Print

Catalyst has begun the process required to establish an expanded access program (EAP) to make Firdapse available in the US to patients diagnosed with LEMS through their neuromuscular disease specialists.  The product, currently in Phase III development, will be provided at no cost until sometime after approval.  Program enrollment will begin in the next few months, pending FDA review and approvals.

Patrick McEnany, CEO of Catalyst said, “As part of our ongoing commitment to  the LEMS community, we are making Firdapse available to those who would like access to this investigational drug, but are unable to participate in clinical studies or to travel to sites where it is available.”

Patients diagnosed with LEMS or physicians treating such patients can call toll free 1-844-FIRDAPSE (1-844-347-3277) to inquire about this program.

http://bit.ly/1mDjgjT

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

Catalyst today closed its previously announced public offering of shares of its common stock. Catalyst sold 13,023,750 shares, including 1,698,750 from the overallotment. Priced at $2.21 per share, the net proceeds from the sale of the shares is expected to be $26.8 million.

Piper Jaffray & Co. acted as the sole book-running manager for the offering, with Roth Capital Partners and H.C. Wainwright & Co., LLC acting as co-managers.

http://bit.ly/1hzw4ja

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

 

Leave a comment

Catalyst priced its public offering of 11,325,000 shares of its common stock at $2.21 per share. Catalyst has also granted the underwriters a 30-day option to purchase up to an additional 1,698,750 shares of common stock to cover over-allotments, if any.

Net proceeds from the sale of the shares by Catalyst after expenses are expected to be approximately $23.3 million. Catalyst plans to use the net proceeds for:

  • Continuing development of Firdaps for the treatment for LEMS
  • Pre-commercialization activities relating to Firdapse
  • Continuing development of CPP-115
  • General corporate purposes

The offering is subject to customary closing conditions and is expected to close on April 8, 2014.

Piper Jaffray & Co. is acting as the sole book-running manager, Roth Capital Partners is acting as co-lead manager, and H.C. Wainwright & Co., LLC is acting as a co-manager with respect to this offering.

http://bit.ly/1ijC7uu

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

 

Leave a comment

Catalyst announced it intends to offer shares of its common stock in a public offering and to grant the underwriters a 30-day option to purchase additional shares to cover over-allotments, if any. Catalyst plans to use the net proceeds for:

  • Continuing development of Firdapse™ for the treatment for LEMS
  • Pre-commercialization activities relating to Firdapse™
  • Continuing development of CPP-115
  • General corporate purposes

Piper Jaffray & Co. is acting as the sole book-running manager. 

http://bit.ly/1mA4zLj

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

Catalyst announced that it has reached the patient enrollment target of 36 patients for the double-blind, placebo-controlled, discontinuation portion of its pivotal Phase 3 trial evaluating the safety and efficacy of Firdapse for the symptomatic treatment of LEMS. The Company continues to screen additional, previously identified LEMS patients who have expressed interest in participating in this study. As allowed in the protocol for this study, all LEMS patients who are not randomized can continue to receive Firdapse as participants in the two-year follow-up period.

The company is on track to report top-line results in the third quarter of 2014.

http://bit.ly/1dNrkvo

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

Today we announce the appointment of Barrett S. McGrath as Chief Commercial Officer, a newly created position. McGrath will lead the formation of Catalyst’s North America commercial strategy and organization. 

“With more than 30 years of commercial and business development experience in the orphan and ultra-orphan markets across a range of therapeutic areas, Barrett brings to Catalyst a depth of knowledge and expertise at a pivotal time,” said Patrick McEnany. “He has been a part of the development or execution of more than 20 launch programs. This experience will be invaluable as we begin our plans for an NDA submission of Firdapse to the FDA early next year and initiate pre-commercial activities.”

http://bit.ly/1phvLQG

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

Catalyst Pharmaceutical Partners announced that the independent Data Monitoring Committee (DMC) overseeing the Company’s ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) recommended that based on a review of safety and clinical data the trial should continue as planned.

The international, multicenter Phase 3 clinical trial is designed as a randomized, double-blind, placebo-controlled, discontinuation trial enrolling 36 patients diagnosed with LEMS. The trial is being conducted at 22 centers in the United States, Canada, South America and Europe.

http://bit.ly/1jqJDsJ

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

“Catalyst made significant progress towards our clinical and business goals in 2013,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “As a result, we are now close to completing enrollment of patients in our Phase 3 pivotal clinical trial for Firdapse™ to treat patients with Lambert-Eaton Myasthenic Syndrome. We are confident enrollment will be completed by the end of this quarter, with top-line data from the double-blind portion of our pivotal trial in the third quarter of this year.”

In addition to completing enrollment, Catalyst anticipates preparing for a regulatory NDA submission, announcing new hires and participating in disease awareness activities, which are all important to process of potentially gaining FDA approval.

http://bit.ly/PP8Yjf

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

This month, BioWorld’s Marie Powers, writes on the Firdapse™ cardiac safety study and it’s positive results.

Please read the article, and see what the next step is for Firdapse™ and what else Catalyst has in store for 2014.

http://cdn2.hubspot.net/hub/280996/file-467083034-pdf/BWT_010914_Catalyst.pdf

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

Leave a comment

Announcing positive results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals to assess the cardiac safety of Firdapse™ tablets (amifampridine also known as 3,4-DAP). Firdapse™ is approved in the E.U., where it is marketed by BioMarin. Firdapse™ is also currently in Phase 3 development in the U.S. for Lambert-Eaton Myasthenic Syndrome (LEMS) by Catalyst.

http://ir.catalystpharma.com/releasedetail.cfm?ReleaseID=817834

DISCLAIMER: Catalyst Pharmaceutical Partners, Inc. (Catalyst) is covered by the analysts at various brokerage firms that issue reports on the company.  Please note that any opinions, estimates or forecasts regarding Catalyst’s performance, clinical trials, company, management, competitors, forecasts made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Catalyst or its management. Catalyst does not by its reference above or distribution imply, and expressly disclaims, any endorsement of or concurrence with any information, estimates, forecasts, opinions, conclusions or recommendations provided by analysts.

1 Comment
Follow

Get every new post delivered to your Inbox.

Join 194 other followers

%d bloggers like this: