PureTech Health plc American Depositary Shares - PRTC STOCK NEWS

PureTech Health plc announced that the FDA granted orphan drug designation for its cancer treatment candidate, LYT-200, targeting pancreatic cancer. LYT-200, a human IgG4 monoclonal antibody, addresses poor survival rates in challenging solid tumors. Currently in a Phase 1/2 clinical trial, it has not yet reached the maximum tolerated dose. The designation allows for potential tax credits and seven years of market exclusivity upon approval. Topline results from the trial are expected in H1 2022.

Zai Lab has secured exclusive rights to develop and commercialize KarXT (xanomeline-trospium) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The agreement entails an upfront payment of $35 million to Karuna Therapeutics and potential milestone payments up to $152 million. Zai Lab will undertake the development and commercialization efforts, with tiered royalties on net sales. KarXT targets psychiatric conditions, showing promising results in late-stage trials for schizophrenia and Alzheimer's-related psychosis.

PureTech Health reported as of September 30, 2021, PureTech Level Cash and Cash Equivalents of $387.3 million and Consolidated Cash of $441.0 million. The company has raised $1.6 billion since July 2018, with 96% from third-party investors. Executives will participate in a fireside chat at the Jefferies London Healthcare Conference on November 17, 2021, at 7:20 AM EST. A webcast will be available online.

PureTech Health announces a groundbreaking paper published in Nature’s Scientific Reports detailing the development of the first superabsorbent hydrogel technology from naturally derived materials.

This innovation is aimed at addressing obesity and gut-related conditions by mimicking the properties of raw vegetables. The research shows that these hydrogels protect gut tissue from toxins in ex-vivo models. Their product, Plenity, is FDA-cleared and assists in weight management, with future product candidates poised to target various indications.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) announced the appointment of Simona Levi, Ph.D., J.D., as Chief Legal Officer and Corporate Secretary for its Founded Entity, Vedanta Biosciences. Dr. Levi brings over 25 years of legal experience within the life sciences sector, having previously served at Cell Signaling Technology and Biogen. Her expertise in intellectual property, corporate governance, and complex transactions is expected to support Vedanta's goal of developing new oral therapies based on bacterial consortia.

Vedanta Biosciences has appointed Simona Levi, Ph.D., J.D., as Chief Legal Officer and Corporate Secretary. With over 25 years of legal experience in the life sciences sector, including roles at Biogen and Cell Signaling Technology, Dr. Levi is expected to enhance Vedanta's legal framework as it develops oral therapies targeting the microbiome. Her appointment aligns with Vedanta's vision to innovate in drug delivery systems. The company holds over 40 patents and is recognized for its extensive library of beneficial bacteria.

PureTech Health (LSE:PRTC, Nasdaq:PRTC) announced that its founded entity, Vedanta Biosciences, achieved significant results in its Phase 2 trial of VE303 for preventing recurrent C. difficile infections. The trial demonstrated a 31.7% absolute risk reduction in recurrence rates compared to placebo, achieving primary endpoints. Following these results, the Biomedical Advanced Research and Development Authority (BARDA) exercised a $23.8 million option to support a Phase 3 trial of VE303, set to begin in 2022.

Vedanta Biosciences announced successful Phase 2 trial results for VE303, an oral treatment aimed at preventing recurrent C. difficile infections. The trial showed a 31.7% absolute risk reduction in recurrence at 8 weeks compared to placebo, translating to over 80% reduced odds of recurrence. Following these results, BARDA has exercised a $23.8 million funding option to support a Phase 3 trial set to begin in 2022. The study included 79 high-risk patients, reinforcing VE303's role in restoring gut microbiome health while addressing challenges faced by current treatments.

PureTech Health's Founded Entity, Akili Interactive, has announced successful topline results from a Phase 2 study of SDT-001, a digital therapeutic for children with ADHD, conducted in Japan. The study demonstrated significant improvements in inattention symptoms, paralleling prior studies of AKL-T01. Shionogi, Akili's partner, will consult with Japan’s PMDA for a Phase 3 study. This milestone marks Akili's first clinical trial outside the U.S., with the treatment being well-received and showing no serious adverse effects, which bodes well for the digital medicine's future in Japan.