After announcing that the U.S. Food and Drug Administration’s [FDA] Oncologic Drugs Advisory Committee [ODAC] voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma [PTCL], Allos Therapeutics, Inc. (Nasdaq: ALTH) appears likely to get FDA approval for the drug.
Needham & Company, LLC, a subsidiary of The Needham Group, Inc., thinks the terminology issued by the Advisory Committee suggests that the drug will be approved by the FDA on September 24. The firm thinks the company will obtain an ex-U.S. partnership in the longer time and it reiterates a Buy rating on the stock.
Needham & Company, LLC, a subsidiary of The Needham Group, Inc., is a nationally recognized investment banking and asset management firm focused solely on growth companies and their investors. Needham’s mission is to provide its clients with the long-term advice they need to achieve their business goals.
In additon, Cannacord Capital's team of over 50 research professionals are saying that shares of Allos will likely be priced to perfection this morning following the OCAC's endorsement of FOLOTYNTM and they are recommending that investors take their profits.
Cannacrod Capital is committed to maintaining integrity and an independent view, providing meaningful insight into the global capital markets.
Biotech investors interested in seeing more details about these stories and accessing the complete database of clinical trials and upcoming FDA decisions can access that information here.