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Acadia Pharmaceuticals Announces Exclusive License Agreement with Saniona for SAN711

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Acadia Pharmaceuticals (NASDAQ: ACAD) has secured an exclusive worldwide license agreement with Saniona for SAN711, a first-in-class GABAA-α3 positive allosteric modulator. The company plans to develop SAN711 for essential tremor treatment, with Phase 2 studies expected to begin in 2026. Under the agreement, Saniona will receive a $28 million upfront payment plus potential milestone payments up to $582 million and tiered royalties ranging from mid-single digits to low double digits on net sales. The milestone payments include up to $147 million for development achievements and up to $435 million tied to annual sales thresholds.

Acadia Pharmaceuticals (NASDAQ: ACAD) ha stretto un accordo di licenza esclusiva a livello mondiale con Saniona per SAN711, un modulator positivo allosterico GABAA-α3 di prima classe. L'azienda intende sviluppare SAN711 per il trattamento del tremore essenziale, con l'inizio degli studi di Fase 2 previsto per il 2026. Ai sensi dell'accordo, Saniona riceverà un pagamento iniziale di $28 milioni, oltre a potenziali pagamenti di traguardo fino a $582 milioni e royalties scalate che variano da cifre medio-basse a cifre basse-doppie sui ricavi netti. I pagamenti di traguardo includono fino a $147 milioni per risultati nello sviluppo e fino a $435 milioni legati a soglie di vendita annuali.

Acadia Pharmaceuticals (NASDAQ: ACAD) ha firmado un acuerdo de licencia mundial exclusivo con Saniona para SAN711, un modulador alostérico positivo GABAA-α3 de primera clase. La empresa planea desarrollar SAN711 para el tratamiento del temblor esencial, con estudios de Fase 2 que se espera comiencen en 2026. Según el acuerdo, Saniona recibirá un pago inicial de $28 millones más pagos por hitos potenciales que podrían alcanzar hasta $582 millones y regalías escalonadas que varían desde cifras bajas hasta cifras bajas dobles sobre las ventas netas. Los pagos por hitos incluyen hasta $147 millones por logros en el desarrollo y hasta $435 millones relacionados con umbrales de ventas anuales.

Acadia Pharmaceuticals (NASDAQ: ACAD)는 Saniona와 함께 SAN711에 대한 전 세계 독점 라이센스 계약을 체결했습니다. SAN711은 최초의 GABAA-α3 양성 알로스테릭 조절제입니다. 이 회사는 SAN711을 필수 떨림 치료를 위해 개발할 계획이며, 2026년부터 2상 연구가 시작될 것으로 예상하고 있습니다. 계약에 따라 Saniona는 2800만 달러의 선불 지급과 함께 최대 5억8200만 달러의 주요 지급액 및 순 판매에 대해 중간 단일 숫자에서 저단 가격까지의 단계적 로열티를 받을 것입니다. 주요 지급액에는 개발 성과에 대해 최대 1억4700만 달러가 포함되고 매년 판매 기준에 따라 최대 4억3500만 달러가 포함됩니다.

Acadia Pharmaceuticals (NASDAQ: ACAD) a conclu un accord de licence exclusif mondial avec Saniona pour SAN711, un modulateur allostérique positif GABAA-α3 de première classe. L'entreprise prévoit de développer SAN711 pour le traitement du tremblement essentiel, avec le début des études de Phase 2 prévu pour 2026. Dans le cadre de l'accord, Saniona recevra un paiement initial de 28 millions de dollars ainsi que des paiements d'étape potentiels pouvant atteindre 582 millions de dollars et des redevances échelonnées allant de chiffres à un chiffre moyen à des chiffres à deux chiffres bas sur les ventes nettes. Les paiements d'étape comprennent jusqu'à 147 millions de dollars pour les réalisations de développement et jusqu'à 435 millions de dollars liés à des seuils de vente annuels.

Acadia Pharmaceuticals (NASDAQ: ACAD) hat eine exklusive weltweite Lizenzvereinbarung mit Saniona für SAN711 gesichert, einen erstklassigen positiven allosterischen Modulator für GABAA-α3. Das Unternehmen plant, SAN711 zur Behandlung von essenziellem Tremor zu entwickeln, wobei die Phase-2-Studien voraussichtlich 2026 beginnen werden. Im Rahmen der Vereinbarung erhält Saniona eine einmalige Vorauszahlung von 28 Millionen US-Dollar sowie potenzielle Meilensteinzahlungen von bis zu 582 Millionen US-Dollar und gestaffelte Lizenzgebühren, die von mittleren einstelligen bis zu niedrigen zweistelligen Prozenten der Nettoumsätze reichen. Die Meilensteinzahlungen beinhalten bis zu 147 Millionen US-Dollar für Entwicklungsleistungen und bis zu 435 Millionen US-Dollar, die an jährliche Verkaufsziele gebunden sind.

Positive
  • Secured exclusive worldwide rights to a first-in-class drug candidate
  • Expanding pipeline in neurological disorders with unmet medical needs
  • Structured deal with milestone-based payments reducing upfront financial burden
Negative
  • Significant upfront payment of $28 million required
  • Phase 2 study not starting until 2026, indicating long development timeline
  • Substantial future payment obligations up to $582 million in milestones

Insights

This licensing deal represents a strategic expansion of ACAD's CNS portfolio, with a $28 million upfront payment and potential milestone payments up to $582 million. The deal structure, with tiered royalties of mid-single to low double digits, is industry-standard and balances risk-sharing. The long timeline to Phase 2 initiation (2026) suggests significant development work ahead, impacting near-term financials minimally but adding long-term potential.

Essential tremor represents an attractive market opportunity with innovation and competition. However, investors should note that clinical success is still uncertain given the early stage and significant R&D investment will be required before potential commercialization. The deal strengthens ACAD's CNS pipeline while maintaining financial flexibility through the milestone-based structure.

SAN711's mechanism as a selective GABAA-α3 positive allosteric modulator represents an innovative approach to treating essential tremor. The high selectivity could potentially offer better efficacy and safety compared to current treatments that often have broader mechanisms of action. Essential tremor affects approximately 4% of adults over 40, making it one of the most common neurological disorders.

The development timeline to 2026 for Phase 2 indicates thorough preclinical work and Phase 1 studies are planned. This methodical approach, while extending the development timeline, could optimize the probability of success. The compound's first-in-class status could provide significant competitive advantages if successful, though clinical validation remains pending.

- SAN711 is a first-in-class, highly selective GABAA-α3 positive allosteric modulator

- Targeting initiation of Phase 2 study of SAN711 for the treatment of essential tremor in 2026

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced it has entered into an exclusive worldwide license agreement with Saniona (OMX: SANION) for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. The first indication the Company plans to pursue is development of SAN711 for essential tremor, a neurological condition that includes shaking or trembling movements in one or more parts of the body. Acadia is planning to initiate a Phase 2 study of SAN711 in essential tremor in 2026.

"Licensing SAN711 to expand our pipeline underscores our unwavering commitment to delivering innovative therapies for patients with central nervous system disorders," said Catherine Owen Adams, Chief Executive Officer. "Essential tremor is a condition that has not seen innovation in treatment for decades, creating a compelling opportunity to address a long-overlooked need. Our work with SAN711 will draw on our deep expertise in developing and commercializing cutting-edge treatments for neurological disorders."

Under the terms of the License Agreement, Saniona will receive US $28 million upfront plus potential milestone payments of up to US $582 million. In addition, Saniona is eligible to receive tiered royalties of mid-single digits to low double digits on net sales of commercial products that may result from development of SAN711. The potential milestone payments to Saniona consist of up to US $147 million subject to achievement of development and commercial milestones related to potential first and second indications, and up to US $435 million subject to achievement of thresholds of annual net sales of SAN711 worldwide. Acadia will lead further clinical development, regulatory submissions, and global commercialization efforts for SAN711 while also providing financial support for Saniona’s ongoing Phase 1 study and preparations for Phase 2.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “intends,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i.) the timing of the commencement of a Phase 2 clinical trial evaluating SAN711; (ii.) the likelihood of success of such clinical trial; (iii.) the prospects for FDA approval of SAN711 for essential tremor; and (iv.) the success of any efforts to commercialize SAN711. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties, assumptions and other factors include, but are not limited to: the timing, enrollment and results of ongoing and future clinical trials and our ability to continue to stay in compliance with applicable laws and regulations. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the period ended September 30, 2024 filed with the Securities and Exchange Commission on November 7, 2024, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.

Investor Contact:

Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com

Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson

(818) 395-3043

media@acadia-pharm.com

Source: Acadia Pharmaceuticals Inc.

FAQ

What is the value of Acadia's (ACAD) licensing deal with Saniona for SAN711?

The deal includes a $28 million upfront payment plus potential milestone payments up to $582 million, and tiered royalties from mid-single digits to low double digits on net sales.

When will Acadia (ACAD) begin Phase 2 trials for SAN711 in essential tremor?

Acadia plans to initiate Phase 2 studies of SAN711 for essential tremor in 2026.

What condition will Acadia (ACAD) target with SAN711?

Acadia plans to develop SAN711 for essential tremor, a neurological condition causing shaking or trembling movements in one or more body parts.

Acadia Pharmaceuticals Inc.

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