FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism
11 Décembre 2023 - 2:30PM
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. In the United States, TransCon
PTH (palopegteriparatide) is an investigational prodrug of
parathyroid hormone (PTH [1-34]) for adult patients with
hypoparathyroidism.
“We are pleased that the FDA can continue its review of TransCon
PTH and look forward to working with the agency during its review,”
said Jan Mikkelsen, President and CEO at Ascendis Pharma. “Given
the significant unmet needs of the hypoparathyroidism community, we
remain committed to making TransCon PTH available for U.S. patients
as rapidly as possible.”
About Ascendis Pharma A/SAscendis Pharma is
applying its innovative TransCon technology platform 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, Ascendis uses its TransCon
technologies to create new and potentially best-in-class therapies.
Ascendis is headquartered in Copenhagen, Denmark and has additional
facilities in Germany (Heidelberg and Munich) and the United States
(Palo Alto and Redwood City, California, and Princeton, New
Jersey). Please visit ascendispharma.com to learn more.
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) Ascendis’ plan
to work with the FDA during its review of TransCon PTH, (ii) the
PDUFA goal date of May 14, 2024, (iii) Ascendis’ ability to make
TransCon PTH available for U.S. patients as rapidly as possible,
(iv) Ascendis’ ability to apply its platform technology to build a
leading, fully integrated global biopharma company, and (v)
Ascendis’ use of 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: dependence on third party manufacturers,
distributors and service providers for Ascendis’ products and
product candidates; unforeseen safety or efficacy results in
Ascendis’ development programs or on-market products; unforeseen
expenses related to commercialization of any approved Ascendis
products; unforeseen expenses related to Ascendis’ development
programs; unforeseen selling, general and administrative expenses,
other research and development expenses and Ascendis’ business
generally; delays in the development of its programs related to
manufacturing, regulatory requirements, speed of patient
recruitment or other unforeseen delays; Ascendis’ ability to obtain
additional funding, if needed, to support its business activities;
the impact of international economic, political, legal, compliance,
social and business factors, including inflation, the effects on
its business from the worldwide COVID-19 pandemic and ongoing
conflicts such as that in the region surrounding Ukraine and
Russia. 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 Ascendis’ Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission (SEC)
on February 16, 2023 and Ascendis’ other future reports filed with,
or submitted to, the SEC. Forward-looking statements do not reflect
the potential impact of any future 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. © December 2023 Ascendis Pharma A/S.
Investor Contacts: |
Media
Contact: |
Tim Lee |
Melinda Baker |
Ascendis Pharma |
Ascendis Pharma |
+1 (650) 374-6343 |
+1 (650) 709-8875 |
tle@ascendispharma.com |
media@ascendispharma.com |
ir@ascendispharma.com |
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Patti Bank |
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ICR Westwicke |
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+1 (415) 513-1284 |
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patti.bank@westwicke.com |
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