WALTHAM, Mass. - The U.S. Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) Fact Sheet for healthcare providers regarding PEMGARDA™ (pemivibart), a monoclonal antibody developed by Invivyd, Inc. (NASDAQ: IVVD), for the prevention of COVID-19 in certain immunocompromised individuals. The revised Fact Sheet, dated September 26, 2024, now includes in vitro neutralization data showing PEMGARDA's activity against prevalent SARS-CoV-2 variants, including KP.3.1.1 and LB.1.
This update follows the submission of data by LabCorp's Monogram Biosciences lab to the FDA on September 3, 2024, which demonstrated that PEMGARDA is likely to maintain effective neutralization against current variants circulating in the U.S. The previous version of the Fact Sheet had indicated that variant KP.3.1.1 might have reduced susceptibility to pemivibart, based on preliminary and non-peer-reviewed data.
Invivyd's Chairman, Marc Elia, emphasized the importance of accurate and reliable industrial-grade virology applications using the actual pharmaceutical agent authorized for medical use. He noted that the updated Fact Sheet corrects a potentially misleading chapter in PEMGARDA's lifecycle and highlighted the company's commitment to scientific research and its partnership with the FDA in ensuring the rigor of neutralization potency assessments.
PEMGARDA is a half-life extended investigational monoclonal antibody engineered from adintrevimab, which has shown clinical efficacy in a global Phase 2/3 trial for the prevention and treatment of COVID-19. It targets the SARS-CoV-2 spike protein receptor binding domain, inhibiting virus attachment to host cells. Authorized for emergency use, PEMGARDA is not a substitute for vaccination but is intended as a prophylactic measure for those unlikely to mount an adequate immune response to COVID-19 vaccination.
Invivyd continues to monitor SARS-CoV-2 variants actively using validated, robust methods and states that there are currently no known circulating variants resistant to PEMGARDA. The company also encourages reliance on validated scientific studies and cautions against neutralization findings from other laboratories that may not meet the same quality and control standards.
The information in this article is based on a press release statement from Invivyd, Inc.
In other recent news, Invivyd Inc., a biopharmaceutical company, has made considerable strides in the development of monoclonal antibodies to combat COVID-19. Invivyd's investigational antibody PEMGARDA has maintained in vitro neutralization potency against the latest SARS-CoV-2 variants, including KP.3.1.1 and LB.1. The company's Phase 3 trial of PEMGARDA demonstrated an 84% reduction in symptomatic COVID-19 risk.
In financial developments, Invivyd's second-quarter revenues reached $2.3 million, falling short of the anticipated $6.9 million, but the company expects revenue growth later in the year. H.C. Wainwright maintained a Buy rating on Invivyd, reflecting confidence in the company's performance.
Invivyd has also initiated a Phase 1 clinical trial for its monoclonal antibody candidate, VYD2311, aimed at combating COVID-19. The company recently appointed Timothy Lee as Chief Commercial Officer, a move expected to enhance the company's commercial strategy. These are recent developments in Invivyd's ongoing efforts to combat respiratory viruses.
InvestingPro Insights
To complement the update on Invivyd's PEMGARDA and its FDA authorization, let's take a closer look at the company's financial health and market performance. According to InvestingPro data, Invivyd (NASDAQ: IVVD) currently has a market capitalization of $121.83 million USD, reflecting its position as a smaller player in the biotechnology sector.
One of the key InvestingPro Tips highlights that Invivyd holds more cash than debt on its balance sheet. This financial cushion could be crucial for the company as it continues to develop and commercialize PEMGARDA and other potential products in its pipeline. However, another InvestingPro Tip indicates that the company is quickly burning through cash, which is not uncommon for biotech firms in the development stage but warrants attention from investors.
The company's revenue for the last twelve months as of Q2 2024 stands at $2.26 million USD, with a remarkable gross profit margin of 96.11%. This high margin suggests that if Invivyd can scale its operations, particularly with the potential success of PEMGARDA, it could become highly profitable in the future.
Despite these positive indicators, it's important to note that Invivyd is currently not profitable, with a negative operating income of -$211.15 million USD for the same period. This aligns with another InvestingPro Tip stating that analysts do not anticipate the company to be profitable this year.
Investors should also be aware that Invivyd's stock has taken a significant hit over the last six months, with a price total return of -76.0%. However, there has been a strong return of 19.97% over the last month, possibly reflecting market optimism about the updated FDA authorization for PEMGARDA.
For those interested in a more comprehensive analysis, InvestingPro offers 8 additional tips for Invivyd, providing a deeper understanding of the company's financial position and market prospects.
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