SNDX Stock Is The Talk Of The Town Today: Here’s Everything To Know About The Latest FDA Approval

• The agency approved the medicine for both adults and pediatric patients with acute myeloid leukemia who are 1 year or older and have a susceptible nucleophosmin 1 (NPM1) mutation.
• In the second quarter, Revuforj achieved $28.6 million in net revenue, representing a 43% increase over the first quarter of 2025.
   

The U.S. Food and Drug Administration on Friday said that it has approved Syndax Pharmaceuticals’ (SNDX) Revuforj for some relapsed or refractory acute myeloid leukemia (ACL) patients with particular mutations.

The agency approved the medicine for both adults and pediatric patients one year and older with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.  

Implication For Patients, Syndax

According to Syndax, mutations in the NPM1 gene are the most common genetic alteration observed in AML, occurring in approximately 30% of adults with the condition. Patients with the mutation have a poor prognosis, and there are currently no approved therapies that selectively target the underlying disease mechanism driving the cancer, it said.

Revuforj was launched in the U.S. in November 2024 for the treatment of a specific type of leukemia called relapsed or refractory acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. The new FDA approval expands the indication for the drug.

In the second quarter, Revuforj achieved $28.6 million in net revenue, representing a 43% increase over the first quarter of 2025.

How Did Stocktwits Users React?

Shares of the company soared 4% on Friday morning at the time of writing. On Stocktwits, retail sentiment around SNDX stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume improved from ‘high’ to ‘extremely high’ levels.

A Stocktwits user believes the stock is a good buy below $20.

Another raised doubts about the possibility of a major rally.

SNDX stock is up by 15% this year but down by about 20% over the past 12 months. 

Read also: Teladoc Stock Shot Up 8% Today: BofA Views It As Differentiated Asset But Remains Cautious On Near-Term Outlook

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