Catyalyst Pharma (CPRX): FDA Agreement Derisks Firdapse - HC Wainwright
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H.C. Wainwright analyst, Andrew Fein, reiterated his Buy rating on shares of Catalyst Pharmaceutical Partners (NASDAQ: CPRX) noting that the company recently reached an agreement with FDA on the protocol design, endpoints, and statistical analysis of the second Phase 3 study of Firdapse in LEMS.
Following the agency’s Refuse-to-File letter in response to the initial NDA earlier this year, the analyst believes that this SPA is a material step forward by derisking the Firdapse bull thesis from a regulatory point of view.
The analyst believes the regulatory component of the story had remained a source of anxiety for investors and believes the experimental and commercial components are relatively derisked leaving two key points to consider:
1) Firdapse works, based on commercial experience with the chemical relative 3,4-DAP, as well as based on the first Phase 3 study conducted by Catalyst
2) we believe that Catalyst should be able to easily penetrate a small orphan market that until now has struggled with the supply of compounded 3,4-DAP, and the company’s ongoing expanded access program should help with a successful rollover into commercial sales.
No change to the price target of $6.
Shares of Catalyst Pharmaceutical Partners closed at $1.14 yesterday.
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