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NEWS

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…
December 17, 2025

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Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Shots: Trial assessed tinlarebant (5mg, QD, PO; n=69) vs PBO (n=35) in 104 STGD1 pts (12-20yrs.), meeting its 1EP of 36% reduction in lesion growth per retinal imaging, quantified as 35.7% using the pre-specified MMRM model & confirmed at 35.4% with a post-hoc autoregressive-MMRM analysis Trial also showed reduced lesion growth rate by 33.6% in fellow…
December 2, 2025

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Bayer
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Bayer Reports Topline P-III (OCEANIC-STROKE) Trial Data on Asundexian for Secondary Stroke Prevention

Shots: Bayer has reported P-III (OCEANIC-STROKE) trial data assessing asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,300) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack Trial met its primary efficacy & safety EPs, with a significant reduction in the risk of…
November 24, 2025

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Merck new
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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
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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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