Roth Capital Remains Cautiously Optimistic on Spectrum Pharma (SPPI) Following Apaziquone Phase 3 SPA Agreement

Roth Capital affirms Spectrum Pharmaceuticals (Nasdaq: SPPI) at Neutral and price target of $6 after the company announced that it reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone.

Analyst Joseph Pantginis commented, We have a level of guarded optimism regarding apaziquone based on the clinical data to date. However, we believe the drug continues to face hurdles on both the regulatory and investor confidence fronts. Recall that the rights to apaziquone were returned to Spectrum from Allergan (AGN-NC) in January 2013. On the regulatory side, following the planned NDA, we expect an Advisory Committee to be convened, at which point the company will make its case for an accelerated approval pathway for apaziquone based on pooled data from two Phase III studies (unconventional). The unmet medical need and supportive clinical data may help the company's case, however the FDA is more likely than not recommending waiting for the outcome of the next Phase III, which will take quite some time to complete. We currently do not include apaziquone in our valuation and await further visibility on the Phase III as well as details of the expected AdCom.

For an analyst ratings summary and ratings history on Spectrum Pharmaceuticals click here. For more ratings news on Spectrum Pharmaceuticals click here.

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