Invivyd's Breakthrough Year: Analyst Reiterates Buy Rating Amid Regulatory Advancements and Market Potential

Invivyd is on the brink of a transformative year with a clear regulatory path for its VYD2311 monoclonal antibody, designed for COVID-19 prevention and treatment. The FDA has agreed to a streamlined trial process, potentially shifting the company's business model to a more stable framework. Invivyd's commercial execution with PEMGARDA has shown promising growth, and VYD2311's favorable safety profile and potential for infrequent dosing contribute to its blockbuster potential. Analyst Patrick Trucchio, a 4-star analyst with a 7.1% average return, has reiterated a Buy rating and $5.00 price target on the stock.

Invivyd (NASDAQ: IVVD) has made significant strides in its quest to bring a novel monoclonal antibody, VYD2311, to market for COVID-19 prevention and treatment. The company has received guidance from the U.S. Food and Drug Administration (FDA) to align with a streamlined, expedited pathway toward potential biologics license application (BLA) approval for VYD2311. This streamlined process, which includes a single Phase 2/3 randomized, double-blind, placebo-controlled trial, could potentially shift Invivyd's business model to a more stable framework [1].

The primary endpoint of the trial is to reduce symptomatic COVID-19, resembling the CANOPY Cohort B. Invivyd's target product profile for VYD2311 is a low-dose, intramuscular, scalable, low-cost, long-lasting, protective option for adults and adolescents (12 years+; 40kg+), and potentially for pediatrics (aged 0 to 12 years), subject to FDA alignment [1]. The company anticipates a compact trial (12-week primary endpoint analysis) that will evaluate the prevention of COVID-19 among ordinary Americans, enabling rapid enrollment.

The FDA's alignment on a rapid pathway for VYD2311 comes on the heels of Invivyd's positive full Phase 1/2 clinical data for the candidate, which demonstrated an attractive safety profile and a 76-day observed half-life for the intramuscular route of administration [2]. The company also plans a head-to-head safety evaluation of VYD2311 with the COVID-19 vaccine, pending regulatory alignment.

Invivyd's commercial execution with PEMGARDA®, a half-life extended investigational monoclonal antibody, has shown promising growth. PEMGARDA® net product revenue was $11.8 million in the second quarter of 2025, representing a 413% year-over-year increase [2]. The company expects to cement its position as the leading provider of monoclonal antibody technology for COVID-19 protection as PEMGARDA® moves into the fall season.

Analyst Patrick Trucchio, a 4-star analyst with a 7.1% average return, has reiterated a Buy rating and a $5.00 price target on Invivyd's stock, reflecting the potential of VYD2311 and the company's broader pipeline [1].

References:
[1] https://seekingalpha.com/news/4485867-invivyd-aligns-with-fda-on-fast-track-approval-path-for-covid-19-antibody-vyd2311
[2] https://investors.adagiotx.com/news-releases/news-release-details/invivyd-reports-second-quarter-2025-financial-results-and-recent