|Healthcare Review: Isis Pharma, Keryx Biopharma, Inovio Pharmaceuticals, PTC Therapeutics, Agile Therapeutics|
|By Staff and Wire Reports|
|Friday, 23 May 2014 13:46|
Isis Pharma ($
Keryx Biopharma ($KERX) had plunged more than 10% after the close following the FDA's three-month extension of the initial Prescription Drug User Fee Act goal date for its review of Zerenex, but the stock has since recouped losses and is now trading higher. Oppenheimer sees the delay as a minor speed bumps for KERX, noting that the extension wasn't imposed due to clinical data but only because the FDA needs more time to evaluate CMC-related information (Briefing.com).
Inovio Pharmaceuticals' ($INO) board approves a one-for-four reverse split of the company's common stock. The announcement comes ahead of expected mid-2014 phase-2 clinical data on INO's lead pipeline asset VGX-3100, a therapeutic vaccine to treat cervical intraepithelial neoplasia.
PTC Therapeutics ($PTCT) +119.2% after the Committee for Medicinal Products for Human Use of the European Medicines Agency issues a positive opinion on PTCT's application for a conditional marketing authorization of its Ataluren muscular dystrophy treatment. The news is a major upside surprise: Credit Suisse says a potential early EU approval for Ataluren has not been priced in to shares.
Agile Therapeutics ($AGRX) intends to raise $55M in an IPO on Nasdaq by selling 9.2M shares at $6 each, which is down from a prior plan to bring in $60M with an offering of 4.6M shares at $12-14.Insiders intend to purchase $25M worth of stock, up from $15M previously.