Astrogen

Astrogen and Cigalah Sign Exclusive MENA Partnership for AST-001 in a Deal Valued at up to USD 209 Million Plus Royalties

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DATE CREATED	2026-01-02	HIT	164
- AST-001 is currently under review by the Korea MFDS for the treatment of core symptoms of Autism Spectrum Disorder (ASD), and has been granted Orphan Drug Designation - Agreement includes technology transfer and commercialization rights for AST-001 across the MENA region - Cigalah to pay Astrogen up to USD 77.5 million in regulatory and commercial milestones, in addition to tiered royalties of up to the double digit - Partnership accelerates the commercialization of a first-in-class therapy targeting core symptoms of ASD DAEGU, South Korea – January 2, 2026 – Astrogen, inc. (“Astrogen”) today announced that it has entered into an exclusive agreement for the technology transfer and commercialization of AST-001 with Cigalah Medpharm, part of Cigalah Group. AST-001 is Astrogen’s lead therapeutic candidate specifically developed to treat the core symptoms of Autism Spectrum Disorder (ASD). The partnership spans 16 countries across the Middle East and North Africa (MENA) region, including key markets such as the Kingdom of Saudi Arabia (KSA), the United Arab Emirates (UAE), and Egypt. Under the terms of the agreement, Astrogen will supply AST-001 valued at USD 131 million, and is eligible to receive up to USD 77.5 million in regulatory and commercial milestone payments, in addition to double digits tiered royalties on net sales of AST-001. Initial sales to begin through named patient basis in select markets to enable early access for patients, followed by a full commercial launch upon completion of technology transfer, regulatory approvals, and pricing agreements. A key component of the partnership is the commitment to localizing pharmaceutical manufacturing within the region. Astrogen will proceed with technology transfer to Alpha Pharma, Cigalah’s manufacturing arm located in King Abdullah Economic City, KSA. This initiative aligns with Saudi Vision 2030, which emphasizes strengthening domestic pharmaceutical production, improving patient access, and enhancing supply-chain resilience for high-value CNS therapies. “We are thrilled to partner with Cigalah, a proven leader in the MENA pharmaceutical market with deep regulatory expertise and robust commercial infrastructure,” said Dr. Su-Kyeong Hwang, CEO of Astrogen, inc. “This agreement is a transformative milestone in Astrogen’s global expansion strategy. By leveraging Cigalah’s regional capabilities and expertise in local manufacturing, we aim to accelerate the availability of AST-001 to families in the MENA region who urgently need effective treatment options for ASD.” Mr. Yaser Naghi, Chairman and CEO of Cigalah Group, commented: “Cigalah is committed to bringing innovative, life-changing therapies to patients across the MENA region. ASD remains an area with significant unmet medical need, and Astrogen’s AST-001 represents a promising advancement in this field. This partnership not only enables us to deliver an important new therapeutic option, but also further strengthens our local manufacturing ecosystem through Alpha Pharma. We look forward to a long and impactful collaboration.” About AST-001 AST-001 is an investigational drug candidate currently under NDA review by South Korea MFDS for the treatment of core symptoms of ASD in pediatric patients. The drug utilizes a proprietary oral syrup formulation designed to cross the blood–brain barrier and distributes to the brain. Its mechanism of action targets small conductance calcium-activated potassium (SK) channels, modulating dopaminergic signaling and restoring the excitation/inhibition (E/I) balance—one of the key pathophysiological features of ASD. AST-001 has demonstrated favorable tolerability, with clinical exposure in more than 400 subjects across clinical trials conducted in South Korea. Additionally, AST-001 has been granted Orphan Drug Designation (ODD) at the development stage in South Korea and becoming the 51st substance to receive this designation. Astrogen is actively preparing for regulatory interactions with the U.S. FDA, the EMA, and China’s NMPA to advance global development. About Autism Spectrum Disorder (ASD) ASD is a complex neurodevelopmental disorder characterized by persistent deficits in social communication and interaction, accompanied by restricted and repetitive behaviors. Its etiology is multifactorial, involving genetic, environmental, and prenatal factors. Once considered rare, ASD prevalence has risen significantly over recent decades due to improved diagnostic awareness and potential true increases in incidence. Today, more than 61 million individuals worldwide are estimated to live with ASD. The disorder affects adaptive functioning, communication, daily living, and social interaction, placing a significant burden on families and healthcare systems. Effective therapeutic options remain limited, underscoring the substantial unmet need. South Korea, in particular, is facing a severe ASD crisis, with data showing the shortest average life expectancy for individuals with ASD among developed nations. Average age at death for persons with ASD in South Korea is only 16.6–28.2 years, significantly below peer countries such as the U.S. (36.2–39.4), Denmark (33.3), Australia (35.3), Canada (46.2), and Sweden (53.8). Currently, there is no approved pharmacological treatment for children under five, despite early childhood being a critical period for brain plasticity. The treatment gap—with currently approved therapies limited to addressing irritability or aggression but not the core symptoms of ASD—has been associated with long-term disability, premature mortality, and in extreme cases, parent–child tragedy. About Astrogen, inc. Astrogen is a clinical-stage pharmaceutical company dedicated to developing innovative therapies for rare diseases and neurological disorders. In addition to AST-001, the company is advancing a pipeline that includes: AST-004 for Rett Syndrome, a rare neurodevelopment disorder with prevalence of about 1 in 10,000 to 15,000 live female births; AST-031, a selective norepinephrine reuptake inhibitor for Attention-Deficit/Hyperactivity Disorder (ADHD), which affects more than 300 million individuals globally; and AST-035, a small-molecule molecular glue degrader targeting glioma. For more information, visit the company’s website at www.astrogen.co.kr. About Cigalah Medpharm Trading LLC Founded in 2015 in the UAE, Cigalah Medpharm is Part of Cigalah Group, established in the late 1980s under Yousuf M.A. Naghi & Sons Group. Cigalah Group is one of the largest healthcare and consumer product distributors in the Middle East and is recognized as the No. 1 pharmaceutical distributor in Saudi Arabia in terms of registered SKUs with the SFDA. The Group represents multiple multinational pharmaceutical companies and maintains a strong presence across the GCC and broader MENA region. For more information, visit the company’s website at www.cigalah.com.