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MoonLake files FDA application for sonelokimab in hidradenitis suppurativa, reports $498.5M cash

🇺🇸 MoonLake Immunotherapeutics (MLTX) · Wed 04 Nov 2026

The company submitted its US biologics licence application on 30 September and expects an FDA acceptance decision by end-November, with a PDUFA date by mid-December.

MoonLake Immunotherapeutics has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for sonelokimab in adults and adolescents aged 12 and over with moderate-to-severe hidradenitis suppurativa. The company said the filing went in on 30 September 2026.

Announcing its third-quarter update on 4 November 2026, MoonLake said it expects the FDA to decide on acceptance of the application by the end of November. It anticipates that a Prescription Drug User Fee Act (PDUFA) goal date will be set by mid-December.

The update also covered the company's psoriatic arthritis programme. MoonLake reported positive Week 16 results from the Phase 3 IZAR-1 study and said it has completed enrolment in IZAR-2.

On finances, the company reported cash of $498.5 million, which it said is sufficient to fund operations to mid-2028.

By way of context, the FDA normally decides within 60 days of receipt whether a BLA is complete enough to be formally accepted for review, and the PDUFA date is the agency's target for completing that review.

What it means for your team

  • Regulatory teams should watch for the FDA's acceptance decision, expected by end-November, and the PDUFA date, expected by mid-December, which will set the review timeline.
  • The proposed indication covers adolescents from 12 years as well as adults, so paediatric-relevant aspects of the filing may attract attention during review.
  • Market-access teams tracking hidradenitis suppurativa can use the expected PDUFA date as the first marker for a potential US launch window.
  • The stated cash runway to mid-2028 indicates the company is funded through the review period, according to its own guidance.

Company's press release (SEC filing): MoonLake Immunotherapeutics ↗

Article written by VigiEye from the official source (MoonLake Immunotherapeutics). Claims are the company's own. AI-assisted; check the source before acting.

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