Endovia Health Sciences (EDVA) and Lupvindol BioSciences announced an FDA minor-use determination making CannEpil eligible to pursue conditional approval for canine bone-cancer pain. The investigational CBD and THC oral solution will retain minor-use status through approval of the applicable New Animal Drug Application. Conditional approval requires safety and manufacturing standards and a reasonable expectation of effectiveness, with additional effectiveness data collected afterward for full approval.
The companies will meet with the FDA on November 19, 2026 to discuss studies, manufacturing requirements and regulatory submissions. They are sourcing and finalizing U.S. manufacturing capabilities. Endovia anticipates a potential 2027 veterinary launch, subject to FDA review, regulatory requirements and manufacturing readiness. CannEpil has not received FDA approval or conditional approval.
Endovia Health Sciences (EDVA) closed the initial funding tranche from C/M Capital Master Fund, linked to its exclusive global licensing agreement for CannEpil with Argent BioPharma, to advance CannEpil’s development and commercialization.
The capital will support Endovia’s FDA-regulated veterinary development program and international commercialization initiatives for CannEpil, initially pursued for management of cancer-related pain in companion animals, beginning with canine oncology in partnership with Lupvindol Biosciences. Endovia is also evaluating additional cannabinoid formulations and intellectual property for potential licensing, acquisition or collaboration.
The company highlights a favorable U.S. policy backdrop, including a new FDA initiative on botanical drug development and proposed federal legislation, H.R. 10150, which would provide qualifying FDA‑approved botanical drugs with 12 years of market exclusivity if enacted.
Endovia Health Sciences (NYSE American: EDVA) welcomes recent federal steps supporting the proposed rescheduling of marijuana from Schedule I to Schedule III, viewing this as an important evolution in U.S. cannabinoid policy and a potential catalyst for research, pharmaceutical development and state‑regulated medical cannabis markets.
Endovia is advancing its proprietary cannabinoid formulation CannEpil®, expecting to submit materials in the coming week and request an FDA pre‑submission conference to discuss its regulatory and development pathway. The company is also reviewing additional cannabinoid and beverage formulations and intellectual property for possible licensing, acquisition or collaboration, while working with capital partners to finalize expanded financing to support development and growth. Endovia recently rebranded, with its corporate name and ticker changing to Endovia Health Sciences and EDVA on August 24, 2026.
Endovia Health Sciences (NYSE American: EDVA), formerly Splash Beverage (SBEV), announced that the FDA Center for Veterinary Medicine has established Investigational New Animal Drug (INAD) File No. 14145 for its CannEpil® veterinary development program. This is the first regulatory milestone under Endovia Health’s collaboration with Lupvindol Biosciences and formally begins FDA regulatory engagement for CannEpil as an investigational veterinary pharmaceutical.
Endovia Health is initially targeting cancer‑related pain in canine oncology and plans to pursue the FDA’s Minor Use / Minor Species (MUMS) designation and Conditional Approval pathway. According to the company, Splash holds exclusive global rights to develop and commercialize CannEpil, and the business has rebranded to reflect a diversified cannabinoid‑based health sciences platform.