Hyperion Therapeutics Inc. (HPTX) announced that the FDA's decision on its Ravicti NDA for the treatment of Urea Cycle Disorders may be delayed as the regulatory agency is continuing to work on label and post-marketing requirements in connection" with the application. The FDA's decision date was originally set for January 23, 2013. The stock touched a new high of $14.55 on Wednesday before closing the day 19.33% higher at $14.32.
Alnylam Pharmaceuticals Inc. (ALNY) on Wednesday announced that the underwriters of its previously announced public offering of common stock have exercised their option to purchase an additional 1.2 million shares at the public offering price of $20.13 per share.
The company noted that it will issue a total of 9.2 million shares in the offering and will receive aggregate net proceeds of about $173.8 million. The offering is expected to close on or about January 22, 2013, subject to the satisfaction of customary closing conditions.
ALNY closed Wednesday's trading 9.99% higher at $22.14. In after-hours, the stock was down 1.90% to $21.72.
Amgen Inc.'s (AMGN) anemia treatment Aranesp did not improve morbidity and mortality in systolic heart failure patients, according to results from a phase III trial.
The phase III trial, dubbed RED-HF Trial, did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure, said the company.
Aranesp is indicated for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
AVEO Pharmaceuticals Inc. (AVEO) dropped more than 3% to $7.86 in after-hours trading Wednesday following a proposed public offering of shares of its common stock.
IDEXX Laboratories Inc.'s (IDXX) Executive Vice President and Chief Financial Officer - Merilee Raines, is expected to retire in May 2013. Ms. Raines has been the company's CFO since 2003 and has been employed at IDEXX since 1985.
OXiGENE Inc. (OXGN) has regained compliance with the minimum bid price of $1.00 per share requirement for continued NASDAQ listing. The company was given an additional time until June 24, 2013 to regain compliance.
On December 28, 2012, the company implemented a reverse split of its common shares at the ratio of 1:12 in an effort to raise its closing bid price above $1.00 per share for at least ten consecutive trading days.
AtriCure Inc. (ATRC) on Wednesday priced its previously announced underwritten public offering of shares at a price of $7.25 each. Net proceeds from the offering are expected to be approximately $23.5 million. The stock climbed nearly 7% to close Wednesday's trading at $8.01.
Onyx Pharmaceuticals, Inc. (ONXX) on Wednesday announced it is offering 4.4 million shares of its common stock in an underwritten public offering - with the gross proceeds expected to be approximately $358.6 million. The company has also granted the underwriters a 30-day option to purchase up to an additional 660,000 shares. The offering is expected to close on or about January 22, 2013. The stock fell nearly 5% to close Wednesday's trading at $79.28 on a volume of 4.66 million shares.
Paladin Labs Inc. (PLB.TO) on Wednesday entered into an exclusive licensing agreement with Apeiron Biologics AG for APN311, a novel biologic to treat children with high-risk neuroblastoma. Under the terms of the agreement, Paladin has been granted the exclusive rights to market and sell APN311 in Canada and Sub-Saharan Africa (including South Africa). Financial terms of the deal were not revealed.
Australian biotech company QRxPharma Ltd. (QRXPY.PK) announced Wednesday that it will resubmit its Moxduo IR NDA this quarter, with an expected new PDUFA date to be set for Q3 2013.
MoxDuo IR is an immediate-release oral capsule developed under the company's Dual Opioid platform technology, which is intended to provide effective analgesia while reducing the frequency and severity of opioid-related side effects.
Last June, the FDA issued a complete response letter for Moxduo and asked the company to submit additional information with regard to the safety and effectiveness of the drug.
NeoStem Inc.'s (NBS) subsidiary, Progenitor Cell Therapy LLC has signed a Services Agreement to provide services to support Adaptimmune Ltd. and Adaptimmune LLC's NYESO-1c259-T cell therapy product. NYESO-1c259-T is being developed for multiple oncology indications. NBS closed Wednesday's trading at $0.61, down 3.17%.
Covidien (COV) on Wednesday launched its OneShot Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension. The stock, which is trading near its 52-week high, closed Wednesday's trading 0.20% higher at $60.04.
InterMune Inc. (ITMN) closed Wednesday's trading 3.39% higher at $10.38 on an unusually high volume. The company plans to sell an aggregate of $105 million principal amount of its 2.50% convertible senior notes due 2017 and 13.5 million shares of its common stock at a price to the public of $9.90 per share in concurrent underwritten public offerings.
by RTT Staff Writer
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