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ANAC Awaits Climax, KERX, MSLP, BTHE, GALT Fly, RPRX Sinks, AUXL's Day In Court


Anacor Pharmaceuticals (ANAC) will release preliminary results from the first of two phase III studies of Tavaborole for onychomycosis on Tuesday at approximately 7:00 a.m. ET. A conference call is scheduled for 8:00 a.m. ET to discuss the results.

Keryx Biopharmaceuticals Inc. (KERX) soared as much as 100% in intraday trading on Monday after the company announced that its investigational drug - Zerenex (ferric citrate), met primary and all key secondary endpoints in a phase III long-term study as a treatment for hyperphosphatemia in end-stage renal disease patients on dialysis.

The company expects to make regulatory submissions in the U.S. and EU for Zerenex in the second quarter of 2013.

Repros Therapeutics Inc. (RPRX) plunged over 40% on Monday to close at $11.11 following a revised date for expected clinical results from the first pivotal study of Androxal, known as ZA-301, in the treatment of secondary hypogonadism. The company now plans to provide the data in Q3, 2013 instead of Q2, 2013.

Auxilium Pharmaceuticals Inc. (AUXL) and Xstelos Holdings Inc. (XTLS) on Monday filed a lawsuit against Upsher-Smith Laboratories Inc. for infringement of Testim patents. Testim is licensed to Auxilium Pharma by Xstelos.

Upsher-Smith is seeking approval for testosterone gel under a 505(b)(2) regulatory pathway and a NDA to this effect was filed early this month.
Auxilium and Xstelos allege that Upsher Smith's testosterone gel infringes on ten U.S. patents, covering Testim. The referenced Testim patents will expire between 2023 and 2025.

BrainStorm Cell Therapeutics (BCLI.OB) has appointed Alon Natanson as its new Chief Executive Officer. Natanson succeeds Adrian Harel, who will move into an executive scientific role in the company.

The stock closed Monday's trading 9.05% higher at $0.24.

MusclePharm Corp. (MSLP) on Monday rose over 37% as it successfully completed two closings of a registered direct offering of its Series D Convertible Preferred Stock with Frost Group, LLC, headed by Miami entrepreneur Dr. Phillip Frost, being the lead investor. The net proceeds to MusclePharm from the closings were about $3.5 million after deducting placement agent fees and offering expenses.

Galectin Therapeutics Inc. (GALT) on Monday announced that the proceedings from the galectin-focused symposium it hosted last September have been published online by the American Chemical Society. The publication is proof of the great interest in continuing to expand the therapeutic applications for galectin-targeted proteins said the company.

GALT closed Monday's trading 10.50% higher at $2.63.

CytRx Corp.'s (CYTR) in vivo trial investigating aldoxorubicin in combination with unconjugated doxorubicin has demonstrated positive results and provided the basis for its ongoing phase 1b clinical trial of the combination therapy in cancer patients with advanced solid tumors.

Sanofi (SNY) on Monday announced the availability of Auvi-Q, the first and only voice-guided epinephrine auto-injector, in U.S. retail pharmacies nationwide with a prescription from a healthcare provider. The device is for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.

Separately, Sanofi unit Genzyme announced that its supplemental Biologics License Application seeking approval of LEMTRADA for the treatment of relapsing multiple sclerosis has been accepted by the FDA for review. The FDA's decision is expected in the second half of 2013.

LEMTRADA is also under review in the EU and the opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is anticipated in Q2 2013.

La Jolla Pharmaceutical Co. (LJPC) on Monday announced that it has administered the first dose for its phase 1/2 clinical trial of GCS-100 in patients with chronic kidney disease. The study is an open-label, multi-center test of GCS-100 in patients with Stage 3b and 4 CKD.

Shares of Boston Therapeutics Inc. (BTHE) closed Monday's trading over 21% higher at $0.51 following news about its proprietary non-systemic chewable tablet, SUGARDOWN, reducing the post-meal elevation of blood glucose by up to 61% in healthy volunteers in a clinical study. No severe adverse effects were observed during the study.

Idenix Pharmaceuticals Inc. (IDIX) has entered into a non-exclusive collaboration with Janssen Pharmaceuticals Inc. to initiate phase II all-oral combination studies including IDX719, Simeprevir (TMC435) and TMC647055 for the treatment of Hepatitis C Virus. (HCV)

IDX719 is Idenix's once-daily pan-genotypic NS5A inhibitor, Simeprevir (TMC435) is a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, and TMC647055 is a once-daily non-nucleoside polymerase inhibitor, boosted with low dose Ritonavir, being developed by Janssen.

IDIX closed Monday's trading at $4.91, up 3.81%. In the extended trading, the stock gained 1.43% to $4.98.

Immunomedics Inc. (IMMU) on Monday signed a deal with Algeta ASA for the development of its humanized anti-CD22 antibody, Epratuzumab, combined with Algeta's proprietary thorium-227 alpha-pharmaceutical payload.

Epratuzumab has been licensed to UCB, S.A., for all autoimmune disease indications worldwide. UCB is evaluating Epratuzumab in phase III trials for lupus. Immunomedics has retained the rights in oncology indications for which UCB has been granted a buy-in option.

Oncolytics Biotech Inc. (ONCY) announced Monday that in a phase I study, the intravenous administration of REOLYSIN in combination with FOLFIRI in patients with metastatic colorectal cancer was safe and well tolerated. There was disease control in majority of the evaluable patients, including patients that had previously progressed on Irinotecan said the company.

In an effort to identify and develop partnership and acquisition opportunities to leverage its business model, Questcor Pharmaceuticals Inc. (QCOR) on Monday appointed Michael Aldridge to the new position of Senior Vice President, Corporate Strategic Development.

QCOR, which is 56% down from its 52-week high, closed Monday's trading at $25.65, down 1.19%.

by RTTNews Staff Writer

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