Toss a complete response letter (CRL) onto two missed PDUFA dates and a few adcoms that were discussed but never actualized to get an idea of where Intercept Pharmaceuticals Inc. now stands with its NDA for obeticholic acid (OCA) to treat fibrosis due to nonalcoholic steatohepatitis (NASH).
While the FDA approved Zogenix Inc.’s Fintepla (fenfluramine), an oral treatment for patients ages 2 and older with seizures associated with Dravet syndrome, a rare, pediatric-onset form of epilepsy, the company stock continued its months-long struggle.
The FDA sent a complete response letter (CRL) to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration (AMD).
Nearly a week after filing for a $115 million IPO that it had put off for more than a year, and two months after dosing the first patient in its phase I trial in metastatic castration-resistant prostate cancer, Poseida Therapeutics Inc. has closed on a $110 million series D to continue its CAR T-cell therapy programs.
While Biohaven Pharmaceutical Holding Co. Ltd.’s phase II/III proof-of-concept study of troriluzole for treating obsessive-compulsive disorder (OCD) failed to meet its primary outcome measure at week 12, the company found enough silver in the study’s lining to press on for a larger phase III trial.
Gilead Sciences Inc. has acquired a 49.9% equity interest in privately held Pionyr Immunotherapeutics Inc., which could receive up to $1.15 billion in potential future milestone payments in the deal.
Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.
Against a backdrop of general economic uncertainty bolstered in part by a strong biopharma market, two IPOs launched June 19 and ended their first trading day well above their high-end asking prices.
Repare Therapeutics Inc., which identifies synthetic lethal precision oncology targets for drug candidates, and Forma Therapeutics Holdings Inc., which is developing therapeutics to treat rare hematologic diseases and cancers, launched IPOs with an anticipated combined value of $497.6 million in gross proceeds.
