Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
January 23 2024 - 6:30AM
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, has
received correspondence from the U.S. Food and Drug Administration
(FDA) regarding the Company’s supplemental Biologics License
Application (sBLA) for the F8 formulation of tesamorelin. The FDA
has notified the Company that it is continuing its review of the
application beyond the Prescription Drug User Fee Act (PDUFA) goal
date of January 22, 2024. Further information will be
provided in due course.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies addressing unmet medical
needs. Further information about Theratechnologies is available on
the Company's website at www.theratech.com, on SEDAR+
at www.sedarplus.ca and on EDGAR at www.sec.gov.
Follow Theratechnologies on Linkedin and X (formerly
Twitter).
Contacts:
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.comInvestor Inquiries:Philippe
DubucSenior Vice President and Chief Financial
Officerpdubuc@theratech.com438-315-6608
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