Key Developments: KYTHERA Biopharmaceuticals Inc (KYTH.OQ)

KYTH.OQ on NASDAQ Stock Exchange Global Select Market

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

KYTHERA Biopharmaceuticals submits new drug submission to Health Canada for ATX-101 as First-in-class treatment for the reduction of submental fat
Monday, 11 Aug 2014 04:05pm EDT 

KYTHERA Biopharmaceuticals Inc:Announced that it submitted a New Drug Submission (NDS) to Health Canada seeking approval for the company's investigational drug, ATX-101 (deoxycholic acid), as an injectable treatment for the reduction of submental fat.NDS is supported by results from two pivotal Phase III trials, REFINE-1 and REFINE-2, which were reported in late 2013.In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.  Full Article

KYTHERA Biopharmaceuticals announces FDA acceptance of ATX-101 New Drug Application
Thursday, 10 Jul 2014 04:32pm EDT 

KYTHERA Biopharmaceuticals Inc:Announces that its New Drug Application (NDA) for ATX-101 (deoxycholic acid), has been accepted for filing by the U.S. Food and Drug Administration (FDA).Acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review.NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015.  Full Article

Kythera Biopharmaceuticals, Inc submits new drug application for ATX-101 as first in class treatment for reduction of submental fat
Monday, 12 May 2014 07:30pm EDT 

Kythera Biopharmaceuticals, Inc:Says that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin.Positive and consistent results from two pivotal Phase III trials - REFINE-1 and REFINE-2 - were reported in late 2013 and provide the basis for the NDA submission.In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.Chief medical officer says since the company began evaluating ATX-101 through global clinical development program, it has demonstrated positive results in reducing fat under the chin, paired with an excellent safety profile and high patient satisfaction.Beyond this NDA submission, KYTHERA also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015.  Full Article

Kythera Biopharmaceuticals, Inc acquires rights to ATX-101 outside U.S. and Canada from Bayer Consumer Care
Monday, 10 Mar 2014 04:05pm EDT 

Kythera Biopharmaceuticals, Inc:Acquired all rights outside of the U.S. and Canada to ATX-101from Bayer Consumer Care.Under the new agreement, KYTHERA Holdings Ltd., a wholly-owned Bermuda subsidiary of KYTHERA Biopharmaceuticals, Inc., acquired rights to develop and commercialize ATX-101 outside the U.S. and Canada.Bayer will receive $33 mln in KYTHERA common stock, plus a $51 mln note, payable no later than 2024.Bayer is also eligible to receive certain long-term sales payments on annual sales outside of the U.S. and Canada.  Full Article

Kythera Biopharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Tuesday, 8 Oct 2013 07:44pm EDT 

Kythera Biopharmaceuticals Inc announced the pricing of an underwritten public offering of 2,622,950 shares of its common stock at a public offering price of $45.75 per share. The size of the offering was upsized from $100 million to approximately $120 million. In addition, KYTHERA has granted the underwriters a 30-day option to purchase up to an additional 393,442 shares of common stock. All of the shares in the offering are to be sold by KYTHERA, with expected net proceeds to KYTHERA of approximately $112.2 million, after deducting underwriting discounts and commissions and estimated offering expenses, but excluding any exercise of the underwriters' option to purchase additional shares of common stock. The offering is expected to close on or about October 15, 2013, subject to customary closing conditions. J.P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers, and representatives of the underwriters for the offering. Leerink Swann LLC is also acting as a joint book-running manager. Cowen and Company, LLC is acting as co-manager.  Full Article

Kythera Biopharmaceuticals Inc Announces Proposed Public Offering of Common Stock
Monday, 7 Oct 2013 04:02pm EDT 

Kythera Biopharmaceuticals Inc announced it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of $100 million. All of the shares of the common stock to be sold in the offering will be offered by KYTHERA. KYTHERA intends to use the net proceeds of the offering to fund the ongoing development and preparation for potential commercialization of ATX-101, including the preparation and submission of its New Drug Application, or NDA, for ATX-101, and the balance for working capital and general corporate purposes, including research and development. J.P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers, and representatives of the underwriters for the offering. Leerink Swann LLC is also acting as a joint book-running manager. Cowen and Company, LLC is acting as co-manager. KYTHERA intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold to cover over-allotments, if any.  Full Article

Kythera Biopharmaceuticals Inc Announces Positive ATX-101 Top Line Phase III Trial Results for Reduction of Submental Fat
Monday, 16 Sep 2013 05:26pm EDT 

Kythera Biopharmaceuticals Inc announced that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints. These two pivotal Phase III trials were conducted in the U.S. and Canada to compare the efficacy and safety of a 2 mg/cm2 dose of ATX-101 versus placebo for the reduction of submental fat, which commonly presents as a double chin. ATX-101 is a formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat.1 If approved, it will be a submental contouring injectable drug. REFINE-1 and REFINE-2 are two identical multicenter, double-blind, randomized, placebo-controlled trials that enrolled more than 1,000 subjects with moderate to severe submental fat in 70 centers in the U.S. and Canada. Validated clinician- and patient-rating scales were used to evaluate primary efficacy endpoints, assessed 12 weeks after the last treatment.  Full Article

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'
Saturday, 13 Apr 2013 04:45pm EDT 

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
Saturday, 6 Apr 2013 10:30am EDT 

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'
Friday, 1 Mar 2013 09:10am EST 

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

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