Peptide News Digest

#Pah

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Clinical Trials · View digest

Insmed Presents Phase 3 ASPEN Post-Hoc BRINSUPRI Data in Non-Cystic Fibrosis Bronchiectasis Patients With Prior NTM Infection Plus New TPIP PAH Analysis at ERS Congress Wednesday

Insmed Incorporated (NASDAQ: INSM) presented Wednesday September 9, 2026 at the ERS Congress in Barcelona a post-hoc analysis of the Phase 3 ASPEN trial evaluating BRINSUPRI (brensocatib, a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor approved in August 2025 for non-cystic fibrosis bronchiectasis (NCFB) in ages 12+) in the subgroup of ASPEN patients with prior nontuberculous mycobacterial (NTM) infection. The analysis is one of five Insmed abstracts at the meeting, alongside a COMPERA 2.0 risk-assessment post-hoc analysis of treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension, additional ARIKAYCE (amikacin liposome inhalation) data on the psychosocial burden and healthcare resource use of MAC lung disease, and treatment-pattern analyses. Brinsupri launched August 2025 via specialty pharmacy in the U.S. and is under EMA and MHRA review with Japanese filing in H2 2026. TPIP is Insmed's mid-stage prostacyclin analog delivered via dry powder inhaler, targeting PAH as a differentiated option relative to United Therapeutics' Tyvaso (nebulized treprostinil).

Regulatory · View digest

Merck Winrevair (Sotatercept-csrk) Pulmonary Arterial Hypertension Label Expansion PDUFA Target Date September 21, 2026

Merck (NYSE: MRK) awaits its September 21, 2026 PDUFA target action date for a further label expansion of Winrevair (sotatercept-csrk, an activin signaling inhibitor administered as subcutaneous injection every three weeks) in pulmonary arterial hypertension (PAH). Winrevair was originally FDA-approved March 26, 2024 for adults with PAH (WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening events, based on the Phase 3 STELLAR trial. The pending label expansion is expected to cover an earlier line of therapy and/or a broader patient population based on the ZENITH and HYPERION Phase 3 trials that reported earlier in 2026 (ZENITH: PAH high-risk patients on maximal background therapy; HYPERION: newly diagnosed PAH). The Winrevair franchise reached $260 million in Q2 2026 revenue and is on track to reach $1 billion annual run rate before end of 2026. Sotatercept-csrk is a fusion protein of activin receptor type IIA and the Fc portion of human immunoglobulin.