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Incyte
NEWS

The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

Shots: FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
May 16, 2025

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INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2025

Shots:   Q1’2025 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The talk of the town remained Intra-Cellular Therapies’ acquisition by Johnson & Johnson for ~$14.6B   The quarter highlighted breakthrough results, pivotal clinical data, including Eli Lilly and Incyte's P-III Study Data of Baricitinib to treat Alopecia Areata  PharmaShots brings…
April 1, 2025

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Incyte
NEWS

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…
March 18, 2025

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Incyte
NEWS

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: 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…
March 10, 2025

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Incyte & Genesis Therapeutics
NEWS

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

Shots: Incyte has partnered with Genesis to advance research, discovery, & development of novel small molecules using GEMS (Genesis Exploration of Molecular Space) AI platform, initially focusing on targets selected by Incyte As per the agreement, Incyte will gain exclusive rights to develop & commercialize products arising from this deal in exchange for $30M…
February 21, 2025

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Incyte and Syndax
NEWS

Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD) 

Shots:     Based on P-II (AGAVE-201) study, Niktimvo got FDA approval to treat chronic GvHD patients who failed at least two lines of previous therapy  Niktimvo patients (0.3 mg/kg, Q2W, n=79) achieved 75% ORR in 6mos. with 1.5mos. mToR; 60% maintained response at 12mos. Study also met key exploratory EPs, 56% patients achieved ≥7-point improvement in…
August 14, 2024

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Immunology Top 20 2024
TOP 20

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…
July 25, 2024

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