Arkayli Biopharma has received FDA's 'Study May Proceed' response for its IND application and a $2.98 million SBIR grant from NIH to advance ARK001 for infantile hemangioma. The company is set to initiate a Phase 1B clinical trial to evaluate the safety of this non-systemic treatment.
NIH SBIR grant of $2.98 Million ... 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 · MADISON, Wis., Oct. 6, 2026 /PRNewswire/ -- Arkayli BioPharma Inc. ("Arkayli"), a biopharmaceutical company dedicated to developing innovative therapies for rare dermatologic ... 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 · MADISON, Wis., Oct. 6, 2026 /PRNewswire/ -- Arkayli BioPharma Inc. ("Arkayli"), a biopharmaceutical company dedicated to developing innovative therapies for rare dermatologic conditions, today announced that the U.S. The company is preparing to initiate a Phase 1B clinical trial evaluating the safety of ARK001 in infants diagnosed with proliferating infantile hemangioma (IH). In addition, exploratory measures of effect will be assessed as part of the study. Arkayli believes that ARK001 has the potential for improved treatment of IH, through the topical, non-systemic treatment of this disfiguring skin disease. There is a high unmet market need for a safe, effective, topically applied therapy that can be used early in diagnosis and prescribed by pediatricians and dermatologists. ... This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve inherent risks and uncertainties, including statements regarding the timing and success of the proposed Phase 1b clinical trial, the ability to secure Series A financing, and regulatory pathways. "ARK001 is designed to address critical unmet needs in this vulnerable patient population, potentially offering a topical approach to treatment of this rare pediatric disease. With the NIH grant, we are focused on preparing for the Phase 1b trial, and we also are looking to accelerate our pipeline development through a Series A financing round."
Original title: “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 - BioSpace”