north40000
10 months ago
New CPRX CEO Richard Daly is interviewed by IBD at investors.com. Pipeline discussion includes 3 rare disease, orphan drugsโFirdapse for treatment of neuromuscular conditions in small cell lung cancer patients, Fycompa for epilepsy and newly licensed Agamree with an NDA filed by partner Santhera for Duchenne muscular dystrophy.
Daly has previous experience with ABT, BMY, AZN, Takeda and 9 years on BOD of CPRX.
We hold 17k shares of CPRX in 2 portfolios.
tw0122
1 year ago
FDA approval Catalyst Pharmaceuticals Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera Pharmaceuticals
Source: GlobeNewswire Inc.
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today reported that Santhera Pharmaceuticals ("Santhera") has obtained U.S. Food and Drug Administration ("FDA") approval for AGAMREE® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy ("DMD") in patients aged two years and older. AGAMREE offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need. In July 2023, Catalyst secured the exclusive North American license and commercial rights for AGAMREE from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for AGAMREE to Catalyst.
FDAโs approval of AGAMREE® was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for a period of up to 48 months. Compared with current standard-of-care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory, and behavior.
โWe strongly believe that this novel steroid has the transformational potential to make a significant difference for patients living with Duchenne Muscular Dystrophy and potentially other chronic inflammatory diseases. The approval of AGAMREE underscores the potential of reshaping the DMD treatment paradigm for this life-threatening rare disease. The addition of AGAMREE expands our rare neuromuscular disease portfolio, and we look forward to executing on our proven commercial capabilities to bolster our long-term growth potential,โ said Patrick J. McEnany, Chairman and CEO of Catalyst Pharmaceuticals. โOur unwavering commitment extends beyond this important milestone as we are resolute in our mission to ensure that DMD patients in the U.S. have access to this treatment option as we believe that AGAMREE may offer the potential of increasing the duration of ambulation and mobility in these patients, thereby significantly improving their overall quality of life. We expect to launch the product in the first quarter of 2024. At that time, we will introduce a comprehensive financial assistance program aimed at helping ensure accessibility and minimizing patient co-pays and deductibles, thereby enhancing affordability for all DMD patients. We look forward to successfully commercializing this product with a continued commitment to serving our patient communities."
Upon the transfer of AGAMREE's NDA into its neuromuscular franchise, Catalyst will harness its product portfolio synergies by leveraging its well-established expertise and proven commercial capabilities. The Company plans to launch the product in Q1 2024, spearheaded by its seasoned and experienced U.S. commercial and medical affairs neuromuscular teams.
AGAMREE was granted Orphan Drug and Rare Pediatric Disease designations status for DMD in the U.S. and will be eligible for seven years of orphan drug exclusivity upon approval date and has issued pending patents that could provide protection until 2040.
georgie18
4 years ago
CPRX...$4.37...CORAL GABLES, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that its Board of Directors has authorized the repurchase of up to $40 million of shares of Catalyst's outstanding common stock.
georgie18 Monday, 03/01/21 05:56:40 AM
Re: None 0
Post #
4106
of 4108
CPRX...$3.89...Cup N Handle Continuation Pattern setting up here...Handle needs to Break/Hold the $5 range for confirmation...imo...we shall see...
Chart...https://schrts.co/BkZsqTNi
georgie18
4 years ago
CPRX...$3.42...in the P/M...8K...https://www.otcmarkets.com/filing/html?id=14491440&guid=EvceUWsDF2zCrth
Q3-20 Financial Results
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Product revenue, net in the third quarter of 2020 was $29.2 million, compared to $30.9 million for the third quarter of 2019.
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Operating income for the third quarter of 2020 was $11.7 million, compared to $13.8 million in the third quarter of 2019.
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Reported net income of $43.3 million, or $0.42 per basic and $0.41 per diluted share, in the third quarter of 2020, compared with net income of $13.6 million, or $0.13 per basic and diluted share, for the third quarter of 2019.
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Net income in the third quarter of 2020 includes $31.3 million ($0.30 per basic and $0.29 per diluted share) of benefit from recording of deferred tax asset, upon reversal of valuation allowance.
georgie18
4 years ago
CPRX...$3.23...CORAL GABLES, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a new U.S. patent to Catalyst Pharmaceuticals for Firdapse® (amifampridine), U.S. Patent No. 10,793,893, Methods of Administering 3,4-Diaminopyridine, expiring April 7, 2034.
whytestocks
5 years ago
News: $CPRX 3 Stocks Robinhood Investors Love
Robinhood, a free app offering commission-free trading of stocks, options, and more, has attracted a lot of attention in recent months. Many investors who use it seem drawn to specific names, and they're not necessarily stocks that receive a lot of coverage. Among Robinhood's 100 most popular s...
Got this from CPRX - 3 Stocks Robinhood Investors Love
georgie18
5 years ago
CPRX...$3.87...in the P/M...CORAL GABLES, Fla., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/128,672. The allowed application, "Methods of Administering 3,4-Diaminopyridine", claims a method of treating a human patient diagnosed with a 3,4-DAP sensitive disease by administering 3,4-DAP (or salts thereof) to slow acetylating patients having certain mutations in each allele of the NAT2 gene.
https://www.otcmarkets.com/stock/CPRX/news/story?e&id=1667289
georgie18
5 years ago
CPRX...$4.14...in the P/M...CORAL GABLES, Fla., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that Canadaโs national healthcare regulatory agency, Health Canada, has approved the use of Firdapse® (amifampridine) for the treatment of patients in Canada with Lambert-Eaton myasthenic syndrome (LEMS), an ultra-rare, debilitating and potentially life-threatening neurodegenerative condition.