Merck’s remigromig meets non‑inferiority in DME trial but raises safety concerns
Merck presented one‑year data from the pivotal Phase 2b/3 BRUNELLO trial of remigromig in diabetic macular edema. Both the 0.5 mg and 0.8 mg dose arms achieved the primary endpoint of non‑inferior best‑corrected visual acuity versus monthly 0.5 mg ranibizumab, with mean gains of +9.1 and +8.7 letters respectively, compared with +11.8 letters for ranibizumab. Adverse events related to proliferative diabetic retinopathy occurred more frequently with remigromig (6.7% and 6.1%) than with ranibizumab (0.9%). Jefferies subsequently cut its peak‑sales forecast for remigromig by 60% to $300 million.
Why it matters
Jefferies’ forecast cut reflects analyst concern that the safety signal and smaller vision gains may limit commercial potential, reducing expected revenue for Merck. The trial results also signal that regulatory discussions will focus on the safety profile before any approval.
Key facts
- 1The BRUNELLO trial enrolled 984 participants who were randomized 1:1:1 to the two remigromig doses or ranibizumab. stocktitan.net
- 2Mean BCVA gain at Year 1 was +9.1 letters for remigromig 0.5 mg (95% CI 8.1‑10.1). investingnews.com
- 3Mean BCVA gain at Year 1 was +8.7 letters for remigromig 0.8 mg (95% CI 7.7‑9.8). investingnews.com
- 4Mean BCVA gain for ranibizumab was +11.8 letters (95% CI 10.7‑12.8). investingnews.com
- 5Adverse events related to proliferative diabetic retinopathy occurred in 6.7% of the 0.5 mg arm and 6.1% of the 0.8 mg arm, versus 0.9% with ranibizumab. investingnews.com
- 6Jefferies reduced its peak sales forecast for remigromig by 60% to $300 million and lowered its price target for Merck to $176. finance.yahoo.com
Summary written by AlphAI AI Desk from 10 of 10 sources. Not investment advice. Figures are as stated by the linked sources.