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8- 10.1After-hours26.10.02 05:303Ownership#●●●
Unicycive Therapeutics, Inc.
Director Meredith Manning of Unicycive Therapeutics has filed a Form 3, marking the initial statement of beneficial ownership of the company's securities. This filing formalizes the insider's equity holdings.…more
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- 9.29Pre-market26.09.29 20:468-KKey event
Unicycive Therapeutics, Inc.
Unicycive Therapeutics has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), incorporating data from a new manufacturing vendor to resume the FDA approval process. The company also appointed Meredith S. Manning as an independent director to strengthen its board. As of June 30, 2026, the company held $61.4 million in cash, providing an operational runway into the second half of 2027.…more
$3.89+0.39%vs prev closeView filingShare - 9.28After-hours26.09.29 05:318-KKey event
Unicycive Therapeutics, Inc.
Unicycive Therapeutics has been named in a securities class action lawsuit filed in the U.S. District Court regarding public statements about its new drug application for oxylanthanum carbonate. The company maintains that the claims are meritless and intends to defend itself vigorously.…more
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News
GlobeNewswire- 4d agoPre-market26.10.21 20:05#●●●#●●●
Unicycive Therapeutics Resubmits NDA for OLC, FDA Sets PDUFA Date for March 2027…more
Unicycive Therapeutics has received FDA acceptance for its resubmitted New Drug Application for OLC, a treatment for hyperphosphatemia. The FDA has set a PDUFA target action date of March 25, 2027, though regulatory approval remains subject to further review and potential facility inspections.…more
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- 10.1Pre-market26.10.01 20:05
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Unicycive Therapeutics has appointed biopharmaceutical industry veteran Meredith Manning to its Board of Directors. The company aims to leverage her commercialization expertise as it prepares for the potential approval of its lead product and transitions into a commercial-stage firm.…more
$3.89+0.39%vs prev close - 9.29Pre-market26.09.29 20:05
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Unicycive Therapeutics has resubmitted its New Drug Application for OLC, incorporating manufacturing data from a new third-party vendor to address previous regulatory hurdles. The company expects FDA acceptance within 30 days, with a potential approval decision anticipated in approximately six months.…more
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