AMRN Gets Thumbs Down, WMGI Opens Wallet, HBIO To Spin Off HART

(RTTNews) - Aastrom Biosciences Inc. (ASTM) said that its previously announced one-for-twenty reverse stock split of the company's common stock became effective on Oct.16, 2013. The reverse stock split is intended to satisfy the $1.00 minimum bid price requirement for the continued listing on NASDAQ and to attract greater institutional ownership of the company's shares.

ASTM closed Wednesday's trading at $3.74.

Amarin Corp. plc (AMRN) on Wednesday said that the FDA panel has voted 9 to 2 against the expanded approval of Vascepa for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) with mixed dyslipidemia.

The final decision of the FDA is scheduled for December 20, 2013.

Vascepa is currently approved by the FDA for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (more than or equal to 500 mg/dL) hypertriglyceridemia.

Cleveland BioLabs Inc.'s (CBLI) wholly-owned Russian subsidiary, BioLab 612, LLC, has entered into a three-year contract valued at 149 million rubles, or approximately $4.6 million, with the Ministry of Industry and Trade of the Russian Federation for clinical development of Entolimod (CBLB502). The contract funds will be used to support the clinical safety and efficacy assessment of Entolimod in colorectal cancer.

Entolimod is under phase I trial in advanced solid tumors and is also under pivotal studies as a radiation countermeasure.

CBLI closed Wednesday's trading at $1.63, up 5.84%.

Dynavax Technologies Corp. (DVAX) is expected to initiate a large-scale, phase III clinical study of HEPLISAV, its investigational adult hepatitis B vaccine, in the first quarter of 2014.

The planned study, dubbed HBV-23, will be an 8,000 subject, observer-blinded, multicenter trial of the safety and immunogenicity of HEPLISAV compared with Engerix-B in adults 18 to 70 years of age.

DVAX closed Wednesday's trading 5.13% higher at $1.23. In after-hours, the stock gained 1.63% to $1.25.

Harvard Bioscience Inc. (HBIO) is all set to spin-off its wholly owned regenerative medicine device subsidiary, Harvard Apparatus Regenerative Technology Inc., as an independent public company on October 21, 2013.

Harvard Bioscience expects a "when issued" public market for HART common stock to begin on or about October 21, 2013 on the NASDAQ Capital Market under the ticker symbol "HART." Following the spin-off, "regular way" trading of HART common stock is expected to start on November 4, 2013 under the ticker symbol "HART".

HBIO closed Wednesday's trading at $5.34, up 5.74%.

Vanda Pharmaceuticals Inc.'s (VNDA) New Drug Application for HETLIOZ for the treatment of Non-24-Hour Disorder in the totally blind is scheduled to be reviewed by an FDA panel on November 14, 2013. The FDA's final decision on HETLIOZ is set for January 31, 2014.

Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle.

VNDA closed Wednesday's trading at $9.87, up 2.49%.

Wright Medical Group Inc. (WMGI) has agreed to acquire Biotech International, a privately held French orthopaedic extremities company for a total price of up to $80 million. The transaction is expected to significantly expand Wright's direct sales channel in France and international distribution network and add Biotech's complementary extremity product portfolio to further accelerate growth opportunities in Wright's global Extremities business.

As part of the transaction, Biotech will spin off its dental business before the close of the transaction. The transaction is expected to close in the fourth quarter of 2013.

WMGI closed Wednesday's trading at $27.42, up 1.22%.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

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