Welcome to our dedicated page for Catalyst Pharmaceuticals news (Ticker: CPRX), a resource for investors and traders seeking the latest updates and insights on Catalyst Pharmaceuticals stock.
Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) is a biopharmaceutical leader focused on rare neuromuscular and neurological disorders, including its FDA-approved therapy for Lambert-Eaton Myasthenic Syndrome (LEMS). This page provides official updates and analysis of Catalyst's developments in drug commercialization, regulatory milestones, and clinical research.
Investors and healthcare professionals can monitor critical updates including FDA decisions, clinical trial progress, and strategic partnerships. All content is sourced from verified filings, press releases, and reputable financial analysis to ensure accuracy.
Key focus areas include developments around Firdapse® commercialization, pipeline advancements for CPP-115, and regulatory strategies for orphan drug designations. The curated news collection enables efficient tracking of Catalyst's position in the competitive rare disease therapeutics market.
Bookmark this page for consolidated access to Catalyst's latest business and scientific developments. Check regularly for updates impacting the company's growth trajectory in a sector where regulatory approvals directly influence market performance.
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.
Catalyst Pharmaceuticals reported strong financial results for Q3 2021, achieving $35.9 million in FIRDAPSE revenue, a 23.1% increase year-over-year. The company plans to expand U.S. approval of FIRDAPSE to include pediatric LEMS patients. Catalyst's cash position stands at $174.8 million, bolstering its long-term growth strategy. The company also received favorable court support for orphan drug exclusivity and made strategic decisions for sustainable growth. However, GAAP net income for Q3 2021 was $10.3 million, down from $43.3 million in Q3 2020, due to a significant prior year tax asset.
Catalyst Pharmaceuticals (CPRX) announced it will release its Q3 2021 financial results after market close on November 9, 2021. Following this, a conference call and webcast are scheduled for November 10, 2021, at 8:30 AM EST to discuss the results and provide a corporate update. The call can be accessed via US/Canada dial-in at (877) 407-8912 or international at (201) 689-8059. Catalyst focuses on developing medicines for rare diseases, notably FIRDAPSE, approved in the US and Canada for LEMS treatment.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced a favorable ruling from the 11th Circuit Court of Appeals regarding the FDA approval of Ruzurgi® for pediatric LEMS patients, which conflicted with Catalyst's Orphan Drug exclusivity for Firdapse® (amifampridine). The court remanded the case to enforce Catalyst's exclusivity rights. Catalyst aims to ensure uninterrupted access to Firdapse® for patients, including transitioning from Ruzurgi®. The company emphasizes the importance of Orphan Drug incentives in developing treatments for rare diseases, especially given the 6,500 rare diseases without approved therapies.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that its CEO Patrick J. McEnany and CSO/COO Steven Miller, Ph.D., will participate in the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 9:05 AM EDT. The event will feature a presentation and virtual one-on-one meetings. The webcast will be available on the company's website, with a replay accessible for 14 days. Catalyst focuses on developing high-quality medicines for rare diseases, including Firdapse® for LEMS. Firdapse® is also being evaluated for MuSK-MG and has received Orphan Drug Designation.
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