Street Calls of the Week
SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO), trading at $6.93 near its 52-week low of $6.71, announced Friday that the U.S. Food and Drug Administration has granted Fast Track Designation to its lead investigational compound, CER-1236, for the treatment of Acute Myeloid Leukemia. According to InvestingPro data, the clinical-stage biotech company has seen its shares decline over 96% in the past year.
The designation adds to CER-1236’s existing Orphan Drug Designation and is designed to accelerate development and review of therapies addressing serious conditions with unmet medical needs.
"We continue to believe that CER-1236 represents a truly novel approach to cancer immunotherapy and are gratified by this regulatory milestone," said CERo Therapeutics CEO Chris Ehrlich in a press release statement.
The Fast Track status provides CERo with opportunities for increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis.
CER-1236 is currently being evaluated in a first-in-human, multi-center Phase 1/1b study. The trial is examining the therapy’s safety and preliminary efficacy in patients with acute myeloid leukemia that is either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed with specific mutations.
The study includes dose escalation to determine the highest tolerated dose, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include adverse events, dose-limited toxicities, and response rates.
CERo’s technology platform creates what the company calls Chimeric Engulfment Receptor T cells (CER-T), which are designed to eliminate tumors by incorporating phagocytic mechanisms to destroy cancer cells.
In other recent news, Cero Therapeutics Holdings, Inc. has made significant strides in its business activities. The company has dosed the second patient in its Phase 1 clinical trial for acute myeloid leukemia, with ongoing monitoring for safety and efficacy. In financial developments, Cero completed an additional sale of Series D preferred stock, generating approximately $397,600 in gross proceeds from institutional investors. Furthermore, the company entered a new equity purchase agreement worth up to $17.5 million, continuing its equity line program with an institutional investor.
Cero Therapeutics also announced it has regained compliance with Nasdaq’s minimum bid price requirement, resolving a previous deficiency notice. The company had faced a compliance issue when its stock price fell below the $1.00 per share minimum for 30 consecutive business days earlier this year. Additionally, Cero amended its securities purchase agreement to include new institutional investors in its Series D preferred stock sale, expanding its investor base. These developments underscore Cero’s ongoing efforts to strengthen its financial position and advance its clinical trials.
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