01.04.2015 10:13:19
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DYAX Surges, RDHL Boosts Pipeline, NBIX Cuts A Deal, OCAT Working With Vision
(RTTNews) - Capricor Therapeutics Inc. (CAPR) has completed enrollment of its first phase II clinical trial of its investigational drug Cenderitide in ambulatory heart failure patients, achieving the target of 14 patients. The company expects to report top line data from this trial during the second half of 2015.
CAPR closed Tuesday's trading at $8.62, down 4.75%.
Shares of Dyax Corp. (DYAX) were up more than 49% in extended trading on Tuesday, following positive results from the company's phase 1b clinical trial of DX-2930, which is being developed for the prevention of hereditary angioedema attacks.
In the trial, 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. The subjects in the 300 mg, 400 mg and placebo dose groups reported having at least 2 hereditary angioedema (HAE) attacks in the 3 months prior to study entry.
After the treatment period, the HAE attack rate was 0 in the 300 mg of DX-2930 group and 0.045 attacks per week in the 400 mg of DX-2930 group, compared to 0.37 attacks per week in the placebo group. This means that there is a 100% reduction for the 300 mg dose group compared to placebo, according to the trial results.
DX-2930 has also received fast track designation from the FDA for HAE.
DYAX closed Tuesday's trading at $16.75, down 1.73%. In after-hours, the stock surged 49.81% to $25.10.
ESSA Pharma Inc. (EPI.V) has filed with the FDA an Investigation New Drug application seeking permission to commence human testing of EPI-506 in prostate cancer patients. If all goes well, the company expects to recruit the first patient into its proposed phase 1/2 clinical trial of EPI-506 in the third quarter of 2015.
The upcoming phase 1/2 clinical trial will evaluate the maximum tolerated-dose, pharmacokinetics, safety and efficacy of EPI-506 in treating prostate cancer patients who have failed abiraterone or enzalutamide or both, the current standard-of-care drugs in metastatic castration resistant prostate cancer.
EPI.V closed Tuesday's trading at C$7.20, down 2.70%.
Neurocrine Biosciences Inc. (NBIX) has entered into an exclusive collaboration and licensing agreement for the development and commercialization of its VMAT2 inhibitor, NBI-98854, in Japan and other select Asian markets with Mitsubishi Tanabe Pharma Corp.
Neurocrine retains full commercial rights to NBI-98854 in North America, Europe and other countries outside of Asia. Under the agreement terms, Mitsubishi Tanabe will initially develop NBI-98854 in Japan for the chorea associated with Huntington's disease and tardive dyskinesia.
In addition to Japan, Mitsubishi Tanabe's territory also includes China, South Korea, Philippines, Indonesia, Taiwan, Singapore, Malaysia, Thailand, and Hong Kong.
NBI-98854 is under a phase 3 trial, dubbed KINECT 3, in patients with Moderate-Severe Tardive Dyskinesia.
NBIX closed Tuesday's trading at $39.71, down 4.38%.
Ocata Therapeutics Inc. (OCAT) has completed dosing of its phase 1/2 studies for dry age-related macular degeneration and Stargardt's Macular Degeneration evaluating subretinal transplantation of retinal pigment epithelium cells, with a total of 38 patients having been safely dosed.
The company is all set to initiate a phase 2 study for dry age-related macular degeneration and a pivotal study for Stargardt's Macular Degeneration for its RPE ( retinal pigment epithelium) therapy.
Ocata was previously granted Advanced Therapy Medicinal Product designation for its RPE therapy for macular degeneration. The SMD program has orphan status both in Europe and the US.
The company's stock was uplisted to the NASDAQ Global Market from the OTC Marketplace on February 26, 2015.
OCAT closed Tuesday's trading at $6.16, up 0.49%.
RedHill Biopharma Ltd. (RDHL) has acquired the rights to a phase II drug candidate - ABC294640 - and additional intellectual property rights from Apogee Biotechnology Corp., a privately-held biotech company located in Hummelstown, Pennsylvania, U.S.
The investigational ABC294640 is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting a number of potential inflammatory, oncology and gastrointestinal indications.
RedHill will pay Apogee an upfront payment of $1.5 million, as well as an additional $4 million in potential milestone payments, and potential tiered royalties starting in the low double-digits.
RDHL closed Tuesday's trading 0.55% higher at $14.55.
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