Invivyd, Inc. - Common Stock (IVVD)

WALTHAM, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that it will present at the following investor conferences:

Power Metallic Mines Inc. (TSX-V: PNPN; OTCQB: PNPNF; Frankfurt: IVV) today announced the appointment of Seamus O’Regan Jr., Canada’s former Minister of Energy & Natural Resources, to its Board of Directors.

WALTHAM, Mass., Aug. 22, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the closing of its previously announced underwritten public offering of 89,234,480 shares of its common stock, which includes the exercise in full by the underwriter of its option to purchase an additional 14,423,076 shares of common stock, at a public offering price of $0.52 per share and pre-funded warrants to purchase 21,342,442 shares of its common stock at a public offering price of $0.5199 per pre-funded warrant, which represents the per share price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. All of the shares and pre-funded warrants were offered by Invivyd. The gross proceeds from this offering were approximately $57.5 million, before deducting underwriting discounts and commissions and offering expenses payable by Invivyd.

WALTHAM, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the pricing of an underwritten public offering of 74,811,404 shares of its common stock at an offering price of $0.52 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 21,342,442 shares of its common stock at a price of $0.5199 per pre-funded warrant. The gross proceeds from this offering are expected to be approximately $50.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Invivyd. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. All of the shares and pre-funded warrants are being offered by Invivyd. In addition, Invivyd has granted the underwriters an option for a period of 30 days to purchase up to an additional 14,423,076 shares of Invivyd common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about August 22, 2025, subject to the satisfaction of customary closing conditions.

WALTHAM, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Invivyd. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

WALTHAM, Mass., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA® (pemivibart) against the currently dominant and growing XFG variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, XFG did not generate any meaningful change to the in vitro neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitopes targeted by pemivibart and VYD2311 remain structurally intact. PEMGARDA (pemivibart) is authorized by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients.

WALTHAM, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended June 30, 2025, and provided recent business highlights.

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.

WALTHAM, Mass., July 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced the addition of Akiko Iwasaki, Ph.D., Professor of Immunobiology at Yale School of Medicine, to the SPEAR (Spike Protein Elimination and Recovery) Study Group. The SPEAR Study Group was launched earlier this month to focus on the biology and clinical disease or injury associated with persistent presence of spike antigen from SARS-CoV-2 virus or COVID-19 vaccines.

WALTHAM, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced the June 20, 2025 updated National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the Prevention and Treatment of Cancer-Related Infections now recommend the use of available monoclonal antibodies for pre-exposure prophylaxis of COVID-19. The NCCN Guidelines advise clinicians to refer to guidance from Infectious Diseases Society of America (IDSA), Centers for Disease Control and Prevention (CDC), or U.S. Food and Drug Administration for available monoclonal antibody options. This recommendation reflects the growing alignment among key organizations - including IDSA and CDC - reinforcing the critical role of monoclonal antibodies in protecting immunocompromised individuals from COVID-19.

WALTHAM, Mass., June 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate designed to prevent and treat COVID-19.

WALTHAM, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that results from its CANOPY Phase 3 clinical trial of pemivibart have been published online as an Advance Article in the peer-reviewed journal Clinical Infectious Diseases (CID), available here. The publication, titled “Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY)” highlights attractive safety, substantial clinical antiviral activity, the immunobridge between calculated serum virus neutralizing antibody (sVNA) titers and pemivibart and historical clinical efficacy data, and nominally statistically significant and clinically meaningful efficacy of pemivibart versus placebo in a contemporary U.S. population facing, immune-evasive Omicron SARS-CoV-2 viruses.   

WALTHAM, Mass., July 02, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that it has formed a best-in-class clinical and translational study group, the SPEAR Study Group, with leading investigators focused on the biology and clinical disease or injury associated with chronic exposure to SARS-CoV-2 virus or mRNA vaccine-mediated spike protein. The SPEAR Study Group will structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibody (mAb) therapy in people suffering from Long COVID or Post-Vaccination Syndrome (PVS), conditions believed to be mediated by persistent viral reservoirs or circulating spike protein. Persistent SARS-CoV-2 spike protein has been identified in both populations, and both populations have overlapping manifestations of apparent clinical disease. As many as 5% or more of Americans have reported recent Long COVID symptoms, an extraordinary medical burden that will continue to evolve as infections continue in the U.S.The SPEAR Study Group was initiated in response to a growing number of case reports and reported case series from across the U.S. suggesting meaningful symptom relief / remission of Long COVID following use of PEMGARDA® (pemivibart), a monoclonal antibody currently authorized by the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised individuals. PEMGARDA is not authorized for the treatment of Long COVID. While these emerging reports are anecdotal and uncontrolled, they collectively support a longstanding, mechanistically plausible hypothesis: that prolonged exposure to pathogenic SARS-CoV-2 spike protein or other forms of persistent virus or viral material may drive disease in some patients, and that reducing this burden through monoclonal antibody therapy may offer a promising therapeutic approach worthy of rigorous clinical investigation. Clinical research to be planned by the SPEAR Study Group is critical to exploring disease biology and evaluating efficacy endpoints that can enable registrational studies if appropriate in the future.

WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to severely immunocompromised adults and adolescents (aged 12 or older) at risk for progression to severe COVID-19 when predominant regional variants are susceptible to pemivibart.

WALTHAM, Mass., May 21, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today commends new U.S. Food and Drug Administration (FDA) leadership on taking important steps to acknowledge and resolve the significant uncertainty surrounding the contemporary COVID-19 vaccine booster efficacy landscape. In a New England Journal of Medicine (NEJM) publication on May 20, 2025, titled “An Evidence-Based Approach to Covid-19 Vaccination,” and in a follow-on live webinar on May 20, 2025, FDA leadership correctly identified gaps in the modern understanding of COVID-19 vaccine booster efficacy and provided a mechanism to resolve those gaps and move forward.

WALTHAM, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended March 31, 2025, and provided recent business highlights.

WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development of vaccines and monoclonal antibodies (mAbs) for COVID-19 prevention, in order to rebuild American’s trust in scientific data, public health recommendations, and preventatives, including mAbs and vaccines, when effective. Americans will need a robust arsenal to manage COVID-19 and other viral infectious disease for decades to come.

WALTHAM, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that management will participate in a fireside chat at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on Tuesday, May 20, 2025, at 11:00 a.m. ET in New York, NY.

WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has initiated a discovery program for a measles monoclonal antibody (mAb). Multiple healthcare providers (HCPs) who are treating active measles and monitoring contacts and outbreaks have inquired directly to Invivyd about the possibility of accessing such a medicine, as there are no currently approved therapies for measles or for post-exposure prophylaxis. Measles monoclonal neutralizing antibody discovery efforts would join current Invivyd discovery programs for next-generation COVID-19, respiratory syncytial virus (RSV), and influenza mAbs designed to treat acute infection or provide a high-quality alternative to vaccination.

WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, May 15, 2025, at 8:30 a.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and provide recent business highlights.

WALTHAM, Mass., April 21, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it has signed a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The deal allows for drawdown of capital in the future if certain conditions and milestones are met.

WALTHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) is pleased to announce the appointment of Ajay Royan to its Board of Directors. Mr. Royan is a venture capitalist focused on transformational companies that have solved critical problems in healthcare, technology, and energy. Mr. Royan’s investment firm, Mithril, is a significant long-term holder of Invivyd stock, and Mr. Royan led the 2022 shareholder action that focused Invivyd on its mission to deliver protection from serious viral infectious diseases, starting with COVID-19.

WALTHAM, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights.

WALTHAM, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA™ (pemivibart) against the currently dominant LP.8.1 variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, LP.8.1 did not generate any meaningful change to the neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitope these mAbs target remains structurally intact. PEMGARDA (pemivibart) is authorized in the U.S. for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients.

WALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Invivyd’s request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA™ (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA). Existing PEMGARDA™ (pemivibart) EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect.