2016-12-21 07:00 ET - News Release -- Collaboration designed to leverage Merus’ Biclonics® bispecific antibody technology to expand Incyte’s discovery capabilities and large-molecule portfolio --- Incyte to make up-front payment of $120 million and purchase $80 million of Merus common shares; Merus eligible to receive potential development, regulatory and commercial milestones and sales royalties ---- Merus conference call scheduled today at 8:30 a.m. ET, 2:30 p.m. CET

 

WILMINGTON, Del. & UTRECHT, Netherlands --  Incyte Corporation (NASDAQ:INCY) and Merus N.V. (NASDAQ:MRUS) announced today that they have entered into a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The Collaboration and License Agreement grants Incyte the exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs.

2016-12-20 07:30 ET - News Release -- KP201/IR could be the first single entity (APAP-free), IR hydrocodone product for pain analgesia with abuse-deterrent properties

 

CORALVILLE, Iowa, Dec. 20, 2016  -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that its Investigational New Drug application for KP201/IR has been granted “Fast Track” designation by the U.S. Food and Drug Administration (FDA). KP201/IR, KemPharm’s co-lead product candidate, is a single-entity benzhydrocodone HCl immediate release abuse-deterrent prodrug for the treatment of acute pain.  KemPharm expects to initiate human clinical trials of KP201/IR in the first half of 2017.

2016-12-20 07:00 ET - News Release

– Funds Vadadustat Global Phase 3 PRO2TECT and INNO2VATE Studies –-– Committed Capital and Potential Milestone Payments Could Exceed $1 Billion –

– Akebia and Otsuka Share Revenue and Commercialization Costs Equally –– Akebia to Host Conference Call at 8:30 a.m. Eastern Time Today –

 

Company Website: http://www.akebia.com -- CAMBRIDGE, Mass. & TOKYO -- Akebia Therapeutics, Inc. (NASDAQ: AKBA) and Otsuka Pharmaceutical Co., Ltd. today announced they have entered into a collaboration and license agreement in the U.S. for vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anemia associated with chronic kidney disease (CKD). Anemia related to CKD affects an estimated 1.8 million patients in the U.S. and arises from the kidney’s failure to produce adequate amounts of erythropoietin, a key hormone stimulating the production of red blood cells.1 Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. 2

– Larotrectinib Approximately 85% Enrolled to Goal; Completion of Enrollment for Primary Efficacy Analysis Expected Early 2017 –

– NDA Submission for Larotrectinib Expected Late 2017 or Early 2018 –

– Company to Host Investor Conference Call and Webcast Today at 8:00 a.m. EST –

 

STAMFORD, Conn., Dec. 19, 2016 -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced a comprehensive program update for larotrectinib (LOXO-101), a selective inhibitor of tropomyosin receptor kinase (TRK), and its pipeline drug candidates, LOXO-292 and LOXO-195.