PTC Therapeutics Reports Third Quarter Financial Results and Provides Corporate Update PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the third quarter ended September 30,...

SOUTH PLAINFIELD, N.J. , Nov. 6, 2014 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the third quarter ended September 30, 2014 .

"During the quarter we continued to make significant progress during this transformative time for PTC. For the first time in the company's history, we recognized revenue from the sale of Translarna™ (ataluren) for the treatment of Duchenne muscular dystrophy through our European reimbursed early access programs. Furthermore, before the end of the year, we plan to begin submitting a New Drug Application with the FDA on a rolling basis for Translarna as a treatment for nonsense mutation Duchenne muscular dystrophy (nmDMD). We are committed to making Translarna available to all patients who may benefit and this is another step forward in achieving this goal," stated Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "We continued to expand our clinical efforts with the completion of enrollment for our confirmatory Phase 3 ACT DMD clinical trial, the initiation of our confirmatory Phase 3 ACT CF clinical trial, the preparation of a Phase 2 proof-of-concept study of Translarna in MPS I, and the anticipated initiation of a Phase 1b/2a clinical trial of RG7800 in spinal muscular atrophy patients in conjunction with our partners, Roche and the SMA Foundation. Our discovery efforts are also progressing with plans to file an investigational new drug application, or IND, with the FDA for PTC596, our cancer stem cell program, and the declaration of a development candidate in our antibacterial program. After recently completing a successful public equity offering where we raised net proceeds of approximately $117.5 million , PTC is well positioned to realize our goal of discovering, developing and commercializing new treatments that have the potential to transform the lives of patients."

Corporate Highlights:

Third Quarter 2014 Financial Highlights:

Today's Conference Call and Webcast Reminder: The PTC management team will host a conference call to discuss the company's financial results and recent and upcoming developments today, Thursday, November 6, 2014 , at 9:00 a.m. ET . The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 21354324.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors Relations" section of the company's website at ir.ptcbio.com . A replay of the webcast will be archived on the PTC website for 30 days following the call.

About PTC Therapeutics, Inc. PTC is a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and in collaborations with leading biopharmaceutical companies. PTC has received conditional marketing authorization in the European Economic Area for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Translarna is an investigational new drug in the United States . For more information on the company, please visit our website www.ptcbio.com

Forward Looking Statements: This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements, other than those of historical fact, contained in this release, including statements regarding the future expectations, plans and prospects for PTC; the timing and scope of our commercial launch; our Phase 3 clinical trials for Translarna™ (ataluren) in nmDMD and nmCF; our Phase 2 proof-of-concept study in MPS I; our collaboration in SMA with Roche and the SMA Foundation including anticipated milestone payments; our current and planned regulatory filings, including with the FDA and the EMA; our earlier stage programs, including BMI1 and our antibacterial program; our strategy, future operations, future financial position, future revenues or projected costs; the development of and potential market for Translarna and our other product candidates; and objectives of management, are forward-looking statements. Other forward-looking statements may be identified by the words "plan," "guidance," "anticipate," "believe," "estimate," "expect," "intend," "may," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.

Our actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements we make as a result of a variety of risks and uncertainties, including those related to the initiation and conduct of clinical trials, availability of data from clinical trials, expectations for regulatory approvals, our scientific approach and general development progress, the availability or commercial potential of Translarna and our other product candidates and the factors discussed in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q in PTC's most recent Quarterly Report as well as any updates to these risk factors filed from time to time in PTC's other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent PTC's views only as of the date of this press release. You are urged to carefully consider all such factors. The forward-looking statements contained herein represent PTC's views only as of the date of this press release, and we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this release except as required by law.

SOURCE PTC Therapeutics, Inc.