AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots: The P-III (BaxHTN) trial assessed baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension over 12wks.; P-III (Bax24) trial readout is expected in late 2025 Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted…

ByRidhi RastogiSeptember 1, 2025

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Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Shots: Merck has reported P-III (VICTOR) trial data assessing Verquvo (n=3,053) vs PBO (n=3,052) in pts with stable chronic heart failure & reduced ejection fraction Trial did not meet its 1EPs of reducing CV death or HF hospitalization (18% vs 19.1%); however, 2EPs showed numerically lower rates of CV death (9.6% vs 11.3%) & HF…

ByRidhi RastogiSeptember 1, 2025

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Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots: Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…

ByRidhi RastogiSeptember 1, 2025

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Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots: FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's review Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

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BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

Shots: The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-up Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

ByRidhi RastogiAugust 29, 2025

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Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Shots: The US FDA has approved Camcevi ETM (leuprolide mesylate, 21mg, Q3M LAI) for the treatment of advanced prostate cancer; Application is under the EMA’s review Approval was based on P-III trial assessing Camcevi ETM in 144 advanced prostate cancer pts, which showed superior efficacy, with 97.9% pts achieving the 1EP Camcevi (Q6M LAI) is…

ByRidhi RastogiAugust 29, 2025

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Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Shots: The UK’s MHRA has approved Oczyesa (octreotide SC depot) for the maintenance treatment in adult with acromegaly who have responded to & tolerated somatostatin analogs, following EC approval on Jun 30, 2025; UK launch expected in Q4’25 Approval was based on extensive data from 7 trials, incl. 4 P-I trials, 1 P-II trials &…

ByRidhi RastogiAugust 29, 2025

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AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Shots: Health Canada has approved Rinvoq (15mg; QD) as a monotx. & in combination with corticosteroid to treat adults with giant cell arteritis (GCA) Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…

ByRidhi RastogiAugust 28, 2025

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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…

ByRidhi RastogiAugust 28, 2025

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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…

ByRidhi RastogiAugust 28, 2025

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

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

Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

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