Shares of Vanda Pharma (NASDAQ:VNDA) soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the FDA for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.
Below are the nine remaining companies from my article last month on a dozen extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions at 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.
1.) Vion Pharma (VION): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA will receive a standard (10-month) review by the FDA with a PDUFA decision date deadline of 12/12/09.
2.) Hemispherx Biopharma (HEB): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen 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.
3.) Acusphere (OTC:ACUS): Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.
4.) Arca Biopharma (ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
5.) BioDelivery Sciences (BDSI): Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision date of 6/15/09 and a $27M milestone payment if approved from partner Meda AB. Onsolis is a small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the cheek.
BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis last December based on the feedback it received from a complete response ruling by the FDA in August 2008. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission.
6.) Spectrum Pharma (SPPI): Zevalin sBLA (priority review) as consolidation therapy follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved. Cell Therapeutics (CTIC) recently sold its 50% interest in a joint venture between the two companies to market Zevalin so SPPI owns a 100% stake in the cancer drug. A three-month delay in the PDUFA decision date to 7/2/09 was announced on 2/23/09 as SPPI submitted additional data to the FDA, which was classified as a major amendment to the sBLA filing.
SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.
7.) Labopharm (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.
8.) Transcept Pharma (TSPT): The decision date for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed for insomnia from middle of night awakenings is 7/30/09.
9.) Advanced Life Sciences (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 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.
Disclosure: No positions.
