Benzinga · Apr 5, 2022
The Daily Biotech Pulse: Thervance Gains On Positive Late-Stage Readout, Bristol-Myers Squibb Snags 3 Approvals In Europe, Decision Day For BioXcel
Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Theravance Announces Phase 3 Data For Ampreloxetine Showing Clear Benefit In Multiple System Atrophy Patients Theravance Biopharma, Inc. (NASDAQ: TBPH) announced results from the second Phase 3 study, assessing the durability of clinical effect of ampreloxetine compared to placebo for the treatment of symptomatic neurogenic orthostatic hypotension. The primary endpoint was not statistically significant for the overall population of patients, which included patients with Parkinson's disease, pure autonomic failure and multiple system atrophy. Yet the pre-specified subgroup analysis by disease type suggests the benefit seen in patients receiving ampreloxetine was largely driven by MSA patients. The stock was advancing 5.26% to $10 in premarket trading. Novartis Receives Approval To Manufacture Zolgensma In Second Manufacturing Facility In US Novartis AG (NASDAQ: NVS) said the U.S. Food and Drug Administration has granted commercial licensure approval for its Durham, North Carolina site, a multiproduct gene therapy manufacturing facility. This approval allows the 170,000 square-foot facility to make, test and release commercial Zolgensma, as well as produce gene therapy product for current and future clinical trials, the company said. The clearance brings online the second commercially licensed manufacturing facility for Novartis Gene Therapies, joining the Libertyville, Illinois site. Fluidigm Announces Completion Of Strategic Capital Infusion, Renaming To Standard BioTools Fluidigm Corporation (NASDAQ: FLDM) announced the closing of the previously announced strategic capital infusion from Casdin Capital and Viking Global. The company also announced its renaming to Standard BioTools Inc. Its common stock is expected to begin trading on Nasdaq under the symbol "LAB" beginning on Wednesday. Standard BioTools, the company said, will focus on significantly advancing its mission to become an essential solutions partner ...
