Kala Pharmaceuticals (NASDAQ:KALA) may encounter some volatility after receiving a CRL from the FDA regarding its marketing application for dry eye disease candidate KPI-121. The agency stated that another clinical will be needed.
The company says results from its ongoing Phase 3 study, STRIDE 3, should be sufficient to address the FDA’s request. It expects to refile the application in H1 2020.
Shares are currently up 14% after hours.
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