Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March
Amylyx Pharmaceuticals, Inc. AMLX said a virtual meeting of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee to review the new drug application for AMX0035 has been scheduled for March 30, 2022.
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis. The regulator is reviewing the company's application with a priority review designation and has assigned a PDUFA date of June 29.
Regencell Announces Positive Results From Study Of Liquid Formulation COVID Treatment
Regencell Bioscience Holdings Limited RGC announced positive results from an analysis of a total of 37 individuals enrolled in its study of its novel COVID-19 oral TCM candidate RGC-COV19.
The company said, upon successful completion of the EARTH efficacy trial, RGC-COV19 could be used more broadly for the treatment of the population who seek a natural and holistic approach to effectively reduce and eliminate COVID-19 symptoms and to reduce the risk of hospitalization and death.
J&J Unit Strikes Collaboration With Remix For Developing Small Molecule Therapies That Modulate RNA Processing
Johnson & Johnson's JNJ Janssen unit and Remix Therapeutics announced a strategic collaboration for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix's REMaster drug discovery platform.
Under the terms of the agreement, Remix will receive an initial payment of $45 million in cash for upfront and research funding. It may also receive preclinical, clinical, commercial and sales milestone payments and tiered royalties for any resulting products. In exchange, Janssen will have exclusive rights to three specific targets with applications in immunology and oncology.
Under the agreement, Remix is eligible to receive total payments potentially exceeding $1 billion, subject to regulatory approvals and other conditions.
Bristol-Myers Squibb's Application For Breyanzi Label Expansion Gets Priority Review
Bristol-Myers Squibb Company BMY said the FDA has accepted its supplemental biologics license application for Breyanzi, a CD19-directed CAR T cell therapy, to expand its current indication to include earlier use of Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy.
The FDA has granted the application priority review and assigned a PDUFA goal date of June 24.
Click here to access Benzinga's FDA calendar.
Concert Pharma Insiders Sell Shares
Concert Pharmaceuticals, Inc. CNCE disclosed in a series of filings with the SEC that its top officials, including its CEO Roger Tung, sold shares in the company.
10x Genomics, Inc. TXG said its fourth-quarter revenues rose 28% to $143.5 million and the net loss per share narrowed from $3.87 to 16 cents. The net loss per share, however, was wider than the 9 cents per share estimated by analysts.
The company guided 2022 revenues to $600 million to $630 million, below the consensus estimate of $679.87 million.
The stock was sliding 24.65% to $71.57 in premarket trading.
Outset Medical, Inc.'s OM fourth-quarter revenues climbed 63.2% to $28.2 million and the non-GAAP loss per share widened from 60 cents to 77 cents. The company guided full-year revenues to $142 million to $150 million, above the consensus estimate of $140.44 million.
The stock was up 5.2% at $36 in premarket trading.
On The Radar
The FDA is scheduled to rule on Agios Pharmaceuticals, Inc.'s AGIO new drug application for mitapivat, its most advanced drug candidate, as a treatment option for pyruvate kinase deficiency. PKD is a rare, inherited disease that presents as chronic hemolytic anemia, which is the accelerated destruction of red blood cells.
European Crohn's and Colitis Organization Congress Presentations
Galapagos NV GLPG & Gilead Sciences, Inc. GILD: new analyses from Phase 2/3 SELECTION and Phase 3 SELECTION long-term extension studies of Jyseleca (filgotinib) in ulcertative colitis
West Pharmaceutical Services, Inc. WST (before the market open)
Syneos Health, Inc. SYNH (before the market open)
Insmed Incorporated INSM (before the market open)
Repligen Corporation RGEN (before the market open)
T2 Biosystems, Inc. TTOO
Quidel Corporation QDEL
Coherus BioSciences, Inc. CHRS
Prothena Corporation plc PRTA
Globus Medical, Inc. GMED
Ligand Pharmaceuticals Incorporated LGND
Ironwood Pharmaceuticals, Inc. IRWD
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