FDA Extends PDUFA Date for SomatoKine to October 03, 2005
10 Juin 2005 - 1:14PM
Business Wire
Insmed Incorporated (NASDAQ: INSM) today announced that it has
received notification from the United States Food and Drug
Administration (FDA) that the agency expects to complete the
priority review of SomatoKine(R) on or before October 03, 2005,
which is a three month extension from the original user fee goal
date. The extension is a result of the agency classifying responses
to questions about the NDA as a major amendment to the NDA. The
agency has reset the user fee goal date to give it additional time
to review the information contained in the Company's response. "We
welcomed the opportunity to address questions the FDA had regarding
our NDA," said Geoffrey Allen, President and CEO of Insmed. "The
Company has not been notified of any specific deficiencies and we
believe we have thoroughly and comprehensively addressed all of
their questions. We remain confident that SomatoKine will become an
important therapy for the treatment of growth hormone insensitivity
syndrome (GHIS). About Insmed Incorporated Insmed is a
biopharmaceutical company focused on the discovery and development
of drug candidates for the treatment of metabolic diseases and
endocrine disorders with unmet medical needs. For more information,
please visit www.insmed.com. Statements included within this press
release, which are not historical in nature, may constitute
forward-looking statements for purposes of the safe harbor provided
by the Private Securities Litigation Reform Act of 1995.
Forward-looking statements in this press release include, but are
not limited to, statements regarding planned clinical trial design,
our regulatory and business strategies, plans and objectives of
management and growth opportunities for existing or proposed
products. Such forward-looking statements are subject to numerous
risks and uncertainties, including risks that product candidates
may fail in the clinic or may not be successfully marketed or
manufactured, the company may lack financial resources to complete
development of product candidates, the FDA may interpret the
results of our studies differently than we have, competing products
may be more successful, demand for new pharmaceutical products may
decrease, the biopharmaceutical industry may experience negative
market trends and other risks detailed from time to time in the
company's filings with the Securities and Exchange Commission. As a
result of these and other risks and uncertainties, actual results
may differ materially from those described in this press release.
For further information with respect to factors that could cause
actual results to differ from expectations, reference is made to
reports filed by the Company with the Securities and Exchange
Commission under the Securities Exchange Act of 1934, as amended.
The forward-looking statements made in this release are made only
as of the date hereof and Insmed disclaims any intention or
responsibility for updating predictions or financial guidance
contained in this release.
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024