Key Developments: KYTHERA Biopharmaceuticals Inc (KYTH.O)
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17 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Kythera Biopharmaceuticals Inc Announces Positive Magnetic Resonance Imaging (MRI) Results from Phase IIb Study of ATX-101 in Reduction of Submental Fat or 'Double Chin'
Kythera Biopharmaceuticals Inc announced that positive results that found MRI measurements of patients treated with ATX-101 demonstrated a statistically significant reduction in submental fat (SMF), commonly known as double chin, during an oral session at The Aesthetic Meeting 2013, organized by the American Society for Aesthetic Plastic Surgery (ASAPS), April 11-16, New York, NY. MRI assessments were performed in the study as a quantifiable and objective measure of submental fat volume and thickness. The same study also demonstrated positive results based on validated clinician- and patient-reported outcome measures. The results are from a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study (ATX-101-09-15) to evaluate the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug currently in Phase III clinical trials in the U.S. and Canada for the reduction of SMF. ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), which is an endogenous molecule that aids in the breakdown of dietary fat. Results from the Phase IIb study showed that patients treated with 2 mg/cm2 of ATX-101 demonstrated: Reduction of submental fat - Patients achieved statistically significant reduction in submental fat thickness as measured from baseline vs. placebo based on MRI (p<0.05 and p<0.001, week 16 and 32, respectively). Full Article
Kythera Biopharmaceuticals Inc Announces Positive Interim Results from Open-Label Phase IIIb Study of ATX-101
Kythera Biopharmaceuticals Inc announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the “Innovations and Renewals” session of the 11th Anti-Aging Medicine World Congress (AMWC), April 4-6, Monte Carlo, Monaco. The study, presented by investigator Susan Weinkle, MD, FAAD, evaluated the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug in Phase III trials for the reduction of unwanted submental fat (SMF), commonly known as “double chin.” The results found that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician- and patient-reported outcome measures. ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), a molecule found in the body that helps break down dietary fat. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment are outlined below. Observations were made using validated rating instruments for which one-grade changes are considered to be clinically meaningful: Reduction of submental fat 87% of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Similarly, 83% of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). Full Article
Kythera Biopharmaceuticals Inc Announces Positive Interim Results from Open-Label Study of ATX-101 in Reduction of Unwanted Submental Fat (SMF) or 'Double Chin'
Kythera Biopharmaceuticals Inc announced positive interim results from a Phase IIIb, multi-center, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin. The results, presented at the Late Breaking Research Symposium at the 71st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla., found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101. ATX-101 is a synthetically-derived formulation of deoxycholic acid (DCA), a naturally-occurring molecule found in the body that aids in fat metabolism. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found: Reduction of submental fat: 87% of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS); similarly, 83% of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS); and 96% of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG). Full Article
Kythera Biopharmaceuticals Inc Announces Closing Of Initial Public Offering And Exercise Of Underwriters Over-allotment Option
Kythera Biopharmaceuticals Inc announced the closing of its initial public offering of 5,060,000 shares of its common stock at an Initial Public Offering (IPO) price of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 660,000 additional shares of common stock. KYTHERA Biopharmaceuticals` common stock is listed on the NASDAQ Global Select Market under the trading symbol "KYTH." All of the shares in the offering were offered by KYTHERA Biopharmaceuticals. J.P. Morgan Securities LLC and Goldman, Sachs & Co. acted as joint book-running managers for the offering. Leerink Swann LLC acted as lead co-manager and Lazard Capital Markets LLC acted as co-manager. Full Article
Kythera Biopharmaceuticals Inc Announces Pricing Of Initial Public Offering
Kythera Biopharmaceuticals Inc announced the pricing of its Initial Public Offering (IPO) of 4,400,000 shares of its common stock at a price to the public of $16.00 per share. The shares of KYTHERA's common stock will trade on the NASDAQ Global Select Market under the symbol "KYTH." All of the shares of common stock are being offered by KYTHERA. In addition, KYTHERA has granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock to cover over-allotments, if any. The offering is expected to close on October 16, 2012, subject to customary closing conditions. J.P. Morgan Securities LLC and Goldman, Sachs & Co. are acting as joint book-running managers for the offering. Leerink Swann LLC is acting as lead co-manager and Lazard Capital Markets LLC is acting as co-manager. Full Article
Kythera Biopharmaceuticals Inc Sees IPO Of 4 Million Shares Pricing At $14 To $16-DJ
Dow Jones reported that Kythera Biopharmaceuticals Inc estimated terms of its Initial Public Offering (IPO) at four million shares at a price between $14 and $16 apiece. The Company had filed plans for an IPO of up to $86.3 million in May. Kythera plans to use the IPO proceeds to fund ATX-101 clinical trials, working capital and general corporate purposes, including research and development. The Company has applied to list on the Nasdaq Global Market under the symbol KYTH. Full Article
Kythera Biopharmaceuticals Inc Announces Positive Results From Second ATX-101 European Phase III Trial For Reduction Of Submental Fat
Kythera Biopharmaceuticals Inc announced presentation of initial trial results from Study ATX-101-10-17, the second of two pivotal European Phase III clinical trials with ATX-101, a facial injectable drug for the aesthetic treatment of submental fat, which commonly presents as an undesirable double chin. The ATX-101-10-17 trial met its pre-specified primary endpoints based on clinician and patient assessments. At the 2 mg/cm2 dose, ATX-101 resulted in a statistically significant reduction of submental fat, relative to placebo, as measured using a 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (mean of 0.77 vs. 0.36; p<0.0001, week 24). Similarly, ATX-101 (2 mg/cm2) resulted in a statistically significant percentage of subjects, relative to placebo, achieving a pre-defined categorical change using a 7-point Subject Self Rating Scale (SSRS) (64.8 % vs. 29.3%; p<0.001, week 24). Additional Patient Reported Outcomes included a Patient-Reported Submental Fat Impact Scale (PR-SMFIS), which was developed to measure the visual and psychological impacts of submental fat, including whether patients perceived themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101. Statistically significant differences were achieved, at 2 mg/cm2 relative to placebo, for all six individual PR-SMFIS measures (p<0.001, week 24). Full Article
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