30.04.2015 06:04:52
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FLXN Gets Funded, LXRX Awaits Phase III Data, It's Decision Time For LuViva
(RTTNews) - Agios Pharmaceuticals Inc. (AGIO), in collaboration with its cancer metabolism partner Celgene Corp. (CELG), plans to initiate clinical development of AG-881 in the second quarter of 2015. AG-881 will be the third IDH, or isocitrate dehydrogenase, mutant inhibitor discovered by Agios to enter clinical development.
Under the terms of the new AG-881 collaboration, Agios will receive an initial payment of $10 million from Celgene in the second quarter of 2015 and is eligible to receive regulatory milestone payments of up to $70 million.
AGIO closed Wednesday's trading 0.58% higher at $99.32.
Amgen's (AMGN) Biologics License Application for Repatha for the treatment of high cholesterol is all set to be reviewed by an FDA panel on June 10, 2015.
Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.
The FDA's decision date for the Repatha BLA is August 27, 2015.
AMGN closed Wednesday's trading at $160.98, down 0.93%.
Bellicum Pharmaceuticals Inc. (BLCM) has entered into a license agreement with Leiden University Medical Center, Netherlands, for worldwide rights to develop, manufacture and commercialize high-affinity TCR (T cell receptor) product candidates targeting solid tumors expressing the preferentially-expressed antigen in melanoma, or PRAME.
The company's first TCR product candidate under this agreement is BPX-701, and is expected to enter phase 1/2 clinical trials before the end of 2015.
Bellicum went public on the NASDAQ exchange on December 18, 2014, priced at $19 per share. The stock has thus far hit a low of $18.20 and a high of $33.63.
Chembio Diagnostics Inc's (CEMI) SURE CHECK HIV 1/2 testing device will be made available in self-test kits in Europe for the first time.
Chembio's SURE CHECK HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview Complete. Outside the U.S., Chembio markets the product through distributors, under the brands SURE CHECK HIV 1/2 Assay and STAT-VIEW HIV 1/2 Assay.
CEMI closed Wednesday's trading at $4.74, up 1.07%.
Flexion Therapeutics Inc. (FLXN) has been awarded a grant worth roughly $2 million by the U.S. Department of Defense to conduct a phase 2 clinical trial of FX006 as a treatment for osteoarthritis pain in active military and medically retired veterans with post-traumatic osteoarthritis of the knee.
A phase III study of FX006 as a treatment for pain associated with osteoarthritis of the knee is also underway.
FLXN closed Wednesday's trading at $16.82, down 0.30%.
Guided Therapeutics Inc (GTHP.OB) is awaiting a response from the FDA on its amended premarket approval application for LuViva Advanced Cervical Scan, which is being evaluated as a triage device for women who receive a positive Pap test result.
LuViva was issued a not-approvable letter by the FDA on September 6, 2013. Following a face-to-face meeting with the FDA in May 2014, the company filed an amendment to the premarket approval application for LuViva on July 25, 2014. The FDA is expected to respond to the PMA Amendment in May.
Guided Therapeutics currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others.
GTHP.OB closed Wednesday's trading at $0.20, unchanged from the previous day's close.
Lexicon Pharmaceuticals Inc. (LXRX) is all set to implement a reverse stock split at a ratio of one share of newly issued common stock for each seven shares of issued and outstanding common stock at 5:00 p.m. Eastern Time on May 20, 2015.
The company's common stock will commence trading on a split-adjusted basis as of the opening of trading on May 21, 2015.
Lexicon is slated to report top-line data from a pivotal phase 3 clinical trial of telotristat etiprate, dubbed TELESTAR, for patients with carcinoid syndrome in the third quarter of 2015. The company has also commenced enrollment of patients in the first of its two pivotal phase 3 clinical trials of sotagliflozin for type 1 diabetes and is preparing to initiate screening in the second pivotal phase 3 study.
LXRX closed Wednesday's trading at $1.08, up 1.89%. In after-hours, the stock was down 2.78% to $1.05.
XBiotech (XBIT) has enrolled the first patient into its revised U.S. phase 3 study of Xilonix in metastatic colorectal cancer patients.
Initially launched in March 2013, with patients having been recruited at more than 60 U.S. cancer centers, the study was paused last September to propose to the FDA changes in inclusion criteria to allow broader eligibility for cancer patient enrollment.
XBIT closed Wednesday's trading at $19.94, up 0.25%.
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Aktien in diesem Artikel
Agios Pharmaceuticals Inc | 32,00 | 3,23% | |
Amgen Inc. | 253,15 | 1,02% | |
Chembio Diagnostics Inc | 0,46 | 0,22% | |
XBiotech Inc | 4,24 | 0,47% |