-- Edasalonexent Was Safe, Well Tolerated and Generated Positive Biomarker Results in Adult Subjects --

-- Top-Line Phase 2 Results in Boys with Duchenne Muscular Dystrophy On Track: Expected in the First Half of Q1 2017 --

 

CAMBRIDGE, Mass. -- Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced the publication of Phase 1 data on edasalonexent in adult subjects. Edasalonexent is a potential disease-modifying therapy being developed for Duchenne muscular dystrophy (DMD). The Phase 1 trials demonstrated that edasalonexent (CAT-1004), an oral inhibitor of NF-kB, was safe, well tolerated, and inhibited activated NF-kB in adult subjects and the data are presented in an article titled “A Novel NF-kB Inhibitor, Edasalonexent (CAT-1004), in Development as a Disease-Modifying Treatment for Patients with Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects” in the Journal of Clinical Pharmacology (J Clin Pharmacol. 2017 Jan 11. doi: 10.1002/jcph.842.)

- First Reported Fast Track Designation for LGMD2B Treatment -

 

SAN DIEGO, Jan. 18, 2017 -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), making it the first known therapeutic candidate for the treatment of LGMD2B to receive the designation. In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.

$960 million deal will enhance Lilly's existing pain management portfolio for migraine; adds potential near-term launch to its late-stage pipeline

 

INDIANAPOLIS and CAMBRIDGE, Mass., Jan. 18, 2017  -- Eli Lilly and Company (NYSE: LLY) and CoLucid Pharmaceuticals, Inc. (NASD: CLCD) today announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. This all-cash transaction will enhance Lilly's existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

 

CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

2017-01-17 09:45 ET - The FDA designation adds five years of market exclusivity for Pulmatrix' inhaled product for treating fungal infections in the lungs of CF patients

 

LEXINGTON, Mass., Jan. 17, 2017 -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a "Qualified Infectious Disease Product" (QIDP) by the U.S. Food & Drug Administration.