Alexza Pharmaceuticals (ALXA) said today the U.S. Food and Drug Administration's psychopharmacologic advisory committee voted to recommend its schizophrenia and bipolar mania treatment Adasuve for approval.
The committee voted to recommend the drug be approved as a single dose in 24 hours when used with the FDA's recommended risk evaluation and mitigation strategy.
The drug is an inhaled version of antipsychotic drug loxapine, delivered via Alexza's Staccato system, which is aimed at treating the agitation resulting from schizophrenia and bipolar mania within 10 minutes.
Valeant Pharmaceuticals (NYSE:VRX) is commercializing the treatment.
The FDA is not required to take the recommendation of its advisory panel, although it frequently does so.
Alexza shares are surging on the news.
YM BioSciences (YMI) is seeing particularly active trading following updated results of ongoing studies of its myelofibrosis treatment.
The treatment, CYT387, appears to demonstrate an ability to render and maintain myelofibrosis patients transfusion independent for clinically-relevant periods, while also improving other symptoms, according to a phase I and phase II study.
YM BioSciences shares are seeing a big gain in trading Tuesday.
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