MRNA to Get CEPI Funding for Phase III Study on Pandemic Influenza Jab

Moderna MRNA announced that the Coalition for Epidemic Preparedness Innovations (“CEPI”) will invest up to $54.3 million in funding to support a pivotal phase III study evaluating its investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, and help advance the same to licensure.

The late-stage study would mark the first mRNA-based pandemic influenza vaccine to advance into a pivotal study. The study will start in early 2026. This CEPI funding is a key step toward strengthening pandemic preparedness and enabling faster, more equitable vaccine access worldwide.

The phase III study will evaluate the safety and immunogenicity of mRNA-1018 in the United States and the United Kingdom, building on positive phase I/II data in healthy adults. Potential licensure may also rely on data from a phase III study on Moderna’s investigational seasonal influenza vaccine, mRNA-1010.

If successfully developed and approved, in the event of an influenza pandemic, Moderna will set aside 20% of its H5 pandemic vaccine production to supply low and middle-income countries at affordable prices.

MRNA’s Price Performance

In the past six months, shares of Moderna have increased 19.5% compared with the industry’s rise of 22.4%.

MRNA’s Recent Development Activities

The project supports a broader CEPI-Moderna collaboration aimed at rapidly developing vaccines for epidemic and pandemic threats through the latter’s mRNA platform.

Unlike traditional vaccines, which can take months to produce, mRNA-based vaccines can be developed quickly and offer manufacturing scalability.

If licensed, the mRNA-1018 would enhance the global H5 vaccine portfolio, providing a rapid-response platform and support CEPI’s goal of developing effective vaccines within 100 days of identifying a new pandemic threat.

Moderna is developing more than 40 mRNA-based investigational candidates across different stages of clinical studies, targeting various indications, including cancer.

Besides mRNA-1018, Moderna is developing mRNA-3927 [for propionic acidemia (PA)], mRNA-3705 [for methylmalonic acidemia (MMA)] and mRNA-1365 (for RSV-hMPV combination). The company also started early-stage clinical studies on vaccines for Epstein-Barr virus, HIV, Lyme disease and Nipah virus.

Given that the COVID-19 pandemic has ended, sales of Moderna's COVID-19 vaccines have also fallen drastically in recent times. As a result, the successful development of other vaccine candidates remains in key focus for the company.

MRNA's Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. EPS estimates for 2026 have moved up from $7.81 to $8.08 during the same period. ANIP stock has rallied 26.5% in the past six months.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.

In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has lost 12.4% in the past six months.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 64 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.82 to $1.06. In the past six months, shares of CSTL have surged 113.7%.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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