Catalyst Pharmaceutical Inc. - CPRX STOCK NEWS

Catalyst Pharmaceuticals (CPRX) announces participation in Rare Disease Day by ringing the Nasdaq opening bell on February 28, 2022. This event highlights the collaboration between the biopharma industry and patient advocacy groups to raise awareness and develop treatments for rare diseases. Approximately 30 million Americans are affected by rare disorders, yet only 5% of these diseases have approved treatments. Catalyst aims to support patients with Lambert-Eaton myasthenic syndrome (LEMS) through its FDA-approved drug FIRDAPSE.

Catalyst Pharmaceuticals announced the launch of a podcast named LEMS Aware aimed at raising awareness within the Lambert-Eaton Myasthenic Syndrome (LEMS) community. The podcast will feature discussions with patients, physicians, and advocates, focusing on topics unique to LEMS. The inaugural episode is set to release on February 28, 2022, coinciding with Rare Disease Day. This initiative underscores Catalyst's commitment to enhancing education and resources for patients, particularly as only 5% of over 7,000 rare diseases have an FDA-approved treatment.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced estimated total revenues for 2021 of approximately $141 million, up 18% year-over-year, with Q4 revenues of around $38 million, a 24% increase from 2020. Looking ahead, the company projects 2022 revenues between $195 million and $205 million, a growth of 38%-45%. Catalyst has regained orphan drug exclusivity in the U.S. for Amifampridine (FIRDAPSE) and enters 2022 with a strong cash position of $191 million and no funded debt, poised for potential acquisitions.

Catalyst Pharmaceuticals has achieved a significant legal victory as the District Court granted summary judgment in its lawsuit against the FDA. This ruling confirms that the FDA's approval of Ruzurgi® for treating pediatric patients with LEMS infringes on Catalyst's exclusivity rights for FIRDAPSE®. Consequently, the FDA's prior marketing approval for Ruzurgi® is invalid. Catalyst is prepared to assist patients transitioning from Ruzurgi® to FIRDAPSE®, ensuring uninterrupted treatment. The company remains focused on developing medicines for rare diseases.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced that the U.S. Court of Appeals for the 11th Circuit has favored the company in its lawsuit against the FDA, which will vacate FDA's approval of Ruzurgi, a competing amifampridine product. CEO Patrick J. McEnany stated the company is committed to ensuring patients' access to amifampridine for Lambert-Eaton myasthenic syndrome (LEMS). FIRDAPSE, Catalyst's approved treatment, remains available in the U.S. and Canada. The announcement notes potential risks related to further legal appeals and outcomes affecting Catalyst's future operations.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced that the 11th Circuit Court of Appeals denied Jacobus Pharmaceutical's petition for rehearing regarding the FDA's approval of Ruzurgi® for pediatric LEMS patients. This ruling supports Catalyst's position and anticipates a forthcoming mandate for summary judgment in their favor. CEO Patrick J. McEnany emphasized the company's commitment to patient care, ensuring uninterrupted access to amifampridine, whether through commercial or compassionate use programs. Catalyst aims to provide the necessary support to patients transitioning to FIRDAPSE.

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Patrick J. McEnany, Chairman and CEO, along with Dr. Steven Miller, CSO/COO, will participate in two investor conferences:

• Solebury Trout 1x1 Management Access Event: January 10-20, 2022, featuring one-on-one virtual meetings.
• H.C. Wainwright Global BIOCONNECT Virtual Conference: January 10-13, 2022, with a pre-recorded corporate presentation available on-demand.

Catalyst focuses on developing novel medicines for rare diseases, including FIRDAPSE® for Lambert-Eaton myasthenic syndrome.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced a significant milestone as its partner, DyDo Pharma, initiates a Phase 3 clinical study in Japan for FIRDAPSE® (amifampridine) targeting Lambert-Eaton myasthenic syndrome (LEMS). Currently, no approved treatments exist for this rare disorder in Japan. Catalyst's collaboration with DyDo, formalized through a sub-license agreement in June 2021, strengthens the potential for FIRDAPSE® to become a novel therapy in the region. The company will supply clinical and commercial support, earning milestones and revenue contingent on regulatory approval.

Catalyst Pharmaceuticals (Nasdaq: CPRX) announced participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. CEO Patrick J. McEnany and COO Steven Miller will engage in a pre-recorded fireside chat. A webcast of this discussion will be available on the company's website starting November 22, 2021, at 10:00 a.m. ET. Catalyst focuses on developing high-quality medicines for rare diseases, with its product FIRDAPSE approved by the FDA in 2018.