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Finch Therapeutics Group, Inc. (Nasdaq: FNCH) has paused enrollment in its Phase 3 clinical trial, PRISM4, for CP101, a treatment for recurrent C. difficile infection, following a clinical hold from the FDA on February 24, 2022. The hold was issued due to concerns regarding SARS-CoV-2 donor screening protocols. Finch had previously navigated similar issues during the pandemic but now faces additional requirements from the FDA. Despite the hold, Finch aims to quickly address the FDA's requests to minimize delays in reporting trial data.
Finch Therapeutics, a clinical-stage microbiome therapeutics company, announced that its CEO, Mark Smith, PhD, will join a panel discussion at the Chardan Metagenomics and Microbiome Medicines Summit on March 1, 2022, at 3:15 pm ET. The event will be accessible via a live webcast on Finch's website, archived for 30 days post-event. Finch is noted for its Human-First Discovery® platform, leading in developing microbiome therapies, including its candidate CP101 for preventing recurrent C. difficile infections, which has received FDA designations.
Finch Therapeutics has appointed three key executives: Bryan Gillis as Chief Technology Officer, Alka Batycky as Chief Development Officer, and Howard Franklin as Senior VP of Late-Stage Development. These appointments aim to enhance Finch's capabilities in advancing its clinical programs, particularly the Phase 3 program for recurrent C. difficile. The new leaders bring over 20 years of expertise across biotechnology, operations management, and clinical development, supporting Finch's growth in microbiome therapeutics and drug development.
Finch Therapeutics (Nasdaq: FNCH) announced the issuance of two new patents for its microbiome product candidate FIN-211, aimed at treating children with autism spectrum disorder (ASD) and gastrointestinal symptoms. This expands Finch’s patent portfolio to 59 issued patents with over 130 applications pending. The first patent relates to a donor-derived microbial community, while the second covers encapsulated microbiota compositions. The company plans to initiate a Phase 1b trial of FIN-211 in early 2022, focusing on safety and tolerability in ASD patients. The development highlights a significant unmet need in ASD therapeutics.
Finch Therapeutics Group (Nasdaq: FNCH) announced that CEO Mark Smith will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 9:45 am ET. Additionally, Finch will participate in the H.C. Wainwright BioConnect Conference, with a pre-recorded overview available from January 10, 2022. Both presentations will be accessible on Finch’s website for around 30 days post-event. Finch focuses on microbiome therapeutics, with its lead candidate, CP101, in late-stage development for recurrent C. difficile infections, having received Breakthrough Therapy status.
Finch Therapeutics Group, Inc. (Nasdaq: FNCH) has promoted Joseph Vittiglio to Chief Business and Legal Officer, effective December 2021. With over 25 years of experience in the life sciences sector, Vittiglio's leadership is expected to enhance strategic partnerships and business developments at Finch. His prior role included guiding Finch through a successful IPO, raising $130.8 million. Finch is advancing its microbiome product pipeline, including CP101, which is undergoing a Phase 3 trial for recurrent C. difficile infection, with additional programs set for clinical trials in 2022.
Finch Therapeutics (Nasdaq: FNCH) announced CEO Mark Smith will participate in two virtual investor conferences. The first is the Jefferies London Healthcare Conference, featuring a pre-recorded fireside chat available on November 18, 2021. The second is the Evercore ISI 4th Annual HealthCONx Conference, with a fireside chat on December 2, 2021. Both webcasts will be archived on Finch's website for approximately 30 days. Finch is focused on microbiome therapeutics, with its lead candidate, CP101, in late-stage development for recurrent C. difficile infection.
Finch Therapeutics reported new positive topline data from the 132-participant PRISM-EXT Phase 2 trial for CP101, showing an 80.3% sustained clinical cure rate through 8 weeks and 78.8% through 24 weeks in recurrent C. difficile infection (CDI). Additionally, the company initiated enrollment in the PRISM4 Phase 3 trial and presented positive data at the ACG annual meeting. Despite a net loss of $10.0 million for Q3 2021, cash reserves of $149.2 million should fund operations into mid-2023, suggesting operational stability for upcoming trials.
Finch Therapeutics Group announced leadership changes as Zain Kassam steps down as Chief Medical Officer (CMO) to address a family health matter. He will serve as a special advisor, while Debra Silberg transitions from clinical advisor to interim CMO. Silberg brings extensive experience in gastroenterology and drug development, having held significant roles at Takeda and Shire. Finch is known for its microbiome therapeutics, particularly its lead candidate, CP101, which is in late-stage clinical development for recurrent C. difficile infection.
Finch Therapeutics (Nasdaq: FNCH) announced positive topline results from the PRISM-EXT Phase 2 trial evaluating CP101 for preventing recurrent C. difficile infection. The trial, involving 132 participants, reported an 80.3% sustained clinical cure rate through 8 weeks, maintaining 78.8% through 24 weeks, with a favorable safety profile. A post-hoc analysis revealed an 88.2% sustained clinical cure rate for participants receiving up to two doses of CP101. Finch has also commenced enrollment for the PRISM4 Phase 3 trial, further advancing CP101's clinical development.
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