Articles

Catabasis Pharmaceuticals Announces Positive Top - Line Results from Part A of the MoveDMD Trial , a Phase 1 / 2 Trial of CAT - 1004 for the Treatment of Duchenne Muscular Dystrophy

January 25, 2016

Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, announced on January 25 positive top-line results from Part A of the MoveDMD trial, a Phase 1/2 trial of CAT-1004 for the treatment of Duchenne muscular dystrophy (DMD or Duchenne).

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SUMMIT THERAPEUTICS RECEIVES REGULATORY APPROVAL TO INITIATE PhaseOut DMD, A PHASE 2 CLINICAL TRIAL OF SMT C1100 IN PATIENTS WITH DMD

January 21, 2016

Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and Clostridium difficile infection, announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency and the Research Ethics Committee to initiate PhaseOut DMD, a Phase 2 proof of concept clinical trial of SMT C1100 in patients with DMD.

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FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

January 14, 2016

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.

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PTC Completes Rolling NDA Submission to FDA and Submits Phase 3 ACT DMD Clinical Trial Results to EMA for Translarna™ (ataluren) for Treatment of Nonsense Mutation Duchenne Muscular Dystrophy

January 8, 2016

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced on January 8 the completion of its rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Translarna™ (ataluren), an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

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Grünenthal and Akashi Therapeutics Inc. Announce Joint Drug Development Program for HT-100 in the Treatment of Patients with Duchenne Muscular Dystrophy (DMD)

January 8, 2016

Grünenthal announced on January 8 the joint global drug development program with Akashi Therapeutics, Inc., for HT-100, an orally available small molecule drug candidate designed to reduce fibrosis and inflammation and to promote healthy muscle fiber regeneration in Duchenne Muscular Dystrophy (DMD) patients.

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