Catyalyst Pharma (CPRX): FDA Agreement Derisks Firdapse - HC Wainwright

November 14, 2016 7:35 AM EST
Get Alerts CPRX Hot Sheet
Price: $1.10 +2.80%

Rating Summary:
    8 Buy, 0 Hold, 0 Sell

Rating Trend: Up Up

Today's Overall Ratings:
    Up: 11 | Down: 31 | New: 42
Trade CPRX Now!
Join SI Premium – FREE

Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.

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.

For an analyst ratings summary and ratings history on Catalyst Pharmaceutical Partners click here. For more ratings news on Catalyst Pharmaceutical Partners click here.

Shares of Catalyst Pharmaceutical Partners closed at $1.14 yesterday.



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In






Related Categories

Analyst Comments

Related Entities

H.C. Wainwright

Add Your Comment