|Healthcare Review: Aeterna Zentaris, Sarepta, MannKind, Athersys, Pernix Therapeutics|
|By Staff and Wire Reports|
|Monday, 06 January 2014 14:51|
The FDA accepts Aeterna Zentaris' ($AEZS) NDA for macimorelin acetate in AGHD for filing.The application was submitted in November.Approval would make macimorelin acetate the "the first orally-administered product that induces growth hormone release to evaluate AGHD."PDUFA date: November 5, 2014.
Sarepta ($SRPT) shares are taking back some of the day's losses (15.1% at the trough after a negative view issued by Citi) on news that an FDA official has sent a letter to people who have written the agency regarding the early approval of eteplirsen, noting in part, the "FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular." Adam Feuerstein opines that the consensus view on Sarepta is that the muscular dystrophy drug has virtually no chance to receive early FDA review, but that the agency "would... might... possibly... be willing to review eteplirsen based on the existing phase II data," and that "Sarepta's door isn't shut entirely."
Shares of MannKind ($MNKD) are strong to start the week.SA contributor Maredin Capital Advisors — who has "owned shares for the better part of six years and endured quite a bit of volatility in the process" — likens Afrezza's market potential to Lipitor and Plavix and says FDA approval is "a low hurdle at this juncture." The author goes on to say that Afrezza "will likely become the dominant player in the $44B insulin market due to its unique pharmacokinetics/efficacy and convenience." The article appeared elsewhere last month. Also bullish is SA contributor Stock Whisper, who highlights the company's presentation at the Piper Jaffray healthcare conference.
Shares of Athersys ($ATHX) are trading notably higher on heavy volume. Perhaps helping to tip sentiment is SA contributor U.S. Biotech Investor, who highlights results from preclinical studies of MultiStem and says "investors are beginning to recognize and appreciate the potential value of the [company's] portfolio." The author (who penned a bullish post on the shares back in November) says reforms in Japanese pharmaceutical legislation and new information gleaned from Piper Jaffray's healthcare conference have created even more upside for the stock, which, according to the article, could go to $15.
Cantor cuts Pernix Therapeutics ($PTX) to Sell from Hold. "On December 18, PTX was sued for breach of contract, specific performance, and attorney's fees in the U.S. District Court of the Southern District of Texas by a group of Cypress shareholders," analyst Irina Rivkind notes, adding that she anticipates either "a negative reaction in the stock or potential dilution to shareholders from an equity financing event."$2 target maintained, as Rivkind still thinks the company has enough assets to warrant a takeout in that price range.