On June 25, 2025 Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, reported the successful first in-person meeting with the U.S. Food and Drug Administration (FDA) (Press release, HAMLET Pharma, JUN 25, 2025, View Source [SID1234654118]). The meeting was held on June 24, 2025. The ‘take home message’ from the discussion was a clear pathway to the Phase III trial leading to market approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Hamlet team summarized the scientific and clinical background and presented data from Hamlet’s successful and recently completed Phase II study (Dec 2024). The impressive data to date in the Alpha1H program was well received by the FDA and the fruitful discussion included the clinical team in Prague and Target Health’s regulatory expertise and leadership.

The discussion proceeded to cover FDA’s helpful feedback on a new Phase III trial design for NMIBC patients, which will support the registration of Alpha1H. Hamlet BioPharma will now incorporate FDA’s input into its Phase III protocol. The company remains on track to initiate the Phase III trial, subject to final protocol agreement and regulatory clearance. The meeting marked a key milestone in the regulatory pathway and provided an opportunity to align with the FDA on key aspects of the trial design.

`’Congratulations to the Hamlet team,” says Adam Harris, MM, RAC, from Target Health, who was regulatory lead for the meeting with the FDA.

"We appreciate the FDA’s engagement and valuable feedback as we continue the late-stage development of Alpha 1H and the treatment of Bladder Cancer," comments Catharina Svanborg, CEO, Hamlet Biopharma. "This meeting brings us one step closer to delivering a new treatment option for patients facing bladder cancer."