European Commission Declines To Renew Marketing Authorization Of Translarna Duchenne Muscular Disorder PTC Therapeutics' Translarna loses EU conditional approval, but countries may allow continued use. PTC submitted four FDA applications, all under review.
PTC Therapeutics Reveals New Sepiapterin Data From Phase 3 Study In Patients With Inherited Disorder, FDA Decision Expected In July PTC Therapeutics presented new Phase 3 data on sepiapterin, showing potential benefits for PKU patients ahead of key regulatory decisions in 2025.
UniQure Stock Nearly Doubles After Striking A Deal With The FDA For Huntington's Drug The company is testing a gene therapy for Huntington's disease and could soon seek an accelerated approval.
Novartis Touts Encouraging Data From Late-Stage Study For Fabhalta In Rare Type Of Blood Disorder Novartis reports positive Phase 3B results for Fabhalta in PNH patients, highlighting improved hemoglobin levels and consistent safety profile after 24 weeks.
PTC Therapeutics Inks Licensing Pact With Novartis Worth Up To ~$3 Billion For Huntington's Program PTC Therapeutics partners with Novartis for its PTC518 Huntington's program in a deal valued up to $2.9 billion, including milestones and royalties.
FDA Grants Conditional Approval For PTC Therapeutics' Gene Therapy As First Ever With Direct Administration In Brain PTC Therapeutics' Kebilidi gains FDA accelerated approval as the first brain-administered gene therapy in the U.S. for AADC deficiency treatment.
3 Top Stocks That Could Still Rocket Higher in 2024 Upcoming Food and Drug Administration decisions could push these stocks through the roof.
PTC Therapeutics Stock Earns RS Rating Upgrade To 83 The Relative Strength (RS) Rating for PTC Therapeutics stock climbed into a new percentile Monday, with a rise from 80 to 83.
PTCT Stock Earnings: PTC Therapeutics Misses EPS, Beats Revenue for Q2 2024 PTCT stock results show that PTC Therapeutics missed analyst estimates for earnings per share but beat on revenue for the second quarter of 2024.
PTC Therapeutics Says FDA Lifts Clinical Hold On Investigational Study In Patients With Rare Weak Nerve Cell Disorder PTC Therapeutics released interim results from its Phase 2 PIVOT-HD study on PTC518 for Huntington's disease. The FDA has lifted the partial clinical hold on the program.
The 3 Most Undervalued Biotech Stocks to Buy in June 2024 https://seekingalpha.com/news/4111624-goldman-sachs-raises-obesity-drug-market-estimate
European Commission Requests Reevaluation Of Opinion On PTC Therapeutics' Duchenne Dystrophy Drug; Pauses Annual Guidance PTC Therapeutics announced that the European Commission has asked the CHMP to re-evaluate its negative opinion on the renewal of Translarna's conditional marketing authorization, keeping it available in Europe.
