Moderna, Inc. MRNA announced the dosing of the first participant in the phase III Nova 301 study, which is evaluating its investigational mRNA norovirus vaccine candidate, mRNA-1403, in the United States.

The randomized, placebo-controlled phase III study will evaluate the safety, efficacy and immunogenicity of mRNA-1403 to prevent moderate-to-severe acute gastroenteritis caused by norovirus.

Recruitment of participants in the pivotal Nova 301 study across the world has also begun.

Shares of Moderna have plunged 32.8% so far this year compared with the industry’s decline of 1.8%.

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More on MRNA's Norovirus Vaccine Study

The company is looking to enroll around 25,000 participants aged 18 years and above in the phase III Nova 301 study worldwide.

The study will enroll around 20,000 participants aged 60 years and older and 5,000 participants aged between 18 and 59 years.

The study will investigate the ability of mRNA-1403 to protect against moderate-to-severe norovirus acute gastroenteritis with more focus on older adults who stand at higher risk of the infection, including hospitalization.

Norovirus is an extremely contagious virus and one of the leading causes of diarrheal disease, which leads to around 200,000 deaths per year.

Apart from mRNA-1403, Moderna is also developing another norovirus vaccine candidate, mRNA-1405, in a phase II study.

MRNA Inks Deal to Promote Respiratory Vaccine Portfolio in Taiwan

In a separate press release, Moderna announced that it has entered into a joint agreement with Cenra Healthcare, the sales and marketing arm of Taiwan’s Cenra, to jointly promote Moderna's mRNA respiratory vaccine portfolio, including its COVID-19 vaccine, Spikevax in Taiwan.

The financial terms of the deal have been kept under wraps.

Per the latest agreement, Moderna will be responsible for manufacturing and distributing its mRNA respiratory vaccines while Cenra Healthcare will look after the promotion and education activities for the same across Taiwan.

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, Inc. ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, 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’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 8.2%.

ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.

In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 46.8%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.

In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 47.1%.

FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.

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