reported that its meeting with the U.S. Food and Drug Administration regarding the development of reproxalap for dry eye disease was positive.
Analyst Justin Kim added that the current underappreciation of reproxalap's potential in ocular surface diseases represents an opportunity for investors.
The biopharma remains on track to submit a new drug application (NDA) for it in Q4/22, reported Oppenheimer analyst Justin Kim in a Sept. 15 research note.
He added that the current underappreciation of reproxalap's potential in ocular surface diseases represents an opportunity for investors.
"Going into an NDA submission for the drug, we believe eventual approval could lead to a meaningful lift for the shares," Kim wrote.
Right now, Aldeyra is trading at about US$6.59 per share. Oppenheimer rates it Outperform with a US$13 per share target price.
Next, Aldeyra may advance ADX-2191 for proliferative vitreoretinopathy toward approval, Kim purported.
He added that "data from Phase 3 Guard (Part 1) results in Q3-Q4/22 and [a] pre-NDA meeting on primary vitreoretinal lymphoma could catalyze a nontrivial revenue opportunity, relative to current share levels."
Also in Aldeyra's ocular disease pipeline is its RASP, or reactive aldehyde species, inhibitor platform for multiple immune-mediated retinal indications. This program, noted Kim, likely will "garner greater appreciation" if and when reproxalap gets approved.
Overall, Kim wrote, given Aldeyra's reproxalap program and "adding optionality from underappreciated retinal programs with ADX-2191 with potential fast-to-market pathways, a broader underlying systemic program targeting RASP and the recent uptick for M&A, we stay bullish."
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