mRNA-1083

FDA Expands Warning for mRNA COVID-19 Vaccines Due to Heart Side Effect Risk in Young Males

2 days ago

• The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses. • New warnings cite data from the FDA's safety surveillance system and a 2023 study showing that while clinical courses were generally mild, myocardial injury was common among affected individuals. • Health officials maintain that these heart conditions remain rare complications, with CDC data indicating they typically resolve quickly, though studies are ongoing to determine potential long-term effects.

Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year

2 days ago

• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA. • The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010. • Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

FDA Delays Moderna's Combination Flu-COVID Vaccine Amid Increased Regulatory Scrutiny

a month ago

• Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers. • The regulatory setback comes amid growing concerns about anti-vaccine sentiment within government, with some states introducing legislation to restrict or ban mRNA-based vaccines despite their established safety profile. • If eventually approved, Moderna's mRNA-1083 would be the first vaccine in the US to offer protection against both flu and COVID-19 in a single shot, potentially improving vaccination rates through increased convenience.

FDA Approves Zevtera for S. aureus Bacteremia, Marking First New Treatment in 15 Years

3 months ago

• Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia. • The approval addresses a significant medical need, with approximately 120,000 S. aureus bloodstream infections occurring annually in the US according to CDC data. • The drug's approval includes coverage for antimicrobial-resistant infections, particularly MRSA, targeting a market projected to reach $5.5 billion by 2030.

Moderna Reports $3.2 Billion in 2024 Revenue, Submits Three mRNA Products for Regulatory Approval

4 months ago

• Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market. • The company has submitted three investigational mRNA products for regulatory approval, including a next-generation COVID vaccine, RSV vaccine for high-risk adults 18-59, and a flu/COVID combination vaccine. • For 2025, Moderna projects revenue between $1.5-2.5 billion and plans to reduce costs by nearly $1 billion, with an expected year-end cash balance of approximately $6 billion.

Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines

6 months ago

• Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety. • The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older. • Novavax is collaborating with the FDA to explore potential accelerated approval pathways for both vaccine candidates, aiming for clarity by Q2 2025. • The Phase 3 trial includes approximately 2,000 participants and builds upon positive Phase 2 data, with initial results expected by mid-2025.

Moderna Restructures Pipeline, Prioritizes Key Approvals, and Cuts R&D Spending

8 months ago

• Moderna is reducing its research and development expenses by 20%, aiming for $16 billion between 2025 and 2028, to focus on profitability. • The company is prioritizing ten product approvals by 2027, including vaccines for COVID-19, flu, and RSV, while streamlining its pipeline. • Positive Phase 3 results were announced for Moderna's RSV vaccine in high-risk adults under 60, with plans to seek expanded FDA approval. • Moderna is delaying its break-even goal to 2028 and anticipates 2025 sales between $2.5 billion and $3.5 billion amid shifting market dynamics.

Pfizer-BioNTech COVID-Flu Combo Vaccine Faces Setback Due to Influenza B Response

9 months ago

• Phase 3 trial of Pfizer-BioNTech's combined COVID-19 and influenza mRNA vaccine reveals suboptimal antibody response for influenza B component, necessitating formula adjustments. • The 8,000-subject study aimed to demonstrate non-inferiority to existing Comirnaty COVID-19 vaccine and standard flu vaccines, following promising phase 1/2 results. • Setback potentially opens opportunity for Moderna, whose competing COVID-flu combination vaccine showed superior immune responses in Phase 3 trials, targeting potential approval by 2025-2026.

Moderna's Combination Flu-COVID Vaccine Shows Superior Immune Response in Phase 3 Trial

a year ago

• Moderna's mRNA-1083 combination vaccine demonstrated significantly higher immune responses against influenza strains and SARS-CoV-2 compared to standard vaccines in adults 50 years and older. • The Phase 3 trial met all primary endpoints with particularly strong results in adults 65+ where the combination vaccine outperformed Fluzone HD for influenza and Spikevax for COVID-19 protection. • The vaccine showed an acceptable safety profile with mostly mild to moderate side effects, positioning Moderna as the first company with positive Phase 3 data for a combination respiratory vaccine.

Drug Development Updates