Incyte Corp Stock Price, News & Analysis

Incyte and Syndax Pharmaceuticals announced the publication of pivotal Phase 2 AGAVE-201 trial results for Niktimvo™ (axatilimab-csfr) in The New England Journal of Medicine. The trial met its primary endpoint across all dose cohorts, with 74% of patients achieving a complete or partial response within the first six months of treatment at the 0.3 mg/kg every 2 weeks dose. Niktimvo has been approved by the U.S. FDA for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. It has also been added to the latest NCCN Guidelines® for chronic GVHD treatment. The drug showed rapid, durable responses in all organs studied and patient subgroups, with 60% of patients reporting clinically meaningful symptom burden reduction.

Incyte (INCY) announced promising early clinical data for INCB123667, a highly selective CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented at ESMO 2024 and during Incyte's investor event, show potential for treating cancers with increased Cyclin E1 activity. Key findings include:

- In platinum-resistant ovarian cancer patients (n=37), a 24.3% overall response rate was observed across three dose levels.

- The highest response rate of 31.3% was found in the 50mg BID cohort.

- A disease control rate of 75.7% was achieved in ovarian cancer patients.

- INCB123667 demonstrated a manageable safety profile with common adverse events including thrombocytopenia, anemia, and neutropenia.

Incyte plans to initiate a pivotal study in ovarian cancer in 2025 and explore combination treatments.

Incyte (Nasdaq:INCY) announced positive results from the Phase 3 POD1UM-303/InterAACT2 trial of retifanlimab (Zynyz®) in combination with platinum-based chemotherapy for treating adults with inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC). The trial met its primary endpoint, demonstrating a 37% reduction in the risk of progression or death. Key findings include:

- Median progression-free survival: 9.3 months (retifanlimab) vs 7.4 months (placebo)
- Median overall survival: 29.2 months vs 23 months
- Overall response rate: 56% vs 44%
- Duration of response: 14 months vs 7 months

Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by year-end 2024.

Incyte (Nasdaq: INCY) has announced the granting of restricted stock unit awards (RSUs) to 14 new employees, totaling 11,497 shares of the company's common stock. These awards were made under Incyte's 2024 Inducement Stock Incentive Plan, with a grant date and vesting commencement date of September 3, 2024. The compensation committee of Incyte's board of directors approved these grants as an inducement for new employees joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over a four-year period, with 25% of the shares vesting on each anniversary of the vesting commencement date, contingent upon the employee's continued service with Incyte. This stock-based compensation strategy aims to align employee interests with those of the company and its shareholders.

Incyte (NASDAQ: INCY) will present key oncology data at the ESMO Congress 2024 in Barcelona. Highlights include:

1. A Presidential Symposium featuring Phase 3 results for retifanlimab (Zynyz®) in squamous cell anal carcinoma (SCAC). These data will support a supplemental Biologics License Application (sBLA) filing planned by year-end 2024.

2. Initial Phase 1 data from a potential first-in-class CDK2 inhibitor program for CCNE1 ovarian and other advanced cancers.

3. An in-person analyst and investor event on September 14, 2024, to review key data, including new results from a later CDK2 data cut-off.

The presentations underscore Incyte's progress in developing treatments for areas with unmet medical needs.

Incyte (Nasdaq: INCY) announced positive topline results from the pivotal Phase 3 inMIND trial evaluating tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The trial met its primary endpoint of progression-free survival (PFS) and key secondary endpoints. Based on these results, Incyte plans to file a supplemental Biologics License Application for tafasitamab in this indication by year-end.

Follicular lymphoma is the most common indolent form of B-cell non-Hodgkin lymphoma, with treatment options for relapsed or refractory cases. Tafasitamab is already approved for certain diffuse large B-cell lymphoma patients in the US and Europe.

Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo™ (axatilimab-csfr) for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies in adults and pediatric patients weighing ≥40 kg. Niktimvo is the first approved anti-CSF-1R antibody targeting inflammation and fibrosis drivers in chronic GVHD.

Key points from the AGAVE-201 study:

• 75% overall response rate within 6 months
• 60% maintained response at 12 months
• 56% achieved ≥7-point improvement in modified Lee Symptom Scale score
• Responses across all affected organs

Niktimvo will be co-commercialized by Incyte and Syndax in the U.S., with launch expected by early Q1 2025.

Incyte (Nasdaq:INCY) has announced its participation in three major investor conferences in September 2024. The company will present at the Wells Fargo Healthcare Conference on September 4 at 12:45 pm (EDT), the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6 at 10:45 am (EDT), and the Cantor Global Healthcare Conference on September 19 at 9:45 am (EDT).

All presentations will be webcast live and can be accessed through Investor.Incyte.com. The webcasts will remain available for replay for 30 days after each event. This series of presentations provides investors with multiple opportunities to gain insights into Incyte's current operations and future prospects.

Incyte (Nasdaq:INCY) has announced the granting of restricted stock unit awards (RSUs) to 19 new employees. The awards, totaling 7,009 shares of the company's common stock, were made under Incyte's 2024 Inducement Stock Incentive Plan. The grants have a date of August 1, 2024, and were approved by the compensation committee of Incyte's board of directors in accordance with Nasdaq Listing Rule 5635(c)(4). These RSUs are designed to serve as an inducement for new employees joining the company.

The vesting schedule for the RSUs is structured over four years, with 25% of the shares vesting on each anniversary of the vesting commencement date. This vesting is contingent upon the employee's continued service with Incyte on each vesting date.