Repros submits additional data, shares soar. After the bell: FDA declines approval for Alimera Sciences and pSividia eye drug Print E-mail
By BioMedReports.com Staff   
Thursday, 23 December 2010 19:41
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 23, 2010.

After the bell Thursday shares of both Alimera Sciences, Inc. (Nasdaq:ALIM) and pSividia (Nasdaq:PSDV), partners on the experimental drug ILUVIAN, were hit hard after they reported that the FDA declined to approve its NDA for the drug. The FDA did not ask for additional trials but will require more safety and efficacy data for the drug which is intended to treat retinal swelling. The disease, known as diabetic macular edema, is the most prevalent cause of moderate vision loss in patients suffering from diabetes. The FDA also raised concerns regarding manufacturing, asking for additional information related to the production, sterilization and packaging of the drug.

In extended trading, shares of Alimera sank more than 28.70% or $3.22 to $8.00 while pSivida slumped more than 34.75%, falling $2.21 to $4.15.

Earlier Thursday:

Shares of Repros Therapeutics Inc. (NasdaqCM:RPRX) caught fire Thursday. The company reported today that it has submitted additional data to the FDA from three different studies for its experimental testosterone deficiency drug. The studies showed that patients treated with Androxal showed that a single assessment of testosterone levels between 8 am and 10 am is indicative of the maximum and average levels of testosterone achieved during a particular day on taking the drug. In November 2010 the FDA stated the preferred method to determine testosterone levels in treatments designed to replace the hormone is a 24 hour assessment. When measurements were taken six times a day, Repros said it observed that Androxal raised testosterone level by an average of 200 ng/dl at 12.5 mg and 260 ng/dl at a 25 mg dose, at each time point. Repros intends to show that, unlike topical testosterone preparations, Androxal maintains the normal daily rhythm of testicular testosterone production with peak levels generally occurring in the morning and trough levels exhibited in the evening.

Shares of Repros nearly doubled on the news, rocketing 82% or $1.15 to $2.56.

Dr. Robert Lanza, the Chief Scientific Officer of Advanced Cell Technology (OTCBB: ACTC) was featured and interviewed as "one of the leading scientists making breakthroughs in his field" on Explorations in Science with best-selling author and television personality, Dr. Michio Kaku.

Cannabis Science, Inc. (OTC Bulletin Board:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis products, announced today that it has formed a Military Advisory Board, that will be comprised of distinguished military leaders, military Health Care Providers, Researchers and Educators.

Cephalon, Inc. (Nasdaq:CEPH) announced today that its Board of Directors has appointed J. Kevin Buchi as Chief Executive Officer and a member of the company's Board.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it has agreed to sell 1,400,000 shares of its common stock at a price of $5.99 per share in a registered direct offering to an accredited institutional investor.

Nutrition 21, Inc. (OTCBB: NXXI), the developer and marketer of clinically substantiated ingredients for dietary supplements, foods and beverages, and animal nutrition, today announced that it has retained an investment banker.

Oncolytics Biotech Inc. (TSX:ONC; NASDAQ: ONCY) today announced, that in accordance with the terms of the warrant indenture for the warrants issued by the Corporation on November 23, 2009, the Corporation has provided the required written notice to holders of such warrants that the expiry date has been accelerated to the close of business on Monday January 24, 2011.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) a developer of oral delivery systems, today reported that its wholly owned Israeli subsidiary, Oramed Ltd., was awarded a government grant amounting to a total net amount of NIS 2.9 million ($807,000 USD), from the Office of the Chief Scientist (OCS) at the Ministry of Industry, Trade and Labor of Israel.

PPJ Enterprise (PPJ) (PINKSHEETS: PPJE), a leader in proprietary automated health care reimbursement cycle (all specialties), on line health information digital systems and practice information management digital system software for health care providers, has announced that the company became "Pinksheets Current Information" on 12/15/2010 after going through a long, hard process to comply with "Pinksheets" requirements.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it has been advised by the American Stock Exchange, that the Company's current application for the issuance of securities related to various Notes offerings that took place in 2008, 2009 and 2010 (these are the issuances that were approved by the Company's shareholders at the annual shareholder meeting on December 3, 2010) is scheduled to be reviewed by the AMEX listing committee on or about January 6, 2011.

YM BioSciences Inc. (NYSE Amex:YMI; TSX: YM) announced today that, in connection with its previously announced public offering for total net proceeds before expenses of US $37,650,000, the underwriters have exercised in full their Over-Allotment Option to purchase an additional 3,750,000 common shares of YM at US $1.60 per share for additional net proceeds of US $5,665,000.

 

 




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