RegulatoryCompany release

Cabaletta Bio plans 1Q28 BLA for rese-cel in myositis after FDA meeting

🇺🇸 Cabaletta Bio, Inc. (CABA) · Thu 05 Nov 2026

The US cell therapy developer expects registrational myositis data in the second half of 2027 and has opened a systemic sclerosis cohort, with cash of $299.4 million.

Cabaletta Bio said on 5 November 2026, alongside its third-quarter results, that it expects topline data from the registrational RESET-Myositis cohort in the second half of 2027. The cohort is testing rese-cel, a CAR T therapy, in dermatomyositis and antisynthetase syndrome. The data are intended to support a US Food and Drug Administration (FDA) Biologics License Application (BLA) submission, planned for the first quarter of 2028.

The company said that, following a Type B meeting with the FDA, multi-year durability data from its Phase 1/2 programme can support the filing. Type B meetings are one of the formal routes sponsors use to agree development and regulatory plans with the agency at key milestones.

Cabaletta also said that data in juvenile dermatomyositis may make it eligible for a Priority Review Voucher. Such vouchers, where granted, can shorten the FDA's review timeline for a later application. The summary does not specify further details of the eligibility pathway.

Separately, the company has opened a registrational cohort in systemic sclerosis with interstitial lung disease. It reported cash of $299.4 million, which it said extends its financial runway into the first quarter of 2028.

What it means for your team

  • Regulatory teams tracking CAR T therapy in autoimmune disease should note the planned 1Q28 BLA, built on registrational cohort data plus long-term Phase 1/2 durability data.
  • The FDA's apparent acceptance of multi-year Phase 1/2 durability data after a Type B meeting is a useful reference point for evidence packages in this field.
  • Possible Priority Review Voucher eligibility via juvenile dermatomyositis data could affect review timing, though this is not confirmed.
  • Market-access teams should note that the new systemic sclerosis cohort points to a wider autoimmune pipeline for rese-cel.

Company's press release (SEC filing): Cabaletta Bio, Inc. ↗

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

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