Catalyst Pharmaceutical Inc. - CPRX STOCK NEWS

Catalyst Pharmaceuticals (CPRX) announced plans to expand its R&D focus, aiming for pipeline growth in earlier stage programs and validated technology platforms. The company reported an estimated $118 million in net revenues for 2020, a 16% increase from 2019, and concluded the year with an estimated $140 million in cash and investments. Catalyst intends to invest more in R&D, seeking a senior executive to oversee this strategy. The development of Firdapse LA is on track, with additional studies planned for HNPP starting in Q1 2021.

Catalyst Pharmaceuticals (CPRX) reported Q3 2020 net revenues of $29.2 million, a slight decrease from $30.9 million in Q3 2019. The company ended the quarter with $127.1 million in cash and investments. Net income surged to $43.3 million ($0.42 per share), bolstered by a $31.3 million tax benefit. A U.S. patent for Firdapse® was issued, expiring in April 2034, and the drug was approved in Canada. Research and development costs decreased to $3.7 million. Catalyst plans to expand Firdapse® commercialization and continue clinical trials for additional indications.

Catalyst Pharmaceuticals (CPRX) will announce its third-quarter 2020 financial results on November 9, 2020, after market close. An investment-community conference call is scheduled for November 10, 2020, at 8:30 a.m. ET to discuss these results and provide a corporate update. The call can be accessed via phone or streamed online through the company's investor webpage. Catalyst focuses on innovative therapies for rare neuromuscular diseases, including Firdapse®, which is approved in the U.S. and Canada for Lambert-Eaton myasthenic syndrome, and is under evaluation for other conditions.

On October 19, 2020, Catalyst Pharmaceuticals (Nasdaq: CPRX) filed lawsuits against Jacobus Pharmaceuticals and PantherRx Rare for infringing U.S. Patent No. 10,793,893, which relates to treatments using amifampridine, specifically targeting their Ruzurgi® product. Catalyst seeks damages and injunctive relief to halt Ruzurgi®'s marketing, asserting the necessity to protect its intellectual property and the investment made in neuromuscular drug development. The FDA-approved Firdapse® product is central to Catalyst's business model, with ongoing evaluations for other conditions.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the issuance of U.S. Patent No. 10,793,893 for Firdapse® (amifampridine), expiring April 7, 2034. This patent is expected to create barriers against generic competition, extending the exclusivity period by nine years beyond current orphan drug protections. The patent specifically addresses methods of administering the drug to slow metabolizers. Catalyst plans to submit the patent for listing in the FDA's Orange Book. Currently, Firdapse is approved for treating Lambert-Eaton myasthenic syndrome and is being evaluated for other conditions.

On September 29, 2020, Catalyst Pharmaceuticals (CPRX) announced that a federal judge ruled in favor of the FDA, dismissing Catalyst's case involving the approval of Ruzurgi® for pediatric LEMS patients. The judge found the Orphan Drug Act's language ambiguous and upheld the FDA's interpretation. Catalyst plans to appeal this decision to the Eleventh Circuit Court. Despite the ruling, Catalyst emphasized that it will continue its marketing for Firdapse® and protect its exclusivity under the Orphan Drug Act, as it represents 99% of the LEMS patient community.

Catalyst Pharmaceuticals (Nasdaq: CPRX) reported on Sept. 29, 2020, that a federal judge has dismissed its case against the FDA regarding the approval of Ruzurgi^® for pediatric LEMS treatment. The judge found the statutory language ambiguous and sided with the FDA's interpretation. Catalyst plans to appeal this decision to the Eleventh Circuit Court. Despite this setback, the approval for Ruzurgi^® remains intact, and the company's ongoing market efforts for Firdapse^®, which serves 99% of the LEMS patient community, will not be affected.

Catalyst Pharmaceuticals (Nasdaq: CPRX) has filed a legal proceeding in Canadian Federal Court against Health Canada concerning its recent approval of Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome (LEMS). Catalyst argues that Health Canada wrongly issued a Notice of Compliance (NOC) for Ruzurgi® despite granting data protection to its own product, Firdapse® (amifampridine phosphate), just 10 days prior. The company claims that Ruzurgi® improperly referenced Catalyst's data in its drug submission, infringing on the regulations meant to protect innovative drugs for eight years.

Catalyst Pharmaceuticals (Nasdaq: CPRX) has entered into an exclusive licensing agreement with KYE Pharmaceuticals to commercialize Firdapse® in Canada, aimed at treating Lambert-Eaton myasthenic syndrome (LEMS) in adults. Under this agreement, Catalyst will supply Firdapse® while KYE handles promotion, sales, and distribution. The partnership aims to enhance patient access to this therapy in Canada, where Firdapse® has recently received approval from Health Canada. CEO Patrick J. McEnany expressed optimism about the collaboration's potential impact on patients suffering from rare diseases.