Relmada targets year-end IND filings for NDV-01 and sepranolone, reports $217.7M cash

Relmada Therapeutics reported second quarter 2026 results and a business update on August 6, 2026. The company said it is advancing NDV-01 toward IND filing expected by year-end 2026 with GMP manufacturing of clinical trial material underway¹, with plans for initiation of the Phase 3 RESCUE registrational program upon IND clearance¹.

On the CNS side, Relmada said its sepranolone IND filing is expected by year-end 2026 and initiation of a Phase 2 proof-of-concept study in Prader-Willi Syndrome is planned upon IND clearance¹. The company noted that formulation development for sepranolone is complete, and it is finalizing the pre-filled syringe delivery system, which is the remaining step ahead of the sepranolone IND submission¹.

For NDV-01, Relmada said it has received written FDA feedback confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations, and primary endpoints¹. The company also said clinical trial sites are engaged and prepared to begin enrollment following IND clearance¹.

Relmada also announced a leadership change, strengthening the leadership team with the appointment of Bipin Dalmia as Chief Business Officer¹, and said it was added to the Russell 2000 and Russell 3000 Indexes effective June 26, 2026¹.

On finances, the company reported a cash balance of $217.7 million as of June 30, 2026, which it said is expected to fund operations through 2029, including completion of the NDV-01 Phase 3 RESCUE program¹. Net loss for the quarter was $12.9 million, or $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 per basic and diluted share, for the three months ended June 30, 2025¹. Relmada will host a conference call on the results.