Merck MRK announced positive top-line data from the phase IIb/III BRUNELLO study, which evaluated its investigational pipeline candidate, remigromig (MK-3000, formerly EYE103), for treating adult patients with diabetic macular edema (“DME”).
The BRUNELLO study met its primary endpoint, wherein treatment with both the 0.5-mg and 0.8-mg doses of remigromig demonstrated non-inferiority to ranibizumab (0.5-mg) for the mean change from baseline in best-corrected visual acuity in patients with DME at week 52. Also, treatment with both doses of remigromig was generally well tolerated.
However, higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse effects were seen in the remigromig groups compared with ranibizumab. Merck said further analyses are underway to characterize these findings.
Remigromig is a first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance of the blood-retinal barrier.
Per management, up to 40% of patients do not fully respond to available therapies and remain at risk of continued vision loss, highlighting the unmet medical need in DME. The company also noted that remigromig represents the first new mechanism of action in 20 years to achieve phase III results non-inferior to anti-VEGF therapy.
MRK’s Price Performance
Year to date, shares of Merck have rallied 43.5% compared with the industry’s rise of 13.7%.
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Merck’s Ongoing Development Activities With Remigromig
The BRUNELLO study is the first of two phase IIb/III studies evaluating remigromig in DME. The company is also evaluating the candidate in the ongoing pivotal phase IIb/III BAROLO study in patients with DME and the phase II proof-of-concept study – SUPER TUSCAN – in patients with neovascular age-related macular degeneration and retinal vein occlusion.
The top-line data from the BRUNELLO study build on Merck’s advancing ophthalmology pipeline.
Management plans to present the BRUNELLO year-one results at the American Academy of Ophthalmology Annual Meeting to be held in October 2026.
We remind investors that the 2024 acquisition of EyeBio added remigromig to Merck’s ophthalmology pipeline.
Merck is also advancing its ophthalmology pipeline with MK-8748 (Tiespectus, EYE201), a bispecific antibody that activates the Tie2 pathway and inhibits VEGF.
MK-8748 is being evaluated in two pivotal phase IIb/III studies for treating neovascular age-related macular degeneration and in two pivotal phase III studies for the treatment of DME.
MRK’s Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen RGEN, Anika Therapeutics ANIK and Precigen PGEN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 16.4% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time frame. ANIK’s shares have surged 110.5% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents per share during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
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