Healthcare Review: Stemline Therapeutics, Epizyme, Acadia Pharmaceuticals, Novavax, Novogen Print E-mail
By Staff and Wire Reports   
Thursday, 14 November 2013 16:45
Stocks were mostly higher Thursday as investors were digesting news on retail earnings and economic data on jobs, trade and productivity. Janet Yellen, the nominee to replace Ben Bernanke as Fed chairman at the end of the year, is testifying before the Senate banking committee as well on Thursday. Analysts said her published introductory remarks were a boost for stock markets that have been propelled higher since the aftermath of the 2008 financial crisis by the Fed's super-low interest rate and bond-buying policies. The Dow Jones industrial average was up 0.3% to 15,872 and the Standard & Poor's 500 index gained 0.4% to 1,789. Both indexes were pushing further into record territory. The Nasdaq composite index was up 0.1% to 3,970 as Cisco fell 12% after a disappointing profit report.

Stemline Therapeutics ($STML +11.2%) rallies after saying investigators will give a clinical update of SL-401 in blastic plasmacytoid dendritic cell neoplasm at ASH. Also on the agenda: Preclinical data for SL-401 in multiple myeloma and chronic eosinophilic leukemia and preclinical data from SL-101 in AML. The company announces one new BPDCN patient CR and notes that "to date there have been 5 CRs and 1 PR" out of seven evaluable patients for an ORR of 86%. (PR)Previously: Aegis sees SL-401 peak sales of $800M to $3B.

Shares of Epizyme ($EPZM -34.3%) sink after the company outlines initial findings from a Phase 1 study of EPZ-5676 in heavily pre-treated advanced hematological malignancies. EPZM says the treatment has been well-tolerated with no dose-limiting toxicities. There was one adverse event-related treatment discontinuation, but the company says it wasn't related to the drug. Treatment effect observed in four of eight MLL-r acute leukemia patients. No treatment effects observed in non-MLL-r patients. The company now plans to initiate a Phase 1 "MLL-r only expansion stage with an 80 mg/m2/day administration schedule without a drug holiday and with possible continued dose escalation."

Acadia Pharmaceuticals ($ACAD) initiates a Phase 2 feasibility trial of pimavanserin in Alzheimer's disease psychosis (for which there are no treatments approved in the U.S.).The company says Phase 3 results in Parkinson's disease psychosis (that's -020) suggest the drug "may offer the potential for an important new therapeutic advance" in ADP. In a recent article, SA contributor Jason Napodano said "several pieces of evidence point to a successful outcome" in ADP. He calls the drug "the next blockbuster for psychosis."

Novavax ($NVAX) jumps 9%.Wednesday evening, the company announced that The New England Journal of Medicine published what NVAX calls "positive clinical data" from a study of the VLP A(H7N9) vaccine candidate. Summary: The vaccine was well tolerated, safety was "in-line with previous findings," and 81% and 97% of 5ug adjuvanted vaccine recipients had protective HAI levels and anti-neuraminidase antibody responses, respectively.

Shares of Novogen ($NVGN) rally 24%.The move may be attributable to what the company calls an "important discovery" in the fight against genetic and degenerative disorders. NVGN says its scientists "came to suspect that the action of [the company's] drugs is not so much the fact that the stem cells are cancerous, but that they are behaving abnormally." Building on this, NVGN began a "pilot study looking into [the drugs'] effect on abnormal stem cells responsible for causing degenerative diseases." In short, the company says "early data completely supports" its hypothesis.


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