July 2025 – Page 7

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

1 month ago talkbio0Tagged Antineoplastic Agents, Clinical Trial Design, Complete, Drops - Drug Form, Frequency of Responses, melanoma, Prices, Rejection, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

Alkermes Advances Narcolepsy Therapy with Promising Phase 2 Trial Results for Alixorexton

1 month ago talkbio0Tagged alixorexton, Alkermes, Cataplexy, Daytime Somnolence, Excessive (qualifier value), late-stage testing, Narcolepsy, Narcolepsy type 1, normative wakefulness, Orexin Receptor Agonist, Vibrance-1 study

Alkermes; narcolepsy; alixorexton; Phase 2 trial; orexin 2 receptor agonist; narcolepsy type 1; normative wakefulness; late-stage testing; Vibrance-1 study; cataplexy; excessive daytime sleepiness

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

1 month ago talkbio0Tagged Antisense Oligonucleotides, Aortic Valve Insufficiency, Automation, Biogen, Biotechnology, expansion, gene therapy, Investments, Manufacturing, North Carolina, Research Triangle Park

Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

1 month ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

1 month ago talkbio0Tagged ELEVIDYS, gene therapy, Liver Failure, Market, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Authority, United States Food and Drug Administration, Withdraw (activity)

FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority

FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

1 month ago talkbio0Tagged Advisory Committees, brexpiprazole, Clinical Trials, drug efficacy, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Rexulti, sertraline, United States Food and Drug Administration

Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

1 month ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy