Dyax Announces Positive Results from Phase 1b Clinical Trial of DX-2930

Management to Host Conference Call with Detailed Data Presentation Today at 5:00 p.m. ET

BURLINGTON, Mass.--- Dyax Corp. (DYAX) today announced positive safety, pharmacokinetic, biomarker, and efficacy results from the Phase 1b clinical study of their investigational product, DX-2930. Discovered by Dyax, DX-2930 is a fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema (HAE) attacks.

The ongoing Phase 1b study is a multi-center, randomized, double-blind, placebo-controlled, multiple-ascending dose study designed to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. An analysis of HAE attack rate was also conducted following a pre-specified statistical analysis plan. A total of 37 subjects were randomized to active drug or placebo in a 2:1 ratio across 4 dosing groups of 30, 100, 300, or 400 mg. Each subject received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose.

Read more: Dyax Corp ( DYAX )

Health Canada Approves 1mg/vial Presentation of EGRIFTA(TM) (tesamorelin for injection)

MONTREAL, CANADA--( Mar 30, 2015) - Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that Health Canada has approved a Supplement to a New Drug Submission for the 1mg/vial presentation of EGRIFTA™ (tesamorelin for injection) (EGRIFTA™).

 

This follows the approval of the 2mg/vial presentation which was received in April 2014. For the time being, only the 1mg/vial presentation will be marketed.

"We have eagerly been waiting for this decision. EGRIFTA™ was discovered in Canada and we feel particularly proud that the approval of this presentation will give us the opportunity to make our product available to Canadian patients," said Luc Tanguay, President and CEO, Theratechnologies Inc.

Read more: Theratechnologies Inc ( TH )

Coronado Biosciences Announces the Formation of Mustang Therapeutics, Inc. in Partnership With the City of Hope in Duarte, CA

NEW YORK, March 19, 2015  -- Coronado Biosciences, Inc. (CNDO) announced today the formation of a new company, Mustang Therapeutics, Inc. Mustang will initially focus on the preclinical and clinical development, as well as commercialization of proprietary Chimeric Antigen Receptor (CAR-T) technology. This portfolio of CAR-T cells was developed by Dr. Stephen Forman, Director, T cell Therapeutics Research Laboratory and the Francis and Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation, and Dr. Christine Brown, Associate Director, T cell Therapeutics Research Laboratory and Associate Research Professor. The deal is valued in excess of $40 million for the development of these CAR-T cells via up-front and milestone payments to City of Hope. It is anticipated that the first two CAR-T cells from this partnership will begin enrollment in human clinical trials at the City of Hope this year.

Read more: Coronado Biosciences Inc ( CNDO )

Fujifilm Holdings to Acquire Cellular Dynamics International, Inc.

TOKYO and MADISON, Wis., March 30, 2015 -- FUJIFILM Holdings Corporation (President:Shigehiro Nakajima) (TSE:4901) ("Fujifilm") and Cellular Dynamics International, Inc. (CEO:Robert J. Palay) (ICEL) ("CDI"), a leading developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today announced that the two companies have entered into a definitive agreement whereby Fujifilm will acquire CDI via an all-cash tender offer to be followed by a second step merger. Fujifilm aims to acquire all issued and outstanding shares of CDI's common stock for $ 16.5 per share or approximately $ 307 million (on a fully diluted basis). The offer represents a premium of 108% to CDI's closing price on March 27. Upon completion of the transaction, CDI will continue to run its operations in Madison, Wisconsin and Novato, California as a consolidated subsidiary of Fujifilm. The announced transaction was unanimously approved by the Boards of Directors of both companies.

Read more: Cellular Dynamics International Inc ( ICEL )

Orexigen's Mysimba™ Approved in Europe for the Treatment of Obesity

SAN DIEGO, March 26, 2015  -- Orexigen Therapeutics, Inc. (OREX) today announced that the European Commission has granted marketing authorization for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to 2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). This authorization applies to all 28 European Union (EU) member states.

"The granting of European marketing authorization for Mysimba is a significant milestone for Orexigen.  European approval is an important step in our pursuit to bring new treatment options to the many patients who struggle with obesity in Europe and around the world," said Mike Narachi, CEO of Orexigen.

Read more: Orexigen Therapeutics Inc ( OREX )