Once-Weekly TransCon® CNP (Navepegritide) Receives Positive CHMP Opinion for the Treatment of Achondroplasia in Children

COPENHAGEN, Denmark, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for once-weekly TransCon CNP (navepegritide) in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed. The final European Commission (EC) decision on Ascendis Pharma's Marketing Authorisation Application (MAA) is expected during Q4 2026.

GlobeNewsWire • Oct 16, 2026

FDA Grants Priority Review to BridgeBio's Dwarfism Drug Filing

BBIO wins FDA priority review for infigratinib, potentially making it the first approved oral therapy for achondroplasia.

Zacks Investment Research • Oct 7, 2026

Ascendis to Share Latest Advances in Hypoparathyroidism and Achondroplasia Programs at ASBMR 2026

COPENHAGEN, Denmark, Oct. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the latest advances in its hypoparathyroidism and achondroplasia programs will be showcased during ASBMR 2026, the annual meeting of American Society for Bone & Mineral Research being held in Boston from October 9-12, 2026. Updates include an oral presentation by Aliya Khan, M.D., of combined skeletal data from the Phase 2 PaTH Forward and Phase 3 PaTHway trials showing normalization of bone mass and microarchitecture in clinical trial patients treated with TransCon® PTH (palopegteriparatide) over a 5-year period.

GlobeNewsWire • Oct 6, 2026

Ascendis Pharma: Back To Full Independence

Ascendis Pharma faces negative sentiment after Novo returned TransCon rights, compounding prior partner exits and pipeline disappointments. Despite pipeline contraction, ASND's approved products—Skytrofa, Yorvipath, and Yuviwel—show robust growth, and Yorvipath net sales should exceed $1.1 billion this year. Yuviwel's strong U.S. launch and favorable BioMarin settlement provide freedom to operate.

Seeking Alpha • Sep 16, 2026

Why Is Ascendis Pharma Stock Trading Lower on Tuesday?

Ascendis Pharma A/S (NASDAQ:ASND) shares are trading lower on Tuesday as investors digest news that the company will regain rights to certain TransCon technology-based programs and a share buyback.

Benzinga • Sep 15, 2026

Ascendis Pharma A/S (ASND) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript

Ascendis Pharma A/S (ASND) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript

Seeking Alpha • Sep 15, 2026

This Cellectis Analyst Is No Longer Bullish; Here Are Top 5 Downgrades For Tuesday

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.

Benzinga • Sep 15, 2026

Ascendis Announces Planned $400 Million Share Repurchase Program

COPENHAGEN, Denmark, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that its Board of Directors has authorized the Company to repurchase up to $400 million of the Company's ordinary shares (the Share Repurchase Program).

GlobeNewsWire • Sep 14, 2026

Ascendis to Regain Rights to TransCon® Technology in Metabolic and Cardiovascular Diseases

- All rights to TransCon technology-based products in metabolic and cardiovascular diseases, including once-monthly TransCon Semaglutide, will revert to Ascendis- Ascendis to initiate multiple programs in metabolic and cardiovascular diseases, including obesity

GlobeNewsWire • Sep 14, 2026

First Infant Data from Ascendis Trial of Once-Weekly TransCon CNP (Navepegritide) Presented at ESPE 2026

– Achondroplasia Foramen Magnum Score was stable or improved between baseline and Week 52 with TransCon CNP treatment

GlobeNewsWire • Sep 9, 2026