Zydus Lifesciences US Arm Clears Key FDA Step for Rare Menkes Disease Drug

Zydus Lifesciences announced that the US Food and Drug Administration has accepted the resubmitted new drug application (NDA) for CUTX-101, a treatment for Menkes disease. The application was filed by Sentynl Therapeutics, Zydus’ wholly owned US subsidiary.

New FDA Decision Timeline

The FDA has classified the resubmission as a Class I response and has fixed January 14, 2026 as the new PDUFA target date. This means the regulator will complete its review by that date.

What Happened Earlier

Sentynl had earlier received a complete response letter in September 2025. The FDA’s concerns were related only to manufacturing practice (cGMP) compliance at the production site. Importantly, there were no issues raised about the drug’s safety or effectiveness.

About CUTX-101

CUTX-101 is designed to treat Menkes disease, a rare genetic disorder that mainly affects male children. If approved, it would become the first FDA-approved treatment available for this condition.

Zydus Q2 FY26 Earnings Performance

Zydus Lifesciences reported strong Q2 results, with revenue rising 17% year-on-year to ₹6,123 crore and net profit jumping 38% to ₹1,258.6 crore. The US formulations business contributed nearly 45% of total revenues.

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Zydus Lifesciences Share Price Movement

Zydus Lifesciences share price (NSE: ZYDUS) was trading at ₹923.10 on December 16 at 10:00 am IST, up 0.16% for the day. The stock opened at ₹924.10 and moved in a range of ₹922.35 to ₹928.95 during the session. The company has a market capitalisation of about ₹92,980 crore and trades at a P/E ratio of 18.9. Zydus Lifesciences has a 52-week high of ₹1,059.05 and a low of ₹795.00. It offers a dividend yield of 1.19%, with a quarterly dividend payout of ₹2.75 per share.

Conclusion

The FDA’s acceptance of CUTX-101’s resubmission marks an important step for Zydus Lifesciences. Approval could address an unmet medical need and further strengthen the company’s presence in the US market.

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