Shares of Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) spiked Tuesday, rising 80% to $35.90 as results of a pivotal phase III study showed its lead candidate, ripretinib, enabled people with fourth-line and beyond gastrointestinal stromal tumors (GIST) to live a median of 6.3 months before disease progression vs. one month with a placebo. Ripretinib also reduced the risk of disease progression or death by 85%.
Stopped early for favorable results, an African trial testing four Ebola drugs has found two of the therapies, Regeneron Pharmaceuticals Inc.'s REGN-EB3 and the NIH-developed MAb-114, gave Ebola-infected participants a greater chance of survival than either Gilead Sciences Inc.'s remdesivir or Zmapp (Mapp Biopharmaceutical Inc., Defryus Inc.), considered the standard of care based on the previous Prevail II trial.
Kala Pharmaceuticals Inc. said it would look to data from a third phase III trial of its dry eye disease candidate, KPI-121 0.25%, to satisfy the request, in an FDA complete response letter (CRL), for efficacy data from an additional trial to support its NDA. The study, called STRIDE (Short Term Relief In Dry Eye) 3, is already underway with Kala targeting a top-line readout by year-end to support a resubmission in the first half of 2020.
Bayer AG has agreed to pay $240 million in cash plus as much as $360 million in milestones for total ownership of Bluerock Therapeutics, a cell therapy company it launched and funded with Versant Ventures in 2016 with an initial $225 million series A investment. Valuing Bluerock at nearly $1 billion, the deal gives Bayer full rights to the startup's Cell+Gene platform, as well as a Parkinson's disease (PD) program expected to enter the clinic by year-end.
Shares of Miragen Therapeutics Inc. (NASDAQ:MGEN) fell 17.2% to $1.30 Thursday on news that key phase II data for its lead candidate, cobomarsen for blood cancer, would be delayed until 2021 while support for another program, MRG-110 for heart failure, will be pulled by Les Laboratoires Servier SAS after a strategic review at the French pharma.
Emergo Therapeutics Inc., a Durham, N.C.-based startup that raised a $12 million series A last year, has successfully completed a phase IIa trial demonstrating positive data for its lead candidate, an oral formulation of norketotifen, in 36 people with allergen-induced allergic rhinitis.
Rakuten Medical Inc., the developer of a precision photoimmunotherapy platform targeting head and neck cancer, has raised about $100 million in a series C-1 preferred stock financing from Rakuten Inc., a global internet services company headquartered in Japan that now owns 22.5% of the company.
Shares of California-based Allakos Inc. (NASDAQ:ALLK) rose 110.5% to a record close of $65.26 Monday amid a broader market plunge on positive phase II results with AK-002, its experimental therapy for people with two rare conditions, eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE).
Rakuten Medical Inc., the developer of a precision photoimmunotherapy platform targeting head and neck cancer, has raised about $100 million in a series C-1 preferred stock financing from Rakuten Inc., a global internet services company headquartered in Japan that now owns 22.5% of the company.