Atara extends losses after FDA clinical hold
Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo.
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ: REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ...
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Oculis Is An Interesting Growth Bet On Non-Invasive Eye Care
Oculis' main value driver appears to be OCS-01, which targets a respectable $4B DME TAM with its non-invasive eye drops. See ...
Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch
Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a ...
Solid Biosciences: Differentiating Factors Of SGT-212 To Set Itself Apart
Initiation of Phase 1b study using SGT-212 for the treatment of patients with Friedreich's Ataxia expected in 2H25. Click ...
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has ...
RedHill stock rises on expanded Medicare coverage
Shares of RedHill Biopharma Ltd. (NASDAQ:RDHL) climbed 5% intra-day Tuesday following the announcement that its H. pylori treatment, Talicia, is now covered by Humana (NYSE:HUM)'s Part D Plan. This ...
Vertex Pharmaceuticals' SWOT analysis: stock outlook amid pipeline progress
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX), with a substantial market capitalization of $110.13 billion, continues to ...
FDA lifts clinical hold on Amylyx ALS drug study
Shares of Amylyx Pharmaceuticals (NASDAQ:AMLX) fell 13% in morning trading Tuesday amid news that an FDA clinical hold on a Phase 1 study for its ALS drug candidate AMX0114 has been lifted. Amylyx ...
What Makes Exelixis (EXEL) an Investment Bet?
Riverwater Partners, an investment management company, released its “Sustainable Value Strategy” Q4 2024 investor letter. A ...