CPRX
Catalyst Pharmaceutical Partners, Inc.NASDAQ
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  • Wed, Nov. 9, 4:41 PM
    | Wed, Nov. 9, 4:41 PM
  • Mon, Oct. 31, 8:58 AM
    • Nano cap Catalyst Pharmaceuticals (NASDAQ:CPRX) is up 14% premarket on average volume on response to its announcement that the FDA has approved the company's protocol for its second Phase 3 clinical trial assessing Firdapse (amifampridine phosphate) for the treatment of symptoms of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness in the limbs.
    • The two-site, double-blind, placebo-controlled, parallel design withdrawal study will enroll ~28 patients. The co-primary endpoints will be the same as the first Phase 3: the change from baseline in Quantitative Myasthenia Gravis at Day 14 and the change from baseline in Subject Global Impression (SGI) score at Days 8 and 14. The trial should commence this quarter.
    • Earlier this year, the company received a "Refusal to File" letter from the FDA in response to its initial NDA submission, meaning that the filing was incomplete and would require additional data.
    • Amifampridine enhances neuromuscular transmission by blocking the potassium channel. This causes depolarization of the presynaptic membranes which opens the calcium channel thereby enabling muscle fibers to contract.
    | Mon, Oct. 31, 8:58 AM | 4 Comments
  • Fri, Oct. 7, 11:57 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) upgraded to Outperform from Market Perform by BMO Capital. Price target raised to $48 (42% upside) from $42.
    • Catalyst Pharmaceuticals (NASDAQ:CPRX) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $4 (199% upside) from $1.
    • AmerisourceBergen (NYSE:ABC) upgraded to Market Outperform from Market Perform by Avondale Partners.
    • Alnylam Pharmaceuticals (NASDAQ:ALNY) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $40 (14% upside) from $107. Downgraded to Equal Weight from Overweight by Barclays. Price target lowered to $50 (42% upside) from $85. Downgraded to Neutral from Overweight by JPMorgan. Downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $36 (3% upside) from $38.
    • Merrimack Pharmaceuticals (NASDAQ:MACK) downgraded to Neutral from Overweight with a $5.75 (2% upside) price target by JPMorgan.
    • Iradimed (NASDAQ:IRMD) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $11.50 (11% upside) from $28.
    • Trinity Biotech (NASDAQ:TRIB) downgraded to Equal Weight from Overweight by Stephens & Co.
    • Depomed (NASDAQ:DEPO) downgraded to Neutral from Buy by Mizuho Securities.
    • Align Technology (NASDAQ:ALGN) downgraded to Neutral from Overweight with a $96 (8% upside) price target by Baird.
    | Fri, Oct. 7, 11:57 AM | 16 Comments
  • Wed, Oct. 5, 1:05 PM
    • Micro cap Catalyst Pharmaceuticals (CPRX +28.6%) breaks out from a brief consolidation on a healthy 15x surge in volume. Shares have rallied over 123% since bottoming at $0.68 on July 28.
    • No particular news accounts for today's action other than an upgrade by Piper Jaffray to Overweight with a $4 price target, but an upgrade does not normally result in such a large spike in volume. On September 30, Nasdaq informed the company that it regained compliance with its listing requirements by virtue of its stock remaining above the $1.00 minimum bid price.
    • The positive money flow is most certainly connected to the company's progress on a new Phase 3 study to support a regulatory filing for Firdapse (amifampridine phosphate) for the treatment of an autoimmune disorder called Lambert-Eaton myasthenic syndrome. Earlier this year, the company received a "Refusal to File" letter from the FDA in response to its initial submission, meaning that the filing was incomplete and would require additional data. In June, the company finalized the study protocol with the agency. Enrollment is now underway. According to ClinicalTrials.gov, the estimated study completion date is October 2017.
    | Wed, Oct. 5, 1:05 PM
  • Wed, Oct. 5, 12:46 PM
    | Wed, Oct. 5, 12:46 PM | 2 Comments
  • Wed, Oct. 5, 11:01 AM
    | Wed, Oct. 5, 11:01 AM
  • Wed, Oct. 5, 9:18 AM
    | Wed, Oct. 5, 9:18 AM | 2 Comments
  • Fri, Sep. 23, 12:45 PM
    | Fri, Sep. 23, 12:45 PM | 2 Comments
  • Fri, Sep. 23, 11:01 AM
    | Fri, Sep. 23, 11:01 AM | 5 Comments
  • Wed, Aug. 24, 12:48 PM
    | Wed, Aug. 24, 12:48 PM
  • Wed, Aug. 24, 11:02 AM
    | Wed, Aug. 24, 11:02 AM
  • Tue, Aug. 9, 4:48 PM
    | Tue, Aug. 9, 4:48 PM | 12 Comments
  • Mon, Jun. 13, 12:37 PM
    • Micro cap Catalyst Pharmaceuticals (CPRX +6.9%) is up on more than double normal volume in response to its announcement that it has reached agreement with the FDA on the protocol for its Phase 3 confirmatory study assessing Firdapse (amifampridine phosphate) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), an autoimmune disorder characterized by muscle weakness in the legs, face and neck. A small single-center study, part of the protocol, is expected to commence later this year.
    • Several months ago, the company received a "Refusal to File" letter from the FDA in response to its New Drug Application (NDA) meaning that the filing was incomplete and would require additional clinical data.
    • Amifampridine enhances neuromuscular transmission by blocking the potassium channel. This causes depolarization of the presynaptic membranes which opens the calcium channel thereby enabling muscle fibers to contract.
    • Previously: Catalyst Pharma down 48% after FDA says new Phase 3 study needed for Firdapse NDA (April 26)
    | Mon, Jun. 13, 12:37 PM
  • Tue, May 17, 9:51 AM
    | Tue, May 17, 9:51 AM
  • Tue, May 10, 5:13 PM
    • Catalyst Pharmaceutical (NASDAQ:CPRX): Q1 EPS of -$0.07 in-line.
    | Tue, May 10, 5:13 PM
  • Tue, Apr. 26, 12:46 PM
    | Tue, Apr. 26, 12:46 PM | 2 Comments