Trading FDA Decisions: 14 Candidates

by: Mike Havrilla

Below is a summary of companies from the FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.

Dyax Corp. (NASDAQ:DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).

The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. ViroPharma (VPHM) has a PDUFA date of 10/1/09 for its Cinryze C1 Inhibitor sBLA to expand its label to include the treatment of HAE.

BioDelivery Sciences (NASDAQ:BDSI) - Onsolis approval is possible by mid-2009 (click here for my full article) and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement and a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.

Discovery Labs (DSCO) has a 4/17/09 PDUFA decision date for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded to the mid-dollar range as the decision date nears and insiders have purchased over 338,000 shares of stock in the past six months.

Hemispherx Biopharma (NYSEMKT:HEB) - A decision is expected by 5/25/08 for the Company's resubmission of its Ampligen NDA, which is designated as an Orphan Drug for the treatment of chronic fatigue syndrome, which has no FDA approved treatments on the market.

Northfield Labs (NFLD) - The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09. Around the same time late last year, Biopure (BPUR) received a clinical hold notice from the FDA, which blocks future clinical trials of its blood substitute candidate Hemopure. Since the FDA cited general concerns over deaths in clinical trials of blood substitutes, NFLD remains as the only game in town in the quest for a blood substitute since its BLA was accepted with a priority review.

Vanda Pharma (NASDAQ:VNDA) has a PDUFA date of 5/6/09 for its iloperidone NDA as a resubmission to a not approvable ruling on 7/25/08 for the atypical anti-psychotic in the treatment of schizophrenia.

ARCA Biopharma (NASDAQ:ABIO) has a PDUFA date of 5/31/09 for the Gencaro (bucindolol) NDA in the treatment of chronic heart failure. Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (NYSE:LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA 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.

Transcept Pharma (TSPT) has a PDUFA date of 7/30/09 for its Intermezzo (zolpidem sublingual lozenge) NDA for as-needed use to treat insomnia from middle of night awakenings.

Advanced Life Sciences (OTCPK:ADLS) has a PDUFA date of 8/1/09 for its cethromycin NDA, which is a once-daily antibiotic for the treatment of community acquired pneumonia.

NeurogesX (NASDAQ:NGSX) has a PDUFA date of 8/22/09 for its Qutenza (NGX-4010) capsaicin skin patch NDA for post-herpetic neuralgia (nerve pain that occurs after shingles outbreak).

ISTA Pharma (ISTA) has a PDUFA date of 9/12/09 for its Bepreve (bepotastine) eye drop NDA for ocular itching associated with allergic conjunctivitis.

Spectrum Pharma (NASDAQ:SPPI) has a PDUFA date of 7/2/09 for its Zevalin sBLA (priority review) as consolidation therapy in the treatment of follicular B-cell non-Hodgkin's lymphoma (NHL) if the patient experiences a response to first-line treatment. SPPI recently purchased the 50% stake in a joint venture for the drug from Cell Therapeutics (NASDAQ:CTIC).

Labopharm (DDSS) has a PDUFA of 7/18/09 for its rapid-onset trazodone (DDS-04A) 505(b)(2) application for the treatment of major depressive disorder, which represents a new formulation of an existing drug that is also available in generic formulations.

Isolagen (ILE) submitted a BLA earlier this week for Isolagen Therapy (with a PDUFA date of 1/9/10), which is a novel cell-based therapy for the treatment of wrinkles. Isolagen Therapy would represent a new class of treatment in the facial aesthetic market as patients would receive their own cells to repair the skin if the FDA grants approval. Additionally, the company noted that it recently completed a Phase 2/3 trial for the treatment of acne scars with statistically significant efficacy results.