Senti Biosciences Inc., a synthetic biology company developing an immuno-oncology drug, has landed a $53 million series A round led by New Enterprise Associates. The money is expected to help advance its cancer asset to the starting line for an investigational new drug filing and accelerate the scaling of what it calls a "genetic circuit programming platform."
Obseva SA, the developer of a pill intended to improve pregnancy and live birth rates for women undergoing in vitro fertilization (IVF), reported top-line success in a phase III trial of the experimental therapy nolasiban.
Coralville, Iowa-based Kempharm Inc. has won FDA approval for Apadaz for the short-term management of acute pain. The drug is an immediate-release combination of Kempharm's hydrocodone prodrug, benzhydrocodone, and acetaminophen (APAP). It's the first prodrug of hydrocodone/acetaminophen to be approved by FDA.
Durham, N.C.-based Dova Pharmaceuticals Inc., a small rare disease company gearing up for the potential launch of a pre-registration drug for treating thrombocytopenia, has priced an underwritten public offering expected to raise as much as $80.9 million. Funds from the offering, in which shares will be sold at $32 each, would support a potential June launch of avatrombopag in the U.S. for patients with chronic liver disease, and work to expand the drug's approved uses to the treatment of a broader population of patients with thrombocytopenia.
Kallyope Inc., a growing biotech focused on modulating the gut-brain axis to treat metabolic and neurological disorders, has raised $66 million that will help carry its first compounds toward the clinic and ongoing development of its discovery platform, CEO Nancy Thornberry told BioWorld.
ORIC Pharmaceuticals Inc., a South San Francisco-based company going after treatment-resistant solid tumors with an oral glucocorticoid receptor inhibitor, ORIC-101, has completed a $50 million series C financing it said will support the clinical advancement of the asset and work targeting mechanisms of resistance in cancer.
The race to relief for peanut allergy sufferers pounded onward Tuesday, with Aimmune Therapeutics Inc. delivering endpoint-meeting outcomes from a pivotal phase III test of its oral immunotherapy, AR-101. The 499-participant trial found that about 67 percent of evaluable people treated with AR-101 tolerated a single highest dose of at least 600 mg of peanut protein with no more than mild symptoms vs. 4 percent of those given a placebo.
A new report published by Boston's Institute for Clinical and Economic Review (ICER) concludes that two pricey new CAR-T cell therapies, Novartis AG's Kymriah (tisagenlecleucel) and Gilead Sciences Inc.'s Yescarta (axicabtagene ciloleucel), both provided moderate certainty of a small to substantial net health benefit compared to commonly used chemotherapies or no therapy at all in their respective indications.
Merck KGaA's Pfizer Inc.-partnered Bavencio (avelumab), already approved to treat some cancers, failed to outperform docetaxel in treating patients with difficult-to-treat non-small-cell lung cancers (NSCLC), the companies said. Results of the phase III Javelin Lung 200 study showed it missing the prespecified endpoint of improving overall survival (OS) in NSCLC patients with unresectable, recurrent or metastatic PD-L1-positive tumors that progressed after treatment with a platinum-containing doublet therapy.
At least six weeks ahead of its assigned PDUFA date, Janssen Research & Development LLC's apalutamide has become the first FDA-approved therapy to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC), those whose disease has quit responding to medical or surgical treatments that lower testosterone but has yet to spread.
