Below are 12 extreme FDA trades of companies with market caps below $200M 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 investing a small amount of money that you can afford to lose in a basket of stocks included in extreme <font> FDA and Clinical Trial Calendar </font> trades, which are highlighted in periodic articles at <font> BioMedReports.com </font> .
Hemispherx Biopharma (AMEX: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 (please note this is Memorial Day so the markets will be closed for a long weekend and re-open on Tuesday 5/26). <font> Click here for a link to a special report </font> on HEB at BioMedReports.com, including a link to an audio interview with the Chairman/CEO of HEB, Dr. William Carter.
Arca biopharma (NASDAQ:ABIO) : Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09 (please note this date is a Sunday so Monday 6/1 is the more likely date for an announcement or update on the FDA decision). 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. <font> Click here for a special report </font> on ABIO, including a related video.
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.
Discovery Labs (NASDAQ:DSCO) : On 5/11/09, DSCO announced that it has received written notice from the FDA that an end-of-review meeting has been scheduled for 6/2/09 to determine the resolution of the remaining primary issue necessary for the Company to gain U.S. marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.
Following the meeting and receipt of formal written minutes from the FDA, DSCO plans to provide an update, including the expected timeline for the potential approval of Surfaxin. On 4/17/09, DSCO Discovery Labs received a Complete Response Letter (CRL) from the FDA for Surfaxin. In its letter, the FDA focused primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before Surfaxin can be approved.
The FDA questioned whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether DSCO has adequately validated the BAT and determined its final acceptance criteria. Discovery Labs intends to rely on data already submitted to the FDA, as well as limited existing data, to support the comparability of Surfaxin clinical drug product to commercial Surfaxin drug product and demonstrate that the BAT can adequately distinguish change in Surfaxin over time and is an appropriate test for monitoring Surfaxin biological activity throughout shelf-life.
BioDelivery Sciences (NASDAQ:BDSI) : Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision by Monday 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.
Spectrum Pharma (NASDAQ:SPPI) : 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. 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.
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.
Nuvo Research (PINK:NRIFF) (TSE:NRI) : Expected PDUFA decision date of 8/5/09 for the Company's NDA re-submission for Pennsaid, which is a topical NSAID for arthritis pain and inflammation.
NeurogesX (NASDAQ:NGSX) : On 3/19/09, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. The CHMP's recommendation for the MAA, filed under the centralized procedure, is subject to a final decision by the European Commission, usually rendered approximately 60 to 90 days after the CHMP's recommendation.
A decision is expected during 1H09 for approval of Qutenza in the EU (along with a marketing partnership in the same time frame) while the Company's pending NDA for FDA approval has a PDUFA date of 8/16/09 for Qutenza (capsaicin skin patch) in the treatment of post-herpetic neuralgia (PHN) nerve pain. NGSX ended 1Q09 with $18.8M in cash/equivalents and the Company has a market cap of about $50M as of the market close on 5/8/09. Since NGSX used a 4% lidocaine cream to numb the area of skin prior to the application of Qutenza in order to reduce burning, the Company may be required to conduct a small study testing a FDA-approved topical anesthetic along with Qutenza prior to the FDA granting approval which could result in a delay to the mid-August PDUFA date by a few months . NGSX expects to provide clarity on the exact timeline in near-term.
Vion Pharma (OTC: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 an expected PDUFA decision date deadline of 12/12/09 .
Acusphere (OTC:ACUS) : In February, ACUS.PK amended its New Drug Application (NDA) for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. The amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use. On 3/11/09, Acusphere received a complete response letter (CRL) from the FDA which stated that additional clinical studies would be necessary for the Company's original broad label of use claim.
The goal of the amended NDA and narrower claim for Imagify is to improve the risk/benefit ratio for the cardiac imaging agent by limiting its use to patients undergoing pharmacologic stress tests so that additional clinical studies are not required as outlined in the CRL from the FDA. The last update from Acusphere indicated that the Company was invited by the FDA to discuss alternatives and is in the process of scheduling such a meeting. In addition, Acusphere has implemented cost-cutting measures, including a workforce reduction of 40 people (about two-thirds of all employees), moving the stock listing to the pink sheets, suspending SEC reporting obligations, and terminating the Company's Watertown, MA headquarters lease and relocating all personnel to its facility in Tewksbury, MA.
The previous estimated decision date for Acusphere in the BioMedReports.com FDA calendar for Imagify was 5/31/09. However, since the FDA issued a CRL on 3/11/09 for the original NDA with a broad claim of use label, the exact timeline for a new decision on the amended NDA for Imagify with a narrower claim is still pending . The aggressive cost-cutting initiatives by the Company provide expected liquidity to fund operations into 3Q09, which provides time for Acusphere to explore strategic partnerships and financing arrangements as discussions continue with the FDA to clarify the timeline for a new decision on the amended NDA.
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