#ASND

2 months ago

Ascendis Pharma Provides Business and Strategic Roadmap Update at 44th Annual J.P. Morgan Healthcare Conference Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2026 key corporate milestones. Ascendis President and CEO Jan

#ASND Ascendis Pharma Provides Business and Strategic Roadmap Update at 44th Annual J.P. Morgan Healthcare Conference

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2 months ago

Week 52 COACH Trial Topline Results Confirm Consistent and Durable Treatment Benefits in Children with Achondroplasia (ACH) – Once-weekly TransCon ® CNP and TransCon ® hGH combination therapy showed durable growth without compromising safety or tolerability at 52 weeks – Annualized growth velocity (AGV) exceeded the 97th-percentile of average stature children – ACH height Z-score improvements indicated a tripling of

#ASND Week 52 COACH Trial Topline Results Confirm Consistent and Durable Treatment Benefits in Children with Achondroplasia (ACH)

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1!2!3! 🐼

@89sk0.bsky.social

2 months ago

CONGRATULATIONS 😊 🧡 👏 🥳 🥰
#FROMIS_9 ‘하얀그리움' M/V HITS 10M VIEWS ON YOUTUBE!!!

📹 youtu.be/5ZB9JLfIw_Q
#프로미스나인 #하얀그리움 #MV #10M #YOUTUBE #ASND

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3 months ago

Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information

#ASND Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

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3 months ago

Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon ® CNP (navepegritide) in children with achondroplasia

#ASND Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics

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4 months ago

3-Year Renal Data in Adults with Hypoparathyroidism Treated with TransCon® PTH (Palopegteriparatide) to Be Shared at Kidney Week 2025 Ascendis Pharma (Nasdaq: ASND) will share 3-year clinical data showing sustained improvement in renal function, continued normalization of urine calcium handling, and continued safety and efficacy for adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide).Data come from the Phase 2 PaTH Forward and Phase 3 PaTHway trials through Year 3 and will be presented at Kidney Week 2025 in Houston on November 6, 2025 (Poster #TH-PO0227; abstract in JASN 36(10S); DOI 10.1681/ASN.20253yamgex4).TransCon PTH is a once-daily prodrug of PTH (1-34) designed to deliver physiological PTH levels and is approved as YORVIPATH in the United States, European Union, and European Economic Area for adults with hypoparathyroidism.

#ASND 3-Year Renal Data in Adults with Hypoparathyroidism Treated with TransCon® PTH (Palopegteriparatide) to Be Shared at Kidney Week 2025

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5 months ago

Ascendis Submits Marketing Authorisation Application to the European Medicines Agency for TransCon® CNP for Treatment of Children with Achondroplasia Ascendis (Nasdaq: ASND) submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for TransCon CNP (navepegritide) as a once‑weekly treatment for children with achondroplasia.The MAA is supported by data from three randomized, double‑blind, placebo‑controlled trials and up to three years of open‑label extension data, including the pivotal ApproaCH Trial. Ascendis reported TransCon CNP was generally well tolerated with no discontinuations related to the study drug. Ascendis said it will engage with the EMA during review. In the U.S., TransCon CNP is under FDA priority review with a PDUFA target date of November 30, 2025.

#ASND Ascendis Submits Marketing Authorisation Application to the European Medicines Agency for TransCon® CNP for Treatment of Children with Achondroplasia

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6 months ago

Breakthrough Achondroplasia Combo Therapy: Ascendis to Present First Clinical Data on Dual Treatment at ASBMR 2025 Biotech firm to present 3 oral sessions on rare disease treatments: 52-week achondroplasia results, novel combination therapy data, and 4-year hypoparathyroidism outcomes at ASBMR Seattle meeting.

#ASND Ascendis to Share Latest Endocrinology Rare Disease Data in 3 Oral Presentations at ASBMR 2025

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@kpoppie.bsky.social

6 months ago

Red Velvet’s Wendy Steps into the Cerulean: A High-Fashion Reading of “Cerulean Verge” Concept Imagery

Photo Credits: ASND

#CeruleanVerge #RedVelvet #ASND #Wendy #웬디 #어센드 #Kpop #MiniAlbum #ConceptPhotos #Music #fashion #fashionblogger #fashionista #fashionstyle

Check it out @ kpoppie.com

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7 months ago

Ascendis Reports Massive 339% Revenue Jump as FDA Fast-Tracks Breakthrough Achondroplasia Drug Q2 earnings reveal YORVIPATH hits €103M revenue while TransCon CNP races toward November FDA decision. See full pipeline progress and financial metrics.

#ASND Ascendis Pharma Reports Second Quarter 2025 Financial Results

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7 months ago

FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency Ascendis Pharma (Nasdaq: ASND) has received FDA approval for SKYTROFA® (lonapegsomatropin-tcgd) for treating adult growth hormone deficiency (GHD). This marks a significant expansion from its 2021 pediatric GHD approval. SKYTROFA is administered once-weekly, offering a less burdensome alternative to traditional daily somatropin injections.The approval was based on the foresiGHt Phase 3 trial, which demonstrated efficacy and safety compared to placebo and daily somatropin. This milestone aligns with Ascendis's Vision 2030 goal to become the leading endocrinology rare disease company, with plans to initiate additional trials for various conditions in Q4 2025.

#ASND FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency

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8 months ago

Ascendis to Share Its Latest Endocrinology Rare Disease Data at ENDO 2025 Ascendis Pharma (Nasdaq: ASND) announced two key presentations at ENDO 2025, scheduled for July 12-15, 2025, in San Francisco. The presentations will showcase important clinical data from their Endocrinology Rare Disease portfolio.Dr. Aliya Khan will present Week 156 data from the Phase 3 PaTHway Trial of TransCon® PTH in adults with hypoparathyroidism, demonstrating long-term safety, efficacy, and improved renal function. Additionally, Dr. Carlos Bacino will present Week 52 safety and tolerability data from the pivotal ApproaCH Trial of TransCon® CNP in children with achondroplasia.

#ASND Ascendis to Share Its Latest Endocrinology Rare Disease Data at ENDO 2025

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Red Velvet 레드벨벳 (Unofficial) | WENDY (Unofficial)

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8 months ago

[X: ASNDLABEL, RTed by WENDY_offcl]

ASND Let's go💕

#WENDY #웬디
#fromis_9 #프로미스나인
#ASND #어센드

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Korea JoongAng Daily

@koreajoongangdaily.com

9 months ago

Girl group #fromis_9 will hold its first world tour "Now Tomorrow.," the girl group's new agency #ASND said Thursday.

buff.ly/ThlvBhX

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9 months ago

TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial Ascendis Pharma announced positive Week 26 interim results from the Phase 2 COACH Trial evaluating combination treatment of TransCon CNP and TransCon hGH in children with achondroplasia. The treatment-naïve cohort achieved mean annualized growth velocity of 9.14 cm/year with a +0.53 improvement in ACH height Z-score, while the TransCon CNP-treated cohort showed 8.25 cm/year growth with +0.44 Z-score improvement. The combination therapy demonstrated accelerated body proportionality improvements and was generally well-tolerated with mild adverse events. TransCon CNP is currently under FDA priority review as a monotherapy, while TransCon hGH (SKYTROFA) is already approved for pediatric growth hormone deficiency. The company plans to initiate a Phase 3 trial in Q4 2025, with Week 52 data expected in the same quarter.

#ASND TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial

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9 months ago

FDA Accepts TransCon® CNP NDA for Priority Review Ascendis Pharma announced that the FDA has accepted their New Drug Application (NDA) for TransCon CNP (navepegritide) with Priority Review designation for treating children with achondroplasia. The FDA set a PDUFA date of November 30, 2025, and indicated no plans for an advisory committee meeting. TransCon CNP, a once-weekly investigational prodrug, demonstrated significant improvements in annualized growth velocity compared to placebo in clinical trials. The treatment showed multiple benefits beyond linear growth, including improvements in lower limb alignment, spinal canal dimensions, and muscle strength, while maintaining a safety profile similar to placebo. The Priority Review status indicates the FDA's recognition of TransCon CNP's potential to significantly improve treatment for this serious condition.

#ASND FDA Accepts TransCon® CNP NDA for Priority Review

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9 months ago

NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA Specialised Therapeutics (ST) has announced that SKYTROFA® (lonapegsomatropin) has received approval from Australia's Therapeutic Goods Administration (TGA) for treating pediatric growth hormone deficiency (GHD). This once-weekly injectable therapy is approved for children and adolescents aged 3-18 years with insufficient endogenous growth hormone secretion. GHD affects approximately 2,000 Australian children, occurring at a rate of 2-3 per 10,000 people. SKYTROFA utilizes Ascendis Pharma's proprietary TransConTM technology platform, which enables sustained release of active, unmodified somatropin over one week. The approval follows successful Phase 3 clinical trials (heiGHt, fliGHt, and enliGHten) involving over 300 pediatric patients. The therapy is distributed by ST under an exclusive agreement with Ascendis Pharma A/S covering several Asia-Pacific countries. Currently, SKYTROFA is not listed on the Pharmaceutical Benefits Scheme (PBS).

#ASND NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA

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10 months ago

Breakthrough Treatment Shows Dual Benefits in Achondroplasia: Growth and Bone Structure Improvements in Phase 3 Trial New data reveals TransCon CNP's success in improving both growth velocity and bone structure in achondroplasia patients with strong safety profile. See full results.

#ASND New Data Shows Improvements in Growth and Bone Morphometry in Children with Achondroplasia Treated with TransCon® CNP (Navepegritide)

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10 months ago

New 4-Year Data Shows Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism Ascendis Pharma (NASDAQ: ASND) released promising 4-year data from its Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. The study demonstrated sustained efficacy with 95% patient retention (56 of 59 patients) at Week 214. Key findings include: - 98% of patients maintained normal albumin-adjusted serum calcium levels - 93% remained independent from conventional therapy - 67.8% showed clinically meaningful improvement in kidney function (eGFR) - Bone turnover markers stabilized above baseline - Bone mineral density stayed within normal range The treatment was well-tolerated with mostly mild to moderate adverse events, no serious treatment-related adverse events, and no treatment-related discontinuations.

#ASND New 4-Year Data Shows Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism

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10 months ago

Breakthrough Clinical Data: Ascendis Unveils 4-Year Results for Three Rare Disease Treatments at European Congress New long-term efficacy data from three rare disease programs, including 4-year hypoparathyroidism and 52-week achondroplasia results. See complete trial outcomes.

#ASND Ascendis to Share Its Latest Endocrinology Rare Disease Data at ESPE & ESE 2025

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