Catalyst Collapses On FDA Firdapse Refusal

Investors hit Catalyst Pharmaceuticals Inc. hard on Feb. 17, driving shares down 50%, after the company disclosed the FDA refused to file (RTF) the Florida firm's new drug application (NDA) for Firdapse (amifampridine phosphate), a 3,4-diaminopyridine phosphate, as a symptomatic treatment for two very rare neuromuscular diseases – Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Investors hit Catalyst Pharmaceuticals Inc. hard on Feb. 17, driving shares down 50%, after the company disclosed the FDA refused to file (RTF) the Florida firm's new drug application (NDA) for Firdapse (amifampridine phosphate), a 3,4-diaminopyridine phosphate, as a symptomatic treatment for two very rare neuromuscular diseases – Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

The Catalyst stock ended the day at $1.16, down 69 cents, or a loss of 37.3%.

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 Anticancer

More from Therapy Areas

ASCO: AstraZeneca Changes Management Of Breast Cancer Resistance With SERENA-6

 

AstraZeneca presented data from the SERENA-6 trial that experts said could represent a significant change in how HR+/HER2- breast cancer is treated.

ASCO: Rusfertide Inches Toward FDA Filing With Positive 32-Week Data

 

Takeda/Protagonist are awaiting 52-week data to confirm the results from the VERIFY trial of the drug in polycythemia vera.

ASCO: Trodelvy First-Line TNBC Data Seen As Potentially Practice-Changing

 

Gilead chief medical officer Dietmar Berger said in an interview that the company plans to quickly take the results to regulators and foresees broad first-line use of the drug.