Shares of Klotho Neurosciences, Inc. ( KLTO ) have soared more than 1000% over the past three months on promising results and breakthrough hopes. Klotho stock was in the spotlight again Thursday after announcing an FDA nod on its ALS treatment candidate. 

What's Driving The Rally: 

Klotho announced it has received FDA Orphan Drug Designation for its ALS therapy candidate. The official designation unlocks seven years of market exclusivity, tax credits and regulatory assistance as the potential treatment moves through the approval process. 

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"After the FDA’s review of the data leading to the Orphan Drug Designation, we believe this ODD designation provides strong validation of our science and our approach to treat this disease,” said Dr. Joseph Sinkule, Klotho’s CEO.

Klotho was trading at $1.50 earlier Thursday, which marks a stunning gain of 1,222% from the stock’s year-to-date low of 11 cents, reached on April 4. 

The FDA's orphan drug designation adds to other milestones that have propelled the stock on a wild ride in 2025. 

Last month, Klotho announced positive results from a preclinical trial that showed enhancing Klotho gene expression could significantly reduce age-related organ decline and extend lifespan in animal models. 

The company also raised more than $11 million in June through the exercise of existing warrants and eliminated all outstanding debt, resulting in a debt-free balance sheet.

Will the Rally Last?

The stock has seen wild swings and much of the rally is driven by retail enthusiasm, not by revenue or profit growth. Analyst coverage is minimal, and there are no reliable earnings forecasts.

Klotho also faces a potential Nasdaq delisting if it cannot  maintain its minimum bid price by August 2025, adding another layer of risk.

The Bottom Line

Klotho stock is on a biotech rollercoaster—soaring on breakthrough hopes, but with volatility and uncertainty sky-high. The rally could continue if clinical progress holds, but investors should brace for sharp twists and turns ahead. 

KLTO Stock Price Action: Klotho shares were up 5.8% at $1.44 at the time of publication Thursday, according to Benzinga Pro.

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