Theratechnologies Resumes Distribution of EGRIFTA SV®
Theratechnologies (NASDAQ: THTX) has announced the resumption of EGRIFTA SV® distribution following FDA approval to release two recently manufactured batches. The treatment, exclusively distributed in the United States, is now ready for immediate shipment to network pharmacies.
The FDA's review of the Company's Prior Approval Supplement continues with an action goal date of April 18, 2025. EGRIFTA SV® (tesamorelin for injection) is designed for people with HIV, representing an important treatment option for this patient population.
Theratechnologies (NASDAQ: THTX) ha annunciato la ripresa della distribuzione di EGRIFTA SV® dopo l'approvazione della FDA per il rilascio di due lotti recentemente prodotti. Il trattamento, distribuito esclusivamente negli Stati Uniti, è ora pronto per la spedizione immediata alle farmacie della rete.
La revisione da parte della FDA del Supplemento di Approvazione Precedente dell'azienda continua con una data obiettivo per l'azione fissata per il 18 aprile 2025. EGRIFTA SV® (tesamorelin per iniezione) è progettato per le persone con HIV, rappresentando un'importante opzione terapeutica per questa popolazione di pazienti.
Theratechnologies (NASDAQ: THTX) ha anunciado la reanudación de la distribución de EGRIFTA SV® tras la aprobación de la FDA para liberar dos lotes recientemente fabricados. El tratamiento, distribuido exclusivamente en los Estados Unidos, está ahora listo para el envío inmediato a las farmacias de la red.
La revisión de la FDA del Suplemento de Aprobación Previa de la Compañía continúa con una fecha objetivo de acción del 18 de abril de 2025. EGRIFTA SV® (tesamorelin para inyección) está diseñado para personas con VIH, representando una opción de tratamiento importante para esta población de pacientes.
Theratechnologies (NASDAQ: THTX)는 FDA의 승인을 받아 최근 제조된 두 배치의 배포를 재개한다고 발표했습니다. 이 치료법은 미국에서만 독점적으로 배포되며, 현재 네트워크 약국으로 즉시 배송할 준비가 되어 있습니다.
FDA의 회사 사전 승인 보충에 대한 검토는 2025년 4월 18일의 목표 날짜로 계속 진행되고 있습니다. EGRIFTA SV® (주사용 테사모렐린)는 HIV를 가진 사람들을 위해 설계되었으며, 이 환자 집단을 위한 중요한 치료 옵션을 제공합니다.
Theratechnologies (NASDAQ: THTX) a annoncé la reprise de la distribution de EGRIFTA SV® suite à l'approbation de la FDA pour la libération de deux lots récemment fabriqués. Le traitement, distribué exclusivement aux États-Unis, est maintenant prêt pour un expédition immédiate vers les pharmacies du réseau.
La révision de la FDA du supplément d'approbation préalable de l'entreprise se poursuit avec une date cible d'action fixée au 18 avril 2025. EGRIFTA SV® (tesamorelin injectable) est conçu pour les personnes vivant avec le VIH, représentant une option de traitement importante pour cette population de patients.
Theratechnologies (NASDAQ: THTX) hat die Wiederaufnahme der Verteilung von EGRIFTA SV® nach der Genehmigung durch die FDA zur Freigabe von zwei kürzlich hergestellten Chargen angekündigt. Die Behandlung, die ausschließlich in den Vereinigten Staaten vertrieben wird, ist nun bereit für den sofortigen Versand an Netzwerkapotheken.
Die Überprüfung der FDA des Unternehmensbezogenen Vorabgenehmigungsantrags geht weiter, mit einem Zieltermin für die Maßnahme am 18. April 2025. EGRIFTA SV® (Tesamorelin zur Injektion) ist für Menschen mit HIV konzipiert und stellt eine wichtige Behandlungsoption für diese Patientengruppe dar.
- Immediate resumption of EGRIFTA SV® distribution
- FDA approval for release of two new product batches
- Product ready for immediate distribution to pharmacies
- FDA's Prior Approval Supplement still pending final review
- Distribution to US market only
Insights
The FDA's authorization to resume EGRIFTA SV® distribution marks a crucial operational recovery for Theratechnologies, addressing a significant business risk that had been impacting their revenue stream. EGRIFTA SV®, as a specialized treatment for HIV-related lipodystrophy, represents a key product in the company's portfolio.
The immediate availability for shipment to network pharmacies is particularly significant as it helps minimize further revenue disruption and maintains market continuity. The timing is strategic, allowing the company to restore distribution while the broader Prior Approval Supplement review continues through April 2025.
From a business perspective, this development carries several important implications:
- The release of two manufactured batches suggests a calculated approach to inventory management, balancing immediate market needs while awaiting the complete regulatory review
- The U.S.-exclusive distribution model highlights the importance of maintaining consistent supply in this key market
- The restoration of distribution before the April 18 review date provides a important buffer period for the company to stabilize its market position
The rapid regulatory resolution and immediate availability for shipment indicates effective regulatory compliance and manufacturing readiness, which are essential factors for maintaining market confidence in specialty pharmaceutical companies. This development should help stabilize the company's near-term financial outlook, though investors should monitor the upcoming April FDA review as a key catalyst for long-term performance.
MONTREAL, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the Company to release two recently manufactured batches of EGRIFTA SV®. The product is ready for immediate shipment to network pharmacies.
“We remain committed to providing EGRIFTA SV® to people with HIV and we truly appreciate the FDA’s collaboration to get the treatment back to the patients who rely on it,” said Christian Marsolais, PhD, Senior Vice President and Chief Medical Officer at Theratechnologies.
Review of the Company’s Prior Approval Supplement by the FDA is ongoing with an action goal date of April 18, 2025.
EGRIFTA SV® is distributed in the United States only.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. 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.
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: (i) the review of the Prior Approval Supplement (PAS) within the timelines announced herein; and (ii) the provision of EGRIFTA SV® to people with HIV. 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 PAS will be approved by the FDA; (ii) the review of the PAS will be completed within the timelines disclosed herein; (iii) current market demand for EGRIFTA SV® has not been adversely impacted by the drug shortage; and (iv) the Company’s third party manufacturer will be able to continue the manufacture of EGRIFTA SV® to meet patients demand . 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) FDA’s review of the PAS not being completed by April 18, 2025; (ii) non-approval of the PAS; (iii) issuance of questions as part of the PAS review by the FDA resulting in delays in completing the PAS review and resulting in delays beyond April 18, 2025, to release additional batches of EGRIFTA SV®, if need be; (iv) issuance of a complete response letter following the filing of the PAS as a result of the manufacturing site being classified as Official Action Indicated preventing the Company from releasing additional batches of EGRIFTA SV®, unless new authorizations similar to the one announced herein are obtained from the FDA; and (v) a decrease in demand for EGRIFTA SV® due to the recent shortage adversely impacting the resumption of the commercialization of EGRIFTA SV®;. The Company refers current and potential investors to the “Risk Factors” section of the Company’s 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:
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor inquiries:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
1-551-261-0401
FAQ
When did Theratechnologies (THTX) resume EGRIFTA SV distribution?
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Is EGRIFTA SV available outside the United States?
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