Last $53.18 USD
Change Today -1.78 / -3.24%
Volume 63.6K
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As of 11:34 AM 01/28/15 All times are local (Market data is delayed by at least 15 minutes).

ptc therapeutics inc (PTCT) Snapshot

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ptc therapeutics inc (PTCT) Details

PTC Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery and development of orally administered, proprietary small-molecule drugs that target post-transcriptional control processes. Its lead product candidate is ataluren for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutations or nmCF. The company had completed a Phase IIb clinical trial of ataluren for the treatment of nmDMD and a Phase III clinical trial of ataluren for the treatment of nmCF. In addition, it develops spinal muscular atrophy, which is in Phase I clinical program. The company’s preclinical development programs include PTC596, a development candidate used for the treatment of chemotherapy resistant cancers; and antibacterial small molecule compounds for the treatment of life-threatening infections caused by multidrug-resistant Gram-negative bacteria. PTC Therapeutics, Inc. has collaborations with Roche and the SMA Foundation to develop and commercialize compounds identified under its spinal muscular atrophy sponsored research program; and AstraZeneca AB for the discovery and development of potential new therapies for cancer and other diseases. The company was founded in 1998 and is based in South Plainfield, New Jersey.

133 Employees
Last Reported Date: 03/6/14
Founded in 1998

ptc therapeutics inc (PTCT) Top Compensated Officers

Co-Founder, Chief Executive Officer and Execu...
Total Annual Compensation: $460.8K
Chief Commercial Officer
Total Annual Compensation: $368.2K
Compensation as of Fiscal Year 2013.

ptc therapeutics inc (PTCT) Key Developments

PTC Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 11:00 AM

PTC Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 11:00 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Stuart W. Peltz, Co-Founder, Chief Executive Officer and Executive Director.

PTC Therapeutics, Inc. Begins Rolling NDA Submission to the FDA for Translarna to Treat Duchenne Muscular Dystrophy

PTC Therapeutics, Inc. announced that it has commenced a rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Translarnaâ„¢ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. PTC expects to finalize the application in the fourth quarter of 2015 following the completion of the ACT DMD confirmatory Phase 3 clinical trial.

Food and Drug Administration and European Medicines Agency Grants Orphan Drug Designation to PTC Therapeutics's Translarna in the U.S. and Europe for the Treatment of Mucopolysaccharidosis I

PTC Therapeutics, Inc. announced that both the U.S. Food and Drug Administration and the European Medicines Agency have granted orphan-drug designation (ODD) to Translarna (ataluren) for the treatment of patients with Mucopolysaccharidosis I (MPS I). MPS I is an inherited genetic disorder caused by a deficiency in an essential enzyme that is responsible for the breakdown of by-products in the body's cells. There is significant unmet medical need and new treatments targeting the underlying cause of the disease are needed. MPS I represents the third indication for which Translarna has received orphan-drug designation. Translarna also has orphan-drug designation for Duchenne muscular dystrophy and cystic fibrosis. Translarna is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. In preclinical models of MPS I, Translarna demonstrated that it crosses the blood-brain barrier and penetrates skeletal and cardiac tissues. The same preclinical models indicate that Translarna treatment reduces GAG levels in multiple tissues with no observed signs of cell toxicity or stress. Since Translarna is administered systemically, crosses the blood-brain barrier, and penetrates other tissues relevant to disease, there is potential for Translarna treatment to address the cardiac and neurological defects associated with nonsense mutation MPS I. In the U.S., Orphan drug designation is granted by the FDA'sOffice of Orphan Products Development to promote the development of products that may offer therapeutic benefits for diseases with a prevalence of fewer than 200,000 individuals per year. Orphan-drug designation provides opportunities for grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States, if granted FDA approval. Similarly, EMA's Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. In addition to 10 years of market exclusivity if Translarna is approved for the treatment of nonsense mutation MPS I, the designation also provides special incentives for sponsors including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.


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