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Catalyst Pharmaceuticals

$3.57

0.31 (9.51%)

08:50
06/12/19
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08:50
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08:50

Catalyst Pharmaceuticals files federal lawsuit against FDA

Catalyst Pharmaceuticals announced it has filed a suit against the U.S. Food and Drug Administration and several related parties challenging the recent approval of a new drug application and related drug labeling for Jacobus Pharmaceutical Company's drug Ruzurgi for the treatment of Lambert-Eaton Myasthenic Syndrome in pediatric patients. The complaint was filed in the United States District Court for the Southern District of Florida. The complaint alleges that the defendants' approval of Ruzurgi violated multiple provisions of FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act; violated Catalyst's statutory rights to Orphan Drug Exclusivity and to New Chemical Entity Exclusivity under the FDCA; and was in multiple other respects arbitrary, capricious, and contrary to law, in violation of the Administrative Procedure Act. Among other remedies, the suit seeks an order vacating the FDA's approval of Ruzurgi. "New chemical entities are required to go through the full drug approval process which requires demonstration of safety and efficacy," said CEO Patrick McEnany. "We believe the FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst's orphan drug exclusivity. We are compelled to bring this action, to preserve the specialized regulatory framework provided by the Orphan Drug legislation, and the prospect of future rare disease drug development for all rare disease patients in need of an approved treatment."

CPRX Catalyst Pharmaceuticals
$3.57

0.31 (9.51%)

03/19/19
HCWC
03/19/19
NO CHANGE
HCWC
Catalyst's initial launch of Firdapse 'strong,' says H.C. Wainwright
H.C. Wainwright analyst Andrew Fein reiterated a Buy rating and $9 price target on Catalyst Pharmaceuticals, saying the initial look at the Firdapse commercial launch suggests "healthy momentum" and "strong execution" on the part of the company. The analyst also noted that Firdapse is also being investigated in two Phase 3 trials for the treatment of anti-MuSK antibody positive myasthenia gravis and congenital myasthenic syndromes, with both trials planned to read out in the second half of 2019.
05/06/19
PIPR
05/06/19
NO CHANGE
Target $7.5
PIPR
Overweight
Ruzurgi approval to pressure Catalyst Pharmaceuticals, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro kept his Overweight rating and $7.50 price target on Catalyst Pharmaceuticals but warned that the stock could come under pressure after the FDA's "unexpected" approval of Jacobus' amifampridine, or Ruzurgi, for the treatment of pediatric LEMS patients. Shares of Catalyst Pharmaceuticals were down over 41% after hours, and the analyst expressed uncertainty over whether the company's Firdapse would be able to maintain the orphan drug price point set at launch. Catanzaro expects the management of Catalyst Pharmaceuticals to comment on the development.
05/07/19
CANT
05/07/19
NO CHANGE
Target $10
CANT
Overweight
Jacobus approval should not impact Catalyst's Firdapse, says Cantor Fitzgerald
The FDA last night approved private company Jacobus' Ruzurgi for the treatment of Lambert-Eaton myasthenic syndrome in patients six to less than 17 years of age, Cantor Fitzgerald analyst Charles Duncan tells investors in a research note. This is the first drug approved for pediatric LEMS, the analyst points out. Catalyst Pharmaceuticals' slightly different salt form of amifampridine, marketed as Firdapse, was the first drug approved for LEMS, but for adults only, he notes. The analyst does not see the approval of Ruzurgi as having a large impact in Firdapse's market potential. He estimates that the pediatric population consists of less than 5% of the prevalent LEMS population. Duncan reiterates an Overweight rating on Catalyst shares with a $10 price target.
05/13/19
PIPR
05/13/19
NO CHANGE
Target $7.5
PIPR
Overweight
Piper says Catalyst's 'impressive' Firdapse sales clouded by Jacobus uncertainty
Piper Jaffray analyst Joseph Catanzaro raised his 2019 Firdapse estimates after the "impressive" results reported by Catalyst Pharmaceuticals in the first quarter of sales for the drug, but he also noted that the recent unexpected approval of Jacobus' Ruzurgi for the treatment of pediatric patients with LEMS puts his Firdapse estimates at risk. While acknowledging the potential implications of a Ruzurgi launch, the analyst raised his FY19 Firdapse sales estimate to $72.5M from $41.0M. Catalyst management said they expects Firdapse revenue to "substantially increase" in Q2 over Q1, but would not give 2019 guidance due to last week's news about Ruzurgi, noted Catanzaro, who keeps an Overweight rating and $7.50 price target on Catalyst shares.

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