Thursday, October 22, 2026

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Unicycive (UNCY):

Unicycive’s oxylanthanum carbonate NDA earned a March 25, 2027 PDUFA date after two manufacturing-related rejections, with no FDA clinical or safety concerns.

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@david_katunaric 1 click

Mikro Kap David on X

Yesterday I dug deeper into an 🇦🇺 special situation that reminds me of when I first found $ICCC back in September 2025. In both cases, a high-quality core business is taking share in an oligopolistic niche with a superior product, yet its underlying economics are obscured by a legacy development program that has consumed decades of spending and exhausted nearly everyone who has ever owned the stock. As was the case with ImmuCell, I don’t think this setup requires regulatory approval to work. FAA approval would create significant upside, while abandonment would remove the cost burden, allowing management to focus entirely on the core business and letting its underlying economics shine through. There is also a less “dramatic” but plausible third path: the legacy program’s drag on profitability continues to diminish while the attractive aerospace business grows around it. Both situations also brought experienced industry executives into senior leadership at a potentially important turning point. And, so far, I believe the new management team is making the right moves. There are several ways this could play out, but I believe the favorable outcomes are more likely, while the unfavorable ones shouldn’t carry much downside at the current valuation. I wrote up this company now so that, as new information emerges, you’ll know what matters, what doesn’t, and how each development changes the risk-reward. That should put you in a position to act while others are still parsing headlines and catching up. Link in the comment below.

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UNCY · long

Unicycive Therapeutics INC

Unicycive Therapeutics fell nearly 50% after a second FDA Complete Response Letter tied to a third-party manufacturer for its primary…

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