ASND Ascendis Pharma A/S

140
-5.27  -4%
Previous Close 145.27
Open 146.88
52 Week Low 90.06
52 Week High 158.93
Market Cap $6,763,690,360
Shares 48,312,074
Float 48,312,074
Enterprise Value $6,455,783,042
Volume 354,570
Av. Daily Volume 243,491
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Upcoming Catalysts

Drug Stage Catalyst Date
TransCon
Hypoparathyroidism
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
TransCon hGH
Growth hormone deficiency in children
BLA Filing
BLA Filing
BLA filing announced June 26, 2020.
TransCon CNP - ACcomplisH
Achondroplasia
Phase 2
Phase 2
Phase 2 trial has been initiated.

Latest News

  1. COPENHAGEN, Denmark, July 07, 2020 (GLOBE NEWSWIRE) -- 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. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about July 10, 2020 subject to customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 633,802 ADSs at the public offering price, less the underwriting commissions.

    Ascendis…

    COPENHAGEN, Denmark, July 07, 2020 (GLOBE NEWSWIRE) -- 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. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about July 10, 2020 subject to customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 633,802 ADSs at the public offering price, less the underwriting commissions.

    Ascendis estimates net proceeds from the offering to be approximately $569.2 million (assuming no exercise of the underwriters' option to purchase additional ADSs), after deducting the underwriting commissions and estimated offering expenses. Ascendis intends to use the net proceeds of the offering to support the clinical development, regulatory approval and commercial preparations for TransCon hGH, to fund clinical development of its other endocrinology rare disease programs, including TransCon PTH and TransCon CNP, to identify and progress development of new product candidates, including in the therapeutic area of oncology, and for working capital and general corporate purposes.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink LLC are acting as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC, Cantor Fitzgerald & Co. and Canaccord Genuity LLC are acting as co-lead managers for the offering and Oppenheimer & Co. Inc., Wedbush Securities Inc. and Kempen & Co are acting as co-managers for the offering.

    A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 30, 2018 and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention:  Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ascendis Pharma A/S

    Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.

    Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

    Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the satisfaction of customary closing conditions related to the offering, (ii) the expected closing of the offering, (iii) references to whether Ascendis will consummate the offering, (iv) Ascendis' expectations regarding the anticipated closing date, (v) Ascendis' intended use of the net proceeds from the offering, (vi) Ascendis' product pipeline and expansion into additional therapeutic areas, and (vii) Ascendis' expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: risks and uncertainties related to completion of the public offering on the anticipated terms or at all, market conditions and the satisfaction of customary closing conditions related to the public offering, unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis' ability to obtain additional funding, if needed, to support its business activities and the effects on its business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see the prospectus supplement related to the proposed public offering and Ascendis' current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. © July 2020

     Investor contact: Media contact:
     Patti BankAmi Knoefler
     Westwicke Partners Ascendis Pharma
     (415) 513-1284   (650) 739-9952   
        
      

    Source: Ascendis Pharma A/S 

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  2. 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, today announced that it has commenced an underwritten public offering of $500,000,000 of American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 of ADSs at the public offering price, less the underwriting commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be…

    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, today announced that it has commenced an underwritten public offering of $500,000,000 of American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 of ADSs at the public offering price, less the underwriting commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink are acting as joint book-running managers for the offering.

    A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 30, 2018 and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention:  Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ascendis Pharma A/S

    Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.

    Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

    Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Ascendis' (i) expectations regarding the completion, timing and size of the public offering, (ii) expectations with respect to granting the underwriters a 30-day option to purchase additional ADSs, (iii) product pipeline and expansion into additional therapeutic areas, and (iv) expectations regarding its ability to utilize its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: risks and uncertainties related to completion of the public offering on the anticipated terms or at all, market conditions and the satisfaction of customary closing conditions related to the public offering, unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis' ability to obtain additional funding, if needed, to support its business activities and the effects on its business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see the preliminary prospectus supplement related to the proposed public offering and Ascendis' current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. © July 2020

    Investor contact:Media contact:
    Patti Bank Ami Knoefler
    Westwicke PartnersAscendis Pharma
    (415) 513-1284(650) 739-9952
     

    Source: Ascendis Pharma A/S

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  3. – 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, today announced that it received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) on its agreement with the proposed Paediatric Investigation Plan (PIP) for TransCon hGH (lonapegsomatropin), an investigational long-acting…

    – 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, today announced that it received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) on its agreement with the proposed Paediatric Investigation Plan (PIP) for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin (human growth hormone or hGH) in development for treatment of growth hormone deficiency (GHD). The positive opinion is based on the non-clinical safety program, as well as data from the three phase 3 clinical trials provided to PDCO from the ongoing TransCon hGH development program, which will be included in the upcoming Marketing Authorisation Application (MAA).

    The PIP opinion from PDCO endorsed the TransCon hGH program as acceptable for assessment of safety and efficacy for the use of TransCon hGH as a treatment for growth hormone deficiency in children from 6 months to less than 18 years of age, mirroring the population covered by the studies conducted in the program. 

    "We are delighted to receive the positive opinion from PDCO regarding our PIP, which is based on a comprehensive data package from our non-clinical and clinical development program for TransCon hGH. As planned, we will move forward with our marketing application submission in Europe this quarter," said Dana Pizzuti, M.D., Ascendis Pharma's Senior Vice President of Development Operations. "We believe this opinion recognizes the unique attributes of TransCon hGH and how our TransCon technology enables the long-acting release of unmodified somatropin which provides a predictable mode of action without changing the expected safety profile. We are very pleased with our PDCO discussions as the approval of our PIP reflects to our knowledge the first time PDCO has concluded that a clinical development program for a long acting growth hormone treatment is appropriate to support the clinical development in children."

    Ascendis submitted a Biologics License Application for TransCon hGH for the treatment of pediatric GHD to the U.S. Food and Drug Administration in June 2020, and the company recently conducted productive meetings with European regulatory personnel, including a pre-submission meeting with EMA and meetings with the rapporteur and co-rapporteur.

    About the Paediatric Committee (PDCO)

    The Paediatric Committee (PDCO) is the European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining paediatric needs.

    About the Paediatric Investigation Plan (PIP)

    A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when a marketing-authorisation holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and covered by intellectual property rights.

    About TransCon™ Technology

    TransCon refers to "transient conjugation." The proprietary TransCon platform is an innovative technology designed to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action may be maintained. TransCon technology is designed to be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and to be used systemically or locally.

    About Pediatric Growth Hormone Deficiency (GHD)

    Pediatric GHD is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone. Children with GHD are not only characterized by short stature, but they also may experience metabolic abnormalities, psychosocial challenges and poor quality of life.

    For decades, the standard of care for GHD has been a daily subcutaneous injection of hGH, which improves growth and overall endocrine health.

    About Ascendis Pharma A/S

    Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.

    Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

    Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.

    For more information, please visit www.ascendispharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our plans to submit a MAA for TransCon hGH to the EMA in the third quarter of 2020, (ii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iii) our expectations regarding our ability to create potentially best-in-class therapies and (iv) our product pipeline. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; our ability to obtain additional funding, if needed, to support our business activities and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. © July 2020 Ascendis Pharma A/S.

    Investor contact:Media contact:
    Patti Bank Ami Knoefler
    Westwicke Partners Ascendis Pharma
    (415) 513-1284 (650) 739-9952
      
      
      

     

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  4. COPENHAGEN, Denmark, June 26, 2020 (GLOBE NEWSWIRE) -- 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), a long-acting once-weekly prodrug of somatropin (human growth hormone or hGH) for treatment for pediatric growth hormone deficiency (GHD). 

    "TransCon Growth Hormone is the first product candidate we have taken from idea stage, through multiple Phase 3 clinical trials, and now to BLA submission. We believe the TransCon technology has the potential to address major unmet medical needs and…

    COPENHAGEN, Denmark, June 26, 2020 (GLOBE NEWSWIRE) -- 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), a long-acting once-weekly prodrug of somatropin (human growth hormone or hGH) for treatment for pediatric growth hormone deficiency (GHD). 

    "TransCon Growth Hormone is the first product candidate we have taken from idea stage, through multiple Phase 3 clinical trials, and now to BLA submission. We believe the TransCon technology has the potential to address major unmet medical needs and we look forward to continuing the late stage clinical development of our other endocrinology rare disease product candidates, TransCon PTH and TransCon CNP, as well as filing an Investigational New Drug application for our first oncology product candidate later this year," said Jan Mikkelsen, Ascendis Pharma's President and Chief Executive Officer. "Most importantly, we are very grateful to all of the participants and investigators in our TransCon hGH trials, and we look forward to discussions with the FDA in an effort to bring this potential new treatment option to children with GHD."

    TransCon hGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin. Currently, there is no approved long-acting growth hormone treatment on the market in the U.S. or Europe. TransCon hGH has orphan designation for GHD in both the United States and Europe.

    Ascendis Pharma plans to submit a Marketing Authorisation Application (MAA) for TransCon hGH to the European Medicines Agency in the third quarter, also for pediatric GHD. Additionally, the company expects to initiate a phase 3 trial with TransCon hGH in pediatric GHD in Japan in the fourth quarter, and a phase 3 trial is ongoing in Greater China through the company's strategic investment in VISEN Pharmaceuticals.

    About TransCon™ Technology

    TransCon refers to "transient conjugation." The proprietary TransCon platform is an innovative technology designed to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action may be maintained. TransCon technology is designed to be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and to be used systemically or locally.

    About Pediatric Growth Hormone Deficiency (GHD)

    Pediatric GHD is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone. Children with GHD are not only characterized by short stature, but they also may experience metabolic abnormalities, psychosocial challenges and poor quality of life.

    For decades, the standard of care for GHD has been a daily subcutaneous injection of hGH, which improves growth and metabolic effects. For caregivers and patients, the treatment burden with daily injections is high, which may lead to poor adherence and reduced overall treatment outcomes.

    About Ascendis Pharma A/S

    Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.

    Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

    Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.

    For more information, please visit www.ascendispharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our plans to submit a Marketing Authorisation Application for TransCon hGH to the European Medicines Agency in the third quarter 2020 for pediatric GHD, (ii) our plans to initiate a phase 3 trial with TransCon hGH in pediatric GHD in Japan in the fourth quarter 2020, (iii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iv) our expectations regarding our ability to create potentially best-in-class therapies and (iii) our product pipeline. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; our ability to obtain additional funding, if needed, to support our business activities and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. ©June 2020 Ascendis Pharma A/S.

    Investor contact:Media contact:
    Patti BankAmi Knoefler
    Westwicke PartnersAscendis Pharma
    (415) 513-1284(650) 739-9952
     

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  5. - 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 -

    COPENHAGEN, Denmark, June 22, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced the presentation of preclinical data for TransCon IL-2 β/γ, an oncology product candidate designed to provide sustained systemic release…

    - 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 -

    COPENHAGEN, Denmark, June 22, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced the presentation of preclinical data for TransCon IL-2 β/γ, an oncology product candidate designed to provide sustained systemic release of a receptor-biased IL-2 (IL-2 β/γ), at the American Association of Cancer Research (AACR) Virtual Annual Meeting II from June 22 to June 24, 2020. 

    "Our preclinical results have demonstrated that TransCon IL-2 β/γ selectively binds and activates the IL-2 β/γ receptor and provides sustained and long-lasting exposure. By applying our TransCon technology to this clinically validated cytokine, we have overcome the two most significant limitations of IL-2 therapy, improving both the receptor-binding properties and the pharmacokinetic profile," said Juha Punnonen, M.D., Ph.D., Ascendis Pharma's Senior Vice President and Head of Oncology. "Based on the promising preclinical results we've seen with our TransCon IL-2 β/γ and TransCon TLR7/8 Agonist product candidates, we believe our TransCon technologies - which enable systemic and long-acting intratumoral administration - have the potential to improve treatment outcomes in cancer patients. We look forward to our first Investigational New Drug application, or similar, in oncology later this year for TransCon TLR7/8 Agonist, followed by a planned filing for TransCon IL-2 β/γ in 2021."

    TransCon IL-2 β/γ is a novel long-acting prodrug of IL-2 β/γ designed to address limitations of alternative IL-2 treatments, including aldesleukin, which has been available since the 1990's as a treatment for advanced kidney cancer and advanced melanoma. TransCon IL-2 β/γ is designed with a parent drug that selectively binds and activates the IL-2Rβ/γ. By applying the innovative TransCon technology platform, preclinical data also showed that TransCon IL-2 β/γ demonstrated a long in vivo half-life of approximately 32 hours, expected to support potential dosing of every three weeks in patients. Preclinical results show a single dose of TransCon IL-2 β/γ selectively expanded lymphocyte counts (CD8+ T cells and NK cells) in non-human primates, with minimal signs of systemic inflammation (IL-5 and IL-6 markers) or endothelial cell damage (E-Selectin and VCAM-1 markers) and no dose-limiting toxicities.

    Presentation Details

    American Association of Cancer Research (AACR) Virtual Annual Meeting II

    TitleDate/Time
    P4507: TransCon™ IL-2 β/γ: a novel long-acting prodrug of receptor-biased IL-2 designed for improved pharmocokinetics and optimal activation of T cells for the treatment of cancerMonday, June 22, 2020



    8:45 a.m. Eastern



    The poster is available on the company's website under Selected Publications in the Pipeline section:

    https://ascendispharma.com/product-pipeline/publications/

    About TransCon™ Oncology Programs

    Ascendis Pharma is developing potentially best-in-class oncology therapies by applying its TransCon technologies for systemic and intratumoral administration to clinically validated pathways in order to improve efficacy and reduce systemic toxicity. Multiple oncology programs are currently in preclinical evaluation.

    About TransCon™ Technology

    TransCon refers to "transient conjugation." The proprietary TransCon platform is an innovative technology to create new therapies that are designed to potentially optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.

    About Ascendis Pharma A/S

    Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies.

    Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and is advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs.

    Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, and in Palo Alto and Redwood City, California.

    For more information, please visit www.ascendispharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our plans to submit our first Investigational New Drug application, or similar, in oncology later this year for TransCon TLR7/8 Agonist, followed by a planned filing for TransCon IL-2 β/γ in 2021, (ii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iii) our expectations regarding our ability to create potentially best-in-class therapies and (iv) our product pipeline. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of our oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of our oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; our ability to obtain additional funding, if needed, to support our business activities and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC on April 3, 2020. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.

    Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. ©June 2020 Ascendis Pharma A/S.

    Investor contact:
    Patti Bank
    Westwicke Partners
    (415) 513-1284
    
    
    
    Media contact:
    Ami Knoefler
    Ascendis Pharma
    (650) 739-9952
    

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