23:55:18 EDT Tue 15 Jul 2025
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Theratechnologies Inc (2)
Symbol TH
Shares Issued 45,980,019
Close 2025-04-08 C$ 2.21
Market Cap C$ 101,615,842
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Theratechnologies gets U.S. FDA OK for Egrifta SV PAS

2025-04-08 16:37 ET - News Release

Mr. Paul Levesque reports

THERATECHNOLOGIES RECEIVES FDA APPROVAL OF PRIOR APPROVAL SUPPLEMENT (PAS) FOR EGRIFTA SV SBLA

The U.S. Food and Drug Administration (FDA) has approved Theratechnologies Inc.'s prior approval supplement (PAS) to the supplemental biologics licence application (sBLA) for Egrifta SV (tesamorelin for injection). Tesamorelin for injection is the only treatment approved in the United States to reduce excess abdominal fat in adults with HIV and lipodystrophy.

Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing Theratechnologies to resume regular distribution of Egrifta SV. The FDA also recently approved the new F8 formulation of tesamorelin for injection, which is set to replace Egrifta SV and will be marketed in the United States as Egrifta WR.

"Securing FDA approval of the prior approval supplement for the Egrifta SV sBLA closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions," said Paul Levesque, president and chief executive officer of Theratechnologies. "Now that we have also obtained approval of Egrifta WR, we look forward to transitioning patients to this more convenient formulation, which we have designed to improve the patient experience."

About Theratechnologies Inc.

Theratechnologies is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care.

We seek Safe Harbor.

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