Shares of Synergy Pharmaceuticals Inc. (SGYP: Quote) rose as much as 25% in intraday trading on Wednesday before closing 18% higher at $6.21.
Reason – The company’s investigational oral drug for the treatment of chronic idiopathic constipation – Plecanatide, was well tolerated and met the primary and key secondary endpoints of a phase IIb/III clinical study.
A phase IIb study to assess Plecanatide in the treatment of irritable bowel syndrome with constipation (IBS-C) is currently underway.
The FDA on Wednesday acknowledged Merck & Co. Inc.’s (MRK: Quote) resubmitted New Drug Application for ezetimibe and atorvastatin tablets, an investigational lipid-lowering combination medicine.
Last March, the FDA issued a complete response letter for the combo drug requesting Merck to submit additional data.
The resubmitted NDA, which included additional data, has been deemed complete for review, and the company expects the FDA’s review to be completed in the first half of 2013.
Questcor Pharmaceuticals Inc. (QCOR: Quote) has agreed to acquire privately-held BioVectra Inc., a supplier to the global pharmaceutical industry, for an upfront payment of C$50 million.
BioVectra has been Questcor’s manufacturing partner for the API in Questcor’s H.P. Acthar Gel (repository corticotropin injection) for nearly a decade. Questcor believes that the transaction provides vertical integration, third party manufacturing capabilities and further secures Acthar manufacturing trade secrets.
The transaction, which is said to close this month, is expected to be immediately accretive to Questcor’s non-GAAP earnings.
Endologix Inc. (ELGX: Quote) has appointed Shelley Thunen to the position of Chief Financial Officer, effective immediately. Thunen succeeds Robert Krist, who, as previously announced, has decided to retire.
The company is scheduled to announce its Q4 and full-year financial results on Feb.20, 2013.
ELGX closed Wednesday’s trading 0.91% higher at $14.37.
AMAG Pharmaceuticals Inc. (AMAG: Quote) has appointed Greg Madison as executive vice president and chief commercial officer.
Prior to being appointed in AMAG, Madison was with Genzyme Corp., where he spent the past 12 years in various commercial roles in their renal division, most recently as the division’s vice president and general manager.
AMAG shares rose over 8% to close Wednesday’s trading at $15.89.
NuPathe Inc. (PATH: Quote) announced that its additional U.S. patent application for its investigational migraine patch – Zecuity, has been issued a notice of allowance.
Given this action, NuPathe expects the patent to issue within the next few months. Once issued, the patent will provide additional patent protection for Zecuity, according to the company.
The NDA for Zecuity is under FDA review with a decision date set for January 17, 2013.
Effective January 2, 2013, listing of the common stock of Vical Inc. (VICL) has been transferred to the NASDAQ Global Select Market, the highest of the three market tiers at NASDAQ.
The company said it is honored to be recognized by NASDAQ for its established record of sound management and fiscal responsibility.
VICL closed Wednesday’s trading 6.19% higher at $3.09.
Emergent BioSolutions Inc.’s (EBS: Quote) investigational compound TRU-016, for the treatment of chronic lymphocytic leukemia has been granted orphan medicinal product designation by the European Commission.
TRU-016 is currently being evaluated in a randomized phase II study in combination with bendamustine compared to bendamustine alone in relapsed chronic lymphocytic leukemia, or CLL, patients. Results from this study are expected in the second half of 2013.
TRU-016 was granted orphan drug status for the treatment of CLL by the FDA in December of 2011.
EBS closed Wednesday’s trading at $16.90, up 5.36%.
Shares of Titan Pharmaceuticals Inc. (TTNP.OB) rose more than 14% after the company announced that its New Drug Application for Probuphine has been accepted for review and granted Priority Review designation by the FDA.
The company is seeking approval of Probuphine, a subdermal implant, for the maintenance treatment of opioid dependence in adult patients.
The FDA decision date is set for April 30, 2013.
Effective January 2, 2013, Canadian specialty pharmaceutical company Stellar Pharmaceuticals Inc. has changed its name to Tribute Pharmaceuticals Canada Inc., and it has been assigned a new ticker ‘TBUFF’.
Astex Pharmaceuticals Inc. (ASTX: Quote) has initiated a phase II clinical trial, evaluating SGI-110 in the treatment of advanced hepatocellular carcinoma patients who failed prior treatment with blockbuster cancer drug Nexavar.
The study includes two parts – Part A and Part B.
The company said that Part A would enroll 15 patients in Stage 1 hepatocellular carcinoma who will be evaluated for safety, disease control, and for methylation status of certain tumor suppressor genes known to be involved in HCC. If Part A is successful, Part B will enroll 31 additional patients in Stage 2 of the disease.
According to Cincinnati Children’s Hospital, Stage I means the cancer can be removed with surgery, and Stage II means most of the cancer may be removed in an operation, but very small amounts of cancer are left in the liver following surgery.
ImmunoCellular Therapeutics Ltd. (IMUC: Quote) has appointed Gary Titus to its board of directors. Titus is currently the Senior Vice President and Chief Financial Officer of SciClone Pharmaceuticals Inc. (SCLN)
Last September, Jacqueline Brandwynne stepped down from ImmunoCellular’s board of directors.
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by RTT Staff Writer
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