Stock Monitor: Audentes Therapeutics Post Earnings Reporting

LONDON, UK / ACCESSWIRE / May 10, 2018 / If you want access to our free research report on Ascendis Pharma A/S (NASDAQ: ASND), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ASND as the Company's latest news hit the wire. On May 08, 2018, the Denmark-based biopharmaceutical Company announced that it has dosed the first subjects in a first-in-human Phase-1 trial of TransCon CNP, a long-acting prodrug of a C-type natriuretic peptide (CNP) in development as a therapeutic option for achondroplasia and potentially for other fibroblast growth factor receptor (FGFR)-related skeletal disorders. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Audentes Therapeutics, Inc. (NASDAQ: BOLD), which also belongs to the Healthcare sector as the Company Ascendis Pharma. Do not miss out and become a member today for free to access this upcoming report at:

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Top-line Data from Phase-1 Trial to be Available in Q4 2018

The double-blind, randomized, placebo-controlled Phase-1 trial will evaluate single ascending doses of TransCon CNP in healthy adult subjects to assess safety, tolerability and pharmacokinetics. The Company anticipates top-line data from the phase-1 trial to be available in Q4 2018. TransCon CNP is the third product candidate in Ascendis Pharma's rare disease endocrinology pipeline to advance into the clinic, developed using its innovative TransCon technology platform.

TransCon CNP has been Designed to Provide Continuous CNP Exposure to Optimize Efficacy without Cardiovascular Risk

Jonathan Leff, M.D., Chief Medical Officer of Ascendis Pharma, stated that Achondroplasia is a serious condition resulting in extensive comorbidities. Given the lack of any FDA-approved therapy, it represents a significant unmet medical need.

Jonathan added that TransCon CNP has been designed to provide continuous CNP exposure to optimize efficacy without cardiovascular risk in a convenient once-weekly dose.

He also said that data from this trial will help validate the Company's target product profile, once again translating its promising preclinical results into clinical data.

TransCon CNP Exerted Positive Effects in Juvenile Cynomolgus Monkeys and in Mouse Model of Achondroplasia

To determine if once weekly TransCon CNP was effective in promoting linear bone growth, TransCon CNP was administered subcutaneously once weekly to healthy juvenile male cynomolgus monkeys at doses of 0, 10, 40, and 100 µg/kg/week for 6 months. Vosoritide was administered daily at a dose of 20 µg/kg/day. A control group received a vehicle. Tibial growth was measured radiographically at weeks 4, 8, 12, 22, and 26. To determine if TransCon CNP would reverse the phenotype in an achondroplasia disease model, newborn achondroplasia mice were administered 5.6 mg CNP/kg/day TransCon CNP for 15 days compared to vehicle.

Conclusion: In young healthy cynomolgus monkeys, once-weekly TransCon CNP increased long bone growth in a dose-dependent fashion. In a murine model of achondroplasia, TransCon CNP improved growth plate architecture and prevented both disease-related craniosynostosis and premature fusion of the synchondrosis of the foramen magnum. These results suggested that TransCon CNP might ameliorate some of the more disabling achondroplasia traits, including spinal stenosis.

About Achondroplasia

Achondroplasia is a disorder of bone growth that prevents the changing of cartilage (particularly in the long bones of the arms and legs) to the bone. It is characterized by dwarfism, limited range of motion at the elbows, large head size, small fingers, and normal intelligence. Achondroplasia can cause health complications such as interruption of breathing, obesity, recurrent ear infections, and an exaggerated inward curve of the lumbar spine. More serious problems include a narrowing of the spinal canal that can pinch the upper part of the spinal cord and a buildup of fluid in the brain. Achondroplasia is caused by mutations in the FGFR3 gene. Inheritance is autosomal dominant.

About Ascendis Pharma A/S

Founded in 2007 and headquartered in Copenhagen, Ascendis Pharma is a clinical stage biopharmaceutical company applying its TransCon technology to develop a pipeline of long-acting prodrug therapies with best-in-class profiles to address large markets with significant unmet medical needs. The Company maintains an office in Palo Alto, California and has research and development facilities in Heidelberg, Germany and Copenhagen, Denmark.

Stock Performance Snapshot

May 09, 2018 - At Wednesday's closing bell, Ascendis Pharma's stock climbed 2.21%, ending the trading session at $64.18.

Volume traded for the day: 44.36 thousand shares.

Stock performance in the last month ? up 3.27%; previous three-month period ? up 25.07%; past twelve-month period ? up 132.13%; and year-to-date - up 60.22%

After yesterday's close, Ascendis Pharma's market cap was at $2.69 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.7% at the end of the session.

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