FDA Schedules Advisory Committee Meeting To Discuss Secondary Hypogonadism
September 26 2016 - 9:15AM
Repros Therapeutics Inc.® (Nasdaq:RPRX) today noted that it will
participate as a sponsor in a forthcoming public advisory committee
meeting of the Bone, Reproductive and Urologic Drugs Advisory
Committee recently announced by the Food and Drug Administration
(FDA). The general function of the committee is to provide advice
and recommendations to the FDA on the FDA's regulatory issues. The
meeting, to be held on December 6, 2016, from 8 a.m. to 5 p.m.,
will be open to the public.
The announced agenda follows:
“Agenda: The committee will discuss appropriate clinical trial
design features, including acceptable endpoints for demonstrating
clinical benefit, for drugs intended to treat secondary
hypogonadism while preserving or improving testicular function,
including spermatogenesis.”
Parties interested in obtaining additional information should
reference the appropriate government website.
About Repros Therapeutics
Inc.®
Repros Therapeutics focuses on the development
of small molecule drugs for major unmet medical needs that treat
male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not
historical facts contained in this release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are subject to various risks, uncertainties
and other factors that could cause the Company’s actual results,
performance or achievements to differ materially from those
expressed or implied by such forward-looking statements. These
statements often include words such as “may,” “will,” “expect,”
“anticipate,” “continue,” “estimate,” “project,” “intend,”
“believe,” “plan,” “seek,” “could,” “can,” “should” or similar
expressions. These statements are based on assumptions that the
Company has made in light of the Company’s experience in the
industry, as well as the Company’s perceptions of historical
trends, current conditions, expected future developments and other
factors the Company believes are appropriate in these
circumstances. Forward-looking statements include, but are not
limited to, those relating to the timing and nature of the results
of clinical studies and the impact of such results. Such statements
are based on current expectations that involve a number of known
and unknown risks, uncertainties and other factors that may cause
actual events to be materially different from those expressed or
implied by such forward-looking statements, including risks that
additional phases of clinical studies may not be successfully
undertaken or completed, that the FDA may not ultimately approve
the product candidate, the risk that any marketing approvals, if
granted, may have significant limitations on use, that even if an
NDA is approved, the Company may not be able to successfully
commercialize the product candidate, risks relating to the
Company's ability to protect its intellectual property rights and
such other risks as are identified in the Company's most recent
Annual Report on Form 10-K and in any subsequent quarterly reports
on Form 10-Q. These documents are available on request from Repros
Therapeutics or at www.sec.gov. Repros disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
For more information, please visit the Company’s
website at http://www.reprosrx.com.
CONTACT:
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com
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