Ascendis Pharma, Inc.

96 articles with Ascendis Pharma, Inc.

• Ascendis Pharma A/S Announces Preliminary Six-Month Data from Open-Label Extension of Phase 2 PaTH Forward Trial and Files IND Amendment to Initiate Phase 3 PaTHway Trial of TransCon PTH in Adult Hypoparathyroidism

  9/28/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced preliminary six-month results from the open-label extension (OLE) portion of PaTH Forward, a global phase 2 trial evaluating the safety,

• Ascendis Pharma A/S Announces Filing of the Clinical Trial Notification for Phase 3 Clinical Trial of TransCon™ hGH for Pediatric Growth Hormone Deficiency in Japan

  9/23/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced that it has filed a Clinical Trial Notification (CTN) with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to initiate the company’s phase 3 riGHt Trial of TransCon™ hGH (lonapegsomatropin), a long-acting prodrug of somatropin (hGH), for the treatment for pediatri

• Ascendis Pharma A/S Announces Support for Children’s Growth Awareness Week and Day 2020

  9/15/2020

  – Introduces #Together4Growth to increase awareness of children’s growth disorders, including a four-question Growth Quiz to help parents identify signs and symptoms –       –  Public encouraged to visit www.together4growth.com and share their growth disorder stories using #Together4Growth – COPENHAGEN, Denmark, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative technologies to address unmet medica

• Ascendis Pharma A/S Announces Participation at the 18th Annual Morgan Stanley Virtual Global Healthcare Conference

  9/11/2020

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, announced that the company will participate in the 18th Annual Morgan Stanley Virtual Global Healthcare Conference in September.

• Ascendis Pharma A/S Announces Presentations for TransCon™ PTH and Hypoparathyroidism at American Society for Bone and Mineral Research Annual Meeting

  9/10/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced three presentations for its TransCon PTH program for hypoparathyroidism (HP) at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, taking place September 11–15.  In addition, results from the randomized, double-blind phase 2 PaTH Forw

• Ascendis Pharma A/S Submits Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon™ hGH for Treatment of Pediatric Growth Hormone Deficiency

  9/8/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that uses its novel TransCon technologies to address unmet medical needs, announced today the submission of a MAA to the EMA seeking approval for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin (human growth hormone or hGH), for the treatment of pediatric patients who are diagnosed with growth hormone deficiency (GHD).

• Ascendis Pharma A/S Announces U.S. Food and Drug Administration (FDA) Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD)

  9/4/2020

  – Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2021 – – FDA indicated that it is currently not planning to hold an Advisory Committee Meeting –

• Ascendis Pharma A/S Announces Presentations for TransCon™ PTH and Hypoparathyroidism at 22nd European Congress of Endocrinology

  9/4/2020

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, announced two presentations for its TransCon PTH program in adult hypoparathyroidism at the 22nd European Congress of Endocrinology 2020, taking place online September 5–9, 2020.

• Ascendis Pharma A/S Announces Participation at the 2020 Wells Fargo Virtual Healthcare Conference

  9/2/2020

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, announced that the company will participate in the 2020 Wells Fargo Virtual Healthcare Conference in September.

• Ascendis Pharma A/S Reports Second Quarter 2020 Financial Results and Announces New Data from the Four-Week, Fixed Dose, Double-Blind Portion of the PaTH Forward Trial

  8/27/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced new data from PaTH Forward and financial results for the quarter ended June 30, 2020.

• Ascendis Pharma A/S Announces Second Quarter 2020 Financial Results and Business Update Conference Call on August 27

  8/13/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, today announced that the company will hold a conference call and live webcast on Thursday, August 27, 2020 at 4:30 p.m. Eastern Time 

• Ascendis Pharma A/S Announces Upcoming Investor Presentations in August

  8/4/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, today announced that the company will participate in two upcoming investor conferences in August. Company executives will provide a business overview and update on the company’s pipeline programs. Details Event 2020 Wedbush PacGrow Healthcare Virtual Conference Location Virtu

• Ascendis Pharma A/S Announces Pricing of Public Offering of ADSs

  7/8/2020

  Ascendis Pharma A/S (Nasdaq:ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, today announced the pricing of its underwritten public offering of 4,225,352 American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis, at a price to the public of $142.00 per ADS.

• Ascendis Pharma A/S Receives Positive Opinion from the Paediatric Committee of the European Medicines Agency on the Agreement of a Paediatric Investigation Plan

  7/6/2020

  – Supports the investigation of TransCon hGH for treatment of growth hormone deficiency in the pediatric population from 6 months to less than 18 years of age – – Company on track to submit European marketing application in third quarter 2020 – – No additional studies required – COPENHAGEN, Denmark, July 06, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, tod

• Ascendis Pharma A/S Announces Proposed Public Offering of ADSs - July 06, 2020

  7/6/2020

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, announced that it has commenced an underwritten public offering of $500,000,000 of American Depositary Shares, each of which represents one ordinary share of Ascendis.

• Ascendis Pharma A/S Announces Submission of Biologics License Application (BLA) to FDA for TransCon™ hGH in Pediatric Growth Hormone Deficiency– European marketing application on track for third quarter 2020 submission –

  6/26/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for TransCon hGH (lonapegsomatropin)

• Ascendis Pharma A/S Announces Presentation of Preclinical Data for TransCon IL-2 β/γ at AACR Virtual Annual Meeting 2020

  6/22/2020

  - In vitro data demonstrated selective binding and activation of IL-2 β/γ  receptor, associated with reduced IL-2 α   receptor binding - - Selective expansion and activation of cells in vivo consistent with receptor bias - - Long half-life and pharmacodynamic effect expected to support dosing every 3 weeks in patients - - No dose-limiting toxicities and maximum tolerated dose was not reached -

• Ascendis Pharma A/S Announces Participation in ENDO Online 2020

  6/8/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced presentations related to its rare disease endocrinology programs at ENDO Online 2020, the annual meeting of the Endocine Society, taking place June 8 - 22, 2020. “The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch

• Ascendis Pharma A/S Reports First Quarter 2020 Financial Results

  5/19/2020

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced financial results for the quarter ended March 31, 2020.

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  BioSpace Movers & Shakers, May 15

  5/15/2020

  Pharma, biotech and life sciences companies bolster their executive teams and boards with these Movers & Shakers.