FDA Decision Calendar: 16 Extreme Trades
By Mike Havrilla on 2/4/09
for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades.
(BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + 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.
GTC Biotherapeutics (GTCB) – A decision is expected by 2/7/09 for the Atryn (recombinant human antithrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising ever since.
Hemispherx Biopharma (HEB) – A decision is expected by 2/25/08 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. Ampligen is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a "promising" designation by the Agency on Health Research Quality
, "Ampligen, an investigational drug that is not approved by the FDA, given intravenously to severely debilitated patients, yielded the most promising results."
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.
Somaxon Pharma (SOMX) – The Company's Silenor (doxepin) NDA for the treatment of insomnia was filed under the 505(b)(2) pathway since doxepin is an approved drug, which is already available on the market in generic formulations. Somaxon's new formulation of doxepin is at lower doses (1, 3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg, which result in a higher incidence of side effects.
Vanda Pharma (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 (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 (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.
Novacea (NOVC) 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 (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 (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 (SPPI) + Cell Therapeutics (CTIC) have a PDUFA date of 4/2/09 for their 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. CTIC also plans to begin a rolling NDA submission for pixantrone during 1Q09 for the treatment of relapsed, aggressive NHL.
Angiotech Pharma (ANPI) expects a decision by mid-2009 for its Bio-Seal Lung Biopsy Track Plug 510(k) application.
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.