The new designation was granted weeks after the FDA awarded the experimental drug an Orphan Drug designation.
CERo Therapeutics Holdings (CERO) announced on Friday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s lead investigational compound, CER-1236, for Acute Myeloid Leukemia (AML).
On Stocktwits, retail sentiment around CERO stock jumped from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.
A Stocktwits user expects a “big bounce” for the stock soon.
FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical need. The designation provides CERo with the opportunity for increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis, it said.
The new designation comes weeks after the FDA granted the experimental drug an Orphan Drug designation. The FDA’s Orphan Drug program is designed to advance the development of drugs that treat rare conditions affecting 200,000 or fewer US patients annually.
“These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitted. Further, these designations help to decrease the potential time to market and provide additional benefits across the FDA process that are expected to prove both medically and financially valuable,” said CERo Therapeutics CEO Chris Ehrlich.
The company is currently undertaking early-stage trials of CER-1236 in patients with acute myeloid leukemia. The study is designed to evaluate the safety and preliminary efficacy of the experimental cancer drug.
Shares of the company, however, slumped 12% at the time of writing after the firm said on Thursday that it recently received a letter from the Nasdaq Listing Qualifications department notifying the company that it does not comply with the minimum stockholders’ equity requirement of $2.5 million for continued listing on the Nasdaq Capital Market.
The Nasdaq staff indicated that the company’s securities would be suspended from trading on Nasdaq and delisted on Sept. 8, 2025. The company said that it subsequently requested a hearing to appeal the determination before a panel. The hearing request will stay the suspension of the trading of the company’s common stock and delisting thereof pending such hearing, it said.
The company said that it intends to submit a plan to regain compliance with the Stockholders’ Equity Requirement at the hearing. Such a plan of compliance may include an increase in stockholders’ equity through the consummation of public or private financing transactions, the company said, while adding that there can be no assurances that it will obtain a favorable decision from the hearing panel.
CERO stock is down by 95% this year and by 97% over the past 12 months.
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