Shares of Isis Pharmaceuticals Inc. (ISIS) were up more than 8% in extended trading on Tuesday, following the FDA approval of its drug Kynamro for the treatment of patients with homozygous familial hypercholesterolemia.
Kynamro was licensed to Genzyme in 2008, which is now a unit of French pharmaceutical giant Sanofi (SNY). The drug will sport a Boxed Warning citing the risk of hepatic toxicity. The FDA approval triggers a $25 million milestone payment to Isis from Genzyme.
A Conference Call and Webcast is scheduled for today- January 30, at 09:30 a.m. ET to provide an update on the FDA approval of the marketing of Kynamro.
Sunshine Heart Inc. (SSH) (SHC.AX) said it will be delisting its shares from the official list of the ASX (Australian Securities Exchange) during the first half of the 2013 calendar year in the best interest of the company and all of its shareholders. The common shares of the company will continue to be listed on NASDAQ.
ARCA biopharma Inc. (ABIO) surged more than 72% in extended trading on Tuesday after the company announced that a phase III Adaptive Design Clinical Trial has been planned for its lead developmental drug, Gencaro, in atrial fibrillation. Medtronic Inc. will be collaborating on the initial, phase 2B portion of the proposed trial.
Keryx Biopharmaceuticals Inc. (KERX) on Tuesday commenced a $55 million underwritten public offering of shares of its common stock. The net proceeds from the offering will be used to fund activities related to its investigational hyperphosphatemia drug, Zerenex, and other general corporate purposes. The company announced positive results from a phase 3 long term study of Zerenex on Monday, and since then its shares have gained over 140%.
Itonis Inc. (ITNS.PK) said Tuesday that it is on track to deliver its homeopathic nasal spray for nausea relief, now that it has selected a manufacturer for its product. The manufacturer is a U.S. company that has the production versatility to handle the Itonis' pilot and testing batches as well as the final high-volume production.
Ventrus Biosciences Inc. (VTUS) has proposed public offerings of its common stock and Series A Convertible Preferred Stock. The stock was down more than 8% in after-hours on Tuesday at $2.99.
ARIAD Pharmaceuticals Inc. (ARIA) on Tuesday announced it has completed its previously announced public offering of 15 million shares at a price of $19.60 each. The net proceeds to ARIAD are about $310 million after deducting underwriting discounts and commissions and estimated offering expenses.
ARIA was down 1.11% to $20.10 in after-hours trading.
NewLink Genetics Corp.(NLNK) Tuesday said it intends to offer and sell shares of its common stock in an underwritten public offering. The actual size or terms of the offering are yet to be revealed.
NLNK was up 0.88% at $11.50 in extended trading.
Solta Medical Inc. (SLTM) has agreed to acquire privately-held Sound Surgical Technologies LLC. for $25.5 million in Solta common stock and $5.0 million in cash. The transaction, which expands Solta's presence in the body contouring market, is expected to be accretive within 12 months.
Endocyte Inc. (ECYT) said Tuesday it expects to file an Investigational New Drug application for EC1069, a PSMA-targeted (prostate specific membrane antigen) small molecule drug conjugate therapy for prostate cancer, by the end of 2013.
Urologix Inc. (ULGX) has not regained compliance with the minimum bid price requirement, and it faces delisting from the Nasdaq Capital Market as of the open of business on February 1, 2013, unless it requests a hearing before a NASDAQ Listing Qualifications Panel. The company said it will timely request a hearing before the Panel at which it will petition for continued listing pending its return to compliance with all applicable listing requirements.
Cumberland Pharmaceuticals Inc. (CPIX) has entered into an exclusive agreement with PT.SOHO Industri Pharmasi to introduce its product - Caldolor, indicated for the management of mild to moderate pain, in Indonesia.
Under the terms of the agreement, SOHO receives an exclusive license to Caldolor for the Indonesian market, and Cumberland will receive upfront and milestone licensing payments, as well as transfer prices on future sales of the drug.
CPIX closed Tuesday's trading 3.62% higher at $4.29.
Chembio Diagnostics Inc. (CEMI) announced Tuesday that its products - CervidTB STAT-PAK and DPP VetTB, have been approved as primary and secondary tests for bovine tuberculosis in captive elk and deer by the U.S. Department of Agriculture.
Tuberculin skin tests, which are currently, employed for testing tuberculosis in cervids (captive elk and deer) are said to produce a number of false-negative results, and only limited and conflicting information is available regarding their accuracy. However, Chembio's tests are rapid, easy to perform and are said to provide accurate antibody detection results.
Mesoblast Ltd. (MBLTY.PK) announced Tuesday that it has received clearance from FDA to begin phase II trial of proprietary allogeneic, or "off-the-shelf", mesenchymal precursor cells in patients with active rheumatoid arthritis. The trial is expected to commence during the second quarter 2013, and will recruit across multiple sites in the United States and Australia.
ImmunoCellular Therapeutics Ltd. (IMUC) is all set to begin a clinical trial of ICT-140, a dendritic cell vaccine targeting seven antigens that are over-expressed in ovarian cancer, as well as cancer stem cells, in the second half of 2013. The trial is anticipated to enroll approximately 20 patients with ovarian cancer who have been previously treated with standard chemotherapeutic agents, in 3-4 clinical sites in the U.S.
Anacor Pharmaceuticals Inc.'s (ANAC) first phase III trial of its topical antifungal Tavaborole for onychomycosis met the primary endpoint of "complete cure" as well as secondary endpoints with a high degree of statistical significance. Despite the positive news, shares plunged 20% on Tuesday as investors feared that the complete cure rate of Tavaborole was inferior to a competing compound - IDP-108 that is being developed by Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO).
However, while discussing the first phase III study results during a conference call held yesterday, the company noted that the differences in inclusion criteria and trial methodology make it difficult to reliably compare its results with that of Valeant Pharma's IDP-108 at this time.
Soligenix Inc. (SNGX) set a new 52-week high of $1.70 on Tuesday following the fast track designation for its OrbeShield by the FDA for the reduction of mortality associated with gastrointestinal acute radiation syndrome.
by RTT Staff Writer
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