EU and US could reach trade deal this weekend - Reuters
This update is based on a press release statement from Invivyd, Inc. The company's stock has experienced significant volatility, with a 16.39% gain in the past week despite a 64.17% decline over six months. InvestingPro analysis indicates the stock is currently trading near its Fair Value, with a financial health score rated as WEAK, highlighting the importance of thorough due diligence before making investment decisions. The company's stock has experienced significant volatility, with a 16.39% gain in the past week despite a 64.17% decline over six months. InvestingPro analysis indicates the stock is currently trading near its Fair Value, with a financial health score rated as WEAK, highlighting the importance of thorough due diligence before making investment decisions. The submission, announced today, aims to extend pemivibart's use for treating mild-to-moderate COVID-19 in certain immunocompromised patients who have limited or no access to other treatment options.
This latest analysis includes data on the neutralization of the current dominant SARS-CoV-2 variant XEC, showing that pemivibart's serum virus neutralizing antibody (sVNA) titers are substantially higher in the initial five days post-dosing compared to adintrevimab, its parent molecule. The findings build on previous analyses submitted since July 2024, consistently demonstrating a favorable risk-benefit profile for pemivibart.
Pemivibart, administered intravenously, is designed to deliver higher serum drug concentrations immediately, potentially offering benefits in modifying viral infection and clinical outcomes. This contrasts with the slower distribution of intramuscularly administered adintrevimab. Pemivibart's long-acting nature suggests it could maintain significant antiviral activity for several months after a single dose.
This update is based on a press release statement from Invivyd, Inc. The company's stock has experienced significant volatility, with a 16.39% gain in the past week despite a 64.17% decline over six months. InvestingPro analysis indicates the stock is currently trading near its Fair Value, with a financial health score rated as WEAK, highlighting the importance of thorough due diligence before making investment decisions.
Invivyd received an EUA for pemivibart in March 2024 for COVID-19 PrEP in adults and adolescents with moderate-to-severe immune compromise. If the FDA grants the requested amendment for treatment, Invivyd plans to further assess pemivibart's virologic profile in a clinical study designed in collaboration with the FDA.
The company's efforts to provide therapeutic options for immunocompromised patients are underscored by the limitations of current COVID-19 therapies, such as drug-drug interactions associated with treatments like nirmatrelvir. Dr. Amesh Adalja from the Johns Hopkins Center for Health Security emphasized the need for more therapeutic options, as COVID-19 continues to pose a threat.
The EUA process differs from the timelines established under the Prescription Drug User Fee Act (PDUFA) for New Drug Application (NDA) or Biologics License Application (BLA) approval processes. Invivyd's ongoing industrial virology effort and the robust generation of sVNA titers suggest that the performance of its antibodies could serve as a surrogate endpoint for approval beyond the EUA.
This update is based on a press release statement from Invivyd, Inc.
In other recent news, biotechnology firm Invivyd, Inc. has been grappling with significant developments. The company has been warned by the Nasdaq Stock Market LLC over potential delisting due to its stock price falling below the minimum bid price for 30 consecutive business days. In response, Invivyd is considering options to regain compliance with Nasdaq's standards.
In the midst of these challenges, Invivyd announced the resignation of board member Sara Cotter. The company has yet to release further comments on this development.
Turning to financials, Invivyd reported steady growth in its third-quarter financial results. The company's net product revenue totaled $9.3 million, with an ending cash balance of $107 million. Invivyd is targeting profitability by June 2025 through strategic restructuring aimed at enhancing commercial outreach.
On the product front, Invivyd's antibody, pemivibart, demonstrated an 80% to 90% reduction in symptomatic COVID-19 risk. Moreover, a new antibody candidate, VYD2311, began human studies in August 2024. Despite concerns about pemivibart's efficacy against certain SARS-CoV-2 variants, Invivyd remains confident in its clinical data and regulatory pathway for its products. These are recent developments in the company's ongoing operations.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.