Biopharma · FDA Approvals · Stock
Quince Therapeutics Inc is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. Its proprietary AIDE technology is an inventive drug/device combination platform that uses an automated process to encapsulate a drug into a patient's own red blo…
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LAM-001 · NCT05798923 registry update
countries: {'total_sites': 32, 'us_sites': 32} → {'total_sites': 4, 'us_sites': 4}
IRulya (IRLA) relaunches with LAM-001 Phase 2 readouts guided in BOS (Q1 2027), PH-ILD (Q1 2028), SAPH (Q4 2028)
IRulya Therapeutics (formerly Quince) is advancing inhaled LAM-001 (rapamycin) in three pulmonary indications. Phase 2 data in BOS is expected in Q1 2027, Phase 2b data in PH-ILD in Q1 2028, and Phase 2 data in SAPH (study start 4Q26) in Q4 2028. The $116M cash balance is expected to fund operations through the end of 2028.
LAM-001 · NCT05798923 registry update
primary_completion: 2027-07-16 → 2028-03; completion: 2028-08-30 → 2029-02; countries: {'total_sites': 3, 'us_sites': 3} → {'total_sites': 32, 'us_sites': 32}
Quince Therapeutics: Phase 2b PH-ILD data for LAM-001 expected Q1 2028
The acquisition of Orphai Therapeutics added LAM-001 to Quince’s pipeline. A 75-patient Phase 2b trial in PH-ILD is ongoing with topline results guided for Q1 2028. A separate Phase 2 BOS trial is fully enrolled with results expected Q1 2027.
Quince Therapeutics: Phase 3 NEAT topline readout for eDSP in A-T expected Q1 2026
The company completed enrollment of the pivotal Phase 3 NEAT trial (105 total participants) and confirmed that topline results will be reported in Q1 2026. The trial remains under an FDA Special Protocol Assessment, and positive data would support an NDA submission planned for H2 2026.
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