Catalyst Pharmaceutical Inc. - CPRX STOCK NEWS

Catalyst Pharmaceuticals (Nasdaq: CPRX) reported Q4-20 net revenues of $31.0 million, and FY-20 revenues of $119.1 million, a 16% increase year-over-year. Q4-20 net income was $11.4 million ($0.11 per share), while FY-20 net income soared to $75.0 million ($0.72 per share). The company ended 2020 with $140.3 million in cash and no debt. Catalyst plans to expand its product pipeline and invest in R&D in 2021. A national conference call is scheduled for March 16, 2021, to discuss these results and future strategies.

Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its fourth quarter and year-end 2020 financial results on March 15, 2021, after market close. An investment-community conference call is scheduled for March 16, 2021, at 8:30 a.m. ET to discuss these results. The call can be accessed by phone or via the company's website. Catalyst focuses on innovative therapies for rare neuromuscular and neurological diseases, including LEMS and MuSK-MG. Firdapse, its approved drug for LEMS, is commercially available in the U.S. and has also gained approval in Canada.

Catalyst Pharmaceuticals (Nasdaq: CPRX) supports Rare Disease Day 2021, emphasizing awareness for over 300 million people living with rare diseases. The company will participate in the 'Show Your Stripes' campaign and launch the 'Rare Reason' initiative on social media to highlight involvement in the rare disease community. Catalyst is sponsoring a Facebook Live event on February 26, 2021, to discuss topics related to rare diseases, featuring patient advocates and neurologists. Catalyst's FDA-approved therapy, Firdapse, is aimed at treating Lambert-Eaton myasthenic syndrome (LEMS).

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.