Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism
15 May 2024 - 4:31AM
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S.
Food and Drug Administration (FDA) notified the Company that
information submitted in response to the FDA’s ongoing review of
the New Drug Application (NDA) for TransCon PTH
(palopegteriparatide) for adults with hypoparathyroidism
constituted a major amendment to the NDA. Accordingly, the FDA has
extended the PDUFA target action date by three months, to August
14, 2024, to provide time for a full review of the submission.
“We have responded to all requests received to date from FDA and
will work with the agency as they continue their review of our
NDA,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief
Executive Officer. “Adults with hypoparathyroidism in the United
States, who are receiving TransCon PTH in our clinical trials and
our Expanded Access Program (EAP) will continue to receive their
medication, and the EAP remains open for enrollment for eligible
patients. We remain committed to bringing TransCon PTH to adults
with hypoparathyroidism in the United States, who face an urgent
need for new treatments.”
About Ascendis Pharma A/S Ascendis 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 Europe and the United States. 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) the PDUFA date
for the NDA for TransCon PTH (palopegteriparatide) for adults with
hypoparathyroidism, (ii) Ascendis’ expectation that it will
continue to work with the FDA as the FDA continues its review of
the NDA for TransCon PTH, (iii) Ascendis’ clinical trials and EAP
involving eligible patients with hypoparathyroidism in the United
States, (iv) Ascendis’ commitment to bringing TransCon PTH to
adults with hypoparathyroidism in the United States, (v) Ascendis’
ability to apply its TransCon technology platform to build a
leading, fully integrated biopharma company and (vi) 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; and the impact of
international economic, political, legal, compliance, social and
business factors. 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 7, 2024 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. © May 2024 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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