COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD). “The sBLA submission for TransCon hGH for adult GHD supports our strategy to develop SKYTROFA into a blockb ...

COPENHAGEN, Denmark, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the pricing of its underwritten public offering of 2,000,000 American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis, at a price to the public of $150.00 per ADS. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. In addition, Ascendis has grant ...

COPENHAGEN, Denmark, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has commenced an underwritten public offering of $300,000,000 of American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of ADSs at the public offering price, less the underwriting commissions. Th ...

Shares of Ascendis Pharma (ASND) rose 17% on Monday after it reported top-line results from the pivotal ApproaCH study that evaluated investigational once-weekly administered TransCon CNP in children aged two to 11 years with achondroplasia, the most common form of dwarfism.ASND Drug Shows AGV Benefit in Achondroplasia PatientsThe ApproaCH study met its primary endpoint of annualized growth velocity (AGV) at 52 weeks — children treated with TransCon CNP achieved a mean AGV of 5.89 cm/year compared with 4.41 ...

Ascendis Pharma A/S (ASND) shares ended the last trading session 17.1% higher at $139.57. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 14.1% loss over the past four weeks.This surge in share price came after ASND reported topline results from the pivotal ApproaCH study which evaluated its investigational once-weekly administered TransCon CNP in children aged two to 11 years with achondroplasia, the most common f ...

Ascendis Pharma A/S ASND released topline data on Monday from a trial that included 84 children with achondroplasia, a genetic disorder that causes dwarfism and disproportionate short stature.TransCon CNP (navepegritide), an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly and designed to provide sustained release and continuous exposure of active CNP.CNP regulates blood flow, blood pressure, and the reactivity of platelets and leukocytes.Also Read: Ascendis Pharma Faces ...

–   U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in adults COPENHAGEN, Denmark, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United States Food & Drug Administration (FDA) has granted Orphan Drug exclusivity to YORVIPATH® (palopegteriparatide, developed as TransCon PTH), providing seven years of market exclusivity for YORVIPATH in the United States for t ...

magical_light/iStock via Getty Images Ascendis Pharma (ASND) shocked investors with a big Q2 revenue miss, driven by a large net price cut on Skytrofa that management says was necessary to ensure broader access to the drug. The company did not share the exact price cut, but we can calculate from Q2 demand and adjusted net sales numbers that it is approximately 35%. I am not sure how much of the price cut Ascendis can make up with increased patient numbers, but I am sure that the loss of peak sales on Sk ...

Tuesday, Ascendis Pharma A/S ASND reported second-quarter sales of $38.76 million (35.9 million euros), missing the consensus of $92.7 million, down from 47.4 million euros reported a year ago.Cantor Fitzgerald writes that the Skytrofa update probably overshadowed another key update from the call: the U.S. pricing for Yorvipath, which came out at $285,000/patient/year, much higher than our expectation of $160-190K.The analyst notes that due to the lower Skytrofa guidance, the company’s cash flow breakeven t ...

A bottom-line whiff and reduced guidance made the company an outlier for the wrong reasons on Hump Day.An earnings miss and sharply reduced guidance for its ONE commercialized product doomed Ascendis Pharma (ASND -11.27%) to a bad Wednesday on the stock market. The biotech's shares fell by more than 11% in price after it divulged its latest set of quarterly results. By comparison, the bellwether S&P 500 index suffered a relatively modest drop of 0.2%.Declines and misses in the second quarterAscendis, a biot ...