|Healthcare Review: EnteroMedics, Acadia Pharmaceuticals, Keryx Biopharmaceuticals, Agenus, Navidea BioPharma|
|By Staff and Wire Reports|
|Tuesday, 08 October 2013 14:05|
EnteroMedics ($ETRM) is reiterated with a Buy rating but a new $3 price target (up from $1.50) at Canaccord Genuity, implying a potential 150% upside for the stock. The firm believes the risk/reward is favorable for investors with a speculative risk profile, seeing a high likelihood of a positive FDA panel result in Q4 2013 or Q1 2014 for ETRM's Maestro System for obesity given the relative safety of the device, moderate weight loss, and lack of alternatives for obese patients.
Acadia Pharmaceuticals ($ACAD) shares are down sharply, with no recent news or information to account for the move, though biotech blogger Adam Feuerstein tweets a rumor that today's decline is due to a doctor on a Cowen panel having a bearish stance on its lead drug candidate pimavanserin. Pimavanserin is in Phase 3 development as a potential first-in-class treatment for Parkinson's disease psychosis, and ACAD established an expedited path to an NDA filing in Q2.
Keryx Biopharmaceuticals ($KERX) climbed up after announcing its New Drug Application for Zerenex has been accepted for filing by the FDA. The NDA seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels in patients with chronic kidney disease on dialysis. Included in the NDA filing are safety and efficacy datasets derived from Phase 3 registration, as well as data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.
Agenus ($AGEN) jumped 5% after announcing that GlaxoSmithKline's (GSK) RTS,S malaria vaccine candidate, which contains Agenus' QS-21 Stimulon1 adjuvant, reduced malaria infection in young children and infants up to 18 months post vaccination, according to new Phase 3 data. According to the results, children aged 5-17 months at first vaccination with RTS,S experienced 46% fewer cases of clinical malaria, vs. children immunized with a control vaccine.
Navidea BioPharma ($NAVB) added 3% following release of Phase 3 clinical trial data for its Lymphoseek injection in patients with head and neck squamous cell carcinoma. The now-completed full study indicates Lymphoseek met all pre-specified study endpoints, including sensitivity, negative predictive value and overall accuracy relative to the pathology status of non-SLNs.