Invivyd reports pemivibart maintains efficacy against SARS-CoV-2

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ: IVVD), a clinical-stage biotechnology company with a market capitalization of $125.6 million, has announced that its monoclonal antibody PEMGARDA™ (pemivibart) continues to show consistent in vitro neutralization against the SARS-CoV-2 variant LP.8.1, which, along with XEC and KP.3.1.1, is among the most prevalent strains in the United States according to the Centers for Disease Control. According to InvestingPro analysis, the company’s stock has shown remarkable momentum with a 136.97% return year-to-date, despite current market challenges. The company’s next-generation antibody candidate, VYD2311, also demonstrates stable neutralization against LP.8.1.

This new data supports the effectiveness of PEMGARDA, currently authorized for pre-exposure prophylaxis in certain immunocompromised individuals, against the dominant variants without meaningful changes in neutralization activity. This stability is attributed to the unchanged structural integrity of the targeted epitope since the emergence of the Omicron BA.2 lineage. The company maintains impressive gross profit margins of 92.27%, though InvestingPro data shows it is currently operating at a net loss, with significant ongoing R&D investments.

Invivyd’s Chief Scientific Officer, Robert Allen, Ph.D., remarked on the significance of the findings, stating that the consistent neutralization activity of pemivibart underscores the company’s hypothesis that virus variants likely to spread among humans will also be susceptible to pemivibart due to its molecular design.

The company has submitted these findings to the U.S. FDA and expects an update to the PEMGARDA Fact Sheet for Healthcare Providers. PEMGARDA, engineered from adintrevimab, has shown in vitro activity against several major variants and targets the spike protein receptor binding domain to inhibit virus attachment to host cells.

Timothy Lee, Chief Commercial Officer, emphasized the importance of such treatments for vulnerable patient populations, noting the limited efficacy and durability of vaccines for immunocompromised individuals. Invivyd’s integrated technology platform aims to rapidly develop antibodies to address these needs.

PEMGARDA is authorized under an emergency use authorization (EUA) in the U.S. for pre-exposure prophylaxis of COVID-19 in certain at-risk populations. It is not approved for treatment or post-exposure prophylaxis and is not a vaccine substitute.

VYD2311, leveraging the same backbone as pemivibart, is being developed to offer potential prophylactic and therapeutic benefits for COVID-19 via more patient-friendly administration methods.

This news is based on a press release statement from Invivyd, Inc.

In other recent news, Invivyd, Inc. reported net product revenues of $13.8 million for the fourth quarter, slightly below the estimated $15.4 million. The company’s cash position at the end of 2024 was $69.3 million, surpassing analyst expectations. Despite a setback with the FDA, which declined to expand the Emergency Use Authorization for Invivyd’s monoclonal antibody PEMGARDA for certain COVID-19 treatments, the company plans to continue its development efforts. Invivyd has submitted new data to the FDA to support the use of pemivibart for treating mild-to-moderate COVID-19 in immunocompromised patients. Additionally, H.C. Wainwright has maintained a Buy rating on Invivyd with a $10 price target, citing positive financial results and promising clinical data. Meanwhile, Invivyd received a warning from Nasdaq for its stock price falling below the minimum bid requirement, although this does not immediately affect its listing status. The company is exploring options to address this issue and regain compliance. These recent developments are being closely monitored by investors.

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