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 & UgandaIn the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…

ByRidhi RastogiOctober 8, 2025

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 recurrenceCohort 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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AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Shots:AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in pts with a mean baseline SALT score of 84Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where in both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or PBO…

ByRidhi RastogiAugust 22, 2025

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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 Q3’25Trial met its…

ByRidhi RastogiApril 8, 2025

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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…

ByRidhi RastogiMarch 18, 2025

NEWS

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Shots:Arvinas & Pfizer have reported topline data from ongoing P-III (VERITAC-2) trial of vepdegestrant in ER+/HER2- advanced or metastatic breast cancer pts who had progression with CDK 4/6 inhibitors & endocrine therapy Pts received either vepdegestrant (PO, QD) for 28 days or fulvestrant (intramuscular) on Day 1 & 15 of first 28-day cycle,…

ByRidhi RastogiMarch 12, 2025

NEWS

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots:Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

ByRidhi RastogiMarch 7, 2025

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

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

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

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

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

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

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