. Despite this positive development, the company faces ongoing legal challenges and regulatory scrutiny.

Feb 27, 2026

European Medicines Agency’s Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna’s mRNA Combination Vaccine Against Influenza and COVID-19

Moderna's mCOMBRIAX, a combination vaccine for influenza and COVID-19, has received a positive opinion from the EMA's CHMP, marking a significant advancement in respiratory virus vaccination. This recommendation is based on successful Phase 3 trial results, indicating strong immune responses. The final marketing authorization will be decided by the European Commission.

Feb 19, 2026

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Moderna to Present at Upcoming Conferences in March 2026

Moderna, Inc. has announced its participation in two upcoming investor conferences in March 2026. The TD Cowen 46th Annual Healthcare Conference will take place on March 3, while the Barclays 28th Annual Global Healthcare Conference is scheduled for March 10. Both presentations will be available via live webcast and archived for 30 days on Moderna's website.

Feb 18, 2026

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Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Moderna's investigational seasonal influenza vaccine, mRNA-1010, has been accepted for review by the FDA following a Type A meeting. The company aims for full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The PDUFA goal date is set for August 5, 2026, with potential availability for the upcoming flu season.

Feb 17, 2026

Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKE

Moderna has received marketing authorization from the European Commission for its COVID-19 vaccine mNEXSPIKE, aimed at individuals aged 12 and older. This marks the third vaccine authorized for Moderna in the EU, following Spikevax and mRESVIA. The authorization is based on positive Phase 3 trial results, showing mNEXSPIKE's efficacy and a favorable safety profile.

Feb 16, 2026

Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait

Moderna's mRNA influenza vaccines may be available in other countries before the U.S. due to the FDA's refusal to review mRNA-1010. The company believes its technology could improve vaccine efficacy amid a challenging flu season marked by strain mismatches. While awaiting regulatory decisions abroad, Americans face delays in accessing these innovations.

Feb 13, 2026

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Moderna Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides Business Updates

Moderna reported its fourth quarter and full-year 2025 financial results, revealing a net loss of $2.8 billion and a 40% revenue decrease year-over-year. Despite these challenges, the company plans to achieve up to 10% revenue growth in 2026, supported by new product launches and strategic partnerships. Key updates include the full enrollment of clinical trials for Norovirus and muscle invasive bladder cancer, alongside ongoing regulatory reviews for its influenza vaccine.

Feb 12, 2026

HHS Backs Prasad Amid Moderna Flu Shot Blowback

The HHS has backed Vinay Prasad after the FDA rejected Moderna's mRNA flu vaccine application. The rejection was due to Moderna's failure to follow FDA guidance regarding clinical trials and the use of appropriate control groups. Concerns were raised about the safety of older participants, and the FDA indicated that a resubmission could be more successful if focused on a narrower age group.

Feb 12, 2026

Flu Vaccine Rejection Imperils Moderna’s Breakeven Plans

Moderna's plans to achieve breakeven status by 2028 are threatened by the FDA's unexpected rejection of its flu vaccine mRNA-1010. This decision, made by the head of the Center for Biologics Evaluation and Research, has raised concerns about future revenue from this and the combo flu/COVID vaccine mRNA-1083. Analysts are revising their earnings models in light of this setback, although Moderna is exploring approval pathways outside the U.S.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Moderna announced that the FDA has issued a Refusal-to-File letter for its investigational influenza vaccine mRNA-1010, citing the choice of a licensed standard-dose vaccine comparator as the reason. The company plans to request a Type A meeting with the FDA to clarify the decision, which contradicts prior communications. Despite this setback, mRNA-1010 is under review in other countries, and Moderna does not anticipate any financial impact for 2026.

FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies

The FDA has refused to review Moderna's mRNA flu vaccine, mRNA-1010, citing inadequate trial support. This decision, made by CBER Director Vinay Prasad, has significant implications for Moderna's financial outlook and future vaccine applications. Analysts suggest that the refusal could delay the re-filing of another vaccine candidate, mRNA-1083, and reflects broader regulatory challenges in the U.S. vaccine landscape.

Hiring Outlook: January Brings Year-Over-Year Layoff Decline

The job market in the biopharma sector shows signs of improvement as layoffs have decreased year-over-year. In January 2026, only 463 employees were let go compared to over 1,300 in January 2025. Increased job postings and hiring intentions from major companies suggest a competitive landscape for job seekers, despite notable layoffs from companies like Takeda.

All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us

The FDA has issued a Refusal-to-File letter to Moderna, rejecting its application for the mRNA-1010 flu vaccine. The agency cited insufficient trial data and a lack of a proper comparator in the study. This decision comes amidst a backdrop of increased scrutiny and regulatory challenges faced by biopharma companies, raising concerns about the future of vaccine approvals.

Feb 10, 2026

Moderna to Enter into Long-Term Strategic Agreement with the Government of Mexico

Moderna has signed a Memorandum of Understanding with the Mexican Government and local partners to establish a long-term strategic agreement. This five-year collaboration aims to enhance Mexico's health security by providing access to Moderna's respiratory vaccine portfolio and facilitating technology transfer for local manufacturing of its COVID-19 vaccine. The initiative aligns with Mexico's 'Plan Mexico' to boost local production capacity and pandemic preparedness.

Feb 3, 2026

BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline

BioNTech and Moderna have diverged in their post-pandemic trajectories, with BioNTech expanding its multi-modality pipeline while Moderna faces challenges with its mRNA-focused strategy. BioNTech's market cap has surpassed $20 billion, reflecting its successful diversification and promising late-phase candidates. In contrast, Moderna's sales have plummeted, and it is struggling to regain market share amid regulatory pressures.

Jan 30, 2026

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Moderna Announces Strategic Collaboration with Recordati to Globally Commercialize Investigational Propionic Acidemia Therapeutic (mRNA-3927)

Moderna has announced a strategic collaboration with Recordati to advance its investigational therapeutic mRNA-3927 for propionic acidemia. Under the agreement, Moderna will lead clinical development while Recordati will handle global commercialization. The collaboration includes up to $160 million in payments and milestones, with a pivotal data readout expected in 2026. Propionic acidemia is a rare metabolic disorder with no current disease-modifying treatments.

Jan 30, 2026

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Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M

Moderna has partnered with Recordati to develop mRNA-3927, an mRNA therapy for propionic acidemia, with potential funding of up to $160 million. The therapy showed promising results in a Phase I/II trial, but also reported a high rate of adverse events. Moderna will lead clinical development while Recordati will handle commercialization.

Jan 28, 2026

Roche Makes Obesity Splash, Moderna Cans Vaccine Trials, Sarepta’s New Data, More

Roche announced significant weight loss results for its GLP-1/GIP injectable CT-388 in a Phase II trial, prompting plans for a Phase III study. Meanwhile, Moderna has decided to discontinue late-stage vaccine trials amid challenges posed by anti-vaccine rhetoric. Additionally, Sarepta released new data on its gene therapy Elevidys for Duchenne muscular dystrophy.

Jan 27, 2026

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Moderna to Report Fourth Quarter 2025 Financial Results on Friday, February 13, 2026

Moderna, Inc. will host a live conference call on February 13, 2026, to discuss its fourth quarter 2025 financial results and provide a corporate update. The call will be accessible via a webcast on the company's website. An archived version of the call will be available for one year post-event.

Jan 23, 2026

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Moderna Won’t Run Phase III Vaccine Trials as Skepticism Grows in US: Bloomberg

Moderna is reducing its investment in vaccine development due to increasing skepticism in the U.S. market, as stated by CEO Stéphane Bancel. The company will no longer fund late-stage vaccine studies, focusing instead on oncology and rare diseases. This shift comes amid regulatory challenges and diminishing support for vaccines, particularly after recent policy changes under HHS leadership.

Jan 20, 2026

Moderna & Merck Announce 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection

Moderna and Merck have reported five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, showing that the combination of intismeran autogene and KEYTRUDA significantly reduces the risk of recurrence or death in patients with high-risk stage III/IV melanoma. The treatment demonstrated a 49% reduction in risk compared to KEYTRUDA alone. Further data will be presented at an upcoming medical conference, highlighting the potential of mRNA therapies in cancer care.

Jan 20, 2026

Moderna, Merck Show Long-Term Survival For mRNA-Keytruda Combo

Moderna's mRNA neoantigen therapy combined with Merck's Keytruda has shown promising long-term results in reducing the risk of recurrence or death in advanced melanoma patients. At the five-year mark of the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, the combination maintained a 49% reduction in risk compared to Keytruda alone. The companies are advancing to Phase III trials for melanoma and lung cancer.

Jan 12, 2026

Moderna Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare Conference Expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above midpoint communicated on 3Q25 Earnings Ca

Moderna announced significant updates during the 44th Annual J.P. Morgan Healthcare Conference, forecasting revenues of approximately $1.9 billion in 2025, which is $100 million above previous estimates. The company has also improved its expected operating expenses by $200 million. Looking forward to 2026, Moderna anticipates up to 10% revenue growth and potential approvals for various infectious disease products. The pipeline includes pivotal trial data readouts in oncology and rare diseases expected in 2026.

Jan 5, 2026

Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine

Moderna has submitted applications for marketing authorization of its investigational seasonal influenza vaccine, mRNA-1010, targeting adults aged 50 and older in the U.S., EU, Canada, and Australia. The submissions are based on positive Phase 3 study results showing significant vaccine efficacy and a favorable safety profile. This development marks a significant milestone for Moderna's respiratory portfolio.

Jan 5, 2026

Document

Moderna reported a productive year in 2025, effectively navigating a challenging market while securing multiple regulatory approvals and advancing financial discipline. The company launched mNEXSPIKE, achieving strong early adoption in the U.S., alongside expanding their international partnerships in Brazil and Taiwan. Financially, Moderna has enhanced its balance sheet and streamlined operations to reduce costs significantly. Looking ahead, the company is well-positioned for growth with a promising pipeline across various diseases, including vaccines and oncology treatments.

Moderna Analyst Day Highlights Pipeline Progress and Business Strategy Updates Announces three-year business strategy and commercial growth drivers, targeting up to 10% revenue growth in 2026 Expects to expand seasonal v

Moderna, Inc. (NASDAQ: MRNA) has announced updates during its Analyst Day, highlighting a three-year business strategy that aims for up to 10% revenue growth by 2026. The company plans to expand its seasonal vaccine offerings and invest in oncology and rare disease therapeutics. Their operational improvements are expected to enhance gross margins significantly over the following three years. However, some clinical programs have been discontinued, and the Phase 3 study for a Norovirus vaccine has faced challenges in patient accrual.

Nov 6, 2025

Moderna Reports Third Quarter 2025 Financial Results and Provides Business Updates Reports third quarter revenue of $1.0 billion , GAAP net loss of $(0.2) billion and GAAP EPS of $(0.51) Narrows 2025 projected revenue ra

Moderna reported its financial results for the third quarter of 2025, showing a total revenue of $1.0 billion, a 45% decrease from the prior year. The company experienced a GAAP net loss of $200 million and is adjusting its projected revenue for 2025 downwards to a range of $1.6 to $2.0 billion. Positive developments include increased expectations for year-end cash balance and improved operating expenses, while challenges remain in vaccine sales and overall profitability. Moderna is focusing on operational efficiency and cost reductions to navigate these obstacles.

Moderna Reports Second Quarter 2025 Financial Results and Provides Business Updates Reports second quarter revenues of $0.1 billion , GAAP net loss of $(0.8) billion and GAAP EPS of $(2.13) Updates 2025 projected revenue

Moderna announced its second quarter 2025 financial results marked by a revenue decline and a net loss of $(0.8) billion. The company updated its projected revenue for 2025 to a range of $1.5 to $2.2 billion, reflecting reduced expectations primarily due to delivery timing shifts. Despite the financial setbacks, Moderna secured three recent FDA approvals and achieved positive Phase 3 efficacy data for its seasonal influenza vaccine, which are expected to support future growth.

Moderna Reports First Quarter 2025 Financial Results and Provides Business Updates Reports first quarter revenues of $0.1 billion , GAAP net loss of $(1.0) billion and GAAP EPS of $(2.52) Reiterates 2025 expected revenue

Moderna, Inc. reported its financial results for the first quarter of 2025, revealing revenues of $0.1 billion and a GAAP net loss of $(1.0) billion. The company's anticipated revenue for the entirety of 2025 remains at $1.5 to $2.5 billion while also announcing plans to reduce operating costs by approximately $1.4 to $1.7 billion by 2027. Despite lower vaccination rates impacting sales, Moderna plans to advance up to 10 products toward approval, including multiple oncology candidates. Overall, while there are challenges in sales figures, the company remains focused on cost efficiency and new product development.

Feb 14, 2025

Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates Reports fourth quarter revenues of $1.0 billion , GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91) loss includes

Moderna reported its fourth quarter and fiscal year 2024 financial results, highlighting a significant GAAP net loss of $(1.1) billion for Q4, with revenues of $1.0 billion, a stark decrease from $2.8 billion the previous year. The full-year revenue dropped to $3.2 billion, primarily due to lower COVID-19 vaccine sales, reflecting a shift to a seasonal commercial market. Despite this, the company has made strides in cost reduction and submitted multiple investigational products for regulatory approval, aiming for future growth.

Jan 13, 2025

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Moderna Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference Achieved 2024 product sales of $3.0 to 3.1 billion (unaudited) and an ending cash balance of approximately $9.5 billion (una

Moderna, Inc. provided comprehensive updates on its business and pipeline during the 43rd Annual J.P. Morgan Healthcare Conference. The company reported unaudited product sales for 2024 between $3.0 and $3.1 billion and plans to lower costs by $1.5 billion for 2025 and 2026. Moderna aims for up to three product approvals in 2025, focusing on respiratory viruses and rare diseases. Additionally, while advancements in their vaccine pipeline were noted, some challenges were highlighted, specifically in their CMV vaccine trial outcomes.

Nov 7, 2024

Moderna Reports Third Quarter 2024 Financial Results and Provides Business Updates Reports third quarter revenues of $1.9 billion , GAAP net income of $13 million and GAAP EPS of $0.03 Achieves year-to-date product sales

Moderna reported its financial results for the third quarter of 2024, achieving revenues of $1.9 billion and a GAAP net income of $13 million. The company has initiated two pivotal Phase 3 trials for mRNA vaccines targeting norovirus and influenza, alongside reaffirming its 2024 sales expectations of $3.0 to $3.5 billion. Despite some lower-than-expected RSV vaccine sales, Moderna's overall financial performance shows improvement over the previous year, with a decreased cost structure and strategic focus on product approvals.

Oct 2, 2024

Abbas Hussain Joins Moderna's Board of Directors Hussain brings more than 35 years of commercial leadership and operating experience in healthcare, most recently serving as CEO of Vifor Pharma As former Global President

Moderna, Inc. has appointed Abbas Hussain to its Board of Directors, effective October 2, 2024. Hussain, who has over 35 years of experience in healthcare, previously served as CEO of Vifor Pharma and held key positions at GlaxoSmithKline. His extensive background in global vaccine commercialization is expected to support Moderna's ongoing growth and innovation in mRNA medicines. Executives at Moderna expressed optimism about the value Hussain will bring to the company's future initiatives.

Moderna R D Day Highlights Progress and Strategic Priorities Focuses on ten product approvals through 2027 Expects to submit next-generation COVID vaccine for approval in 2024 Expects to submit flu COVID combination vacc

Moderna, Inc. has announced substantial advancements in its mRNA vaccine pipeline during its annual R&D Day, focusing on ten product approvals by 2027. The company aims to submit next-generation COVID and flu combination vaccines for regulatory approval in 2024. Positive Phase 3 results were reported for several candidates, including an RSV vaccine targeting high-risk adults. Moderna also plans to implement portfolio prioritization strategies to enhance efficiency while aiming to expand into non-respiratory areas such as oncology and rare diseases.

Moderna Reports Second Quarter 2024 Financial Results and Provides Business Updates Reports second quarter revenues of $241 million , GAAP net loss of $1.3 billion and GAAP EPS of $(3.33) Updates 2024 financial framework

Moderna, Inc. reported its second quarter 2024 financial results, revealing revenues of $241 million and a GAAP net loss of $1.3 billion. The company received FDA approval for its RSV vaccine, mRESVIA, and announced positive Phase 3 data for multiple vaccines, including one for COVID-19. However, a significant decline in product sales was noted alongside projected low EU sales in 2024 and possible revenue deferrals. The company has revised its expected net product sales for the year to between $3.0 to $3.5 billion, primarily due to increased competition and changing market conditions.

Jul 23, 2024

David Rubenstein Joins Moderna's Board of Directors Co-Founder and Co-Chairman of The Carlyle Group brings multi-industry investor experience and global policy expertise, replacing retiring director Stephen Berenson Co-f

Moderna, Inc. has announced the appointment of David M. Rubenstein to its Board of Directors, effective August 5, 2024. Rubenstein will replace retiring director Stephen Berenson and join the Audit Committee. Co-founder Robert Langer will also retire, with ongoing efforts to recruit new directors. Rubenstein's expertise in investing and global policy is anticipated to enhance Moderna’s strategic growth as it transitions into a commercial entity.

Moderna Reports First Quarter 2024 Financial Results and Provides Business Updates Reports first quarter revenues of $167 million , GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07) Prepares for launches of R

Moderna reported its first-quarter financial results for 2024, revealing a revenue of $167 million and a net loss of $1.2 billion. The company anticipates regulatory approvals for its RSV vaccine and the launch of an updated Spikevax formula later this year. It has initiated new clinical studies for a neoantigen therapy in collaboration with Merck for various cancers and is advancing multiple vaccine programs to late-stage trials. However, the sharp decline in COVID-19 vaccine sales significantly impacted financial performance.

Moderna Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Business Updates Posts fourth quarter revenues of $2.8 billion, GAAP net income of $217 million and GAAP diluted EPS of $0.55 Reports ful

Moderna reported its financial results for the fourth quarter and fiscal year 2023, indicating fourth quarter revenues of $2.8 billion and a net income of $217 million. Despite a full-year net loss of $(4.7) billion primarily due to non-cash charges, the company is optimistic about the potential for $4 billion in product sales for 2024 and anticipates regulatory approvals for its RSV vaccine in the first half of 2024. Moderna also noted significant advancements in its pipeline across various disease areas, while facing challenges from declining COVID-19 vaccine sales.

Jan 8, 2024

Moderna Provides Business and Pipeline Updates at 42 nd Annual J.P. Morgan Healthcare Conference Company announces product sales for 2023 of approximately $6.7 billion (unaudited) U.S. COVID-19 market share season to dat

Moderna provided comprehensive updates at the 42nd Annual J.P. Morgan Healthcare Conference, highlighting approximately $6.7 billion in product sales for 2023, with a 48% share of the U.S. COVID-19 vaccine market. The company forecasts around $4 billion in sales for 2024, with plans for growth and profitability returning by 2025. Additionally, Moderna detailed its late-stage pipeline, which includes nine programs expected to achieve key milestones in the upcoming years, bolstering its position in the mRNA therapeutics landscape.

Moderna Reports Third Quarter 2023 Financial Results and Provides Business Updates Third quarter 2023 revenues of $1.8 billion Company expects 2023 revenues of at least $6 billion Spikevax U.S. market share to date incre

Moderna reported financial results for the third quarter of 2023, showing revenues of $1.8 billion, with a market share increase for its COVID-19 vaccine, Spikevax, now at 45%. The company anticipates a total revenue of at least $6 billion for the year and forecasts approximately $4 billion in 2024. However, it also recorded a significant net loss of $3.6 billion due largely to non-cash charges from resizing manufacturing capabilities. Despite these challenges, Moderna aims to return to sales growth in 2025 and expects to break even by 2026.

Sep 11, 2023

Moderna and Immatics Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics Collaboration combines leading technologies to develop breakthrough, mRNA-enabled in vivo expressed TCER mo

Moderna and Immatics have announced a strategic collaboration to develop innovative oncology therapeutics, combining Immatics' XPRESIDENT target discovery platform with Moderna's mRNA technology. This partnership will focus on the development of novel cancer vaccines and evaluate the safety and efficacy of Immatics' IMA203 TCR-T therapy in combination with Moderna's mRNA cancer vaccine. Immatics will receive an upfront payment of $120 million and could earn over $1.7 billion through milestones and royalties. The collaboration is subject to customary antitrust clearance in the United States.

Aug 3, 2023

Moderna Reports Second Quarter 2023 Financial Results and Provides Business Updates Second quarter 2023 revenues of $0.3 billion net loss of $1.4 billion and loss per share of $3.62 Company expecting 2023 COVID-19 vaccin

Moderna reported a net loss of $1.4 billion for Q2 2023, with total revenues of $344 million resulting primarily from decreased COVID-19 vaccine sales. Despite challenges, the company anticipates sales between $6 billion and $8 billion for its COVID-19 vaccine, contingent on U.S. vaccination rates. Moderna also provided updates on its pipeline, highlighting that its RSV vaccine and individualized neoantigen therapy are in late-stage trials. The company faces significant production costs and a steep decline in previous sales volumes that may impact future earnings.

May 4, 2023

Moderna Reports First Quarter 2023 Financial Results and Provides Business Updates First quarter 2023 revenues of $1.9 billion GAAP net income of $79 million and GAAP diluted EPS of $0.19 Company in negotiations for new

Moderna, Inc. reported its first quarter 2023 financial results, showing revenues of $1.9 billion and a net income of $79 million. The company is in negotiations for new COVID-19 vaccine orders and has reiterated sales expectations of approximately $5 billion for the year. Moderna is advancing multiple vaccine candidates, including those for RSV and influenza, while also preparing for a commercial launch of its investigational RSV vaccine in 2024. Additionally, strong results from its mRNA-4157 melanoma therapy have prompted the company to initiate Phase 3 trials in melanoma and lung cancer.

Moderna Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Business Updates Fourth quarter 2022 revenues of $5.1 billion GAAP net income of $1.5 billion and GAAP diluted EPS of $3.61 Full-year 202

Moderna reported financial results for Q4 and the full year of 2022, announcing revenues of $19.3 billion and a net income of $8.4 billion. The company is anticipating around $5 billion in COVID-19 vaccine sales for 2023, alongside advancements in its RSV and cancer vaccine candidates, which have received Breakthrough Therapy Designations. However, Moderna experienced a 30% drop in quarterly vaccine sales compared to Q4 2021, attributed to decreased demand. Additionally, costs have risen significantly due to royalties and inventory write-downs related to excess production capacity.

Jan 9, 2023

Moderna Announces Advances Across mRNA Pipeline and Provides Business Update COVID-19 vaccine sales for 2022 approximately $18.4 billion (unaudited) Reiterating 2023 expected minimum COVID-19 vaccine sales of approximate

Moderna has provided significant updates regarding its mRNA pipeline, reporting COVID-19 vaccine sales of approximately $18.4 billion in 2022 and reiterating a target of about $5.0 billion for 2023. The company is focusing on expanding its development programs, with a total of 48 programs, including effective candidates for RSV and personalized cancer vaccines. R&D investments are set to increase to $4.5 billion next year, reflecting confidence in ongoing clinical trials and future product developments. Additionally, partnerships and acquisitions aim to bolster Moderna's technological capabilities and market reach.

Moderna and Merck Announce mRNA-4157 V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination With KEYTRUDA (pembrolizumab) , Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial mRNA-4157 V940, i

Moderna and Merck Announce mRNA-4157 V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination With KEYTRUDA (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial mRNA-4157 V940, in combination with KEYTRUDA, demonstrated a statistically si

Sep 29, 2022

Moderna Creates New Executive Committee Role Ahead of New Product Launches Juan Andres Appointed to President, Strategic Partnerships and Enterprise Expansion Jerh Collins Joins Moderna as Chief Technical Operations and

Moderna Creates New Executive Committee Role Ahead of New Product Launches Juan Andres Appointed to President, Strategic Partnerships and Enterprise Expansion Jerh Collins Joins Moderna as Chief Technical Operations and Quality Officer to Succeed Juan Andres CAMBRIDGE, Mass.--

JAMES MOCK JOINS MODERNA AS CHIEF FINANCIAL OFFICER CAMBRIDGE, MA / ACCESSWIRE /

JAMES MOCK JOINS MODERNA AS CHIEF FINANCIAL OFFICER CAMBRIDGE, MA / ACCESSWIRE / August 17, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that James Mock has been appointed as Moderna s Chi

Moderna Reports Second Quarter 2022 Financial Results and Provides Business Updates Second quarter 2022 revenues of $4.7 billion GAAP net income of $ 2.2 billion and GAAP diluted EPS of $5.24 Company reiterates advance p

Moderna Reports Second Quarter 2022 Financial Results and Provides Business Updates Second quarter 2022 revenues of $4.7 billion GAAP net income of $2.2 billion and GAAP diluted EPS of $5.24 Company reiterates advance purchase agreements for expected delivery in 2022 of approxi

Moderna Reports First Quarter 2022 Financial Results and Provides Business Updates First quarter 2022 revenues of $ 6.1 billion GAAP net-income of $ 3.7 billion and GAAP diluted EPS of $ 8.58 Moderna reiterates its 2022

Moderna Reports First Quarter 2022 Financial Results and Provides Business Updates First quarter 2022 revenues of $6.1 billion GAAP net-income of $3.7 billion and GAAP diluted EPS of $8.58 Moderna reiterates its 2022 signed advance purchase agreements of approximately $21 billi

Apr 11, 2022

Jorge Gomez Joins Moderna as Chief Financial Officer CAMBRIDGE, Mass. (ACCESS WIRE)

Jorge Gomez Joins Moderna as Chief Financial Officer CAMBRIDGE, Mass. (ACCESS WIRE) April 11, 2022 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that Jorge Gomez will join Moderna as Chief Financi

Moderna Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Updates Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of $11.29 Full year 2021 revenues

Moderna Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Updates Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billion and GAAP dil

Moderna Announces Advances Across Its Industry-Leading mRNA Pipeline and Provides Business Update 807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021 approximately 25% of those doses shipped to low-

Moderna Announces Advances Across Its Industry-Leading mRNA Pipeline and Provides Business Update 807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021 approximately 25% of those doses shipped to low- and middle-income countries Product sales for 2021 approxi

Nov 4, 2021

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Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Q3 total revenue of $5.0 billion, net income of $3.3 billion and diluted EPS of $7.70 U.S. FDA granted Priority Review to the

Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Q3 total revenue of $5.0 billion, net income of $3.3 billion and diluted EPS of $7.70 U.S. FDA granted Priority Review to the Biologics License Application for Moderna s COVID-19 Int

Aug 5, 2021

Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% efficacy; Efficacy remains durabl

Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% Efficacy remains durable through six months after second dose Moderna booster candidates d

May 6, 2021

Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates SARS-CoV-2 Variant Booster Program Update : Single booster dose of 50 g of mRNA-1273 or mRNA-1273.351 increased neutralizing

Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates SARS-CoV-2 Variant Booster Program Update: Single booster dose of 50 g of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two Variants of Concern (B.1

Apr 13, 2021