Invivyd (IVVD) Stock News

Invivyd (IVVD) has published results from its CANOPY Phase 3 clinical trial of PEMGARDA® (pemivibart) in Clinical Infectious Diseases. The trial, involving 788 adults across 18 sites, demonstrated 84% relative risk reduction in symptomatic COVID-19 compared to placebo over 6 months. The study included two cohorts: immunocompromised patients and people at risk due to regular indoor interactions. Key findings showed strong protection against modern, immune-evasive SARS-CoV-2 variants. The drug was generally well-tolerated, with mostly mild/moderate adverse events. Notable safety data included infusion-related reactions in 3.6% of Cohort A and 2.2% of Cohort B, and anaphylactic reactions in 0.6% of total participants. This marks the first and only clinical trial of an authorized COVID-19 monoclonal antibody with placebo-controlled data in a contemporary, seropositive U.S. population.

Invivyd (IVVD) announced that its monoclonal antibody PEMGARDA® (pemivibart) has been included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for B-Cell Lymphomas. This follows the Infectious Disease Society of America (IDSA) update in August 2024 recommending PEMGARDA for pre-exposure prophylaxis in immunocompromised patients. The drug is specifically authorized under FDA Emergency Use Authorization for COVID-19 prevention in moderate-to-severe immunocompromised patients aged 12 or older. PEMGARDA is engineered to maintain effectiveness against circulating SARS-CoV-2 variants, particularly benefiting patients with B-cell malignancies who may have reduced vaccine efficacy. This inclusion in NCCN Guidelines, supported by clinical and real-world evidence, represents a significant advancement in protecting vulnerable cancer patients from COVID-19 complications.

Invivyd (NASDAQ: IVVD) commends the FDA's new approach to evaluating COVID-19 medical interventions, particularly regarding vaccine boosters and monoclonal antibody treatments. The FDA now acknowledges uncertainty in COVID-19 vaccine booster efficacy and encourages manufacturers to conduct randomized, placebo-controlled trials. Invivyd's CANOPY Phase 3 trial of pemivibart demonstrated an 84% reduction in COVID-19 risk compared to placebo over six months, significantly exceeding the FDA's 30% threshold for "meaningful" protection. The company plans to advance improved antibodies for more scalable protection and expects to provide updates on their next-generation monoclonal antibody VYD2311 this quarter. Invivyd aims to engage with the FDA on expedited development pathways for high-risk populations.

Invivyd (NASDAQ: IVVD) reported Q1 2025 financial results, with PEMGARDA™ (pemivibart) generating net product revenue of $11.3 million, down from $13.8 million in Q4 2024. The decrease was attributed to a planned transition from contracted to internalized sales force in early 2025, with revenue re-acceleration observed in Q2. The company reported a net loss of $16.3 million ($0.14 per share), improved from $43.5 million loss in Q1 2024. Cash position stands at $48.1 million, with access to an additional $30 million non-dilutive term loan facility. PEMGARDA shows sustained neutralizing activity against dominant SARS-CoV-2 variants, with no documented anaphylaxis cases since its March 2024 EUA. The company expects VYD2311 Phase 1 trial data later in Q2 2025 and is exploring pipeline expansion beyond SARS-CoV-2 into RSV and measles.

Invivyd (NASDAQ: IVVD) has submitted a Citizen Petition to the FDA advocating for a shift in how COVID-19 preventative treatments are evaluated. The company argues that current vaccine efficacy data needs reassessment due to three key factors: the widespread immunity in the population, the emergence of immune-evasive Omicron variants, and better understanding of vaccine efficacy waning.

The petition urges the FDA to require new clinical trials for COVID-19 vaccines that include: 1) seropositive patients in randomized controlled trials, 2) testing against contemporary Omicron variants, and 3) efficacy measurements over 6+ months. Additionally, Invivyd recommends using serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application approval for monoclonal antibodies.

[ "Company is taking proactive steps to influence regulatory framework for COVID-19 treatments", "Petition could potentially streamline approval process for Invivyd's monoclonal antibody treatments", "Company demonstrates scientific leadership in addressing evolving COVID-19 challenges" ]

Invivyd (NASDAQ: IVVD) has announced its participation in the H.C. Wainwright 3rd Annual BioConnect Investor Conference. The company's management will engage in a fireside chat on Tuesday, May 20, 2025, at 11:00 a.m. ET in New York. Management will also be available for investor meetings during the conference.

Interested investors attending the conference can arrange meetings through their H.C. Wainwright representative. The fireside chat will be accessible via live webcast on the company's investor relations website at investors.invivyd.com and will remain available for approximately 30 days after the presentation.

Invivyd (NASDAQ: IVVD) has launched a discovery program for a measles monoclonal antibody (mAb) treatment, responding to healthcare providers' requests for treating active measles infections and post-exposure prophylaxis. The company aims to identify a preclinical candidate in 2025, with a progress update expected by year-end. Currently, there are no approved therapies for measles, with existing options limited to Vitamin A and immune globulin (IVIG), both having significant limitations. With over 20 million unvaccinated Americans and declining vaccination rates, the U.S. risks losing its measles elimination status. The proposed mAb treatment could offer advantages including high neutralizing capability, fewer toxicities, and potential use as prophylaxis for at-risk populations, including young children, immunocompromised individuals, and the elderly.

Invivyd (NASDAQ: IVVD), a biopharmaceutical company focused on protection against serious viral infectious diseases, has scheduled a conference call for Thursday, May 15, 2025, at 8:30 a.m. ET. The call will cover the company's first quarter 2025 financial results for the period ending March 31, 2025, along with recent business updates.

Analysts interested in participating in the Q&A session should join 15 minutes before the start time. The webcast will be available for replay on Invivyd's investor relations website approximately two hours after the call concludes.

Invivyd (Nasdaq: IVVD) has secured a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The non-dilutive financing agreement allows for future capital drawdown subject to meeting specific conditions and milestones.

The company's CFO Bill Duke highlighted that this facility was secured ahead of important anticipated catalysts, including alignment with the FDA on the regulatory pathway for their pipeline candidate VYD2311. The non-dilutive nature of the financing is aimed at maintaining balance sheet flexibility while focusing on per-share value creation.