BioMarin says FDA to delay deciding on approval of DMD drug

23 Dec 2015 | Author: | No comments yet »

Analysts Set BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) PT at $148.28.

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) has received a consensus recommendation of “Buy” from the twenty-three ratings firms that are currently covering the stock, MarketBeat Ratings reports. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. Parini will serve as a member of Vertex’s Executive Committee, reporting directly to Jeffrey Leiden, M.D., Ph.D., Vertex’s Chairman, President and Chief Executive Officer.

Wedbush reaffirmed a “hold” rating and issued a $137.00 price target on shares of BioMarin Pharmaceutical in a research report on Friday, October 30th. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise. Most recently, he served as Senior Vice President and Associate General Counsel and was responsible for the strategic management of Pfizer’s global litigation activities, including civil, intellectual property, government and employment litigation.

Parini also served as Chief Counsel for multiple key business units within Pfizer, advising Pfizer’s leadership team on key business issues related to investment decisions, patent disputes, global pricing strategies and commercial operations activities, among other responsibilities. The company on November 5, 2015 announced that it has executed three separate transactions, including entering into a definitive agreement to acquire XOMA Corporation’s (XOMA) antibody pilot plant manufacturing facility and capabilities. Additionally, Agenus obtained an exclusive license to a phage display library from IONTAS, and entered into an agreement for cell line development technology with Selexis.

Jennison Associates now owns 150,000 shares of the company’s stock valued at $15,798,000 after buying an additional 30,000 shares in the last quarter. These new capabilities, in combination with Agenus’s Retrocyte DisplayTM and SECANT® yeast display platforms, will result in a broad, vertically integrated and highly productive in-vitro antibody discovery and production platform.

The acquisition of XOMA’s facility will enable Agenus to manufacture checkpoint modulator (CPM) antibodies to meet its growing GMP antibody production requirements for development and future clinical trials. Vetr cut BioMarin Pharmaceutical from a “strong-buy” rating to a “buy” rating and set a $126.54 price objective for the company. in a report on Wednesday, October 28th.

The committee reviewed the Kyndrisa data package, which includes three randomized, placebo controlled trials with more than 300 patients and more than 500 patient years of exposure. The committee discussed the overall strengths and weaknesses of the application but was not asked to vote on a recommendation for approval of Kyndrisa. Its approved products are Vimizim (), Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Aldurazyme (laronidase) and Firdapse (amifampridine phosphate).

Aldurazyme, which was developed in collaboration with Genzyme Corporation (Genzyme), was approved for marketing in the United States, the European Union, and subsequently in other countries. If you are reading this article on another website, that means this article was illegally copied and re-published to this website in violation of U.S. and International copyright law.

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