|Healthcare Review: Unilife, BioDelivery Sciences, Echo Therapeutics, EnteroMedics, Myriad Genetics|
|By Staff and Wire Reports|
|Tuesday, 03 December 2013 15:20|
"Novartis now joins Sanofi, Medimmune (AstraZeneca), and Hikma, which have entered into long-term deals," Cantor's Jeremy Feffer says, reiterating a Buy rating on shares of Unilife ($UNIS). Feffer says that although UNIS "is unlikely to finalize the 10-12 agreements management initially expected to sign in 2013 ... the size, scope, and diversity of the deals announced thus far significantly enhance management's credibility." Price target lifted to $8 from $6.See also: UNIS strikes supply agreement with Novartis.
With today's gains, shares of BioDelivery Sciences ($BDSI) are up nearly 12% this week. On Monday, the company said that a Phase 3 trial of Clonidine Topical Gel (in PDN) will go ahead in Q1 2014 after a "positive meeting" with the FDA. Today, the company announced a new VP of sales and managed markets, David Acheson. Among other duties, Acheson will "oversee the sales and managed markets support behind the anticipated launch of Bunavail in 2014."
The premarket sell-off in shares of Echo Therapeutics ($ECTE) accelerated meaningfully into the regular session — the stock is now off double-digits. Investors are apparently unhappy about an offering of stock and warrants. Not helping matters is SA contributor Nick Zheng, who "doubts the Symphony CGM system will be used in EU hospitals even if/when ECTE receives a CE mark."
EnteroMedics ($ETRM) soars after announcing 18-month safety and efficacy results from ReCharge (pivotal VBLOC study). Summary: Treatment group EWL, 25% and 10% TBL; control group, 12% EWL and 4% TBL. Results were statistically superior at p<.0001.SAE rate at 18 months: 4.3% (12-month threshold was 15%)."These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety," CEO Mark Knudson says.
Shares of Myriad Genetics ($MYGN) trade sharply lower out of the gate on the heels of a big decline Monday. There has been some confusion regarding whether a clerical error caused the BRCA1/2 full sequence to be priced the same as a single gene BRCA1 test (Excel sheet can be obtained here) on the 2014 fee schedule. Here's JMP on the issue: "Management maintains that this was another clerical error," but after reaching out to "a half dozen of our lab manager contacts, as well as some reimbursement managers at a few private companies ... most believe that this is not a mistake on CMS's part but rather a reflection of how CMS is re-evaluating the calculus behind reimbursement levels for molecular tests. "A bit more color: "If it is an error, there is unlikely to be a fix in place by January 1."