|Over a week ago |
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Invivyd reports Q1 EPS (32c), consensus (30c) » 16:0405/1105/11/23
Cash, cash equivalents…
Cash, cash equivalents and marketable securities were $333.4M as of March 31, 2023. "We've made great strides in the first part of 2023, including the swift progress in our Phase 1 VYD222 clinical trial underway in Australia, the FDA clearance of our VYD222 IND application, and the continued advancement of our work engineering and characterizing potential next-generation mAb candidates targeting SARS-CoV-2," said Dave Hering, chief executive officer of Invivyd. "These are all important steps in our strategy to serially innovate at a speed that matches the pace of SARS-CoV-2 viral evolution. With the previously authorized anti-SARS-CoV-2 mAbs losing activity against variants of concern, our mission is critical for the millions of immunocompromised people who may not generate adequate protection from COVID-19 vaccines and are at increased risk for severe outcomes."
|Over a month ago|
Invivyd initiated with a Buy at H.C. Wainwright » 06:1705/0105/01/23
H.C. Wainwright analyst…
H.C. Wainwright analyst Patrick Trucchio initiated coverage of Invivyd with a Buy rating and $5 price target. The company's "validated" antibody platform is positioned for success as COVID-19 transitions from pandemic to endemic, the analyst tells investors in a research note. Invivyd is a biopharmaceutical company focused on developing compounds to protect vulnerable people from the consequences of viral threats, beginning with SARS-CoV-2, says the firm.
Invivyd announces FDA has cleared IND application for VYD222 » 07:0604/2504/25/23
Invivyd announced that…
Invivyd announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for VYD222, a monoclonal antibody candidate. Invivyd is developing VYD222 for the prevention of COVID-19 in vulnerable populations, such as immunocompromised people. "We are pleased that the FDA has cleared our IND for VYD222 and we are excited by the progress we've made in our ongoing Phase 1 VYD222 clinical trial," said Dave Hering, chief executive officer of Invivyd. "We have completed dosing of the first cohort and have moved to the second dosing cohort, with initial readouts from the Phase 1 clinical trial on track for the second quarter. The swift progress of our Phase 1 VYD222 clinical trial, along with the FDA's recent clearance of the VYD222 IND, are important steps in our plan to rapidly advance a stream of mAb candidates designed to keep pace with SARS-CoV-2 viral evolution."
Invivyd appoints Allen as CSO, Price as CTMO » 07:0304/1204/12/23
Invivy announced the…
Invivy announced the appointment of Robert Allen as chief scientific officer, CSO, and Stacy Price as chief technology and manufacturing officer, CTMO. In his new role, Dr. Allen will oversee the scientific direction of the company and has responsibility for supporting the discovery of therapies across Invivyd's pipeline. In his new role, Dr. Allen will oversee the scientific direction of the company and has responsibility for supporting the discovery of therapies across Invivyd's pipeline. Dr. Allen brings more than 30 years of experience across the infectious disease space. Prior to joining Invivyd, he served as the chief scientific officer of SmartPharm Therapeutics, a subsidiary of Sorrento Therapeutics. Stacy Price joined Invivyd in March 2023 as chief technology and manufacturing officer, bringing 30 years of experience in commercial and clinical biotechnology operations management to her new role. Prior to joining Invivyd, Price was the chief technical officer at Akouos.
Invivyd announces election of VYD222 for near-term clinical advancement » 07:1103/0603/06/23
Invivyd announces the…
Invivyd announces the election of VYD222 to advance into the clinic as a novel monoclonal antibody therapeutic option for COVID-19. The company aims to leverage evolving COVID-19 regulatory paradigms and maximize efficiency to deliver this much-needed product for immunocompromised individuals and other vulnerable populations. As of January 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention or treatment of COVID-19. Monoclonal antibodies are well suited to meet the need of immunocompromised individuals because they provide a prompt onset of protection, have a well-characterized safety profile, and do not rely on the individual's immune response. VYD222 is one of the mAb components of NVD200, a combination product that Invivyd previously selected for clinical advancement prior to evolution in the current global COVID-19 regulatory paradigm. The company is prioritizing the clinical development of VYD222 instead of NVD200 with the aim of providing patients with a mAb as quickly and efficiently as possible. VYD222 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19. The adintrevimab clinical data package has the potential to support accelerated development of VYD222. The company continues to plan for a Phase 1 clinical trial start in Q1 2023. Once aligned with regulatory authorities, pivotal studies are planned to swiftly follow.
|Over a quarter ago|
Invivyd announces CSO Walker to leave the company » 07:3102/0302/03/23
Invivyd announced that…
Invivyd announced that Laura Walker, Ph.D., the company's chief scientific officer, CSO, and co-founder, decided to leave the company to pursue other opportunities. The management team has initiated a search process to identify her replacement. Until a permanent successor is named, Invivyd team member Lukas Dillinger, Ph.D., has been appointed as interim Head of Discovery and Pre-Clinical.
Invivyd presents rationale on development pathways for monoclonal antibodies » 07:1312/1912/19/22
Invivyd was invited to…
Invivyd was invited to participate in an FDA-EMA workshop on SARS-CoV-2 monoclonal antibodies held on December 15, 2022. Invivyd's chief scientific officer, Laura Walker, Ph.D., alongside Eli Lilly and Company and Regeneron Pharmaceuticals, Inc., presented a joint industry approach for anti-spike monoclonal antibody development to keep pace with SARS-CoV-2 variants. The meeting featured presentations by scientists, clinicians, regulators, and industry representatives to discuss alternative strategies to support the expedited availability of novel monoclonal antibody therapies including those based on development stage products that have reported positive safety and efficacy data in clinical trials. The industry presentation highlighted the significant unmet medical need for therapeutic options to prevent and treat COVID-19 along with scientifically sound, data driven policy change recommendations to shorten development timelines and keep pace with the rapid evolution of variants.
Invivyd appoints Gowler as COO and commercial Officer, Pete Schmidt MD to CMO » 16:0712/0612/06/22
Invivyd announced the…
Invivyd announced the appointment of Jeremy Gowler as chief operating and commercial officer, effective December 16 and the promotion of Pete Schmidt, M.D. to chief medical officer, effective immediately. In his new role Mr. Gowler will oversee operations and commercial activities for the company. Dr. Schmidt will be responsible for overseeing all medical, clinical development and regulatory activities at Invivyd. Dr. Ellie Hershberger, Invivyd's chief development officer, is departing from the Company, but is anticipated to provide consulting services for development activities.
Invivyd announces partnership with Population Health Partners » 07:1111/1711/17/22
Invivyd announced a…
Invivyd announced a partnership with Population Health Partners. Through the partnership, Invivyd will leverage PHP's best-in-class clinical development and regulatory expertise to help optimize Invivyd's product development programs. "This partnership is a reflection of our commitment to the rapid, capital efficient development of multiple candidates on an ongoing basis to match the pace of SARS-CoV-2 viral evolution and deliver timely, best-in-class antibody solutions for the prevention and treatment of serious diseases," said Invivyd CEO Dave Hering. "PHP has great experience in helping organizations like ours overcome the industry challenges inherent in navigating trials focused on large population medicine. This collaboration will add very specific skills and capabilities to our own in-house expertise and will bolster our organization. We are excited to work with PHP and its leadership team at this pivotal point in the evolution of our company."
Invivyd reports Q3 EPS (42c), consensus (49c) » 16:4011/1011/10/22
Reports $419M in cash,…
Reports $419M in cash, cash equivalents and marketable securities, which is expected to support operating runway into Q2 of 2024.