|Spectrum Shares Up Following FDA Approval For Beleodaq; Tekmira' Anti-Ebola Drug Trial Halted For Safety Concerns|
|By Staff and Wire Reports|
|Thursday, 03 July 2014 19:13|
Shares of Spectrum Pharmaceuticals (NASDAQ: SPPI) gained 5.7 percent following the U.S. Food and Drug Administration's Accelerated approval of the New Drug Application (NDA) for Beleodaq.
Accelerated Approval for Beleodaq -- In an 8-K filing on Wednesday, Spectrum reported that it gained accelerated approval for Beleodaq™ (belinostat) for Injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (“PTCL”). This indication was approved by FDA under accelerated approval based on tumor response rate and duration of response.
Additional Notifications from FDA -- On Monday, Spectrum Pharmaceuticals received additional information from the FDA on post marketing requirements for Beleodaq and Folotyn.
The Phase 3 PTCL trial and the Phase 3 cutaneous T-cell lymphoma (“CTCL”) trial of Folotyn have been released by the Food and Drug Administration.
The release further stated, "The new PMRs for Beleodaq and Folotyn include a main study that evaluates the comparative efficacy and safety of Folotyn when used in combination with the treatment regimen cyclophosphamide/ vincristine/doxorubicin/prednisone (“CHOP”) or the combination of Beleodaq plus CHOP, versus CHOP alone for the initial therapy of patients with PTCL."
Stock Action -- Shares of Spectrum Pharmaceuticals closed at $8.72 on Wednesday. The stock jumped as much as 5.7 percent Thursday morning. Shares are currently trading at $9.12, up 4.59 percent.
Tekmira Pharmaceuticals (NASDAQ: TKMR) shares sank 15 percent after the company revealed the Phase I trial of one of its lead drug candidates was put on hold by the Food and Drug Administration for safety concerns.
The anti-Ebola virus RNAi drug is being developed under a $140 million contract with the U.S. Department of Defense and has been granted so-called Fast Track status by the FDA.
The trial was put on hold by the FDA, which demanded a change in protocol to ensure the safety of volunteer subjects.
The agency also requested additional data related to the mechanism of cytokine release, observed at higher doses. Tekmira said, however, the mechanism "is well understood."
Chief Executive Mark Murray said in a statement that "we will continue our dialogue with the FDA to advance the development" of the product.
RBC analyst Michael Yee said the study placed on hold "isn't a primary value driver" and that investor expectations are already very low.
Yee cut his price target to $25 from $30 and maintained an Outperform on the shares, as reported by Bloomberg news service.
Tekmira closed Thursday at $11.63, down 15.54 percent.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced it has been added to the Russell Microcap Index as part of the annual reconstitution by Russell Investments of its U.S. and global equity indexes on June 27, 2014.
GlaxoSmithKline plc (LSE:GSK) and Genmab A/S (Copenhagen:GEN) announced today that the European Commission (EC) has granted marketing authorization for a new indication for the use of Arzerratm (ofatumumab), a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announced today that the Company has recently been featured in several publications.
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind® system, an optical diagnostic device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, today announced that its board of directors has approved a one-for-ten reverse stock split of the Company's common stock to become effective at 5 p.m., Eastern Time, July 9, 2014.
Minerva Neurosciences, Inc. (Nasdaq:NERV), a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat neurosychiatric diseases, will visit the NASDAQ MarketSite in Times Square in celebration of its recent initial public offering.