Invivyd Aligns with FDA for Rapid Approval of COVID-19 Antibody Candidate

Invivyd has aligned with the FDA for a rapid approval pathway for its monoclonal antibody candidate VYD2311 to protect against COVID-19. The company reported a 413% year-over-year increase in revenue from PEMGARDA, despite not achieving near-term profitability. Invivyd is also advancing clinical trials and expanding its pipeline. The stock has a neutral rating from Spark's AI Analyst, reflecting significant financial and technical weaknesses, but recent corporate developments offer potential for strategic improvement.

Invivyd (NASDAQ: IVVD) has received FDA alignment on a streamlined pathway to potential Biologics License Application (BLA) approval for VYD2311, its monoclonal antibody candidate for COVID-19 prevention. The FDA advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support BLA submission for broad population use (12+ years, 40kg+). The clinical trial will evaluate two doses of VYD2311, featuring a 12-week primary endpoint analysis with potential extension to 24 weeks. The antibody demonstrates promising characteristics including a ~76-day half-life and high potency. The company positions VYD2311 as a non-vaccine alternative for COVID-19 prevention, targeting both immunocompromised individuals and the general population seeking protection. Invivyd secures streamlined FDA approval pathway for VYD2311, a COVID-19 antibody alternative to vaccines with significant market potential. Invivyd has achieved a significant regulatory milestone by securing FDA alignment on a streamlined approval pathway for VYD2311, its monoclonal antibody for COVID-19 prevention. This represents a crucial de-risking event in the drug development process. The FDA has agreed that a single Phase 2/3 trial with a relatively modest number of confirmed COVID-19 cases could support a Biologics License Application (BLA), substantially reducing the typical multi-study requirement for full approval. The regulatory pathway is notably efficient, requiring only a 12-week primary endpoint analysis in a randomized, double-blind, placebo-controlled trial, with a potential 24-week secondary analysis. This compressed timeline could accelerate VYD2311's path to market by potentially years compared to traditional development programs. From a regulatory perspective, the FDA's willingness to consider this streamlined approach likely stems from several factors: (1) Invivyd's previous successful execution of the Phase 3 CANOPY trial for pemivibart, (2) demonstrated durability of protection from similar antibodies in their platform, and (3) the established molecular lineage of Invivyd's antibodies with proven clinical efficacy. Importantly, the company already has clinical supply and potential commercial launch product available, indicating manufacturing readiness that often represents a significant hurdle in biologics development. The potential approval would cover a broad population (ages 12+ weighing at least 40kg), including immunocompromised individuals, giving the product substantial market potential if approved. The company is also pursuing a head-to-head safety comparison with COVID-19 vaccines, which could provide competitive differentiation data if allowed by regulators. With declining COVID-19 vaccine uptake, this non-vaccine alternative with a ~76-day half-life and low-dose intramuscular administration could find significant market opportunity, especially given the company's positioning of the product as working alongside natural immunity without immune system activation. WALTHAM, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has received and is aligned with advice from the U.S. Food and Drug Administration (FDA) on a compact and, therefore, rapid pathway to potential Biologics License Application (BLA) approval for Invivyd’s novel monoclonal antibody (mAb) candidate VYD2311, for the prevention of COVID-19. As part of a recent Type C meeting, FDA advised that a single, Phase 2/3 randomized, double-blind, placebo-controlled trial evaluating mAb efficacy from a relatively modest number of RT-PCR -confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans (12 years of age and older, weighing at least 40kg), including immunocompromised people, subject to agreement on safety database size and pending full protocol review. “We believe monoclonal antibodies such as VYD2311 can serve as a powerful alternative to vaccines for COVID-19 prevention, and represent an important potential paradigm shift to move American medicine beyond the real and perceived limitations of COVID-19 vaccines. Amidst declining public trust in vaccines, we want to offer Americans a new, non-vaccine choice,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “COVID-19 monoclonal antibody medicines work alongside natural human immunity without needing to activate the immune system, and, if we can make them widely available, we believe mAbs represent the natural next step beyond vaccination to keep people safe and well, if approved, in the face of pervasive COVID-19.” FDA advice and background statements to Invivyd cited observations on Invivyd’s efficient execution of its Phase 3 randomized clinical trial of pemivibart for the prevention of COVID-19 (CANOPY), the antiviral durability of pemivibart, and the strong protection demonstrated by pemivibart among ordinary Americans in CANOPY Cohort B, while recognizing that Invivyd antibodies stem from a common molecular lineage. Multiple such Invivyd antibodies have undergone successful randomized, placebo-controlled clinical trials, including efficacy assessment in contemporary Americans. In agreement with FDA advice, Invivyd plans to study two doses of VYD2311 to assess any differences in resulting levels of protection or differences in safety, with a goal to unlock further choice for Americans in need of COVID-19 protection. “We are grateful for the FDA’s clear and constructive feedback, which provides a well-defined path forward for our COVID-19 development program. We believe the FDA’s feedback underscores the shared urgency to advance innovative solutions for prevention of COVID-19,” said Rachael Gerlach, Ph.D., Vice President, Regulatory Affairs at Invivyd. “Combined with Invivyd’s unique discovery platform, this alignment is a critical step in bringing forward a potentially important, medically attractive and patient-friendly alternative to COVID vaccination, providing protective monoclonal antibodies, if approved, to any American who wishes protection, whether immune compromised, at high risk for severe disease, or just interested in not getting sick.” The FDA provided advice for pursuit of a traditional BLA pathway for the prevention of COVID-19 caused by SARS-CoV-2 in adults and adolescents weighing at least 40 kg, recommending a Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of RT-PCR-confirmed symptomatic COVID-19, with a timepoint for measuring the primary endpoint coinciding with the expected duration of protection, anticipated as 12 weeks (3 months), and the potential for selection of an additional, longer duration timepoint, which Invivyd anticipates as 24 weeks (6 months). Invivyd’s analysis of CANOPY clinical trial data and Cox Proportional Hazards modeling, combined with biophysical properties of VYD2311, suggest likely robust, long-term protection from symptomatic COVID-19 due to high potency and observed long half-life of ~76 days, following a relatively low dose of VYD2311 via intramuscular route of administration. Invivyd’s most recent analysis aligns well with multiple similar analyses spanning the majority of SARS-CoV-2 virus variation since emerging as a global human disease in 2020, lending confidence to dose selection and anticipated clinical benefit. In addition, as COVID-19 monoclonal antibodies represent additional immune support and do not require engagement of the human immune system with associated inflammation symptoms (reactogenicity), Invivyd anticipates, pending regulatory alignment, a clinical trial cohort exploring randomized, active-controlled safety and tolerability of VYD2311 compared to vaccination. “Our completed first-in-human study of VYD2311 demonstrated high SARS-CoV-2 antiviral titers and an attractive safety profile at very high doses, well beyond doses we contemplate going forward with in development. We look forward to opening a U.S. IND and moving as quickly as possible to finalize a pivotal clinical trial design with the FDA,” said Mark Wingertzahn, Ph.D., Senior Vice President, Clinical Development at Invivyd, “If successful, we have the potential to change practice and provide consumers and central health authorities with an attractive alternative to COVID-19 vaccination. We anticipate sharing our plans as soon as possible once we finalize them with FDA.” Invivyd has quantities of VYD2311 clinical supply and potential commercial launch product available. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About PEM