Below are companies with market caps under $250 million from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. 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 FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases.
BioMimetic Therapeutics (NASDAQ: BMTI): On 6/17/09, BMTI announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009 (4Q09). A modular submission breaks the PMA document into three sections or "modules" filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application and may ultimately shorten the review timeline.
On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. The primary endpoint is based on the fusion rate at six months as assessed on CT scans. The Company expects to release top line data from the trial in the second half of 2009 (2H09).
BioSante Pharma (NASDAQ:BPAX): On 6/17/09, BPAX announced that based upon a review of study conduct and blinded data from the LibiGel Phase 3 Cardiovascular and Breast Cancer Safety Study, the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel Phase 3 clinical program. A very low cardiovascular event rate has occurred thus far in the clinical trials. The Executive Committee evaluated study information from over 1,000 women enrolled totaling approximately 600 women-years of exposure in the Phase 3 LibiGel safety study.
BPAX stated that its objective is to submit a NDA for FDA approval of LibiGel in late 2010 or early 2011 for the proposed treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. In addition to the Phase 3 cardiovascular and breast cancer safety study, BPAX is conducting two LibiGel Phase 3 efficacy trials. The Phase 3 efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).
pSivida Corp. (NASDAQ:PSDV): On 6/15/09, PSDV announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company’s lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye.
Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.
NeuroMetrix (NASDAQ:NURO): Status of pending 510k submissions to the FDA as of NURO’s SEC 10Q filing on 5/15/09 includes the following: The ADVANCE NCS/EMG System is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The system was launched during 2Q08 and is used primarily by neurologists, physical medicine & rehabilitation physicians, hand surgeons, and other specialists.
NURO submitted a 510(k) application to the FDA on the (1) signal detector in December 2008 and filed an application on the (2) stimulator for the device in April 2009 for marketing clearance of a product designed to precisely deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves for regional anesthesia, pain control, and the treatment of focal neuropathies. The FDA does not issue decision date deadlines for medical device 510(k) submissions.
NPS Pharma (NASDAQ:NPSP): On 5/5/09, NPSP provided the following update for GATTEX (teduglutide): Patient enrollment continues in STEPS, an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. The company continues to expect the last patient to enroll in STEPS before the end of the first quarter of 2010. NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.
On 5/5/09, NPSP provided the following update on NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection): Enrollment is proceeding in REPLACE, a Phase 3 registration study evaluating NPSP558 for the treatment of adults with hypoparathyroidism. NPS continues to expect to complete patient enrollment before the end of the first quarter of 2010. NPS believes positive results from REPLACE will enable it to seek U.S. marketing approval for NPSP558 for patients with hypoparathyroidism.
On 3/9/09, Acrux (OTCPK:ARUXF) announced that its Testosterone MD-Lotion development program achieves key milestone and will be commercialized as Axiron. Achieved enrollment of 150 men in a pivotal Phase 3 open-label trial as planned with trial results expected 3Q09 and a FDA submission anticipated by the Compnay during December 2009.
Javelin Pharma (AMEX:JAV): On 6/15/09, JAV reported results from a new Phase 1 pharmacokinetic and safety study of Dyloject in patients with mild to moderate renal (kidney) and mild hepatic (liver) impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject's active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls.
The Company plans to file a NDA for Dyloject with the FDA for U.S. marketing approval during the fall of 2009 at the same dose used in these studies. Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints.
Disclosure: No positions.