|Healthcare Review: AcelRx Pharmaceuticals, Vertex Pharmaceuticals, Oxygen Biotherapeutics, Alimera Sciences, Galectin Therapeutics|
|By Staff and Wire Reports|
|Thursday, 19 December 2013 16:19|
AcelRx Pharmaceuticals ($ACRX) is up handsomely on the session. The company says it has extended its relationship with Hercules Technology Growth Capital and secured as much as $40M in new loans. "The proceeds from this credit facility provide [us] with additional operating capital and contingency funding for our commercialization activities as we continue to prepare for the launch, if approved, of Zalviso," CEO Richard King says.
Vertex Pharmaceuticals ($VRTX) shakes off the Kalydeco R117H miss to trade higher. Summer Street's Carol Werther is out with some commentary on the data and says "patients with the R117H mutation that are 18 and older may be able to obtain reimbursement based on these data." Presumably, she's referencing the subset that did hit statistical significance (see the PR)."We are buyers of VRTX on this weakness as the stock should rebound before year-end," Werther said this morning — as it turns out, the stock rebounded before lunchtime.
Oxygen Biotherapeutics ($OXBT) rises 5% following the company issued an "update" today, in which it reviewed the levosimendan story. OXBT also delineated its "anticipated 2014 milestones," which include the enrollment of the first patient in a Phase 3 study of levosimendan and the completion of "Army-funded preclinical safety studies for Oxycyte."
Alimera Sciences ($ALIM) soars 62% after the company and the FDA have entered into labeling discussions regarding Iluvien. An agreement has been reached that the company's participation in a January Ad Com is "no longer necessary." ALIM says it will "focus instead on drafting its response to the CRL." Submission expected in Q1 2014. The company will address manufacturing facility concerns and will "provide a safety update." Finally, ALIM says it "will not be required to conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval."
Galectin Therapeutics ($GALT) trades higher after the company says GR-MD-02 and GM-CT-01 demonstrated a "positive therapeutic effect" in NASH with fibrosis. NASH-induced mice treated with the galectin-inhibitors showed "improved NASH activity and reduced fibrosis including prevention of accumulation of collagen and/or reduced accumulated collagen in the liver." Data from a first-in-man Phase 1 study of GR-MD-02 is expected early next year.