1. Scrip
  2. >>Therapy Areas

Insmed plummets on FDA prolonged hold on Arikace programme

 
• By Donna Young

Shares of Insmed tumbled as low as 36.8%, or $1.60, on 10 October after the Monmouth Junction, New Jersey-based firm revealed the US FDA plans to continue the clinical hold placed on the company's Phase III trials for Arikace (liposomal amikacin for inhalation) in cystic fibrosis patients with Pseudomonas lung infections.

Shares of Insmed tumbled as low as 36.8%, or $1.60, on 10 October after the Monmouth Junction, New Jersey-based firm revealed the US FDA plans to continue the clinical hold placed on the company's Phase III trials for Arikace (liposomal amikacin for inhalation) in cystic fibrosis patients with Pseudomonas lung infections.

Insmed said it has not yet received a response from the agency about the hold on its nontuberculous mycobacterial (NTM)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Musculoskeletal

More from Therapeutic Category

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By Kevin Grogan

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 
• By Sushmita Panda

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 
• By Alaric DeArment

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.