Invivyd Inc. (NASDAQ:IVVD) received a reiterated Buy rating and a $15.00 price target from H.C. Wainwright. The affirmation comes after Invivyd reported promising results from its Phase 3 trial of PEMGARDA (pemivibart, VYD222), a monoclonal antibody for COVID-19 prevention.
The clinical trial, named CANOPY, showed that PEMGARDA reduced the risk of symptomatic COVID-19 by 84% compared to a placebo among a broad population of adults. These findings are particularly significant as they extend beyond the immunocompromised individuals for whom the treatment already has Emergency Use Authorization (EUA) in the United States.
The U.S. Food and Drug Administration (FDA) has updated the Fact Sheet for PEMGARDA to include the new exploratory data. This update is seen as a positive step towards a potential successful commercial launch of the drug for pre-exposure prevention (PrEP) of COVID-19 in 2024.
H.C. Wainwright's outlook is buoyed by Invivyd's strategic awareness campaign aimed at healthcare providers nationwide. The firm believes these efforts, along with the updated FDA documentation, will bolster the introduction of PEMGARDA into the market.
Investors are keeping a keen eye on the upcoming updates regarding PEMGARDA's market launch, as the recent developments could enhance Invivyd's commercial prospects. The maintained price target reflects a steady confidence in the stock's performance.
Invivyd Inc. reported positive results from its CANOPY Phase 3 clinical trial evaluating pemivibart, an investigational monoclonal antibody for COVID-19 prevention. The trial revealed an 84% relative risk reduction of symptomatic COVID-19 in immunocompetent individuals compared to placebo.
Invivyd has also reported consistent growth for its second quarter of 2024 and anticipates further acceleration in the third quarter. The company is preparing for a commercial push in the upcoming respiratory virus season, focusing on increasing awareness and availability of its COVID-19 prevention treatments.
It's also advancing a pipeline molecule, VYD2311, and expanding access to its antibody prophylaxis, PEMGARDA, for immunocompromised individuals.
However, Invivyd faces supply constraints affecting its ability to expand in international markets. Despite these constraints, the company remains optimistic about future results and the upcoming respiratory virus season. These are the recent developments that have positioned Invivyd as a key player in the fight against respiratory viruses.
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