Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA

Rhea-AI Summary

Theratechnologies (NASDAQ: THTX) announced that the FDA has set a PDUFA goal date of March 25, 2025 for its supplemental Biologics License Application for the F8 formulation of tesamorelin. If approved, the F8 formulation will replace the current F4 formulation (EGRIFTA SV®) in the U.S. market. The new formulation is protected by patent until 2033.

Positive

• Patent protection for new F8 formulation extends until 2033
• Potential replacement of current formulation with improved version pending FDA approval

Negative

• None.

Insights

Medical Research Analyst

The FDA's PDUFA date assignment for Theratechnologies' F8 formulation of tesamorelin represents a significant regulatory milestone. The F8 formulation, if approved, would replace the current EGRIFTA SV® (F4 formulation) with patent protection extending to 2033. This is particularly noteworthy as it would provide 10+ years of market exclusivity. The extension of patent protection through a new formulation is a common strategy in the pharmaceutical industry to maintain market position and protect revenue streams. However, the relatively distant PDUFA date of March 25, 2025 suggests a standard review timeline, indicating no breakthrough or priority review status was granted. The success of this regulatory filing is important for Theratechnologies' long-term market position in the lipodystrophy treatment space.

Financial Analyst

This regulatory update carries strategic importance for Theratechnologies' business continuity. The F8 formulation submission represents a calculated move to extend market protection and potentially improve their commercial position. With a market cap of $71.27M, securing extended patent protection until 2033 could significantly impact the company's valuation and future revenue potential. However, the 15-month review timeline suggests standard processing without any expedited considerations. While the news provides clarity on the regulatory timeline, the extended wait period and uncertainty around approval may create near-term pressure on the stock. Investors should note that this is primarily a defensive strategic move rather than an expansion into new markets or indications.

MONTREAL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental Biologics License Application for the F8 formulation of tesamorelin.

If approved by the FDA, the F8 formulation is intended to replace the F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV^®. The new formulation is patent protected in the U.S. until 2033.

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).

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: the time period related to the review of the sBLA by the FDA.. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the FDA will complete its review within the timelines set forth in the press release; (ii) the Company’s responses to the issues raised by the FDA in its Complete Response Letter (“CRL”) will be satisfactory to the FDA; (iii) the FDA will approve the sBLA for the F8 formulation; and (iv) if approved, health care providers and patients will adopt the F8 formulation. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) the review period of the sBLA which could be longer than the timelines set forth in this press release ;(ii) the non-approval of the sBLA by the FDA, or the issuance of another CRL; and (iii) the negative reception by the marketplace of the F8 formulation, if approved. The Company refers current and potential investors to the “Risk Factors” section of the Company’s annual information form filed under Form 20-F dated February 21, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date.

The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

Contacts:

Investor Inquiries:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
1-551-261-0401

Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800

FAQ

When is the PDUFA date for Theratechnologies' (THTX) tesamorelin F8 formulation?

The FDA has assigned a PDUFA goal date of March 25, 2025 for Theratechnologies' tesamorelin F8 formulation.

How long is the patent protection for Theratechnologies' (THTX) new F8 formulation?

The new F8 formulation is patent protected in the United States until 2033.

What will Theratechnologies' (THTX) F8 formulation replace if approved?

If approved by the FDA, the F8 formulation will replace the F4 formulation, which is currently sold in the U.S. under the trade name EGRIFTA SV®.