Zevra Therapeutics Inc
NASDAQ:ZVRA
Zevra Therapeutics Inc
Zevra Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company, which engages in the discovery and development of proprietary prodrugs. The company is headquartered in Celebration, Florida and currently employs 36 full-time employees. The company went IPO on 2015-04-16. The firm is engaged in creating therapies for diseases with limited or no treatment options. The firm has a diverse portfolio of products and product candidates, which includes a combination of both a clinical-stage pipeline and commercial stage assets. The company employs its LAT platform technology to create a portfolio of approved products. Its product candidates include Arimoclomol, KP1077IH, KP1077N and AZSTARYS. Arimoclomol is an orally delivered, investigational product candidate being developed for Niemann-Pick disease type C (NPC). KP1077 is the Company's lead clinical development product candidate, which is being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), the Company's prodrug of d-methylphenidate (d-MPH). AZSTARYS is a prodrug for the treatment of ADHD in patients aged six years or older.
Zevra Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company, which engages in the discovery and development of proprietary prodrugs. The company is headquartered in Celebration, Florida and currently employs 36 full-time employees. The company went IPO on 2015-04-16. The firm is engaged in creating therapies for diseases with limited or no treatment options. The firm has a diverse portfolio of products and product candidates, which includes a combination of both a clinical-stage pipeline and commercial stage assets. The company employs its LAT platform technology to create a portfolio of approved products. Its product candidates include Arimoclomol, KP1077IH, KP1077N and AZSTARYS. Arimoclomol is an orally delivered, investigational product candidate being developed for Niemann-Pick disease type C (NPC). KP1077 is the Company's lead clinical development product candidate, which is being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), the Company's prodrug of d-methylphenidate (d-MPH). AZSTARYS is a prodrug for the treatment of ADHD in patients aged six years or older.
Revenue Growth: Zevra reported third quarter net revenue of $26.1 million, largely driven by strong performance from MIPLYFFA, which contributed $22.4 million.
MIPLYFFA Success: MIPLYFFA continues to see strong uptake in the US, with a total of 137 prescription enrollment forms received since launch—about 40% of the diagnosed Niemann-Pick disease type C (NPC) population.
European Expansion: The Marketing Authorization Application for MIPLYFFA has been validated and is under review by the European Medicines Agency, with 92 patients enrolled in the Expanded Access Program.
Cost Discipline: Operating expenses decreased significantly year-over-year, resulting in a net loss of only $0.5 million for the quarter compared to $33.2 million a year ago.
Strong Balance Sheet: Zevra ended Q3 with $230.4 million in cash, cash equivalents, and investments, giving it the resources to fund ongoing growth initiatives.
OLPRUVA Scale-back: Zevra is scaling back sales and marketing for OLPRUVA due to limited market traction, shifting focus and resources to MIPLYFFA.
Improved Payer Coverage: MIPLYFFA’s covered lives increased to 66% in Q3, up from 52% in the previous quarter, supporting broader patient access.
