Incyte Corp. | MedPath

Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion

14 days ago

• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities. • The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake. • This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.

Incyte's Povorcitinib Shows Significant Efficacy in Phase 3 Trials for Hidradenitis Suppurativa

2 months ago

• Incyte's oral JAK1 inhibitor povorcitinib demonstrated statistically significant results in two Phase 3 trials (STOP-HS1 and STOP-HS2) for moderate to severe hidradenitis suppurativa, meeting primary endpoints at both 45mg and 75mg doses. • The drug showed particularly strong efficacy in patients previously exposed to biologics, with up to 45% achieving HiSCR50 response compared to 19.5% on placebo, addressing a critical unmet need in treatment-resistant cases. • With a favorable safety profile and rapid onset of action, povorcitinib could become the first oral targeted therapy for hidradenitis suppurativa, with regulatory submissions planned worldwide based on these positive results.

Incyte Faces Market Uncertainty as Povorcitinib Phase III Trial Results Loom

3 months ago

• Morgan Stanley maintains Hold rating on Incyte (INCY) with a $69.00 price target amid concerns over upcoming povorcitinib Phase III trial results in hidradenitis suppurativa. • Incyte's flagship drug Jakafi shows stable U.S. performance in Q4 2024, while Opzelura's 2025 sales projections fall slightly below market consensus despite strong Q4 performance. • Company's conservative 2025 outlook and uncertainty surrounding clinical trial outcomes create downward pressure on stock performance.

Retifanlimab Plus Chemotherapy Shows Promise in Advanced Squamous Cell Anal Carcinoma

5 months ago

• Phase 3 POD1UM-303 trial shows retifanlimab combined with chemotherapy significantly improves progression-free survival in patients with locally recurrent or metastatic squamous cell anal carcinoma (SCAC). • The combination therapy demonstrated a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone, marking a potential new standard of care. • Interim overall survival data also suggest a trend towards improvement with the addition of retifanlimab, with manageable immune-related adverse effects. • The study's success supports a planned supplemental biologics license application (sBLA) for retifanlimab, offering hope for addressing unmet needs in SCAC treatment.

Bioxodes Advances BIOX-101 for Intracerebral Hemorrhage Treatment with New Funding and Clinical Milestones

5 months ago

• Bioxodes secured €2.7 million in Series A extension funding to advance BIOX-101, a novel therapy for intracerebral hemorrhage (ICH). • The funding supports the completion of the BIRCH Phase 2a trial and preparations for a Phase 2b trial of BIOX-101 in ICH. • Interim data from the BIRCH Phase 2a trial, evaluating BIOX-101 in ICH patients, is expected in Q1 2025. • BIOX-101, derived from tick saliva, aims to reduce secondary brain injuries post-hemorrhagic stroke by preventing clot formation and neuroinflammation.

Court Blocks Sun Pharma's Alopecia Drug Launch Following Incyte Patent Dispute

7 months ago

• A US district court in New Jersey has granted Incyte's preliminary injunction against Sun Pharma's Leqselvi (deuruxolitinib), halting its launch for alopecia areata treatment. • The legal dispute centers on Incyte's patent claims regarding deuterated forms of ruxolitinib, potentially impacting Sun Pharma's projected $200 million annual sales target. • Sun Pharma plans to appeal the decision, which affects their recently FDA-approved JAK 1/2 inhibitor for treating severe alopecia areata, a condition affecting over 700,000 Americans.

Keros Therapeutics' Elritercept Shows Promise in Myelodysplastic Syndromes and Myelofibrosis Trials

7 months ago

• Keros Therapeutics is set to release updated Phase II trial data for Elritercept in Q4 2024, targeting ineffective hematopoiesis in myelodysplastic syndromes (MDS) and myelofibrosis (MF). • Elritercept has demonstrated durable transfusion independence and improved patient-reported fatigue in lower-risk MDS, potentially addressing anemia. • In myelofibrosis trials, Elritercept, alone or with Jakafi, has shown improvements in hematopoiesis, spleen volume reduction, and enhanced total symptom scores. • Keros Therapeutics is also advancing Cibotercept for pulmonary arterial hypertension and KER-065 for obesity and neuromuscular disorders.