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Catalyst Pharmaceuticals, Inc. (CPRX)

NasdaqGS - NasdaqGS Delayed price. Currency in USD
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4.2701+0.2201 (+5.43%)
As of 2:34PM EDT. Market open.
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Trade prices are not sourced from all markets
Previous close4.0500
Open4.1200
Bid4.2700 x 1000
Ask4.2800 x 1800
Day's range4.0500 - 4.3300
52-week range2.5500 - 7.6700
Volume1,615,627
Avg. volume1,758,923
Market cap441.644M
Beta (5Y monthly)1.85
PE ratio (TTM)10.49
EPS (TTM)0.4070
Earnings date10 Aug 2020
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target est8.25
  • GlobeNewswire

    Catalyst Pharmaceuticals’ Firdapse® (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS

    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 Canada’s 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. Firdapse® was approved under Priority Review by Health Canada. The marketing application submitted to Health Canada included safety and efficacy data from Catalyst’s two previously reported multi-national clinical trials evaluating Firdapse® for the treatment of patients with LEMS, and the data from these trials was used to support the new drug submission (NDS) to Health Canada. Firdapse® was previously approved for marketing by the U. S. Food and Drug Administration and the European Commission in 2018 and 2009, respectively, and is currently being used to treat LEMS patients in the United States and in more than 15 additional countries.“At Catalyst, we are dedicated to changing the lives of patients suffering from rare neuromuscular diseases, and we are proud that we have brought forward an approved therapeutic option for patients in Canada suffering with LEMS. We anticipate continuing to interact with Health Canada as we try to expand the Firdapse® label to include other indications,” said Gary Ingenito, M.D., Ph.D., Catalyst’s Chief Medical and Regulatory Officer.“We are currently in discussions with a potential marketing and distribution partner in Canada to provide access for Firdapse®, patient-by-patient, as rapidly as possible,” said David Ailinger, Vice President of Business Development at Catalyst.About Lambert-Eaton Myasthenic Syndrome (LEMS)Lambert-Eaton myasthenic syndrome, or LEMS, is a rare autoimmune disorder, most often characterized by muscle weakness of the limbs.  The disease is caused by an autoimmune reaction where antibodies are formed against voltage gated potassium channels in the connection between nerves and the muscles they communicate with.  In approximately 50% of cases, LEMS is associated with an underlying malignancy, most commonly small-cell lung cancer, and in some individuals, LEMS is the first symptom of such malignancy.  LEMS generally affects the extremities, especially the legs.  As the disease most affects the parts of limbs closest to the trunk, difficulties with climbing stairs or rising from a sitting position are commonly noted.  Physical exercise and high temperatures tend to worsen the symptoms.  Other symptoms occasionally seen include weakness of the muscles of the mouth, throat, and eyes.  Individuals affected with LEMS also may have a disruption of the autonomic nervous system, including dry mouth, constipation, blurred vision, impaired sweating, and/or hypotension.About Firdapse® Firdapse® (amifampridine) 10 mg tablets is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing Acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission, and providing for improved muscle function.About Catalyst PharmaceuticalsCatalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG), and spinal muscular atrophy (SMA) Type 3. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is now commercially available in the United States. Prior to its approval, Firdapse® for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA. Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst can successfully commercialize its product in Canada on a profitable basis, (ii) whether Catalyst will reach an agreement with a marketing and distribution partner to commercialize its product in Canada, (iii) whether Catalyst will have competition in Canada for its product, (iv) the impact in the United States if an amifampridine product is purchased in Canada for use in the United States, and (v) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. CONTACT: Investor Contact Brian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media Contact David Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com

  • GlobeNewswire

    Catalyst Pharmaceuticals Announces Change to a Virtual Meeting Format for the 2020 Annual Meeting of Stockholders

    CORAL GABLES, Fla., Aug. 03, 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 a change in the format of its 2020 Annual Meeting of Stockholders (the "Annual Meeting") from an in-person meeting to a virtual-only meeting format. The change is being made as a result of the coronavirus outbreak (COVID-19) and in order to protect the health and safety of Catalyst's stockholders and employees. There will be no in-person meeting. As previously announced, the Annual Meeting will be held on Thursday, August 20, 2020 at 9:00 a.m. eastern time. Stockholders will be able to attend the Annual Meeting and submit questions and vote their shares during the Annual Meeting, from any location that has internet connectivity. Only stockholders of record at the close of business on June 22, 2020 ("Record Date") will be entitled to attend the virtual Annual Meeting. To register for the Annual Meeting, you should follow these instructions as applicable to the nature of your ownership of our common stock: * Registered Stockholders. If your shares are registered in your name with Continental Stock Transfer & Trust Company ("Continental"), and you wish to attend the online-only virtual Annual Meeting, go to www.cstproxy.com/catalystpharma/2020, enter the control number you received on your proxy card (printed in the box and marked with an arrow) and click on the "Click Here to Preregister for the Online Meeting" link at the top of the page. Just prior to the start of the meeting you will need to log back into the meeting site using your control number. Pre-registration is recommended but is not required to attend.   * Street Name Stockholders. Street name stockholders who wish to attend the online-only virtual Annual Meeting must obtain a legal proxy by contacting their account representative at the bank, broker, or other nominee that holds their shares and email a copy (a legible photograph is sufficient) of their legal proxy to proxy@continentalstock.com. Street name stockholders who email a valid legal proxy will be issued a meeting control number that will allow them to register to attend and participate in the online-only Annual Meeting. After contacting Continental, a street name stockholder will receive an e-mail prior to the meeting with a link and instructions for entering the virtual Annual Meeting. Street name stockholders should contact Continental at least five (5) business dates prior to the Annual Meeting date.Stockholders participating in the virtual Annual Meeting will be in a listen-only mode and will not be able to speak during the webcast. However, in order to maintain the interactive nature of the virtual meeting, virtual attendees are able to: (i) vote using the online meeting website, and (ii) submit questions or comments to Catalyst's officers during the meeting via e-mail or the virtual meeting webcast. Starting Monday, August 17, 2020 at 9:00 AM eastern time, stockholders may submit questions or comments before or during the meeting through the virtual meeting portal by typing in the "Submit a Question" box.Stockholders will also have the option to call in to the virtual Annual Meeting by telephone and listen (in listen-only mode) by calling: Within the U.S. and Canada1-888-965-8995 (toll free)   Outside the U.S. and Canada1-415-655-0243 (standard rates apply)   Passcode for telephone access:09485747  We encourage you to access the Annual Meeting 15 minutes prior to the start time. Online check-in will begin at 8:45 a.m. eastern time.On or about July 6, 2020, Catalyst filed with the SEC and mailed to its stockholders a proxy statement (the "Proxy Statement") containing information about the matters to be considered at the Annual Meeting. In connection with the matters described in this press release, Catalyst is filing with the SEC and making available to its stockholders a supplement to its Proxy Statement ("Supplement") containing additional information about the matters to be considered at the Annual Meeting. Catalyst's Proxy Statement, its Supplement, and its annual report for the year ended December 31, 2019, are available for download on Catalyst's website at https://ir.catalystpharma.com/financial-information/annual-reports and on Continental's website at https://www.cstproxy.com/catalystpharma/2020.About Catalyst PharmaceuticalsCatalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse is now commercially available in the United States. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA.Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. CONTACT: Investor Contact Brian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media Contact David Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com

  • GlobeNewswire

    Catalyst Pharmaceuticals to Hold Second Quarter 2020 Financial Results and Corporate Update Conference Call and Webcast on Tuesday, August 11th, 2020

    CORAL GABLES, Fla., Aug. 03, 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 it will release second quarter 2020 financial results after market close on Monday, August 10, 2020. Further, Catalyst management will host an investment-community conference call at 8:30 a.m. ET on Tuesday, August 11, 2020 to discuss the financial results and to provide a corporate update. Investors who wish to participate in the conference call may do so by dialing (877) 407-8912 for domestic and Canadian callers or (201) 689-8059 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the company's website at www.catalystpharma.com and clicking on the webcast link on the Investors home page.A webcast replay will be available on the Catalyst website for 30 days following the call by visiting the Investor page of the company's website at www.catalystpharma.com.About Catalyst PharmaceuticalsCatalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse is now commercially available in the United States. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA.Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst's Annual Report on Form 10-K for fiscal year 2019 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. CONTACT: Investor Contact Brian Korb Solebury Trout (646) 378-2923 bkorb@troutgroup.com Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Media Contact David Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com