Noble Financial Keeps 'Buy' Rating on Cynapsus (CYNA) as APL-130277 Receives FDA Fast Track Designation
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Noble Financial affirms Cynapsus Therapeutics (Nasdaq: CYNA) with a Buy rating and $50 price target after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).
Analyst Nathan Cali noted the following on Monday:
- Importance of Fast Track Designation. Intends to expedite the approval process while granting invaluable access with the FDA; guidance is meant to closely track and aide ongoing clinical trials for a drug, submissions allowed on a rolling basis for FDA review to help ensure trial fluidity for a potential pathway to success; could lead to shorter review time
- Requirements for Fast Track Validate APL-130277 Clinical Program; obtaining Fast Track requires demonstration of either superior efficacy, avoiding serious side effects, decreasing toxicity or ability to address emerging anticipated public health need
- Price Target $50; Bullish on upcoming milestones. We estimate that the current cash balance of $55.1 million is sufficient to extend operations near 2018 and potential commercialization of APL-130277; data for APL-130277, Phase III efficacy trial expected in Q4-2016; possible NDA submission to take place in 1H-2017.
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