7 hours ago
Ascendis Pharma A/S (NASDAQ:ASND) announced on September 14 that it will regain exclusive rights to develop, manufacture, and commercialize TransCon products in metabolic and cardiovascular diseases following the termination of its collaboration with Novo Nordisk A/S (NYSE:NVO).
The rights include once-monthly TransCon Semaglutide, an investigational long-acting prodrug of semaglutide intended for obesity and type 2 diabetes. Neither party will have continuing financial obligations to the other. Once termination becomes effective and the rights revert, management plans to initiate multiple programs across rare and large indications.
The investment question is whether greater control over future products can justify the resources needed to develop them.
Ascendis Pharma A/S (NASDAQ:ASND) would regain flexibility over which indications to pursue, how quickly to advance candidates, and whether to seek another partner. Successful independent development could retain more of a product's commercial economics, while a new collaboration could provide another way to share costs and risk.
Monthly dosing offers a clear development objective. If clinical studies demonstrate effective treatment with acceptable tolerability, fewer injections could make long-term therapy more convenient. That potential benefit would matter most if it helps patients stay on treatment without sacrificing outcomes.
#ascendis #pharma #asnd #regain
The rights include once-monthly TransCon Semaglutide, an investigational long-acting prodrug of semaglutide intended for obesity and type 2 diabetes. Neither party will have continuing financial obligations to the other. Once termination becomes effective and the rights revert, management plans to initiate multiple programs across rare and large indications.
The investment question is whether greater control over future products can justify the resources needed to develop them.
Ascendis Pharma A/S (NASDAQ:ASND) would regain flexibility over which indications to pursue, how quickly to advance candidates, and whether to seek another partner. Successful independent development could retain more of a product's commercial economics, while a new collaboration could provide another way to share costs and risk.
Monthly dosing offers a clear development objective. If clinical studies demonstrate effective treatment with acceptable tolerability, fewer injections could make long-term therapy more convenient. That potential benefit would matter most if it helps patients stay on treatment without sacrificing outcomes.
#ascendis #pharma #asnd #regain
27 days ago
On August 13, Ascendis Pharma (NASDAQ:ASND) reported second-quarter results that showed how far its rare disease portfolio has come. Total product revenue roughly doubled from a year earlier to €315 million, and for the first time all three of the company's approved TransCon therapies, SKYTROFA, YORVIPATH and YUVIWEL, were contributing meaningful sales in the same quarter. That combination is what management is leaning on to justify its 2030 revenue ambitions.
YORVIPATH, the hypoparathyroidism treatment, generated €252 million in the quarter and crossed blockbuster level on an annualized basis just two years after its U.S. launch, while reaching patients in more than 35 countries through either commercial sales or named patient access programs. Long-term trial data presented during the quarter showed response rates sustained between 82% and 86% on the combined endpoint, with patients still on therapy at a 95% rate five years after starting.
SKYTROFA, the once-weekly growth hormone therapy, crossed 20,000 unique patient enrollments and remains the best-selling long-acting growth hormone in the US as measured by brand value, contributing €55 million for the quarter. YUVIWEL, the newest of the three, launched commercially in the US during the quarter and brought in €8 million in its first quarter on the market. Enrollment kept climbing after the quarter closed, from more than 170 unique patients through June 30 to more than 220 by the end of July, with more than 65% of those patients already approved for reimbursement. Ascendis also ended the quarter with €812 million in cash and carries no bank debt or convertible debt, giving it room to keep funding these launches without outside financing.
The growth came with a steeper cost base. SG&A expenses rose to €173 million in the quarter from €145 million in the prior quarter, and R&D expenses climbed to €76 million from €59 million, a comparison made sharper by the fact that the prior quarter's figure had been reduced by a one-time €11 million reversal of earlier inventory write-downs. Reported operating profit of €220 million also leaned heavily on a one-time item, a €158 million gain tied to the sale of a PRV. Strip that out and non-IFRS operating profit was €92 million, a 27% margin that better reflects the underlying business. Total revenue of €339 million for the quarter also included €24 million of non-product collaboration revenue, including a €17 million milestone payment tied to TransCon CNP, money that will not repeat every quarter. And while YUVIWEL's early numbers are strong, formal regulatory decisions for the drug in the U.S. and European Union are not expected until the fourth quarter of 2026, meaning current sales are happening ahead of full approval.
#patients #time #transcon
YORVIPATH, the hypoparathyroidism treatment, generated €252 million in the quarter and crossed blockbuster level on an annualized basis just two years after its U.S. launch, while reaching patients in more than 35 countries through either commercial sales or named patient access programs. Long-term trial data presented during the quarter showed response rates sustained between 82% and 86% on the combined endpoint, with patients still on therapy at a 95% rate five years after starting.
SKYTROFA, the once-weekly growth hormone therapy, crossed 20,000 unique patient enrollments and remains the best-selling long-acting growth hormone in the US as measured by brand value, contributing €55 million for the quarter. YUVIWEL, the newest of the three, launched commercially in the US during the quarter and brought in €8 million in its first quarter on the market. Enrollment kept climbing after the quarter closed, from more than 170 unique patients through June 30 to more than 220 by the end of July, with more than 65% of those patients already approved for reimbursement. Ascendis also ended the quarter with €812 million in cash and carries no bank debt or convertible debt, giving it room to keep funding these launches without outside financing.
The growth came with a steeper cost base. SG&A expenses rose to €173 million in the quarter from €145 million in the prior quarter, and R&D expenses climbed to €76 million from €59 million, a comparison made sharper by the fact that the prior quarter's figure had been reduced by a one-time €11 million reversal of earlier inventory write-downs. Reported operating profit of €220 million also leaned heavily on a one-time item, a €158 million gain tied to the sale of a PRV. Strip that out and non-IFRS operating profit was €92 million, a 27% margin that better reflects the underlying business. Total revenue of €339 million for the quarter also included €24 million of non-product collaboration revenue, including a €17 million milestone payment tied to TransCon CNP, money that will not repeat every quarter. And while YUVIWEL's early numbers are strong, formal regulatory decisions for the drug in the U.S. and European Union are not expected until the fourth quarter of 2026, meaning current sales are happening ahead of full approval.
#patients #time #transcon
