The program is reserved for companies with a proven track record of high-quality, GMP-compliant operations, offering prioritized inspections and regulatory transparency. For Aptahem, participation means:

• Faster regulatory pathway for production of Apta-1, our breakthrough RNA aptamer for severe inflammatory conditions.
• Enhanced confidence from partners and investors, demonstrating the company’s commitment to top-tier quality and innovation.
• Clear quality milestone reducing risks and timelines, supporting future clinical and commercial expansion.

Strategic Value for Investors

Through the PreCheck program, Aptahem signals not only that it develops groundbreaking therapies, but also that it has the processes and quality systems in place to realize their full potential – a strong marker of competence and long-term value creation.

CEO Mikael Lindstam comments

"Applying to FDA PreCheck is a natural next step for Aptahem. It demonstrates our dedication to the highest standards and our ability to deliver innovative therapies quickly and safely."

Read more about the program here: https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing

For further information:

Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com

About Aptahem

Aptahem AB (APTA) is a clinical stage biotechnology company that develops RNA-based pharmaceuticals for the treatment of acute, life-threatening conditions in which a combination of coagulation, inflammation and tissue damage are involved. The company’s lead candidate, Apta-1, is currently in early clinical phase. Apta-1 has in preclinical studies, by its anti-thrombotic, immunomodulating and tissue repairing characteristics, shown very positive and promising results as treatment for sepsis and critical conditions associated with sepsis. For more information, please visit www.aptahem.com.