BioXcel Turns To Commercialization With Positive Phase III Data In Agitation

The company is developing a sublingual thin film of dexmedetomidine that could be used to treat agitation in a wide range of indications after planned initial launches in schizophrenia and bipolar disorder.

soccer ball in goal
BioXcel scored in two Phase III trials • Source: Shutterstock

BioXcel Therapeutics, Inc.'s first potential drug candidate – a sublingual thin film of dexmedetomidine (BXCL501) – met the primary endpoints of two Phase III clinical trials, resulting in rapid and durable reductions in agitation in schizophrenia and bipolar disorder. The company announced the positive data from the SERENITY I and SERENITY II trials on 20 July and said it was turning its focus to regulatory filings and commercialization.

The company is targeting a regulatory filing in the first quarter of 2021 and investors applauded the news. BioXcel's stock...

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

More from Strategy

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

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

In Brief: BioVersys And Shionogi Align In Non-Tuberculous Mycobacteria R&D

 
• By 

Deal Snapshot: Having recently raised an $89m IPO, BioVersys is partnering on and optioning rights to a preclinical NTM development program with Shionogi.

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By 

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.

More from Business

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.

In Brief: Sanofi Cements Support For Adagene

 
• By 

Deal Snapshot: The French drugmaker has been shifting its investments away from cancer to focus on immunology and inflammation but it continues to seek out interesting early-stage oncology assets.

In Vivo CAR-T Interest Grows With AbbVie Acquisition

 

Acquiring Capstan gives AbbVie a stake in two competing in vivo CAR-T delivery platforms, with the field's first readouts expected in 2026.