G1 Therapeutics Inc. plans to submit a marketing application for the U.S. next year based on FDA feedback from the company's end-of-phase II meeting for trilaciclib, a myelopreservation agent designed to protect bone marrow from damage from chemotherapy. The company expects to expand to Europe afterward.
While Immunomedics Inc. resolves issues posed by a complete response letter (CRL) regarding the antibody-drug conjugate sacituzumab govitecan for metastatic triple-negative breast cancer, the company announced a license agreement with Everest Medicines II Ltd. to develop, register and commercialize the drug in much of Asia outside of Japan.
While Immunomedics Inc. resolves issues posed by a complete response letter (CRL) regarding the antibody-drug conjugate sacituzumab govitecan for metastatic triple-negative breast cancer, the company announced a license agreement with Everest Medicines II Ltd. to develop, register and commercialize the drug in much of Asia outside of Japan.
Mateon Therapeutics Inc. and Oncotelic Inc. completed the merger they announced on April 17. Oncotelic becomes a wholly owned subsidiary of Mateon, and the combined company has a pipeline of TGF-beta RNA therapeutics for late-stage cancers, including gliomas, pancreatic cancer and melanoma.
Despite a better than expected first-quarter earnings report, Biogen Inc.'s stock (NASDAQ:BIIB) continued its drift downward Wednesday as shares traded 2.5% lower at the close, ending the day at $224.40.
Clinical-stage biotech Poseida Therapeutics Inc. received a boost Monday from a $142 million series C financing, most of which comes from Novartis AG. The funding goes toward Poseida's lead product, P-BCMA-101, which is enrolling patients for a phase II registrational trial.
Pfizer Inc. and Eli Lilly and Co. reported top-line results from a phase III trial of tanezumab, prompting concerns about the nerve growth factor (NGF) inhibitor's safety and efficacy, another step in the epic process of trying to get the drug approved.
Arrakis Therapeutics Inc. has completed a $75 million series B financing to continue its work on small-molecule medicines that directly target RNA to treat disease, primarily cancers.
Puretech Health plc entered a research collaboration with Boehringer Ingelheim GmbH to leverage Puretech's lymphatic targeting technology for immune modulation and develop product candidates for an undisclosed number of targets. Puretech receives up to $26 million in the deal and is eligible for more than $200 million in development and sales milestones, in addition to royalties on product sales.
Gilead Sciences Inc. and privately held Insitro Inc. entered a three-year collaboration to discover and develop therapies for patients with nonalcoholic steatohepatitis (NASH). Insitro will create NASH disease models and find targets that influence the disease through machine learning to predict patient responses to therapeutic interventions, while Gilead handles the chemistry and development of up to five targets.