This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:
Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025
Read More: Incyte
Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at…
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Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks.
Trial met its co-1EPs demonstrated 15.7% superior weight loss…
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J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps
OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…
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Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks
TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:
GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025
Read More: GSK
Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…
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AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers
Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…
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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…
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HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission
The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…
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Contineum Therapeutics reported the initiation of patient dosing in exploratory P-Ib study of PIPE-791 for chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP)
The company expects to enroll approx. 40 pts. for a treatment duration of 28 days and anticipates topline data in early 2026
PIPE-791…
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The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts.
The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…

