– Ascendis positioned to drive speedy income progress
COPENHAGEN, Denmark, Jan. 12, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: NASDAQ:) as we speak supplied a enterprise and strategic roadmap replace, together with deliberate 2025 key company milestones. Ascendis President and CEO Jan Mikkelsen will current this replace tomorrow, January 13, in the course of the forty third Annual J.P. Morgan Healthcare Convention.
Ascendis is well-positioned for speedy income progress with the launch of our first two Endocrinology Uncommon Illness medicines, SKYTROFA and YORVIPATH, and, following our pre-NDA assembly, deliberate filings for our third, TransCon CNP for achondroplasia, stated Jan Mikkelsen, Ascendis Pharma’s President and Chief Government Officer. Our increasing TransCon expertise platform and partnerships reveal that our enterprise mannequin constructed on quick, profitable drug growth can create substantial stakeholder worth.
Chosen Key Updates and Milestones
TransConâ„¢ hGH (lonapegsomatropin, marketed as SKYTROFA ®) SKYTROFA full-year 2024 income, with a single indication in pediatric GHD, anticipated to be ~ €202 million excluding gross sales deductions associated to prior years (based mostly on unaudited preliminary estimate of full-year 2024 SKYTROFA income of ~ €197 million plus ~ €5 million of gross sales deductions associated to prior years).U.S. SKYTROFA quantity (mg) elevated 84% in 2024 year-over-year leading to an estimated 6.5% market share of the entire U.S. progress hormone marketplace for 2024 (based mostly on third occasion prescription information).Prescription Drug Person Price Act (PDUFA) aim date of July 27, 2025 for FDA overview of supplemental BLA for the therapy of adults with progress hormone deficiency; pending approval, U.S. industrial launch deliberate within the fourth quarter of 2025.Throughout the third quarter of 2025, plan to submit an Investigational New Drug (IND) utility or related for a basket trial evaluating TransCon hGH in further indications. TransCon PTH (palopegteriparatide, marketed as YORVIPATH ®) YORVIPATH full-year 2024 unaudited preliminary income estimate of ~ €29 million.YORVIPATH commercially accessible for prescription in Germany and Austria since January 2024. Exterior Germany and Austria, offering product via early entry routes, reminiscent of Ëœnamed affected person,’ till industrial reimbursement established. ~700 sufferers on therapy in our Europe Direct and Worldwide Markets on the finish of 2024.YORVIPATH commercially accessible for prescription since late December 2024 within the U.S. As of January 9, 2025, 324 sufferers enrolled into the Ascendis Signature Entry Program or direct with specialty pharmacy, with over half of prescriptions for sufferers new to YORVIPATH.Count on industrial launch in not less than 5 further Europe Direct international locations in 2025. TransCon CNP (navepegritide) Following pre-NDA assembly with FDA, plan to submit New Drug Utility (NDA) for the therapy of kids with achondroplasia in the course of the first quarter of 2025, and submit Advertising and marketing Authorisation Utility to the  European Medicines Company in the course of the third quarter of 2025.Introduced new information demonstrating important enhancements in leg bowing, a standard complication in achondroplasia, noticed with TransCon CNP in comparison with worsening noticed with placebo in pivotal ApproaCH Trial.Topline Week 26 outcomes from Part 2 COACH Trial (TransCon CNP together with TransCon hGH) anticipated within the second quarter of 2025.Throughout the fourth quarter of 2025, plan to submit an IND or related for the therapy of hypochondroplasia. Increasing the TransCon Platform & Pipeline New TransCon protein degrader platform designed to allow environment friendly clearance of hormones, cytokines, and different targets. First deliberate TransCon protein degrader product candidate designed to normalize extra FGF-23 hormone ranges for sufferers with X-linked hypophosphatemia. Monetary Replace Unaudited preliminary estimate of complete full-year 2024 product income of ~ €226 million: SKYTROFA full-year 2024 income anticipated to be ~ €202 million excluding gross sales deductions associated to prior years (based mostly on unaudited preliminary estimate of full-year 2024 SKYTROFA income of ~ €197 million plus ~ €5 million of gross sales deductions associated to prior years).YORVIPATH full-year 2024 unaudited preliminary income estimate of ~ €29 million. Unaudited preliminary estimate of complete full-year complete 2024 income of ~ €364 million Consists of $100 million Novo Nordisk (NYSE:) milestone fee as non-product income. December 31, 2024 professional forma money stability of ~ €655 million (based mostly on unaudited preliminary estimate of December 31, 2024 money stability of €560 million plus anticipated fee from Novo Nordisk of $100 million).
The Firm’s slides from the J.P. Morgan presentation can be accessible on the identical Investor Relations web site at https://buyers.ascendispharma.com.
About Ascendis Pharma A/SAscendis Pharma is making use of its modern TransCon expertise platform to construct a number one, absolutely built-in biopharma firm targeted on making a significant distinction in sufferers’ lives. Guided by its core values of Sufferers, Science, and Ardour, Ascendis makes use of its TransCon applied sciences to create new and doubtlessly best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has further amenities in Europe and america. Please go to ascendispharma.com to be taught extra.
Ahead-Trying StatementsThis press launch comprises forward-looking statements that contain substantial dangers and uncertainties. All statements, aside from statements of historic details, included on this press launch concerning Ascendis’ future operations, plans and targets of administration are forward-looking statements. Examples of such statements embody, however will not be restricted to, statements referring to (i) Ascendis’ potential for speedy income progress, (ii) deliberate regulatory submissions for TransCon CNP and TransCon hGH, (iii) the flexibility of Ascendis’ enterprise mannequin to create substantial stakeholder worth, (iv) anticipated full-year 2024 SKYTROFA, YORVIPATH and complete revenues, (v) the PDUFA date of the supplemental BLA for SKYTROFA for the therapy of adults with progress hormone deficiency and Ascendis’ plans for a U.S. industrial launch, if authorized, (vi) Ascendis’ expectations concerning the industrial launch of YORVIPATH in further Europe Direct Nations, (vii) the timing of topline outcomes from the Part 2 COACH Trial of TransCon CNP, (viii) Ascendis’ expectations concerning its TransCon protein degrader platform and first TransCon degrader product candidate, (ix) the anticipated fee from Novo Nordisk, (x) Ascendis’ skill to use its TransCon expertise platform to construct a number one, absolutely built-in biopharma firm, and (xi) Ascendis’ use of its TransCon applied sciences to create new and doubtlessly best-in-class therapies. Ascendis could not truly obtain the plans, perform the intentions or meet the expectations or projections disclosed within the forward-looking statements and you shouldn’t place undue reliance on these forward-looking statements. Precise outcomes or occasions might differ materially from the plans, intentions, expectations and projections disclosed within the forward-looking statements. Numerous essential elements might trigger precise outcomes or occasions to vary materially from the forward-looking statements that Ascendis makes, together with the next: dependence on third occasion producers, distributors and repair suppliers for Ascendis’ merchandise and product candidates; unexpected security or efficacy leads to Ascendis’ growth packages or on-market merchandise; unexpected bills associated to commercialization of any authorized Ascendis merchandise; unexpected bills associated to Ascendis’ growth packages; unexpected promoting, normal and administrative bills, different analysis and growth bills and Ascendis’ enterprise typically; delays within the growth of its packages associated to manufacturing, regulatory necessities, pace of affected person recruitment or different unexpected delays; Ascendis’ skill to acquire further funding, if wanted, to assist its enterprise actions; the influence of worldwide financial, political, authorized, compliance, social and enterprise elements. For an additional description of the dangers and uncertainties that would trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers referring to Ascendis’ enterprise on the whole, see Ascendis’ prospectus complement filed on September 20, 2024 and Ascendis’ present and future studies filed with, or submitted to, the U.S. Securities and Change Fee (SEC), together with its Annual Report on Type 20-F filed with the SEC on February 7, 2024. Ahead-looking statements don’t mirror the potential influence of any future licensing, collaborations, acquisitions, mergers, inclinations, joint ventures, or investments that Ascendis could enter into or make. Ascendis doesn’t assume any obligation to replace any forward-looking statements, besides as required by regulation.
Ascendis, Ascendis Pharma, the Ascendis Pharma emblem, the corporate emblem, TransCon, SKYTROFA ®, and YORVIPATH ® are logos owned by the Ascendis Pharma group. © January 2025 Ascendis Pharma A/S.
Investor Contacts:Media Contact:Scott SmithMelinda BakerAscendis PharmaAscendis [email protected]   +1 (650) 709-8875  [email protected] Financial institution  ICR Healthcare  +1 (415) 513-1284  patti.financial [email protected]  Supply: Ascendis Pharma
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