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.
Merck (NYSE: MRK) Q2 2026 earnings pre-day positioning ahead of the Tuesday August 4, 2026 before-market-open report. Zacks analyst consensus: $16.33 billion revenue, $1.36 diluted EPS (down 36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory (Zacks estimate $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum) ahead of the 2028 US patent cliff that ends Keytruda exclusivity; the initial commercial ramp of LIPFENDRA (enlicitide) oral macrocyclic peptide PCSK9 inhibitor following the July 16, 2026 FDA approval, with peak sales potential estimated at $5 billion by 2034 and analyst commentary describing the safety label as 'the cleanest in the class'; contribution from Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma), and Capvaxive (pneumococcal vaccine); and the integration of the Terns Pharmaceuticals and Cidara Therapeutics acquisitions closed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise; analyst attention also on potential FY 2026 revenue guidance revision from the prior $65.8-67 billion range and non-GAAP EPS guidance from $5.04-5.16.
Merck (NYSE: MRK) reports Q2 2026 earnings Tuesday August 4, 2026 before market open with Zacks analyst consensus at $16.33 billion revenue and $1.36 diluted EPS (-36.2% year-over-year from $2.13 in Q2 2025). Analyst focus areas: Keytruda (pembrolizumab) sales trajectory with the Zacks estimate at $8.06 billion Q2, driven by earlier-stage indication uptake and continued metastatic-setting momentum ahead of the 2028 US patent cliff; the initial commercial launch of LIPFENDRA (enlicitide) macrocyclic peptide oral PCSK9 inhibitor following the July 16, 2026 FDA approval at $315/month list price ($10.50 per tablet), with peak sales potential estimated at $5 billion by 2034; the emerging contribution of Winrevair (sotatercept for pulmonary arterial hypertension), Welireg (belzutifan for renal cell carcinoma and VHL disease), and Capvaxive (pneumococcal vaccine); and pipeline signal from the Terns Pharmaceuticals and Cidara Therapeutics acquisitions completed in H1 2026. Merck has beaten earnings expectations in each of the trailing four quarters with a 7.75% average earnings surprise. Beyond Q2 specifically, analyst attention will focus on the FY 2026 revenue guidance ($65.8-67 billion range on the prior call) and non-GAAP EPS guidance ($5.04-5.16 range) for revisions.