IVVD

Loan Agreement: Invivyd, Inc. secured a $30 million term loan facility with Silicon Valley Bank to support its regulatory pathway for the pipeline candidate VYD2311 and aims for near-term profitability by mid-2025.

Financial Performance: The company reported an FY24 EPS loss of $(1.43), which was better than expected, and sales of $25.38 million exceeded projections, while cash reserves stood at $69.3 million as of December 31, 2024.

Loan Agreement: Invivyd, Inc. has secured a $30 million term loan facility with Silicon Valley Bank to support its development of the monoclonal antibody candidate VYD2311 for COVID-19, allowing for future capital drawdowns based on specific milestones.

Product Overview: VYD2311 is designed to provide new prophylactic and therapeutic options for COVID-19, leveraging Invivyd's proprietary technology platform, while PEMGARDA (pemivibart) is an investigational mAb authorized for emergency use in immunocompromised patients for pre-exposure prophylaxis against COVID-19.

Loan Agreement: Invivyd has secured a $30 million term loan facility with Silicon Valley Bank, allowing for future capital drawdowns based on specific conditions and milestones.

Pipeline Development: The funding will support the development of VYD2311, a monoclonal antibody candidate for COVID-19, as the company seeks alignment with the FDA on its regulatory pathway.

Ajay Royan Joins Invivyd's Board: Ajay Royan, a venture capitalist and significant shareholder, has been appointed to the Board of Directors of Invivyd, Inc., as the company aims to enhance its monoclonal antibody technologies for COVID-19 and other diseases.

Focus on Vulnerable Populations: Royan emphasizes the need for innovative therapies targeting vulnerable groups affected by endemic diseases, advocating for a proactive approach similar to Operation Warp Speed to address their unmet medical needs.

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Biotechnology Market Performance: Biotechnology shares are underperforming, down approximately 2%, with Vaxart and Invivyd experiencing significant declines of about 27.9% and 22.3%, respectively.

Sector Laggards: The article highlights the poor performance of biotechnology stocks alongside computers as notable laggards in the market on Monday.

FDA Decision on Invivyd's Pemgarda: The FDA has denied Invivyd, Inc.'s request to expand the emergency use authorization for Pemgarda (pemivibart) as a treatment for mild-to-moderate COVID-19 in immunocompromised patients, although the existing EUA for pre-exposure prophylaxis remains valid.

Impact on Invivyd Stock: Following the FDA's decision, Invivyd's stock (IVVD) dropped nearly 30%, reflecting investor concerns over the company's future prospects and the need for further data on its monoclonal antibody treatments.

FDA's Decision on PEMGARDA: The FDA declined Invivyd's request to expand the emergency use authorization for PEMGARDA™ (pemivibart) as a treatment for COVID-19 in immunocompromised patients, citing insufficient evidence of superior antiviral activity compared to existing authorized monoclonal antibodies.

Ongoing Development and Future Plans: Despite the setback, Invivyd plans to continue working with the FDA to advance PEMGARDA and rapidly develop another monoclonal antibody candidate, VYD2311, to address the urgent need for effective COVID-19 treatments among vulnerable populations.

FDA Declines EUA Expansion: Invivyd's request to expand the emergency use authorization of PEMGARDA for treating mild-to-moderate COVID-19 in immunocompromised patients was declined by the FDA, leading to a 35.59% drop in share price.

Ongoing EUA and Future Plans: The existing EUA for PEMGARDA as pre-exposure prophylaxis remains effective, and Invivyd plans to release detailed data and regulatory correspondence regarding its treatments in the near future.

Market Performance: Drug shares are lagging behind the market, with a collective decline of about 1%, primarily driven by significant drops in Pliant Therapeutics (down 59%) and Sutro Biopharma (down 12.1%).

Author's Perspective: The opinions expressed in the article reflect the author's views and do not necessarily represent those of Nasdaq, Inc.

Surge in Biotech Interest: Several biotech companies, including HCW Biologics and GH Research, are experiencing significant increases in search activity, indicating heightened investor interest, particularly around their innovative therapies and clinical trials.

Recent Developments: Notable recent announcements include Invivyd's partnership to raise COVID-19 awareness, Annovis Bio's Phase 3 study for Alzheimer's treatment, and MAIA Biotechnology's promising data from its cancer therapy trial, all contributing to the growing attention on these stocks.

Partnership Announcement: Invivyd (IVVD) has partnered with football coach Jim Harbaugh to raise awareness about the ongoing risks of COVID-19, particularly for immunocompromised individuals, and to promote alternative options beyond vaccines.

Coach's Statement: Harbaugh emphasized the continued impact of COVID-19 on health and urged people to visit a dedicated website for more information on available options.

Palantir Technologies Performance: Palantir's shares surged 16.5% in pre-market trading after reporting fourth-quarter revenue of $827.52 million, exceeding estimates, along with adjusted earnings of 14 cents per share, surpassing analyst expectations.

Stock Movements: Several stocks experienced significant pre-market movements, with Evaxion Biotech gaining 72.5% and Universe Pharmaceuticals falling 28.2% following a Nasdaq delisting notice.

Invivyd Inc's COVID-19 Treatment Progress: Invivyd Inc's shares surged following positive data from their ongoing Phase 1/2 trial of VYD2311, a monoclonal antibody candidate that shows promising long-lasting protection against COVID-19, potentially offering high protective antibody levels for six months to a year or longer.

Financial Performance and Stock Movement: The company reported significant revenue growth for its product Pemgarda and ended the fourth quarter of 2024 with $69.3 million in cash, contributing to a 72.8% increase in stock price.

Positive Clinical Data for VYD2311: Invivyd's ongoing Phase 1/2 clinical trial of VYD2311, a novel monoclonal antibody for COVID-19, has shown promising results in safety and pharmacokinetics, with mild adverse events reported and high serum concentrations indicating potential for long-lasting protection.

Potential Advantages Over Vaccines: VYD2311 may offer superior efficacy, safety, and durability compared to traditional COVID-19 vaccines, with the possibility of less frequent dosing and no immune system activation, making it an attractive option for both prevention and treatment of COVID-19.

Market Movers: Tyson Foods and Invivyd saw significant gains after earnings reports, with Tyson up 6% and Invivyd up 24%, while Napco Security experienced a notable drop of 19% following its earnings announcement.

Investment Insights: TipRanks' Smart Score tool is highlighted as a resource for investors to identify top-performing stocks and compare their picks against Wall Street analysts' recommendations.

Updated Analysis Submission: Invivyd, Inc. has submitted an updated immunobridging analysis to the FDA for pemivibart, a monoclonal antibody aimed at treating mild-to-moderate COVID-19 in immunocompromised patients, demonstrating superior antiviral activity compared to adintrevimab, particularly in the critical early post-dosing phase.

Safety Profile and EUA Request: The safety profile of pemivibart, supported by data from the CANOPY Phase 3 trial, shows no new cases of anaphylaxis post-authorization, reinforcing the company's request for an amendment to the Emergency Use Authorization (EUA) for its use in specific patient populations lacking alternative treatment options.

Invivyd Inc. Updates on Neutralization Data: Invivyd announced new in vitro data showing that its drug Pemgarda (pemivibart) and candidate VYD2311 maintain neutralizing activity against the dominant SARS-CoV-2 variant XEC, consistent with previous findings for KP.3.1.1.

Market Reaction and Stock Performance: Despite the positive data, Invivyd's stock (IVVD) fell by 5.5% to $0.4357, with trading volume significantly higher than average at 12.3 million shares.

PEMGARDA™ Neutralization Activity: New in vitro data confirms that PEMGARDA™ (pemivibart) maintains consistent neutralizing activity against dominant SARS-CoV-2 variants, including XEC and KP.3.1.1, with no significant changes anticipated if the targeted epitope remains structurally intact.

FDA Submission and Future Outlook: Invivyd has submitted this neutralization data to the FDA and expects an update to the PEMGARDA Fact Sheet for Healthcare Providers, reinforcing its potential as a valuable tool for immunocompromised patients amidst ongoing COVID-19 challenges.

Insider Trading Activity: Terrance McGuire, a director at $IVVD, sold 83,744 shares on December 27, 2024, representing about 2.5% of his holdings, leaving him with 3,256,776 shares. In the past six months, there have been 15 insider sales and no purchases of $IVVD stock.

Institutional Investor Movements: In the latest quarter, 32 institutional investors increased their positions in $IVVD, while 40 reduced theirs, indicating mixed sentiment among larger shareholders.