Eli Lilly (NYSE:LLY) expects to report results from a third Phase 3 Clinical Trial are expected in late 2009 for arzoxifene to increase bone mineral density in post-menopausal women. Arzoxifene has been shown to reduce bone turnover/breakdown and is also being studied to reduce the risk of breast cancer. The drug significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo. The third Phase 3 trial, GENERATIONS, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density, with results expected in late 2009.
On 4/21/09, Alkermes (NASDAQ:ALKS) announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.
On 4/29/09, Rockwell Medical (NASDAQ:RMTI) announced the completion of patient enrollment in the Phase 2b study of SFP, which is a six-month, dose-ranging study in about 130 hemodialysis patients to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be completed by the end of September and data should be released about 60 days later, which should occur in late November or early December. The Phase 3 clinical trial for SFP should begin sometime during 4Q09-1Q10 and RMTI has guided for adequate cash flow and liquidity to reach this point without the need for raising cash. Click here to view or download my PDF stock profile report for RMTI from late April 2009.
On 5/7/09, Avanir Pharma (NASDAQ:AVNR) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.
On 5/11/09, Acadia Pharma (NASDAQ:ACAD) provided the following update along with its quarterly financial results: Enrollment was completed in the Company's first pivotal Phase 3 trial of pimavanserin in patients with Parkinson's disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.
On 5/11/09, GTx Inc. (NASDAQ:GTXI) reported quarterly results and stated that is conducting a pivotal Phase 3 clinical trial evaluating Acapodene (toremifene) 20 mg for the prevention of prostate cancer in men with high-grade pre-cancerous prostate lesions (high-grade PIN). The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTXI anticipates reporting data for this Phase 3 study in late summer 2009 and will file a NDA with the FDA in late 2009 based upon a positive trial outcome. GTXI also has a pending NDA for toremifene 80 mg (standard 10-month review with FDA decision expected in late October) seeking approval for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.
On 5/28/09, Poniard Pharma (NASDAQ:PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin. Overall survival data are expected 2H09 for this trial.
On 6/1/09, Raptor Pharma (RPTP.OB) announced that it has dosed the first patient in its Phase 2b clinical trial, conducted in collaboration with the University of California, San Diego ("UCSD"), to evaluate Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") capsules in nephropathic cystinosis ("cystinosis"), a rare genetic lysosomal storage disease. Under Raptor's open Investigational New Drug application ("IND"), UCSD is performing the Raptor-sponsored trial at its General Clinical Research Center. The Phase 2b clinical trial will enroll up to six cystinosis patients with a history of good compliance using the currently available immediate-release form of cysteamine bitartrate, the only drug cleared for marketing by the FDA and European Medicines Agency ("EMEA") to treat cystinosis. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Data from the study are expected during 3Q09.
On 6/15/09, pSivida Corp. (NASDAQ: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.
On 6/15/09, Aeterna Zentaris (NASDAQ:AEZS) reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010.
On 6/17/09, BioMimetic Therapeutics (NASDAQ: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 during 4Q09. 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 Company expects to release top line data from the trial during 2H09.
On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoza in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending. The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending.
Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 in favor of the drug's cardiovascular safety profile.
On 7/6/09, Protalix BioTherapeutics (AMEX:PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease.
The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.
On 7/7/09, Cell Therapeutics (NASDAQ:CTIC) announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.
On 6/24/09, 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 4Q09. The Company 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.
On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.
Bristol-Myers (NYSE:BMY) and AstraZeneca (NYSE:AZN) have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.
United Therapeutics (NASDAQ:UTHR) announced on 4/28/09 that the FDA has extended the PDUFA action date for the Company's pending Tyvaso (inhaled treprostinil) NDA. The new PDUFA date is 7/30/09 and UTHR expected the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.
On 6/16/09, a FDA Advisory Panel ruled that Savient Pharma's (NASDAQ:SVNT) experimental gout drug is safe and effective for certain patients with the disorder. SVNT is seeking FDA approval for the infused drug (Krystexxa) for those who have the painful type of arthritis, but fail to improve with first-line treatments or cannot tolerate other treatments. The FDA's panel of outside experts (in a 14-1 vote) ruled that the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems and allergic reactions. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.
On 3/12/09, Endo Pharma's (NASDAQ:ENDP) majority-owned subsidiary Indevus Pharma announced that the FDA accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting 9/2/09 as the PDUFA action date for a possible decision on the NDA. Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.
On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL. The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. On 7/20/09, SPPI announced that the FDA accepted the Company's CRL resubmission for filing as a Class 1 (60-day) review with a new PDUFA action date of 9/7/09 (which falls on Labor Day, so a decision is more likely to be announced on Tuesday 9/8).
The FDA accepted Spectrum Pharma's supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009. The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
On 4/24/09, the FDA accepted as complete for review Theravance's (NASDAQ:THRX) response to the Agency's February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of cSSSI.
On 4/6/09, the FDA Accepted Theravance's NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).
Allos Therapeutics (NASDAQ:ALTH) filed a NDA on 3/25/09 with the FDA for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.
On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency.
GlaxoSmithKline (NYSE:GSK) and XenoPort (NASDAQ:XNPT) have a pending NDA for Solzira (gabapentin enacarbil) seeking approval for the treatment of moderate to severe restless leg syndrome with an early November PDUFA action date for a possible FDA decision.
On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced 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.
On 6/19/09, BioElectronics (BIEL.PK) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II.
The Company will conduct a conference call on 7/28/09 to discuss the results of a recently completed clinical study and to discuss the status of current FDA filings and additional FDA filings expected to occur over the coming weeks, including one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 297 entries as of 8/3/09.. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/2/09, Savient Pharma (NASDAQ:SVNT) announced it received a complete response letter (CRL) from the FDA for the Company's Biologics License Application (BLA) seeking approval of Krystexxa (pegloticase) as a treatment for chronic gout patients who do not respond to conventional therapy. The CRL cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).
The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request. SVNT stated that it is currently targeting a resubmission for early 2010 and expects to provide more details after meeting with the FDA to discuss the CRL. Resubmissions to the Agency are designated as either Class I (60-day) or Class II (six-month) reviews.
On 8/3/09, Repros Therapeutics (NASDAQ:RPRX) announced that, in the interest of patient safety (elevation of liver enzymes), it is voluntarily suspending dosing of all patients in its clinical trials of Proellex. This decision is based on available information regarding the occurrence of clinically significant increases in liver enzymes with 50 mg and 25 mg doses of Proellex, coupled with recent input from a consulting panel of liver experts.
The Company submitted a meeting request to the FDA on 7/30/09 and, in response, the Agency has proposed to change the topic of the previously scheduled End of Phase II meeting for endometriosis in late September into a discussion about the safety of Proellex and overall direction and scope of the program.The suspension of dosing will involve all ongoing clinical trials with Proellex for the treatment of chronic symptomatic uterine fibroids, anemia associated with this condition, and endometriosis.
On 8/2/09, Transcept Pharma (NASDAQ:TSPT) and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Pending FDA approval, Intermezzo has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. The PDUFA action date for the Intermezzo NDA is 10/30/09 for an expected FDA decision.
Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million based upon the timing of an FDA approval of Intermezzo, which approval and payment are subject to review and acceptance by Purdue. In addition, TSPT is eligible to receive up to an additional $90 million upon reaching future milestones related to achievement of intellectual property and U.S. net sales targets along with double-digit royalties ranging up to the mid-20% level on U.S. net sales.
Shares of TSPT have more than doubled since the stock was featured as an FDA Calendar Extreme Trade on 7/20/09 as one of 20 stocks below $5 with pending FDA decisions or clinical trial results.
On 8/3/09, BVX announced a 510(k) submission to the FDA seeking pre-market clearance for the Company's ICON VS electrosurgical generator. The generator has been designed to work with Bovie's Seal-N-Cut line of vessel sealing instruments providing both monopolar and bipolar energy options to the surgeon. The fully digital ICON VS generator has a user friendly interface allowing the surgeon flexibility to choose the type of effect desired. The monopolar and bipolar functions satisfy a wide variety of surgical demands needed during surgeries including vessel sealing.
On 8/3/09, Keryx Biopharma (NASDAQ:KERX) announced an agreement with the FDA for a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (Velcade). The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
The study is a double-blinded, placebo-controlled trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with bortezomib and dexamethasone and will enroll about 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Perifosine is in-licensed by Keryx from Aeterna Zentaris (NASDAQ:AEZS) in the U.S., Canada and Mexico.
On 8/3/09, Icagen (NASDAQ:ICGN) announced that the FDA has lifted the partial clinical hold related to the development of ICA-105665, the Company's novel orally available small molecule KCNQ potassium channel agonist, for the treatment of epilepsy. Accordingly, the Company is planning to initiate a proof-of-concept study in patients with photosensitive epilepsy. The study measures the ability of ICA-105665 to reduce the photic-induced epileptiform EEG responses. The duration of an observed effect will also be measured over time.
A range of doses of ICA-105665 will be studied in successive cohorts, and the response observed in each cohort will determine the subsequent dose for the next cohort. The objective of the study is to determine a potential dose range to study in subsequent, more advanced clinical trials. The study is anticipated to be completed by mid-2010 but interim results may be available earlier. In addition, the Company continues preparations for a proof-of-concept pain study, which is also expected to be initiated during 3Q09 with initial results expected by early 2010.
BloggingStocks: All in all, this was a fairly quiet day. The markets started out soft but managed to hold up most of the day. A CEO confidence reading may have helped somewhat. Here are today's unofficial closing bell levels: Dow 9,858.36 +71.49 (0.73%) S&P 500 ... Read more
Savient Pharmaceuticals Inc. (SVNT), after meeting officials from the U.S. Food and Drug Administration (FDA) on Monday, announced that the agency does not expect further clinical trials to be conducted for its gout drug Krystexxa, as the company has now reverted to its original manufacturing process for producing phase III trial material for Krystexxa.
The [...]
The indices had a volatile session, particularly in the afternoon after the FOMC made their announcement. But the day started off with a bang at the get-go, with a very strong rally that saw the Nasdaq 100 run from 1594 to 1625 inside the first 1-1 1/2 hours. The S&P 500 at that point ran from 993 to 1008. They spent the next couple hours backing and filling and consolidating, rolled over after the FOMC announcement, and then snapped back after holding secondary support sharply. It appeared there was massive short covering as the indices gapped up intraday. After another 45 minutes of consolidation, they failed to break out, and in the last 20 minutes rolled over sharply to take back a big chunk of the gains. Still, net on the day the Dow was up 120 to 9361.61, after reaching as high as 9424 and change. The S&P 500 closed at 1005.81, up 11.46, but had a 1012.78 high earlier, and the Nasdaq 100 was 15 points[More...]
By Todd Sullivan from ValuePlays - Anytime the largest shareholder of a company goes on a buying spree like Barnes and Noble's (NYSE:BKS) Leonard Riggio did recently, I have to look closer.
Riggio, who bought 100,000 shares both in August and September, bought an additional $11.3 (approximately 420,000 shares) million dollars worth in October. This bring his total stake in the company to 24%. Much like Sear Holding's (SHLD) Eddie Lampert's buying spree this summer, when people intimately involved in the company cannot seem to buy enough shares, you have to be interested.
If you recall Barnes and Noble in August predicted a more optimistic outlook than was previously thought and about this time Riggio began his buying spree. On has to infer from this that the future for BKS may be even rosier that predicted in August. For those hoping for a Barnes and Noble and Borders (BGP) merger, this news ought to put a damper on those expectations. Were a merger or other collaboration to be announced anytime in the near future, Riggio's purchases was be reduced to simple insider trading ahead of the announcement. That does not mean it will not happen, just that it will not happen anytime soon.
I am going to look closer here over the weekend and get back next week..... I am very intrigued though..
Todd Sullivan, Contributor to theStockMasters.com and ValuePlays Founder
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. The StockMasters Master Picks Newsletter has a 17.5% Positive return since our inception in October 2006. The Average duration for our stock picks is 3.61 months, and we have the track record to prove it (click here to view Master Picks track record).Our new publication just came out on Monday (10/15) and our newsletter produced over a 132% gain with Onyx Pharmaceuticals (ONXX) and a 53% gain with Savient Pharmaceuticals (SVNT) within 2 months.
We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
Bank of America Corporation (Public, NYSE:BAC) shares are down 8% in the past 5 days. They are the Juggernaut of the Banking Industry and if you think they won't come back, they'll just smash down your wall and put up a BofA ATM in your house.
The StockMasters are all gitty about this dip in BAC, so what if they Q3 profit fell 32%? Get over it, they are not a worthless Washington Mutual (NYSE:MU) per say, they are America's bank and one of the world's largest financial institutions with a $215 Billion market cap.
The Peridot Capitalist, Mr. Chad Brand (Fellow WallStNewsletters.com and Full Monte Contributor) thought Bank of America (BAC) stock at $47 was attractive with a 5.4% dividend yield. The shares moved above $52 since his post, but today are falling back sharply, to $48 each, after the company posted poor third quarter results, just like every other bank has thus far. The dividend now stands at 5.3%, and Chad thinks it is very safe.
If you want to generate even more income on this trade, you could buy the stock to collect the dividend and any capital appreciation, while simultaneously selling out of the money call options on the shares to collect more cash. For example, the May 2008 52.5 calls are selling for about $1.75 each right now. Buying the stock and selling those calls would result in a breakeven point of ~$45 per share over the next 7 months or so. Conversely, your upside would be up to $52.50 on BAC stock, plus dividends and option premiums of around $3 per share (up to 15% in total gains).
Folks, now that BofA has been hit by Wall Street and is $2 below their 52-week low, it's the perfect entry point and in a few weeks it could get even lower. But there isn't a analyst alive that doesn't think Bank of America will return to greatness, its just a matter of time. There isn't a mutual fund or low risk stock out there that will give you a better return in 12 months than damaged shares of BAC.
Bank of America's profit fell short of Wall Street expectations and the CEO isn't trying to fool anyone. "While the significant dislocations in the capital markets have hurt most participants, we are still very disappointed in our third quarter performance," Bank of America chairman and chief executive officer Kenneth Lewis said
The bank unveiled earnings per share of 82 cents. Wall Street had anticipated earnings per share of 1.05 dollars. Revenues moderated 12 percent to 16.3 billion dollars during the July-September period from the third quarter of 2006.
Fellow Masters, wait for a new 52-week low if you aren't convinced, but BofA will comeback.
Article by Ted Gottsegen
Contributor at TheStockMasters.com
Disclaimer: The Author does not hold any positions or shares in the securities mentioned in this publication nor does he stuff his shorts.
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. Our new publication just came out on Monday (10/15) and our newsletter produced over a 100% gain with Onyx Pharmaceuticals (ONXX) and a 50% gain with Savient Pharmaceuticals (SVNT) within 3 months. In October 07's newsletter we cashed out: Activision, Inc. (ATVI) up almost 20% since we told you to buy in April 2007. Service Corp. International (SCI) up 43% since our 1st newsletter back in October 2006.
In March 2007 we said buy Halliburton Company (HAL), it's up more than 25% since we told you to buy. Blockbuster Inc. (BBI) ran up 36% since told Masters to buy back in June 2007.
We recommend stocks that don't take years to see a return, we look for returns within 2 to 5 months, this isn't grandpa's buy and hold strategy.
The Masters don't play when it comes to their money our your's for that matter. Our Original newsletter that has enlightened our our subscribers for over a year. It contains What to Buy, What to Sell, and Market Commentary. We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
I subscribe to Maxim because it happens to be the most entertaining magazine I've ever read that makes me laugh and keeps my attention this side of Mad or Cracked Magazine. But now the one and only Jim Cramer has been popping up in the last few issues of Maxim, which just seems a bit odd.
Cramer has a one page deal where he gives some general advice and of course it always plugs him at the end with 'Jim Cramer is Co-Founder of theStreet.com'. The question I want to know is how much are they paying him?
Love him, hate him, you can't deny the Cramer Effect, and sooner or later he'll turn up on our cereal boxes, Sears catalogs and eventually church flyers. I found one 'article' that Cramer did for Maxim on their online site (click here to view), which I might add isn't 'work safe'. Maxim is a great magazine, no question, but now that it's a stomping ground for Cramer, I'm just taken back a step. I love this photo they used of him which has some great airbrushing to give him back 10 years, yea, Jim is sexier then ever and get your Bud Light on while you're at it.
You just can't get around Cramer's impact, at least not for a few years. It works out great when you own a stock before he mentions it but once that happens even Alfred E. Newman buy shares after-hours or the next day. Don't get me wrong, Cramer isn't all bad, he is to the stock market as Flavor Flav was to hip-hop in the 90's -- a great hype man. He's entertainment, which is why he's showing up in Maxim, and if someone paid you or me the money he's getting to say a few words, we'd be all over it. His track record has been called into question, he's CNBC's poster boy, and above all, the dude is a TV personality, take it for what it is -- Television. You don't believe everything you watch or you read, so when taking investment advice from the guy, myself, or anybody, just remember Alfred's catch phrase and ask yourself should you worry?
So what's next for Cramer? Playgirl? That could get him some great press and attention. Boo-Yah indeed.
Article by Frank Lara Jr.
Contributor at TheStockMasters.com
Disclaimer: The Author does not hold any positions or shares in the securities mentioned in this publication nor does he stuff his shorts.
The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. Our new publication just came out on Monday (10/15) and our newsletter produced over a 100% gain with Onyx Pharmaceuticals (ONXX) and a 50% gain with Savient Pharmaceuticals (SVNT) within 3 months. In October 07's newsletter we cashed out: Activision, Inc. (ATVI) up almost 20% since we told you to buy in April 2007. Service Corp. International (SCI) up 43% since our 1st newsletter back in October 2006.
In March 2007 we said buy Halliburton Company (HAL), it's up more than 25% since we told you to buy. Blockbuster Inc. (BBI) ran up 36% since told Masters to buy back in June 2007.
We recommend stocks that don't take years to see a return, we look for returns within 2 to 5 months, this isn't grandpa's buy and hold strategy.
The Masters don't play when it comes to their money our your's for that matter. Our Original newsletter that has enlightened our our subscribers for over a year. It contains What to Buy, What to Sell, and Market Commentary. We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
Let's recap the worst performing stocks of the day and the 52-week lows and see if anything in the trash is worth mentioning. The market was on fire today so for these stocks to fall tells us that either their complete crap or it was just an unlucky day. Let's get started...
WebMD (WBMD) fell 13% to a new 2 month low. Shares are still overpriced at $50, we'll wait for a new 52-week low before considering buying a web 2.0 company that only trades with a P/E of 235. You've got to be kidding me.
Corinthian Collegee (COCO) fell 9% because no one wants to go there for a "post-secondary education". Shares are now at $14, whatever, let the Apollo Group (APOL) buy them at which point we'll consider bitting.
New 52-week low for Gymboree Corporation (GYMB) at $34 and junk. Don't touch that stock with a 50 foot pole, it's got Fad written all over it.
Level 3 (LVLT) and Ericsson (ERIC) hit new lows today, now that maybe worth dusting off and seeing if it's worth a bite.
ZipRealty (ZIPR) is absolute garbage. Fellow StockMasters slammed them good on 247WallSt there other day, click here to read Frank's takedown - ZipRealty needs to face REALITY
There you have it fellow Masters, way too much trash today, nothing re-cycleable.
AVOID TRASH STOCKS - The Stockmasters Master Picks newsletter has been kicking ass and taking names for the past year. Our new publication just came out on Monday (10/15) and our newsletter produced over a 100% gain with Onyx Pharmaceuticals (ONXX) and a 50% gain with Savient Pharmaceuticals (SVNT) within 3 months. In October 07's newsletter we cashed out: Activision, Inc. (ATVI) up almost 20% since we told you to buy in April 2007. Service Corp. International (SCI) up 43% since our 1st newsletter back in October 2006.
In March 2007 we said buy Halliburton Company (HAL), it's up more than 25% since we told you to buy. Blockbuster Inc. (BBI) ran up 36% since told Masters to buy back in June 2007.
We recommend stocks that don't take years to see a return, we look for returns within 2 to 5 months, this isn't grandpa's buy and hold strategy.
The Masters don't play when it comes to their money our your's for that matter. Our Original newsletter that has enlightened our our subscribers for over a year. It contains What to Buy, What to Sell, and Market Commentary. We've had impressive returns, great feedback, and in turn have already created a unique following of thousands of Stockmasters, on sale at WallStNewsletters.com. for only $45 a year. That's cheaper than a round of beers and an order of hot wings for your crew. Why not have more money in your pocket for beers and wings?
f you recall Barnes and Noble in August predicted a more optimistic outlook than was previously thought and about this time Riggio began his buying spree. On has to infer from this that the future for BKS may be even rosier that predicted in August. For those hoping for a Barnes and Noble and Borders (BGP) merger, this news ought to put a damper on those expectations. Were a merger or other collaboration to be announced anytime in the near future, Riggio's purchases was be reduced to simple insider trading ahead of the announcement. That does not mean it will not happen, just that it will not happen anytime soon.
New 52-week low for Gymboree Corporation (GYMB) at $34 and junk. Don't touch that stock with a 50 foot pole, it's got Fad written all over it.
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