Needham initiated protection on Ocular Therapeutix Inc OCUL, noting the corporate’s lead asset, Axpaxli, an investigational axitinib-based intravitreal implant for moist age-related macular degeneration (moist AMD).
Axpaxli is the corporate’s key worth driver and is below analysis in two section 3 trials. If constructive, these trials may help approval with a product label that permits upkeep therapy with Q6M (each 6 months)-Q12M (each 12 months) dosing, which might symbolize a major enchancment over present therapy choices that provide as much as Q2M (each two months)-Q4M (each 4 months) dosing.
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Ocular Therapeutix has accomplished randomization within the first moist AMD trial, SOL-1. The corporate expects topline outcomes for SOL-1 to be accessible within the fourth quarter of 2025.
The corporate has enrolled 311 topics in SOL-R, Ocular’s second registrational trial of Axpaxli in moist AMD. The corporate additionally plans to hunt FDA suggestions within the first half of 2025 on medical trial design for Axpaxli in non-proliferative diabetic retinopathy (NPDR).
The analyst Serge Belanger has initiated with a Purchase ranking and a worth goal of $15.
Needham writes that intravitreally injected anti-VEGFs make up the ~$15 billion retinal illness market.
The analyst expects Axpaxli to play a job as a second-line therapy within the ~40% of 1.65 million moist AMD sufferers handled with anti-VEGFs who fail to adequately reply to anti-VEGFs and/or are dissatisfied with the excessive variety of required IVT injections. Needham expects peak gross sales of round $1.5 billion primarily based on a 15-20% share of this second-line AMD affected person inhabitants.
“We consider Axpaxli’s product profile and distinctive pivotal ph 3 program provide substantial advantageous differentiation over different merchandise in improvement searching for to offer long-term therapy period,” Needham writes.
Ocular Therapeutix reported a fourth-quarter lack of 29 cents per share, in comparison with a consensus of 24 cents, with gross sales of $17.1 million.
The corporate expects its money stability of $392.1 million to fund operations into 2028 with out elevating extra capital.
Value Motion: OCUL inventory is up 10.10% at $8.42 on the final test on Tuesday.
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Momentum25.95
Progress39.39
High quality–
Worth23.79
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