BioSpace News Archive

Zogenix (Nasdaq: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it has submitted its Type II Variation Market Authorization Application to the European Medicines Agency (EMA) for FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly treatment-resistant form of childhood-onset epilepsy.

PolarityTE, Inc. (Nasdaq: PTE) today announced that it has submitted its complete response to the U.S. Food and Drug Administration’s (FDA) clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE® with a proposed indication for chronic cutaneous ulcers.

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the Nature Communications publication characterizing the novel splicing mechanism induced by compounds identified from the Huntington Disease (HD) program.

Seagen Inc. announced that management will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 3:00 p.m. Eastern Time.

Clarametyx Biosciences Inc. today announced the receipt of a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) for up to $3.15 million over three years.

bluebird bio, Inc . (NASDAQ: BLUE) today announced that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18.

Twist Bioscience Corporation today announced the launch of the Twist 96-Plex Library Prep Kit, a high-performance, cost-effective preparation kit for next-generation sequencing (NGS).

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has extended a licensing and collaboration agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue an intranasal vaccine designed to protect against the SARS-CoV-2 Omicron variant.

Novavax, Inc. today announced that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax’ COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older.

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit” or the “Company”) today announced topline results for the Phase III Ri-CoDIFy study evaluating its investigational drug, ridinilazole, for the treatment of and Sustained Clinical Response (SCR) for patients suffering from C. difficile infection (C. diff. infection or CDI).