Nextcure Inc. won’t advance the non-small-cell lung cancer (NSCLC) and ovarian cancer cohorts in the stage two portion of its phase I/II study of NC-318, a monoclonal antibody targeting Siglec-15 (S15), as a monotherapy. The data and decision prompted the company stock to shed more than half its value July 13 and several analysts to adjust their price targets downward.
Privately held Foghorn Therapeutics Inc., of Cambridge, Mass., cut a collaboration deal with Merck & Co. Inc. to discover and develop therapeutics targeting the chromatin regulatory system in oncology that could eventually bring in as much as $450 million.
Two more companies, Novavax Inc. and Regeneron Pharmaceuticals Inc., are on the receiving end of U.S. federal government funding to develop and deliver a COVID-19 vaccine in 2021.
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study.
Just shy of four years ago, MEI Pharma Inc. and Helsinn Group hashed out a $464 million deal to develop and commercialize pracinostat. Now an interim futility analysis has persuaded them to halt their phase III study in acute myeloid leukemia (AML) while, pending further evaluation, patients enrolled in other pracinostat studies continue their treatment.
Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success.
Zynerba Pharmaceuticals Inc.’s stock was slashed nearly in half June 30 as the company’s pivotal Connect-FX study for treating fragile X syndrome behavioral symptoms failed to achieve statistical significance in its primary and three key secondary endpoints.
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).
