Ascendis Pharma

Ascendis Pharma A/S is a biopharmaceutical company, which engages in the development of drug candidates. It specializes on its TransCon technologies to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug. The company was founded by Jan Moller Mikkelsen, Dirk Vetter, and Harald Rau in September 2006 and is headquartered in Hellerup, Denmark.

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Ascendis Pharma reports strong revenue growth and market potential

Ascendis Pharma's financial performance in Q4 2022 showed revenue growth but operating losses, with a strong cash position.
Strengths lie in the TransCon technology platform, differentiation of products, and established commercial infrastructure.
Challenges include monitoring requirements, launch strategy comparisons, and market access strategies.
Opportunities arise from potential approvals, market dynamics, and clinical benefits of product candidates.

Ascendis Pharma reports robust Q1 revenue, faces regulatory challenges

Ascendis Pharma delivered a strong financial performance in Q1 2023, driven by revenue growth and strategic initiatives.
The company faces regulatory challenges and market dynamics that require resolution and strategic planning for sustained growth.
Opportunities for market expansion and product development exist through leveraging success factors and addressing regulatory hurdles.
Investor interest in Ascendis Pharma's future prospects is evident through analyst inquiries on growth expectations and market strategies.

Ascendis Pharma reports robust Q2 earnings amidst market challenges

Ascendis Pharma's Q2 performance reflects strong revenue generation and strategic advancements in key product pipelines, positioning the company for future growth.
Despite challenges in market shortages and regulatory processes, Ascendis Pharma's focus on innovation and market differentiation presents opportunities for expansion.
The company's emphasis on TransCon technology's unique benefits and market positioning underscores its competitive strength and growth potential in rare disease therapeutics.

Ascendis Pharma reports strong Q3 revenue growth and pipeline progress

Ascendis Pharma's Q3 2023 performance reflects revenue growth driven by SKYTROFA and progress in key pipeline programs.
The company's strategic focus on innovative therapies and patient-centric approaches positions it for future growth and market leadership.
While facing challenges like supply chain disruptions and market competition, Ascendis Pharma has opportunities for expansion and therapeutic innovation.
Balancing financial performance with pipeline advancement and commercial optimization will be crucial for Ascendis Pharma's sustainable success.

Ascendis Pharma excels in revenue growth and market leadership

Ascendis Pharma's strong performance in 2023, driven by SKYTROFA and TransCon PTH, positions the company for continued growth and success.
Despite challenges in market competition and treatment complexities, the company's strategic focus on patient outcomes and revenue growth is evident.
Opportunities in expanding therapeutic areas and maintaining market share stability offer potential for Ascendis Pharma's long-term success and value creation.

Ascendis Pharma reports robust Q1 performance and eyes global expansion

Ascendis Pharma's Q1 2024 performance reflects strong revenue growth, improved operational efficiency, and successful product launches, positioning the company for sustainable growth.
While facing challenges in market competition and financial targets, Ascendis Pharma's strategic strengths in product development and market expansion present growth opportunities.
The company's focus on innovation, commercial execution, and market positioning underscores its potential to become a leader in growth disorders and metabolic diseases.
Investors should monitor Ascendis Pharma's progress in achieving cash flow breakeven, expanding product portfolios, and navigating regulatory landscapes for future growth potential.

Ascendis Pharma excels in Q2 with YORVIPATH approval and revenue growth

Ascendis Pharma's Q2 2024 earnings call highlighted strong financial performance, successful product approvals, and strategic commercialization efforts.
The company faces challenges in pricing strategies, market dynamics, and ensuring patient uptake, but opportunities exist in expanding market reach and advancing pipeline programs.
Overall, Ascendis Pharma's focus on innovation, patient support, and financial growth positions it well for continued success and market leadership in the biopharmaceutical industry.

Ascendis Pharma reports robust Q3 performance and eyes strategic growth

Ascendis Pharma showcased strong performance across its product portfolio and pipeline candidates, with notable revenue growth and promising clinical outcomes.
While facing challenges in market penetration and regulatory processes, the company is well-positioned to capitalize on growth opportunities through strategic collaborations and upcoming product launches.
By navigating challenges effectively and leveraging opportunities, Ascendis Pharma aims to drive sustainable growth and value creation in the pharmaceutical market.

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Here is how Ascendis Pharma A/S (ASND) and Autolus Therapeutics PLC Sponsored ADR (AUTL) have performed compared to their sector so far this year.

Are Medical Stocks Lagging Ascendis Pharma (ASND) This Year?

Ascendis Pharma A/S (ASND) Q4 2023 Earnings Call Transcript

COPENHAGEN, Denmark, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Ascendis Pharma Reports Fourth Quarter and Full Year 2023 Results

COPENHAGEN, Denmark, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference.

Ascendis Pharma to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report full year 2023 financial results and provide a business update on Wednesday, February 7, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and webcast on February 7, 2024, at 4:30 p.m. Eastern Time (ET) to discuss 2023 financial results.

Ascendis Pharma to Report Full Year 2023 Financial Results and Provide Business Update on February 7, 2024

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma's TransCon technology platform to be launched commercially.

Ascendis Pharma Launches 2nd TransCon™ Product: YORVIPATH® Now Available in Germany and Austria for Adults with Chronic Hypoparathyroidism

COPENHAGEN, Denmark, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the formation and launch with Frazier Life Sciences of Eyconis, Inc., a separate company created to develop, manufacture, and commercialize TransCon ophthalmology assets globally, together with an investor syndicate that includes Frazier, RA Capital Management, venBio, and HealthQuest Capital.

New Company Eyconis Formed to Develop Ascendis Pharma Ophthalmology Assets with $150 Million Commitment from External Investors

Ascendis Pharma outlined its Vision 2030 ahead of and during the J.P. Morgan Healthcare Conference. The company expects three endocrinology products to achieve blockbuster status, pipeline to expand in rare disease endocrinology and to mass market indications, and we could see potential spinouts or partnerships. Skytrofa exceeds expectations with strong Q4 net sales of €64 million and guidance for 2024 net sales of €320-340 million.

Ascendis Pharma's Ambitious Vision 2030

COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.

Ascendis Pharma Introduces Vision 2030

Agreement between Ascendis Pharma A/S and ST is for the exclusive distribution and commercialisation of three Ascendis Pharma endocrinology therapies Two of the therapies are already internationally approved, the third is in development following successful Phase 2 data ST's exclusive distribution agreement covers Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand and Vietnam SINGAPORE , Jan. 7, 2024 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has added three new endocrinology therapies to its specialist portfolio, following an exclusive distribution agreement with Danish company Ascendis Pharma A/S (NASDAQ: ASND). Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).

Specialised Therapeutics signs exclusive agreement with Ascendis Pharma A/S for distribution and commercialisation of three endocrinology therapies in Australia and select South-East Asia countries

COPENHAGEN, Denmark, Dec. 28, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, Scott Smith, Executive Vice President & Chief Financial Officer, and Kennett Sprogøe, Ph.D., Executive Vice President, Head of Research & Product Development, will participate in the 42nd Annual J.P. Morgan Healthcare Conference.

Ascendis Pharma to Participate in the 42nd Annual J.P. Morgan Healthcare Conference

COPENHAGEN, Denmark, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new analyses from the blinded and ongoing open-label extension (OLE) portions of ACcomplisH, the Company's Phase 2 randomized, double-blind, placebo-controlled, dose-escalation trial of TransCon CNP in children ages 2-10 years with achondroplasia. In the trial, all 57 patients have now completed one year of treatment with TransCon CNP (navepegritide) at 100 µg/kg/week, the dose agreed with regulatory agencies for the active arm in the pivotal ApproaCH Trial.

Significant Health and Quality of Life Improvements Achieved in Children with Achondroplasia Treated for One Year with TransCon™ CNP (Navepegritide) at 100 µg/kg/week

–   On primary efficacy and key secondary endpoints, TransCon hGH demonstrated statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo

TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

– PDUFA goal date is May 14, 2024 COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024.

FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism

–   Teijin to receive exclusive license to further develop and commercialize TransCon™ hGH, TransCon™ PTH, and TransCon™ CNP in Japan

Ascendis Pharma Announces Strategic Partnership with Teijin Limited in Japan

Ascendis Pharma A/S reported strong sequential growth of Skytrofa and raised its full-year net sales guidance range. The NDA resubmission for TransCon PTH is expected by mid-November, with FDA feedback by mid-December and a potential PDUFA date in January or May. 2024 should be a good year for top line growth, especially if TransCon PTH receives timely FDA approval.

Ascendis Pharma: Skytrofa Net Sales Not The Update Investors Are Waiting For

Ascendis Pharma A/S (ASND) Q3 2023 Results Conference Call November 7, 2023 4:30 PM ET Company Participants Timothy Lee - Investor Relations Jan Mikkelsen - President and Chief Executive Officer Scott Smith - Executive Vice President and Chief Financial Officer Conference Call Participants Paul Choi - Goldman Sachs Joseph Schwartz - Leerink Partners Yaron Werber - TD Cowen Li Watsek - Cantor Fitzgerald Leland Gershell - Oppenheimer Operator Hello, and welcome to Ascendis Pharma Third Quarter 2023 Earnings Conference Call and Webcast. Following the prepared remarks, there will be a question-and-answer period, instructions will be given at that time.

Ascendis Pharma A/S (ASND) Q3 2023 Earnings Call Transcript

COPENHAGEN, Denmark, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the third quarter ended September 30, 2023 and provided business updates.

Ascendis Pharma Reports Third Quarter 2023 Financial Results

The consensus price target hints at a 51.7% upside potential for Ascendis Pharma A/S (ASND). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Does Ascendis Pharma A/S (ASND) Have the Potential to Rally 51.72% as Wall Street Analysts Expect?

• Third Quarter financial results and business update conference call to be held on November 7, 2023 • Resubmission of TransCon PTH NDA for adults with hypoparathyroidism expected before mid-November 2023 COPENHAGEN, Denmark, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report third quarter 2023 financial results and provide a business update on Tuesday, November 7, 2023, after the close of the U.S. financial markets. In addition, Ascendis Pharma announced that it plans to resubmit its NDA for TransCon PTH for adults with hypoparathyroidism to the FDA before mid-November 2023.

Ascendis Pharma Announces Timing of Third Quarter 2023 Financial Results and TransCon PTH NDA Resubmission

The heavy selling pressure might have exhausted for Ascendis Pharma A/S (ASND) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Ascendis Pharma A/S (ASND) Loses -8.26% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

—  Clinical responses with TransCon IL-2 β⁄γ demonstrated as monotherapy or in combination with checkpoint inhibitor, including in two of three small cell lung cancer patients treated with combination therapy

Ascendis Presents Updated and New TransCon™ IL-2 β⁄γ Monotherapy and Combination Therapy Data Confirming Clinical Activity Across Tumor Types at ESMO 2023

— 52-week results from the Phase 3 PaTHway Trial showed that the skeletal dynamics of adult patients with chronic hypoparathyroidism treated with TransCon PTH trended toward a new steady state closer to age-appropriate norms

Ascendis Pharma Presents TransCon™ PTH (palopegteriparatide) Phase 3 52-Week Skeletal Dynamics Data at ASBMR 2023

– At Week 26, 81% of patients in Phase 3 PaTHway Trial with chronic post-surgical hypoparathyroidism, the most common cause of this disease, achieved independence from conventional therapy while maintaining normocalcemia following treatment with TransCon PTH

Ascendis Presents TransCon™ PTH Data at the American Thyroid Association Annual Meeting

- The majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit

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