TEVA Teva

denifanstat · NCT07863193 registry update

countries: {'total_sites': 20, 'us_sites': 20} → {'total_sites': 23, 'us_sites': 23}

Sagimet doses first patient in AURORA Phase 3 trial of denifanstat in moderate to severe acne

Sagimet initiated the AURORA Phase 3 trial of oral denifanstat in moderate to severe acne in the US in October 2026. Topline results are expected in the second half of 2027. This follows positive Phase 3 data generated by partner Ascletis in China, where the NDA was accepted by NMPA in December 2025.

emrusolmin · NCT06568237 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING; enrollment: 350 → 349

emrusolmin · NCT07197866 registry update

countries: {'total_sites': 40, 'us_sites': 10} → {'total_sites': 41, 'us_sites': 10}

Sagimet plans US Phase 3 trial of denifanstat in moderate to severe acne in 2H 2026

Sagimet plans to initiate a US Phase 3 trial of oral denifanstat for moderate to severe acne in the second half of 2026. This follows positive Phase 3 results (ASC40-303) and NDA acceptance by China's NMPA in December 2025 from partner Ascletis.

emrusolmin · NCT07197866 registry update

countries: {'total_sites': 36, 'us_sites': 8} → {'total_sites': 40, 'us_sites': 10}

ecopipam · NCT04492956 registry update

primary_outcomes: ['Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12'] → ['Stuttering Severity Instrument, 4th Edition (SSI-4)']

Sagimet: FDA clears IND for Phase 3 denifanstat acne trial

FDA cleared the IND and issued a Study May Proceed letter for the Phase 3 trial of denifanstat in moderate to severe acne. This removes the regulatory hold and allows the company to initiate the pivotal study.

Teva submits NDA for ecopipam (EBS-101) in Tourette syndrome

Teva submitted a New Drug Application to the U.S. FDA in June 2026 for ecopipam (EBS-101), a first-in-class therapy for Tourette syndrome, following the $700 million acquisition of Emalex Biosciences. The NDA submission advances the asset from pre-submission to active regulatory review, marking a key regulatory milestone for Teva's neuroscience pipeline.

Alvotech resubmits BLAs for AVT05 (golimumab) and AVT06 (aflibercept)

Alvotech resubmitted the U.S. BLAs for AVT05 and AVT06 after addressing the FDA’s Post-Application Action Letter and May 2026 inspection observations. The FDA is expected to conduct a six-month review of the resubmitted applications.

Teva: NDA accepted for olanzapine LAI in schizophrenia

FDA accepted the NDA for once-monthly olanzapine LAI in February 2026. Teva is preparing for a potential U.S. launch in Q4 2026, subject to approval. EU MAA acceptance is expected in Q2 2026.

Sagimet plans Phase 2 denifanstat/resmetirom combo trial in F4 MASH

Sagimet completed the Phase 1 PK trial of denifanstat plus resmetirom and will now advance the combination into a Phase 2 proof-of-concept study in F4 MASH patients. The trial is expected to start in the second half of 2026, subject to regulatory consultation.

Sagimet initiates Phase 1 PK trial of denifanstat + resmetirom; data 1H 2026

Sagimet dosed first participants in an open-label Phase 1 PK study of denifanstat plus resmetirom in ~40 healthy adults to assess DDI, safety and tolerability. Top-line data are expected in 1H 2026 and, if positive, will inform a Phase 2 proof-of-concept study in F4 MASH cirrhosis patients.

Teva: emrusolmin (TEV-56286) receives FDA Fast Track for MSA

The press release states that emrusolmin (TEV-56286) has been granted U.S. FDA Fast Track designation for the treatment of Multiple System Atrophy. This designation is intended to expedite development and review for a serious condition with no approved disease-modifying treatments. No PDUFA date or other regulatory timeline is provided in the text.

Sagimet: FASCINATE-2 Phase 2b denifanstat MASH data

The 8-K exhibit presents the full FASCINATE-2 Phase 2b topline biopsy results for denifanstat in F2/F3 MASH, confirming both primary endpoints were met with statistical significance (NAS ≥2 improvement without fibrosis worsening: 38% vs 16%; MASH resolution + NAS ≥2: 26% vs 11%) and a key secondary endpoint of fibrosis improvement ≥1 stage without MASH worsening (41% vs 18%). These data, previously announced in 1Q2024, are now formally disclosed in an SEC filing, establishing the regulatory path for Phase 3 advancement.