Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) announced that it will reduce its workforce by approximately 30%. The move will primarily affect the commercial team.
The decision to reduce the workforce is part of Catalyst’s efforts to conserve cash for completing the requirements for the submission of a new drug application (NDA) for Firdapse (amifampridine phosphate) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndrome (CMS).
We remind investors that the company had received a “refusal-to-file” letter from the FDA in Feb 2015 in connection with its NDA for Firdapse. The agency determined that the NDA was insufficient after a preliminary review. The company recently met with the FDA to get better clarity on the latter’s requirement of additional data to accept the NDA. The FDA informed that it needs positive results from an additional adequate and well-controlled study in patients with LEMS. Moreover, the company is required to conduct additional studies as per the FDA’s requirement, which will involve additional costs and a further delay in the NDA submission.
Since the studies involve extra costs, Catalyst is looking to reduce its operating expenses. The company expects to execute the workforce reduction with immediate effect. Management, however, believes that its currently available resources are sufficient for completing the development of and refile an NDA for Firdapse in LEMS and CMS.
Catalyst currently has a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include Pfizer Inc. (NYSE:PFE) , Johnson & Johnson (NYSE:JNJ) and Abbott Laboratories (NYSE:ABT) . All three stocks carry the same Zacks Rank as Catalyst.
PFIZER INC (PFE): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
ABBOTT LABS (ABT): Free Stock Analysis Report
CATALYST PHARMA (CPRX): Free Stock Analysis Report
Original post
Zacks Investment Research