News

Arkayli Biopharma Inc. Receives Study May Proceed Response to IND from FDA and SBIR Grant from NIH to Advance Clinical Development of ARK001 for a Rare Pediatric Disease

October 6, 2026

  • Study May Proceed (SMP) letter is based on IND filing to conduct a Phase 1b Trial of ARK001 in Infants with Infantile Hemangioma (IH)

  • NIH SBIR grant of $2.98 Million acknowledges the high unmet need for a non-systemic treatment for IH

  • Appointment of new CEO, Katie MacFarlane, PharmD, to lead the company transition into clinical development

  • The company is launching a Series A financing round

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Arkayli Biopharma receives 2025 Innovation to Commercialization Pipeline (ICP) Program grant award

December, 2025

Forward Biolabs, in partnership with BioForward Wisconsin, recognized Arkayli as an awardee of the 2025 ICP Program to advance operations and strengthen the company’s position for future growth. The award will be used to advance the company’s lead program, ARK001, in development for infantile hemangioma.

Arkayli Biopharma awarded NIH STTR grant to advance its investigational agent, ARK001, for treatment of infantile hemangioma (IH)

May, 2025

Arkayli Biopharma has been awarded a Phase 1 Small Business Technology Transfer (STTR) grant by the National Institutes of Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Funds from the grant will be used to complete preclinical studies that will support the development of ARK001 for treatment of infantile hemangioma (IH). Specifically, Arkayli will perform in vitro experiments on an optimized formulation of ARK001 to demonstrate its effects on mechanisms of IH formation.

Additionally, Arkayli will conduct preclinical toxicology studies to support filing of an Investigational New Drug (IND) application with the Food and Drug Adminstration (FDA) to allow advancement of the development program into human subjects.

Arkayli named a winner of the Center for Advancing Innovation Children’s Health Challenge

July 26, 2022

The Center for Advancing Innovation selected 15+ start-up companies as winners in its open innovation contest, the Innovate Children’s Health Challenge (Read More)

Dr. Beth Drolet together with Arkayli Biopharma, Inc. awarded Wisconsin state funds for developing a new topical skin-based drug delivery system for treatment of hemangiomas

May 10, 2022

Emerging Technologies at UW—Madison gets a boost from state funds “Discovery to Product Awards”  to fund eight campus startups. Emerging technologies developed at UW—Madison will receive funding assistance as the result of an on-campus grant program administered by UW-Madison’s Discovery to Product (D2P) and a matching grant of $300,000 from the Wisconsin Economic Development Corporation (WEDC).. D2P’s annual State Economic Engagement and Development ...