Mike Havrilla submits:Below are extreme trades among 20 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 264 entries as of 7/20/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results. 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. 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 companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports. With shares of Human Genome Sciences (NASDAQ:HGSI) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. Click here for more info at the FDA website regarding the regulatory approval process for medical devices. On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. 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 found with the other three competing products. On 5/29/09, Theratechnologies (THTCF.PK) ($2.00)filed a New Drug Application (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 expected to occur in late 1Q10. On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. 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 by the Agency. On 7/14/09, Genta (GETA.OB) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta’s recently completed Phase 3 trial of Genasensein advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication. On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an “intent-to-file” notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe. On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares. On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis. This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010. Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). The stock price for JAV has increased by about 24% in the last five trading days and the volume was over 2X its average on 7/20/09. In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa. On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies. Hemispherx Biopharma (AMEX:HEB) ($2.49): 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. On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09. On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today that the FDA accepted the Company’s submission in response to the FDA’s March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09, and the Company’s share price has increased by about 58% in the past month. On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09. Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company’s clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company’s completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission. Shares of SOMX have increased by about 239% over the past three months and the Company raised $6 million in a private placement in early July – providing adequate liquidity through 2Q10. On 7/8/09, Noveko (NKOFF.PK) ($1.39) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio. On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) 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 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 is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone. Nuvo Research (NRIFF.PK) ($0.36) 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. Advanced Life Sciences (ADLS.OB) ($0.46): Cethromycin NDA (a once-daily antibiotic for the treatment of community acquired pneumonia - CAP) with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining). On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed Pharma announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed’s New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone). The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date during 4Q09 for a possible FDA decision. On 7/8/09, Transdel Pharma (TDLP.OB) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized. On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in 4Q08. Vical expects the trial to be completed during 4Q09 with final data available during 1H10. On 11/14/08, Nephros (NEPH.OB) ($1.25) 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 requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter. Disclosure: No positions.Complete Story »
