Catalyst Pharmaceuticals to Present at 15th Annual BIO Investor Forum
October 13 2016 - 8:03AM
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating diseases,
today announced that Patrick J. McEnany, Chief Executive Officer,
and Steven Miller, Ph.D., Chief Operating Officer and Chief
Scientific Officer, will present at the 15th Annual BIO Investor
Forum being held at the Westin St. Francis in San Francisco,
October 18-19.
The presentation is scheduled for Tuesday,
October 18th at 9:00 am (PDT). The presentation materials will be
posted at www.catalystpharma.com in the Investors section
under Events & Presentations.
About Catalyst
Pharmaceuticals
Catalyst Pharmaceuticals is a
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating diseases,
including Lambert-Eaton myasthenic syndrome (LEMS), congenital
myasthenic syndromes (CMS), infantile spasms, and Tourette's
Disorder. Firdapse® for the treatment of LEMS has received
Breakthrough Therapy Designation from the U.S. Food and Drug
Administration (FDA) and orphan drug designation for LEMS, CMS and
Mysthenia Gravis. Firdapse is the first and only approved drug
in Europe for symptomatic treatment in adults with
LEMS.
Catalyst is also developing CPP-115 to treat
infantile spasms, epilepsy and other neurological conditions
associated with reduced GABAergic signaling, like post-traumatic
stress disorder and Tourette's Disorder. CPP-115 has been
granted U.S. orphan drug designation for the treatment of
infantile spasms by the FDA and has been granted E.U.
orphan medicinal product designation for the treatment of West
Syndrome by the European Commission. In addition,
Catalyst is developing a generic version of Sabril®
(vigabatrin).
Forward-Looking Statements
This press release contains forward-looking
statements. Forward-looking statements involve known and unknown
risks and uncertainties, which may cause Catalyst's actual results
in future periods to differ materially from forecasted results. A
number of factors, including whether the receipt of
breakthrough therapy designation for Firdapse will
expedite the development and review of Firdapse by
the FDA or the likelihood that the product will be found
to be safe and effective, what study design for a second trial
evaluation of Firdapse for the treatment of LEMS will be acceptable
to the FDA, the timing of such trial, and whether it will be
successful, whether Catalyst’s assumptions in its updated business
plan will be accurate and the impact of unanticipated events or
delays in projected activities on Catalyst’s cash requirements and
on Catalyst’s ability to get to an accepted NDA submission for
Firdapse without the need for additional funding, what clinical
trials and studies will be required before Catalyst can resubmit an
NDA for Firdapse for the treatment of CMS and whether any such
required clinical trials and studies will be successful, whether
the investigator-sponsored study evaluating Firdapse for the
treatment of MuSK-MG will be successful, whether any NDA for
Firdapse resubmitted to the FDA will ever be accepted for filing,
the timing of any such NDA filing or acceptance, whether, if
an NDA for Firdapse is accepted for filing, such NDA will be given
a priority review by the FDA, whether Firdapse will ever be
approved for commercialization, whether Catalyst will be the first
company to receive approval for amifampridine (3,4-DAP), giving it
7-year marketing exclusivity for its product, whether CPP-115 will
be determined to be safe for humans, what additional testing will
be required before CPP-115 is “Phase 2 ready”, whether CPP-115 will
be determined to be effective for the treatment of infantile
spasms, post-traumatic stress disorder, Tourette's Disorder or any
other indications, whether Catalyst can successfully design and
complete a bioequivalence study of its version of vigabatrin
compared to Sabril that is acceptable to the FDA, whether any
such bioequivalence study the design of which is acceptable to
the FDA will be successful, whether any ANDA that
Catalyst submits for a generic version of Sabril will be accepted
for filing, whether any ANDA for Sabril accepted for filing by
the FDA will be approved (and the timing of any such
approval), whether any of Catalyst's product candidates will ever
be approved for commercialization or successfully commercialized,
and those other factors described in Catalyst's Annual Report on
Form 10-K for the fiscal year 2015 and its other filings with
the U.S. Securities and Exchange Commission (SEC), could
adversely affect Catalyst. Copies of Catalyst's filings with the
SEC are available from the SEC, may be found on
Catalyst's website, or may be obtained upon request from Catalyst.
Catalyst does not undertake any obligation to update the
information contained herein, which speaks only as of this
date.
Investor Contact
Brian Korb
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com
Media Contacts
David Schull
Matt Middleman, M.D.
Russo Partners
(212) 845-4271
(212) 845-4272
david.schull@russopartnersllc.com
matt.middleman@russopartnersllc.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
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