Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) shared some key announcements yesterday regarding its progress for drug candidate Firdapse. First, the company has secured a Special Protocol Assessment (SPA) with the FDA for the Phase III study in the indication of MuSK antibody positive myasthenia gravis.
Another less positive note to bite back: the pharmaceutical company is no longer racing down the tracks for an NDA submission for Firdapse in Lambert-Eaton Myasthenic Syndrome (LEMS). While Catalyst had originally been set to submit this NDA by the close of 2017, the company is postponing this submission to the first quarter of 2018.
Analyst Edward Nash of SunTrust is content with Catalyst’s strides and is not fazed by the NDA delay, noting: “Importantly, the company is still on track to report top-line Phase III data from the LEMS trial in 4Q17. This guidance has been narrowed down from a previous 2H17 time-frame. We have made no adjustments to our model or forecasts and still anticipate a positive Phase III outcome from Firdapse for LEMS in 4Q17. This is the next major milestone for CPRX shares.”
As such, the analyst reiterates a Buy rating on CPRX stock with a $5 price target representing an 81% rise over current trading levels. (To watch the Nash’s track record, click here)
TipRanks analytics exhibit CPRX as a Strong Buy. Out of 3 analysts polled by TipRanks in the last 3 months, all 3 are bullish on Catalyst Pharmaceuticals stock. With a potential upside of near 103%, the stock’s consensus target price stands at $5.58