07.05.2015 07:41:34
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ANAC, TTPH Await Data In Q3, FATE Makes Gains, CBPO Sees Good Times Ahead
(RTTNews) - Anacor Pharmaceuticals Inc. (ANAC) expects to announce top-line data from its pivotal phase 3 studies of AN2728 for the potential treatment of mild-to-moderate atopic dermatitis in children and adults in the third quarter of this year.
ANAC closed Wednesday's trading at $56.56, up 1.89%.
ChemoCentryx Inc. (CCXI) expects to report initial data from its phase Ib trial of CCX872 in patients with non-resectable pancreatic cancer in the second half of 2015. The top line results from the company's phase II clinical trial of CCX168 in Europe in anti-neutrophil cytoplasmic antibody-associated vasculitis are expected to be announced by the end of this year.
The company also has plans to initiate a phase IIa proof-of-concept study of CCX168 in patients with aHUS (atypical hemolytic uremic syndrome) and report initial results by the end of 2015.
CCXI closed Wednesday's trading at $6.68, down 4.43%.
China Biologic Products Inc. (CBPO) has lifted its sales outlook for 2015 to a range of $290 million to $295 million from its prior estimate range of $287 million to $292 million. The revised outlook represents a growth of 19% to 21% over 2014.
The company has reiterated its non-GAAP adjusted net income for 2015 in the range of $95 million to $97 million, excluding the potential adverse impact of foreign currency, which represents a growth of 26% to 28% over last year.
Analysts polled by Thomson Reuters expect the company to report sales of 289.57 million for 2015.
CBPO closed Wednesday's trading at $99.08, up 0.61%.
Shares of Fate Therapeutics, Inc. (FATE) were up more than 45% on Wednesday as investors cheered the news of the company executing a strategic research collaboration and license agreement with Juno Therapeutics Inc. (JUNO) to identify and utilize small molecules to modulate Juno's genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients.
The agreement entitles Fate an upfront payment of $5 million and the purchase by Juno of one million shares of Fate common stock at $8.00 per share.
Juno will fund all mutual collaboration activities for an exclusive four-year research term. For each product developed by Juno that incorporates modulators identified through the collaboration, Fate is eligible to receive approximately $50 million in target selection fees and clinical, regulatory and commercial milestones, as well as low single-digit royalties on sales. Fate retains exclusive rights to its intellectual property for all purposes outside of programmed chimeric antigen receptor (CAR) and T cell receptor (TCR) immunotherapies.
FATE touched a new high of $8.78 on Wednesday before closing the day's trading at $7.24, up 45.97%.
MacroGenics Inc. (MGNX) has a packed schedule ahead with a couple of clinical trials to be initiated in the coming months.
The company is all set to commence SOPHIA, a phase 3 pivotal study of its investigational antibody Margetuximab in the third quarter of 2015. This study is planned to evaluate Margetuximab plus chemotherapy against Genentech Inc.'s approved Herceptin (trastuzumab) plus chemotherapy in third-line metastatic breast cancer patients.
The study is expected to be completed in approximately three years, which will include an interim futility analysis.
A phase 1/2 combination study of Margetuximab in gastroesophageal cancer is scheduled to commence in the fourth quarter of 2015.
The company also has plans to initiate a study of MGA271 in combination with an anti-PD-1 antibody in patients with melanoma, non-small cell lung carcinoma and squamous cell carcinoma of the head and neck later this year.
MGNX closed Wednesday's trading at $27.85, up 2.50%.
Tetraphase Pharmaceuticals Inc. (TTPH), which recently completed patient enrollment in the pivotal portion of its second phase 3 clinical trial of Eravacycline for the treatment of complicated urinary tract infections, dubbed IGNITE2, expects top-line data to be available in the third quarter of 2015.
Last month, the company presented positive results from IGNITE1, a pivotal phase 3 clinical trial of intravenous Eravacycline in patients with complicated intra-abdominal infections.
The company aims to submit its New Drug Application for both IV and oral formulations of Eravacycline in complicated urinary tract infections and complicated intra-abdominal infections by year-end 2015.
TTPH closed Wednesday's trading 3.10% higher at $36.89. However, in after-hours, the stock was down 7.51% to $34.12.
Versartis Inc. (VSAR) expects to initiate an international phase 2 study of VRS-317 for adult growth hormone deficiency, dubbed VITAL, in the second half of 2015.
A phase 3 registration study of VRS-317 in naïve to treatment, pre-pubertal children with growth hormone deficiency, dubbed VELOCITY, is underway, and the interim 6-month mean height data from this trial are expected by the end of 2016. The top line data on the VELOCITY trial's 12-month height velocity primary endpoint are anticipated by mid-2017, potentially enabling a Biologics License Application submission, followed by potential FDA approval by late-2018.
VSAR closed Wednesday's trading at $17.29, up 0.41%.
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