09.08.2013 06:26:39
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NKTR Nearing Results, THLD Progresses, Wright Gets It Wrong, ZGNX On Watch
(RTTNews) - Corcept Therapeutics Inc. (CORT) expects interim analysis results of a phase III study of its drug Korlym in the treatment of psychotic depression in the third quarter of 2014. Korlym is already approved by FDA for the treatment of Cushing's syndrome.
CORT closed Thursday's trading at $1.89, down 2.58%.
Medivation Inc. (MDVN) expects results of interim analysis of a phase III trial evaluating Enzalutamide in men with advanced prostate cancer who have not yet received chemotherapy to be released this year. The company is developing Enzalutamide in collaboration with Astellas Pharma Inc.
MDVN closed Thursday's trading at $57.02, down 0.12%.
Nektar Therapeutics (NKTR) expects to report high-level results from a phase II efficacy study of NKTR-181 in chronic pain patients this summer as planned. The company has completed enrollment in a phase III study of NKTR-102 for the treatment of advanced breast cancer, and expects survival data to be available next year.
NKTR gained 3.47% in after-hours on Wednesday and was at $11.32.
Raptor Pharmaceutical Corp. (RPTP) said that there is a strong demand for its drug Procysbi, which gained FDA approval in April of this year for the management of nephropathic cystinosis in children and adults.
Procysbi is also being evaluated in other indications namely Huntington's disease and for the treatment of nonalcoholic fatty liver in children.
The company expects interim results from a phase 2/3 study of Procysbi in Huntington's disease following the first 18 months of treatment in the first quarter of 2014.
RPTP closed Thursday's trading at $10.50, up 3.35%.
Threshold Pharmaceuticals Inc. (THLD) has initiated a phase II study of TH-302 in patients with melanoma. About 70% of development costs associated with this study will be funded by the company's partner - Merck KGaA, Darmstadt, Germany.
THLD closed Thursday's trading at $5.01, down 2.34%.
Shares of Wright Medical Group Inc. (WMGI) dropped more than 10 percent to $24.10 in extended trading on Thursday following a not approvable letter from the FDA for the company's Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.
The FDA requires the company to perform a new clinical study for Augment Bone Graft in order to gain approval since the regulatory agency is of the view that the patient population studied in the clinical study was predominantly low risk.
Zogenix Inc. (ZGNX) said that its second quarter revenue and bottom line improved year-over-year. The company expects FDA decision on Zohydro ER New Drug Application to be announced this summer.
The company is seeking approval of Zohydro ER for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time. An FDA panel voted against recommending Zohydro last December on concerns of potential abuse, addiction and long-term safety.
ZGNX closed Thursday's trading at $1.52, down 1.30%.
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Corcept Therapeutics Inc. | 52,22 | -0,80% | |
Nektar Therapeutics | 0,95 | -1,10% |