Today, in a new special report, BioMedReports.com- the news portal covering the biomedical news and financial sector- has researched and released the details of 12 extreme FDA trades for 11 companies with market caps below $200M- all of which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.
A high risk/reward trading approach to consider for speculative traders is covered in the report which features trades for:
• Hemispherx Biopharma (AMEX: HEB): Ampligen (Poly I: Poly C12U) NDA is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09 (please note this is Memorial Day so the markets will be closed for a long weekend and re-open on Tuesday 5/26).
• Advanced Life Sciences (OTC: ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP) with a PDUFA decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of the FDA is tentatively scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision.
• Spectrum Pharma (NASDAQ: SPPI): SPPI is a dual extreme trade with two pending decisions at the FDA. Zevalin sBLA (priority review) to expand the approved label to include consolidation therapy for follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved with an expected PDUFA decision date of 7/2/09.
• Labopharm (NASDAQ: DDSS): A decision date of 7/18/09 is looming for the Company's rapid-onset formulation of trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market.
• Transcept Pharma (NASDAQ: TSPT): An expected PDUFA decision date of 7/30/09 is pending for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.
The full special report covering more details and profiles for all 11 companies can be found online.
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Disclosure: No positions.
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