Insmed Submits Response to FDA Approvable Letter for iPlex
17 Octobre 2005 - 11:00PM
PR Newswire (US)
RICHMOND, Va., Oct. 17 /PRNewswire-FirstCall/ -- Insmed
Incorporated (NASDAQ:INSM) announced today that it has submitted
its response to the Approvable Letter received from United States
Food and Drug Administration (FDA) for iPlex(TM)
(rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of
children with growth failure who suffer from Severe Primary IGF-1
deficiency (Primary IGFD). In September 2005, the FDA issued an
Approvable Letter indicating that the FDA has completed the review
of the iPlex NDA and has found the application to be sufficiently
complete for full approval pending the submission of additional
information primarily regarding the Chemistry, Manufacturing and
Controls (CMC) section of the application. The Company believes
that its response addresses all issues noted in the Approvable
Letter. FDA is not requiring the Company to conduct additional
preclinical or clinical trials. The Company looks forward to
working with the Agency as they continue the evaluation of the
iPlex New Drug Application (NDA). 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 http://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.
DATASOURCE: Insmed Incorporated CONTACT: Baxter Phillips, III of
Insmed Incorporated, +1-804-565-3041, Fax: +1-804-565-3510, Web
site: http://www.insmed.com/
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