Therapix Biosciences Ltd., of Tel Aviv, Israel, said top-line results of a small single-arm, phase IIa study of its combination of dronabinol (delta-9-tetrahydracannabinol) and Cannamide (palmitoylethanolamide), THX-110, showed a positive effect on symptoms of obstructive sleep apnea (OSA), a serious sleep disorder.
Arkuda Therapeutics, a new company targeting progranulin and lysosomal biology to treat neurodegenerative diseases, has completed a $44 million series A financing led by Atlas Venture, its co-creator, and Pfizer Ventures. Funds managed by Tekla Capital Management LLC and Bioinnovation Capital also participated.
Allogene Therapeutics Inc., a South San Francisco-based company developing off-the-shelf allogeneic T-cell therapies for cancer, is taking a 25% stake in Notch Therapeutics Inc., paying the Canadian startup $10 million up front in an exclusive deal to research and develop new induced pluripotent stem cell (IPSC)-based CAR T therapies. The partners will initially focus on developing next-generation treatments for non-Hodgkin lymphoma (NHL), leukemia and multiple myeloma.
Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
Shares of Agile Therapeutics Inc. (NASDAQ:AGRX) trebled Thursday, rising 223.8% to $1.20 at the market's close following a near-unanimous FDA adcom vote the day before supporting approval for the company's transdermal contraceptive patch, Twirla (levonorgestrel/ethinyl estradiol).
FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product.
SAN FRANCISCO – At what BIO CEO and President Jim Greenwood called a "Dickensian moment in the history of biotechnology – arguably the best of times and the worst of times" for U.S. industry players, new rules piloted by the Committee on Foreign Investment in the U.S. (CFIUS) have made things even more challenging.
A late-stage test of Takeda Pharmaceutical Co. Ltd.'s oral suspension of the steroid budesonide for the treatment of eosinophilic esophagitis (EoE) achieved both its co-primary endpoints, improving histologic and dysphagia symptom responses vs. placebo during the first pivotal phase III study of an EoE treatment ever to be reported in the U.S. The study, part of the largest EoE clinical program globally to date, also met secondary endpoints, including improvements from baseline to final treatment as measured by an established patient-reported outcome measurement.
Allievex Corp., a new company advancing an enzyme replacement therapy for Sanfilippo syndrome type B licensed from Biomarin Pharmaceutical Inc. through a registrational phase II trial, has marked the first close of a series A financing co-led by Novo Holdings and the startup's founder, Pappas Capital.
SAN FRANCISCO – Investor sentiment around Biogen Inc.'s plan to soon seek approval for aducanumab in Alzheimer's disease yielded a clear bold reaction in its rising share price Tuesday. But a more nuanced reading was floated during a CNS panel at the BIO Investor Forum the day after, where a focus on new modalities and a call for open-mindedness carried the conversation. "It almost doesn't matter what investors think," said Ellen Lubman, a panelist and chief business officer of Impel Neuropharma Inc. "The reality is that if truly there's a percentage of people getting a benefit from the drug... that's the reason we're all in this business."
