SCNX News & Events

Scienture announced that the United States Patent and Trademark Office, USPTO, has issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering REZENOPY Nasal Spray 10 mg, effective January 6, 2026, with an expiry date of February 5, 2041. The patent was issued to Summit Biosciences, a subsidiary of Kindeva Drug Delivery L.P. As previously disclosed, Scienture, a wholly owned subsidiary of Scienture Holdings, entered into a definitive agreement with Summit in March 2025 for the exclusive U.S. commercialization rights to REZENOPY. Under the terms of the collaboration, Summit will manufacture and commercially supply REZENOPY. Pending certain commercial obligations, Scienture will own the new drug application, NDA, for REZENOPY in its name and be responsible for the sales, marketing and distribution of the product in the U.S. through Scienture's commercial operations infrastructure.

Scienture provided an update on the commercial launch of REZENOPY. As previously disclosed, Scienture, a wholly owned subsidiary of Scienture Holdings, entered into a definitive agreement with Summit Biosciences in March 2025, for the exclusive U.S. commercialization rights to REZENOPY Nasal Spray 10 mg, which received FDA approval on April 19, 2024. "REZENOPY represents a significant advancement in overdose response as the highest-strength naloxone available on the market at 10 mg. It is specifically designed for patients who often require multiple doses of lower-strength naloxone for stabilization in emergency situations," commented Narasimhan Mani, President and co-CEO of Scienture. "By delivering a higher dose of naloxone, REZENOPY is intended to support opioid receptor antagonism and may help address overdose situations where multiple or potent opioids are involved."

Scienture announced a strategic collaboration to expand national access to Arbli, the first FDA-approved, ready-to-use oral suspension formulation of losartan potassium. Arbli is expected to be available on the BlinkRx platform in Q1 2026. With BlinkRx, 52% more patients start therapy and remain on their medication 40% longer as prescribed. "Arbli represents a meaningful advancement for patients who need a ready-to-use oral suspension of losartan potassium," commented Narasimhan Mani, President and co-CEO of Scienture. "BlinkRx removes friction in the patient journey, from reducing administrative barriers and accelerating therapy initiation to improving adherence, which translates into greater prescription volume, longer duration on therapy, lower access costs, and broader patient affordability and reach."

Reports Q3 revenue $590,050 vs. $64,861 last year. "Q3 was a transformational quarter for Scienture as we commenced sales of Arbli," commented Narasimhan Mani, President and Co-CEO of Scienture. "We delivered strong results this quarter, with significant increases in net revenues and gross profit as we entered full commercial scale-up of our first FDA-approved product, Arbli. In the past month, Arbli was added to key national payor formularies, expanding access to over 100 million covered lives, and we secured GPO agreements reaching more than 2,500 healthcare institutions, representing potential penetration into roughly 20% of the U.S. institutional market. As we broaden our marketing efforts and demand builds across retail, institutional, and long-term care channels, we see significant potential for sustained adoption and long-term value creation. Subsequent to the end of the third quarter, we fundamentally strengthened our balance sheet by substantially reducing our outstanding debt and significantly enhancing our cash position to over $8 million as of November 13, 2025. Having optimized our capital structure, we are now strongly positioned and adequately capitalized to advance our commercial and operational priorities."