MRNA Jun 3, 2026MRNAConferences/Events
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.
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MRNA Jun 2, 2026MRNAPhases
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.
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MRNA May 28, 2026MRNAGeneral
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.
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MRNA May 27, 2026MRNAConferences/Events
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.
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MRNA May 22, 2026MRNAFDA Updates
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.
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MRNA May 13, 2026MRNAGeneral
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.
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MRNA Apr 28, 2026MRNAConferences/Events
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.
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MRNA Apr 7, 2026MRNAConferences/Events
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.
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MRNA Apr 2, 2026MRNAFDA Updates
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.
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MRNA Mar 4, 2026MRNAGeneral
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.
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MRNA Feb 27, 2026MRNAFDA Updates
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.
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MRNA Feb 19, 2026MRNAConferences/Events
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.
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MRNA Feb 18, 2026MRNAFDA Updates
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.
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MRNA Feb 17, 2026MRNAFDA Updates
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.
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MRNA Feb 16, 2026MRNAFDA Updates
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.
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MRNA Feb 13, 2026MRNAGeneral
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.
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MRNA Feb 12, 2026MRNAFDA Updates
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.
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MRNA Feb 12, 2026MRNAFDA Updates
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.
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MRNA Feb 11, 2026MRNAFDA Updates
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.
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MRNA Feb 11, 2026MRNAFDA Updates
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.
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MRNA Feb 11, 2026MRNAGeneral
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.
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MRNA Feb 11, 2026MRNAFDA Updates
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.
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MRNA Feb 10, 2026MRNAGeneral
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.
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MRNA Feb 3, 2026MRNAGeneral
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.
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MRNA Jan 30, 2026MRNAGeneral
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.
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MRNA Jan 30, 2026MRNAGeneral
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.
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MRNA Jan 28, 2026MRNAGeneral
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.
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MRNA Jan 27, 2026MRNAConferences/Events
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.
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MRNA Jan 23, 2026MRNAGeneral
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.
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MRNA Jan 20, 2026MRNAPhases
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.
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MRNA Jan 20, 2026MRNAPhases
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.
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MRNA Jan 5, 2026MRNAFDA Updates
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.
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