Incyte Genomics Inc - INCY STOCK NEWS

Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes, with U.S. launch expected in early February. Niktimvo is the first FDA-approved treatment targeting CSF-1R for chronic graft-versus-host disease (GVHD) in patients who failed at least two prior systemic therapies.

The approval was based on the AGAVE-201 trial results, where 75% of patients receiving 0.3 mg/kg every two weeks achieved response at six months. The approved dose is 0.3 mg/kg (max 35 mg) via intravenous infusion every two weeks for patients weighing at least 40 kg.

Notable adverse reactions occurred in 44% of patients, with 10% discontinuing treatment. The most common side effects included increased AST, infections, and decreased phosphate levels. The treatment has been added to NCCN Guidelines as a category 2A recommendation.

Incyte (NASDAQ:INCY) presented its growth strategy and 2025 milestones at the 43rd Annual J.P. Morgan Healthcare Conference. The company anticipates a transformational 2025 with four potential product launches, four pivotal trial readouts, seven proof of concept data readouts, and at least three Phase 3 study initiations.

Key highlights include the launch of Niktimvo™ (axatilimab-csfr) for chronic graft-versus-host disease, developments in tafasitamab following positive Phase 3 inMIND trial results for follicular lymphoma, povorcitinib's potential in hidradenitis suppurativa, mCALR-targeting molecule for myelofibrosis and essential thrombocythemia, and their CDK2 inhibitor for ovarian cancer treatment.

The company projects more than 10 high-impact launches across its portfolio by 2030, positioning itself for long-term growth.

Incyte (INCY) has announced the granting of restricted stock unit awards (RSUs) to 14 new employees, totaling 9,502 shares of company common stock. These grants were made under the company's 2024 Inducement Stock Incentive Plan, with both grant date and vesting commencement date set for January 2, 2025. The awards were approved by the compensation committee of Incyte's board of directors as an inducement for new employees joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest in four equal annual installments of 25% each, contingent upon continued employment with the company.

Incyte (INCY) has announced equity inducement awards for its new Executive Vice President and Head of U.S. Oncology, Mohamed Issa. The awards, approved by the company's compensation committee under Nasdaq Listing Rule 5635(c)(4), include two separate RSU grants:

1. An initial award of 48,671 restricted stock units (RSUs) with a grant and vesting date of January 6, 2025

2. A subsequent award of 27,812 RSUs to be granted on June 30, 2025

Both awards will vest over four years, with 25% vesting annually, contingent on Dr. Issa's continued employment with the company.

Incyte (Nasdaq: INCY) announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference.

The event will be held on Monday, January 13, 2025, at 10:30 am (PST). The presentation will be webcast live and accessible through Investor.Incyte.com. A replay of the webcast will be available for 30 days.

Incyte (INCY) announced positive results from the Phase 3 inMIND trial of tafasitamab (Monjuvi®) for relapsed or refractory follicular lymphoma. The study met its primary endpoint, showing significantly improved progression-free survival (PFS) of 22.4 months compared to 13.9 months in the control arm, representing a 57% reduction in risk.

The trial demonstrated improvements across secondary endpoints, including complete response (49.4% vs 39.8%), overall response rate (83.5% vs 72.4%), and duration of response (21.2 vs 13.6 months). The treatment was generally well-tolerated, with common side effects including neutropenia (48.5%), diarrhea (37.6%), and COVID-19 (31.4%).

Based on these results, Incyte plans to file a supplemental Biologics License Application for tafasitamab in FL by year-end 2024.

Incyte (INCY) announced positive results from Phase 3 POD1UM-304 trial evaluating retifanlimab (Zynyz®) combined with platinum-based chemotherapy in previously untreated metastatic non-small cell lung cancer (NSCLC) patients. The trial met its primary endpoint with significant improvement in overall survival of 18.1 months versus 13.4 months for chemotherapy alone.

Secondary endpoints were also met, showing 2-month improvement in progression-free survival (7.7 vs 5.5 months), higher overall response rate (52% vs 39%), and longer duration of response (12.7 vs 6.1 months). The treatment was generally well-tolerated with common side effects including anemia (62.7%), decreased appetite (22.6%), and decreased neutrophil count (22.1%). The company plans to submit a supplemental Biologics License Application in 2025.

Incyte (INCY) has announced the granting of restricted stock unit awards (RSUs) to 15 new employees, totaling 7,259 shares of common stock. The grants were made under the company's 2024 Inducement Stock Incentive Plan, with both grant date and vesting commencement date set for December 2, 2024. The compensation committee approved these awards as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest in four equal annual installments of 25% each, contingent upon continued employment with the company.

Incyte (Nasdaq: INCY) has updated its presentation schedule for Citi's 2024 Global Healthcare Conference. The company will now present on Tuesday, December 3, 2024, at 8:00 a.m. Interested parties can access the live webcast through Investor.Incyte.com, and a replay will remain available for 30 days following the presentation.