Ascendis Pharma, Inc.

146 articles with Ascendis Pharma, Inc.

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  FDA Action Alert: Incyte, Verrica and Ascendis

  9/20/2021

  From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.

• Ascendis Pharma A/S Announces Upcoming Investor Presentations - Sep 07, 2021

  9/7/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to potentially create new treatments that make a meaningful difference in patients’ lives, announced that the company will participate in two upcoming investor conferences.

• Ascendis Pharma A/S Announces Proposed Public Offering of ADSs - Aug 31, 2021

  8/31/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to potentially create new treatments that make a meaningful difference in patients’ lives, announced that it has commenced an underwritten public offering of $400,000,000 of American Depositary Shares, each of which represents one ordinary share of Ascendis.

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  Ascendis Scores First Approval with Once-Weekly Pediatric GHD Injector Known as Skytrofa

  8/26/2021

  FDA approved Ascendis Pharma’s Skytrofa for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone.

• Ascendis Pharma A/S Announces Upcoming Investor Presentations in August 2021

  8/6/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create new product candidates that address unmet medical needs, announced that the company will participate in two upcoming investor conferences in August.

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  FDA Action Alert: Incyte and Ascendis

  6/21/2021

  Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.

• Ascendis Pharma A/S Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ hGH

  6/11/2021

  Ascendis Pharma A/S today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information the Company submitted in connection with the FDA’s ongoing review of the Biologics License Application (BLA) constituted a major amendment to the BLA.

• Ascendis Pharma A/S Invites the Public to Attend “A Story of Courage: Living with Hypoparathyroidism” in Support of World Hypopara Awareness Day on June 1, 2021

  5/28/2021

  Online event to include a live reading by Children’s Author, Ariana Feiner, whose short film documentary, A Story of Courage, has won 24 international awards

• Ascendis Pharma A/S Announces First Quarter 2021 Financial Results and Business Update Conference Call on May 27

  5/17/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, announced that the company will hold a conference call and live webcast on Thursday, May 27, 2021 at 4:30 p.m. Eastern Time to review its first quarter 2021 financial results and provide a business update.

• Ascendis Pharma A/S Announces Expansion of Global Clinical Reach for TransCon™ PTH with Filing of the Clinical Trial Notification for Phase 3 Clinical Trial in Adults with Hypoparathyroidism in Japan

  5/12/2021

  Marks next step to bring the potential first ever hormone replacement therapy for hypoparathyroidism to Japan

• Ascendis Pharma A/S Announces Preliminary 58-Week Results from Open-Label Extension of Phase 2 PaTH Forward Trial of TransCon PTH in Adult Hypoparathyroidism Demonstrated Durable Benefit and a Well-Tolerated Safety Profile

  5/10/2021

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, today announced preliminary 58-week results from the continuing open-label extension (OLE) portion of the PaTH Forward Trial

• Ascendis Pharma A/S Announces Presentations for TransCon™ PTH at Upcoming Medical Conferences

  5/6/2021

  Ascendis Pharma A/S announced presentations featuring TransCon PTH at two upcoming medical conferences: the 48th annual meeting of the European Calcified Tissue Society, taking place virtually May 6-8, 2021 and the 23rd European Congress of Endocrinology taking place virtually May 22-26, 2021.

• Ascendis Pharma A/S Announces Participation at the BofA Securities 2021 Virtual Health Care Conference

  5/4/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, announced that the company will participate at the BofA Securities 2021 Virtual Health Care Conference.

• Ascendis Pharma A/S Announces Participation at the J.P. Morgan 10th Annual Napa Valley Biotech Forum

  3/30/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, announced that the company will participate at the J.P. Morgan 10th Annual Napa Valley Biotech Forum.

• Ascendis Pharma A/S Presents 6-Month Open-Label Extension Data from Phase 2 PaTH Forward Trial of TransCon PTH in Adult Hypoparathyroidism at ENDO 2021

  3/23/2021

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today presented the safety and efficacy results of TransCon PTH after six-months of treatment in patients with hypoparathyroidism enrolled in the open-label extension period (OLE) of the phase 2 PaTH Forward Trial, at the Endocrine Society’s annual meeting,

• Ascendis Pharma A/S Announces Participation at Oppenheimer 31st Annual Healthcare Conference

  3/15/2021

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today announced that the company will participate at the Oppenheimer 31st Annual Healthcare Conference. Company executives will provide a business overview and an update on the Company’s pipeline programs.   

• Ascendis Pharma A/S Reports Full Year 2020 Financial Results

  3/10/2021

  Preparations for potential launch of first Endocrinology Rare Disease product candidate, TransCon hGH (lonapegsomatropin), continues on track

• Ascendis Pharma A/S Announces Seven Presentations at ENDO 2021, Demonstrating Commitment to People with Rare Endocrine Diseases

  3/10/2021

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to address unmet medical needs, today announced seven presentations at ENDO 2021, the Endocrine Society’s annual meeting, taking place virtually from March 20-23, 2021.

• Ascendis Pharma A/S Announces Full Year 2020 Financial Results and Business Update Conference Call on March 10

  3/4/2021

  Ascendis Pharma A/S, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, announced that the company will hold a conference call and live webcast on Wednesday, March 10, 2021 at 4:30 p.m. Eastern Time to review its 2020 financial results and provide a business update.

• Ascendis Pharma A/S Announces New “Outgrow GHD” Educational Resource to Support Rare Disease Day 2021

  2/26/2021

  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced the launch of Outgrow GHD , a new online educational resource designed to help caregivers of children with growth hormone deficiency (GHD) in the United States (U.S.) navigate their personal GHD journeys.