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 to the life science industry focused on the highest growth areas of biological discovery and development.
Argenx Announces Positive Long-Term Data For Vyvgart In Generalized Myasthenia Gravis
Argenx (NASDAQ:ARGX) announced interim results from an ADAPT+ Phase 3 three-year extension study evaluating the long-term safety, tolerability and efficacy of Vyvgart for the treatment of adults with generalized myasthenia gravis.
"Patients who participated in ADAPT+ continued to experience consistent efficacy and safety over a year of treatment, reinforcing the potential benefit this targeted therapy can offer to this community," said James Howard, principal investigator of the study.
The stock was up 1.41% at $328.99 in premarket trading.
Related Link: The Week Ahead In Biotech (April 3-April 9): BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight
Bristol-Myers Squibb Snags Approval For Opdivo/Opdivo Combo In Two Cancer Indications In Europe
Bristol-Myers Squibb Company (NYSE:BMY) announced three approvals in Europe. The company said European Commission (EC) has approved Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression, equal to or more than 1%.
The regulator also approved Opdivo combination with Yervoy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression equal to or more than 1%.
Opdivo was also approved as an adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression equal to or more than 1%, who are at a high risk of recurrence after undergoing radical resection.
Arcus Biosciences To Join S&P SmallCap 600 Index
Arcus Biosciences, Inc. (NYSE:RCUS) will replace Investors Bancorp Inc. (NASDAQ:ISBC) in the S&P SmallCap 600 effective prior to the opening of trading on Thursday, according to S&P Dow Jones Indices.
Arcus stock was advancing 13.13% to $39.47 in premarket trading.
Atara Completes Sale Of Cell Therapy Manufacturing Unit to Fujifilm Subsidiary
Atara Biotherapeutics, Inc. (NASDAQ:ATRA) announced FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Holdings Corporation (OTC:FUJIY), has completed the acquisition of Atara's cell therapy manufacturing facility in Thousand Oaks, California for $100 million upfront and the commencement of a long-term strategic supply agreement. This partnership and acquisition were first announced in January.
The agreement is expected to reduce Atara's planned operating expenses over the multiyear partnership period. The upfront consideration, along with the reduction in operating expenses, in addition to Atara's existing cash, cash equivalents and short-term investments is expected to fund Atara's planned operations into the fourth quarter of 2023.
Viridian Strikes Agreement For Up to $75M In Debt Financing
Viridian Therapeutics, Inc. (NASDAQ:VRDN) said it has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE:HTGC) for up to $75 million.
TFF Pharma Gains On Insider Buying
TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) disclosed in two separate filings that two of its directors bought shares in the company or stock option to buy common stock.
The stock was adding 6.32% to $7.40 in premarket trading.
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On The Radar
PDUFA Dates
The FDA is scheduled to rule on BioXcel Therapeutics, Inc.'s (NASDAQ:BTAI) new drug application for BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders.
Clinical Readouts/Presentations
American Academy of Neurology Annual Meeting Presentations
Fulcrum Therapeutics, Inc. (NASDAQ:FULC): Phase 2 data for losamapimod in patients with facioscapulohumeral muscular dystrophy
Sage Therapeutics, Inc. (NASDAQ:SAGE): data from the Phase 2 Luminary study of SAGE-718 in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD): Phase 3 efficacy and safety of trofinetide for the treatment of Rett syndrome
Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures