MoonLake on Track for HS BLA Submission; Relay's Zovegalisib Receives FDA Breakthrough Status

MoonLake Immunotherapeutics says FDA feedback indicates sufficient data from its VELA program to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, with submission planned toward the end of Q3 and an expected acceptance decision within 60 days. The FDA's guidance was that VELA-1 and MIRA would be used to establish efficacy and support safety, while VELA-2 would be submitted to support safety, with the role of VELA-2 in establishing efficacy to be discussed with the agency.

The company's "base scenario" for Section 14 would include two HS trials—VELA-1 and MIRA—with HiSCR75 presented as the primary endpoint and HiSCR50 as a secondary endpoint.

In axial spondyloarthritis, the open-label S-OLARIS Phase 2 trial reported more than 80% of patients achieved an ASAS40 response by week eight, maintained through week 12, and approximately 80% reached inactive or low disease status by week four as measured by ASDAS-CRP. The trial reported large reductions in MRI-measured inflammation in the sacroiliac joints, with an absolute SPARCC MRI score reduction exceeding levels typically considered best-in-class, with 90% of patients showing a reduction.

A key element was the use of 18F-NaF PET imaging to assess osteoblast activity associated with ossification. PET imaging showed a more than 40% reduction in osteoblast activity across evaluated sacroiliac joint quadrants within 12 weeks, findings MoonLake says could indicate potential disease modification by reducing processes linked to structural damage. Baseline characteristics included a roughly even mix of radiographic and non-radiographic axSpA patients.

MoonLake ended 2025 with $394 million in cash and equivalents, has cash runway into the second half of 2027, drew $25 million on its debt facility and retains access to up to $400 million in additional funding. The company was founded in 2021 in Switzerland and went public in April 2022.

Separately, the U.S. FDA granted Breakthrough Therapy designation to Relay Therapeutics' PI3Kα inhibitor zovegalisib (RLY-2608) in combination with fulvestrant for adults with PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer after CDK4/6 inhibitor treatment, supported by Phase 1/2 ReDiscover trial data and an ongoing Phase 3 study.

The regulatory milestone accelerates FDA feedback and review timelines and highlights zovegalisib's potential relevance across both kinase and non-kinase PIK3CA mutations in a difficult-to-treat patient group. Relay is still loss-making, forecast to remain unprofitable, and reliant on external capital and partnered economics such as its Elevar deal on lirafugratinib while it advances its pipeline.