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Merck new
NEWS

Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection

Shots: The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537) Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
November 20, 2025

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Merck new
NEWS

Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF

Shots: Merck has reported topline P-II (CADENCE) trial data assessing Winrevair (sotatercept-csrk; 0.3 or 0.7mg/kg) vs PBO in 164 pts with CpcPH due to heart failure with preserved ejection fraction (HFpEF) Trial met its 1EP, showing a reduction in pulmonary vascular resistance at 24wks. along with a favorable safety profile. Data will be presented at a…
November 19, 2025

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NEWS

Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease

Shots: The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan,…
November 3, 2025

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Bavarian Nordic
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Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Shots: Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…
October 8, 2025

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Eli lilly
NEWS

Eli Lilly Reports Topline P-III (monarchE) Trial Data of Verzenio (Abemaciclib) to Treat Early Breast Cancer

Shots: Eli Lilly has reported topline P-III (monarchE) trial data assessing Verzenio (150mg, BID) + SoC adj. ET vs SoC adj. ET in 2 cohorts (N=5,637) for pts with HR+, HER2-, node-positive early breast cancer at high risk of recurrence Cohort 1 (n=5,120; FDA-approved) incl. pts with ≥4 positive nodes or 1–3 nodes plus tumor ≥5…
August 28, 2025

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Rhythm Pharmaceuticals
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Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…
April 8, 2025

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Incyte
NEWS

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots: The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…
March 18, 2025

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