Below are FDA extreme trades among 16 companies with stock prices under $5 from the BioMedReports.com FDA Calendar (database includes 225 entries as of 6/27/09) which have pending FDA decisions for either new drug products, biological agents, medical devices, or diagnostic tests 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 buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume.
As with previous installments, this article is neither an endorsement of the 16 companies profiled nor a complete list of extreme trades included in the BioMedReports.com FDA Calendar. Related stock indexes for this article include the Regulatory Catalyst Index, the Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index, and the Emerging Diagnostics Index.
Trinity Biotech (NASDAQ:TRIB): On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval. On 3/10/09, TRIB provided the following update on the Company's new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08.
Angiotech Pharma (NASDAQ:ANPI): On 3/9/09, ANPI presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study. ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.
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.
BSD Medical (NASDAQ:BSDM): On 5/18/09, BSDM announced that the FDA has granted Humanitarian Use Device (HUD) designation for the company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device’s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the U.S. per year. Now that FDA has granted the HUD for the BSD-2000, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application.
BSDM believes that data previously submitted to FDA and reviewed by the Agency as part of the Company’s pending medical device Pre-market Approval (PMA) submission can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000. Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the Company’s strong desire to bring the BSD-2000 to market as quickly as possible, the FDA recommended that BSDM pursue a HDE marketing approval to authorize the commercial sale of the BSD-2000 in the U.S. On 1/7/08, BSDM received a letter from the FDA providing guidance as to amendments needed to make the PMA approvable and the Company responded to this letter on 7/17/08.
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. On 5/26/09, HEB announced that the FDA advised the Company that it may require up to 1-2 additional weeks to take action beyond the original PDUFA action date of 5/25/09. Click here for an exclusive interview of HEB’s CEO, Dr. William A. Carter, which was posted at BioMedReports.com on 6/12/09.
Nephros (NEPH.PB): The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while addressing the critical financial and clinical needs of the care provider. The HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company. On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an estimated decision date of Friday 6/12/09 or Monday 6/15/09, but a response from the Agency is still pending.
On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided (5/26/09), but a response from the Agency is still pending.
Santarus (NASDAQ:SNTS): On 4/6/09, SNTS filed NDA for a new tablet formulation to add to its ZEGERID® family of branded prescription pharmaceutical products. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by December 4, 2009. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec® (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
On 6/9/09, SNTS announced that Schering-Plough (NYSE:SGP)HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole + sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market. The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone upon approval, a low double-digit royalty on net sales of OTC Zegerid, and may receive up to an additional $37.5 million in sales milestones. On 6/23/09, SNTS announced the NDA resubmission will receive a Class 2 (six-month) review by the Agency with an estimated PDUFA action date of 12/9/09 for a possible FDA decision.
Labopharm (NASDAQ:DDSS) has a pending NDA for a rapid-onset formulation of trazodone (DDS-04A) filed through the 505(b)(2) pathway as a new formulation of an existing drug for the proposed treatment of major depressive disorder with an estimated PDUFA action date of 7/18/09 for a possible FDA decision.
Nuvo Research (OTC:NRIFF) has a pending NDA re-submission for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10 million and is also eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA. Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100 million. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010.
On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during late 4Q09. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. CTIC should hear back from the FDA in mid to late August on whether the Agency will officially accept the NDA filing for review, decide on the status of the priority review request, and issue a PDUFA action date for pixantrone.
On 6/26/09, ISTA Pharma (NASDAQ:ISTA) announced that the Dermatologic and Ophthalmic Drugs FDA Advisory Committee voted 7-0 that the Company has adequately demonstrated the safety and effectiveness of the Bepreve eye drops, which would be sold by prescription if the agency granted final approval. On 11/13/08, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09 for the FDA to complete its review of the pending NDA.
Vion Pharma (VION.PB) has a pending NDA for Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) 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.
On 4/7/09, IntelGenx (OTC:IGXT) and Cary Pharma (privately held) announced that a New Drug Application (NDA) was submitted to the FDA for their antidepressant (CPI-300), which represents a new strength of a leading antidepressant (name not disclosed) that will provide a more convenient dosing option to patients with major depressive disorder ("MDD"). IGXT and Cary Pharma entered an agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral delivery technology. CPI-300 was formulated using IntelGenx's proprietary controlled release technology. It contains a new strength of a widely prescribed antidepressant.
On 5/18/09, A.P. Pharma (NASDAQ:APPA) announced that it has submitted a NDA for its lead product (APF530) to the FDA for the prevention of chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes the Company’s proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA’s prior safety and efficacy findings for APF530's active ingredient, granisetron (which is already approved and marketed as Kytril). The FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the Company of its determination within 14 days thereafter.
On 6/1/09, Theratechnologies (OTC:THTCF) announced that it filed a NDA with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is 4/1/2010.
On 5/21/09, Human Genome Sciences (NASDAQ:HGSI) announced that it submitted a Biologics License Application (BLA) to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax. Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS).
On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time. HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients.
Disclosure: No Positions.