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

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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

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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

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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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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