Ropanicant for Major depressive disorder

pendingprimaryMADRS total score, change from baseline to Week 6 — ropanicant 30 mg BID vs placebo

NOT DISCLOSED. The 17 June 2026 topline release reports efficacy for the 45 mg BID arm only and makes no statement — numeric or directional — about the 30 mg BID arm, which was randomized 1:1:1 alongside it. Recorded explicitly as an undisclosed arm rather than omitted, because silence on one of two active arms is material to interpreting the result. Suven states detailed findings will be presented at a future medical conference and/or in peer-reviewed publications.

metsafetySafety and tolerability over 6 weeks

Generally well tolerated. Most TEAEs were mild to moderate, transient and resolved without clinically significant intervention, with no unexpected safety signals. No meaningful treatment-related changes in haematology, clinical chemistry or urinalysis; no clinically relevant ECG effects; no meaningful changes in blood pressure, heart rate, respiratory rate, body weight or temperature. Notably for a CNS mechanism: no withdrawal symptoms after discontinuation of ropanicant and no evidence of dissociation.

metsecondarySheehan Disability Scale (SDS) at Week 6 — 45 mg BID vs placebo (0.039)

Nominally significant improvement in functional impairment (p = 0.039). No effect size was disclosed. The exploratory Quality of Life in Depression Scale did not reach significance (QLDS p = 0.068). Suven also reported that improvements in anhedonia correlated with improvements in functioning and quality of life.

metprimaryMADRS total score, change from baseline to Week 6 (Day 43) — ropanicant 45 mg BID vs placebo — ML-estimated mean difference vs placebo -3.572 (Full Analysis Set); -3.570 (modified FAS); -4.067 (Per-Protocol Set) (0.038)

Primary endpoint met for the 45 mg twice-daily dose: -3.572 MADRS points versus placebo at Week 6 in the FAS (p = 0.038), -3.570 in the mFAS (p = 0.038) and -4.067 in the PPS (p = 0.023). Suven frames approximately 2 MADRS points versus placebo as the clinically meaningful threshold. 214 patients randomized across 35 US sites; baseline characteristics balanced (MADRS ~31, CGI-S ~4.3-4.5, SDS ~19.6-21.2, PHQ-9 ~16.7).

missedsecondaryClinical Global Impression - Severity of Illness (CGI-S) at Week 6 — 45 mg BID vs placebo (0.094)

Did not reach nominal statistical significance (p = 0.094). Suven characterises this as 'evidence of treatment benefit ... across secondary endpoints', but at p = 0.094 the CGI-S — the clinician-rated global measure — did not separate from placebo at the conventional threshold. Recorded as missed on the numbers.

metsecondaryMADRS total score, change from baseline to Week 2 (Day 14) — Day 14 change from baseline -12.7 (30 mg BID), -10.5 (45 mg QD), -10.4 (45 mg BID); Day 7 change 5.9 to 13.4 points across doses; baseline MADRS 32.1 (<0.0001)

Change from baseline in MADRS at Week 2 was highly statistically significant (p < 0.0001) across all three treatment arms, with separation already at Day 7. CRITICAL CAVEAT: this was an open-label, single-arm-per-dose study with NO placebo control, so the within-group change cannot be read as a drug effect — the p-value tests change from baseline, not superiority to placebo. The 2-week Day 14 magnitudes (10.4 to 12.7 points) are large relative to the placebo-controlled 6-week Phase 2b difference of 3.6 points, which is exactly the pattern expected when a placebo arm is absent.

metprimaryIncidence of treatment-emergent adverse events through Day 21 (safety and tolerability)

Ropanicant was generally well tolerated with no study-drug-related serious adverse events and no notable differences in the safety profile across the three doses/regimens (45 mg QD, 30 mg BID, 45 mg BID). Safety and tolerability was the primary objective of this open-label study.