Key Developments: Transcept Pharmaceuticals Inc (TSPT.W)
3.03USD
19 Jun 2013
$0.02 (+0.66%)
$3.01
$3.09
$3.09
$3.03
400
432
$6.75
$2.91
Latest Key Developments (Source: Significant Developments)
Transcept Pharmaceuticals Inc Announces Phase Two Clinical Trial Of TO-2061 As Adjunctive Therapy For Obsessive Compulsive Disorder Did Not Meet Primary Endpoint
Transcept Pharmaceuticals Inc announced initial top-line results from Phase two clinical trial evaluating the efficacy and safety of TO-2061 (ondansetron oral tablets 0.5 mg and 0.75 mg) in patients with obsessive compulsive disorder (OCD) who had not adequately responded to treatment with approved first-line therapies. The data from the trial showed that TO-2061 did not meet the primary efficacy endpoint to demonstrate an improvement in OCD symptoms versus placebo. Transcept expects to complete the remaining protocol-specified analyses in early 2013 and will make a determination on any future development of TO-2061 after further review of the data. The Phase two study was a double-blind, placebo-controlled trial to evaluate the safety and efficacy of TO-2061 in 168 OCD patients who had not adequately responded to an approved OCD medication. Patients with a documented history of at least six weeks of inadequate response to an approved OCD medication continued to receive that first line OCD medication during an additional 6-week run-in phase of the study. The primary endpoint of the study was the difference between active and placebo treatment arms in the change from baseline as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Full Article
Transcept Pharmaceuticals, Inc. Appoints Leone Patterson As Vice President And Chief Financial Officer
Transcept Pharmaceuticals, Inc. announced that Leone Patterson joined Transcept, effective June 25, 2012, and will serve as Vice President and Chief Financial Officer (CFO). Ms. Patterson will have primary responsibility for all finance functions at Transcept. She succeeds Thomas Soloway, who was promoted to Executive Vice President and Chief Operating Officer in April 2012. Full Article
Transcept Pharmaceuticals, Inc. Prices Public Offering Of Common Stock
Transcept Pharmaceuticals, Inc. announced the pricing of an underwritten public offering of 4,500,000 shares of its common stock at a price of $9.00 per share. The net proceeds to Transcept from the sale of the shares, after deducting underwriting discounts and commissions and estimated expenses, are expected to be approximately $37.6 million. Transcept has also granted the underwriters a 30-day option to purchase up to an additional 675,000 shares of its common stock to cover over-allotments, if any. The offering is expected to close on or about May 1, 2012, subject to customary closing conditions. Leerink Swann LLC and Lazard Capital Markets LLC are acting as joint book-running managers for the offering. Cowen and Company, LLC and JMP Securities LLC are acting as co-managers of the offering. Transcept intends to use the net proceeds from this offering for general corporate purposes, which may include, among other things, increasing its working capital and funding research and development, including the development of TO-2061, and capital expenditures. Full Article
Transcept Pharmaceuticals, Inc. Announces Proposed Public Offering
Transcept Pharmaceuticals, Inc. announced it is offering to sell shares of its common stock in an underwritten public offering. Transcept expects to grant the underwriters a 30-day option to purchase additional shares of common stock offered in the public offering to cover over-allotments, if any. All of the shares in the offering are to be sold by Transcept. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Leerink Swann LLC and Lazard Capital Markets LLC are acting as joint book-running managers of the offering. Full Article
Transcept Pharmaceuticals, Inc. Announces FDA Approval Of Intermezzo C-IV
Transcept Pharmaceuticals, Inc. announced that U.S. Food and Drug Administration (FDA) has approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than four hours of bedtime remaining before the planned time of waking. The safety and efficacy of Intermezzo were evaluated in two placebo-controlled studies for the treatment of patients with insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. In both a sleep laboratory study and an outpatient study, treatment with Intermezzo after a middle-of-the-night awakening helped patients return to sleep significantly faster than placebo. The most commonly reported adverse reactions in these studies were headache, nausea and fatigue. Transcept has agreed to FDA post-marketing commitments including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment in accordance with the Pediatric Research Equity Act (PREA). Full Article
Transcept Pharmaceuticals, Inc. Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting With U.S. Food & Drug Administration
Transcept Pharmaceuticals, Inc. announced its plan to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The plan to resubmit the Intermezzo NDA results from a meeting with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo should only be taken if patients have at least 4 hours of bedtime remaining, and that patients should refrain from driving for at least 1 hour after arising and until 5 hours after dosing Intermezzo. Full Article
Transcept Pharmaceuticals, Inc. Announces FDA Response to Proposal in Support of Intermezzo New Drug Application
Transcept Pharmaceuticals, Inc. announced that it has received notice from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011 Intermezzo Complete Response Letter. As previously announced, Transcept plans to meet with the FDA on September 14, 2011 to discuss the regulatory path forward for Intermezzo, and expects to provide further updates as appropriate. Full Article
Transcept Pharmaceuticals, Inc. Announces Plans to Reduce Expenses by Decreasing Staff Following Complete Response Letter from FDA on Intermezzo New Drug Application; Sees Charges In Q3 2011
Transcept Pharmaceuticals, Inc. announced that it plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet), the Cmpany's lead product candidate, cannot be approved in its present form. Intermezzo is being developed for use as-needed in the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Transcept expects to record a restructuring charge of approximately $1.1 million in the third quarter of 2011, representing severance and benefit continuation expenses, the majority of which will be paid in the third quarter of 2011. Full Article
FDA Rejects Transcept Pharmaceuticals, Inc.'s Sleep Disorder Drug-Reuters
Reuters reported that U.S. health regulators rejected Transcept Pharmaceuticals, Inc. insomnia drug, citing concerns over next-morning driving ability. The U.S. Food and Drug Administration was concerned that some patients will dose with less than four hours remaining in bed, despite instructions. The proposed label indicates that the drug, Intermezzo, should only be taken when patients have at least four hours of bedtime remaining before being active again. However, the FDA confirmed the single unit dose addressed the risk of inadvertent re-dosing of the drug Intermezzo in a single night. This is the second time the FDA said no to Intermezzo and the specialty pharmaceutical company on Tuesday said it expected such outcome following a teleconference with the FDA. Full Article
Transcept Pharmaceuticals, Inc. Receives Complete Response Letter from FDA on Intermezzo New Drug Application
Transcept Pharmaceuticals, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). In the Complete Response Letter, the FDA confirmed that Transcept has adequately demonstrated that Intermezzo is efficacious for use as needed in the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. However, the FDA stated that it cannot conclude that Intermezzo can be used safely based on the information in the Intermezzo NDA. The proposed label for Intermezzo indicates that Intermezzo should only be taken when patients have at least four hours of bedtime remaining before being active again. In the original, October 2009 Complete Response Letter, the FDA indicated that Transcept must demonstrate that Intermezzo, when taken as directed, would not unacceptably impair next-morning driving ability. Full Article
Transcept's drug for obsessive compulsive disorder fails trial
- Transcept Pharmaceuticals Inc said a mid-stage trial of its experimental drug for obsessive compulsive disorder did not meet the main goal of showing improvements in treating symptoms better than a placebo.
Earnings vs. 
Estimates
Thomson Reuters is the world's largest international multimedia news agency, providing investing news, world news, business news, technology news, headline news, small business news, news alerts, personal finance, stock market, and mutual funds information available on Reuters.com, video, mobile, and interactive television platforms. Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
NYSE and AMEX quotes delayed by at least 20 minutes. Nasdaq delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
