Arkayli Biopharma, a biopharmaceutical company developing innovative therapies for rare dermatologic conditions, announced today that it has received a Study May Proceed (SMP) letter from the U.S. Food and Drug Administration (FDA) for its lead investigational product candidate, ARK001.

The biotech company also received a $2.98 million Small Business Innovative Research (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health.

“The Study May Proceed response to our IND from the FDA represents a key regulatory milestone for Arkayli and a significant step forward for babies and families affected by infantile hemangioma,” Arkayli Biopharma CEO Katie MacFarlane said in a statement. “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.”

The SMP letter is based on an Investigational New Drug (IND) filing to conduct a Phase 1b Trial of ARK001 in infants with Infantile Hemangioma (IH).

The company, which received a D2P SEED Program grant in 2022, is now actively raising a Series A financing round.