MONTREAL, Jan. 09, 2025 (GLOBE NEWSWIRE) — Theratechnologies (NASDAQ:) Inc. (Theratechnologies or the Firm) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical firm centered on the event and commercialization of modern therapies, as we speak introduced {that a} scarcity of EGRIFTA SV ® (tesamorelin for injection) will happen on the affected person degree in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. Whereas the Firm is conscious of remaining stock of EGRIFTA SV ® in sure pharmacies all through america, a number of pharmacies have reported stockouts.
Theratechnologies filed a required Prior Approval Complement (PAS) to the U.S. Meals and Drug Administration (FDA) on December 18, 2024. The Firm subsequently submitted questions as a part of a Kind D assembly request regarding the standing of two just lately manufactured batches of EGRIFTA SV ®, that are ready to be launched to pharmacies. The FDA confirmed that it could reply to the Firm’s questions in writing no later than February 8, 2025.
We stay dedicated to individuals with HIV who depend on EGRIFTA SV ®, as it’s the solely FDA-approved medication of its variety, and we’ll proceed to work with the FDA to expedite the discharge of the brand new batches for sufferers, mentioned Christian Marsolais, Ph.D., Senior Vice President and Chief Medical (TASE:) Officer at Theratechnologies.
The Firm will replace the market on any additional materials developments.
EGRIFTA SV ® is distributed in america solely.
About Theratechnologies
Ahead-Wanting Info
This press launch comprises forward-looking statements and forward-looking info (collectively, the Ahead-Wanting Statements) inside the that means of relevant securities legal guidelines, which are based mostly on administration’s beliefs and assumptions and on info presently accessible to it. You possibly can establish forward-looking statements by phrases similar to might, will, ought to, may, promising, would, outlook, consider, plan, envisage, anticipate, count on and estimate, or the negatives of those phrases, or variations of them.
The Ahead-Wanting Statements contained on this press launch embrace, however usually are not restricted to, statements concerning: (i) the time interval associated to the provision of EGRIFTA SV ® to sufferers; (ii) the date by which the FDA will reply to the Firm’s questions following its request to have a Kind D assembly; and (iii) the timelines associated to the potential launch of the just lately manufactured batches of EGRIFTA SV ®. Though the Ahead-Wanting Statements contained on this press launch are based mostly upon what the Firm believes are affordable assumptions in gentle of the knowledge presently accessible, traders are cautioned in opposition to putting undue reliance on these statements since precise outcomes might fluctuate from the Ahead-Wanting Statements contained on this press launch. Sure assumptions made in getting ready the Ahead-Wanting Statements embrace that: (i) the FDA will present solutions to the questions requested by the Firm by February 8, 2025; (ii) the responses to the questions requested by the Firm will verify that the Firm is ready to launch the just lately manufactured batches of EGRIFTA SV ® or will verify that the evaluate of the PAS will likely be accomplished previous to the expiry of a four-month interval; (iii) present market demand for EGRIFTA SV ® will stay unaffected; (iv) the scarcity of EGRIFTA SV ® is not going to adversely influence the monetary situations of the Firm; and (v) the Firm will be capable to negotiate waivers of defaults with its secured collectors to the extent the drug scarcity interval leads to defaults underneath its credit score agreements. Ahead-Wanting Statements assumptions are topic to a variety of dangers and uncertainties, lots of that are past the Firm’s management, that would trigger precise outcomes to vary materially from these which are disclosed in or implied by such Ahead-Wanting Statements. These dangers and uncertainties embrace, however usually are not restricted to: (i) delays in responding to the Firm’s questions past February 8, 2025; (ii) refusal by the FDA to launch the just lately manufactured batches of EGRIFTA SV ® till the PAS evaluate is accomplished; (iii) FDA’s evaluate of the PAS not being accomplished earlier than April 18, 2025; (iv) non-approval of the PAS; (v) issuance of questions as a part of the PAS evaluate by the FDA leading to delays in finishing the PAS evaluate and leading to delays past April 18, 2025 to launch the just lately manufactured batches of EGRIFTA SV ®; (vi) issuance of an entire response letter following the submitting of the PAS on account of the manufacturing web site being labeled as Official Motion (WA:) Indicated stopping the Firm from releasing the just lately manufactured batches of EGRIFTA SV ®; (vii) a lower in demand for EGRIFTA SV ® resulting from its scarcity doubtlessly adversely impacting the resumption of the commercialization of EGRIFTA SV ®; (viii) losses of key staff because of the scarcity; and (ix) defaults underneath the covenants of the credit score agreements ensuing from the scarcity. The Firm refers present and potential traders to the Danger Components part of the Firm’s Type 20-F dated February 21, 2024 accessible on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov underneath Theratechnologies’ public filings. The reader is cautioned to think about these and different dangers and uncertainties fastidiously and to not put undue reliance on forward-looking statements. Ahead-Wanting Statements replicate present expectations concerning future occasions and converse solely as of the date of this press launch and signify the Firm’s expectations as of that date.
The Firm undertakes no obligation to replace or revise the knowledge contained on this press launch, whether or not on account of new info, future occasions or circumstances or in any other case, besides as could also be required by relevant regulation.
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