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Incyte Corporation (INCY) is a global biopharmaceutical leader focused on innovative therapies in oncology, dermatology, and immunology. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's clinical developments, regulatory milestones, and strategic initiatives.
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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.
Incyte (NASDAQ: INCY) reported its Q2 2024 financials, showing a 9% increase in total revenues year-over-year, reaching $1.044 billion.
Key drivers: Jakafi® (ruxolitinib) revenues grew 3% to $706 million, and Opzelura® revenues surged 52% to $122 million. The company completed a $2 billion share repurchase, reflecting confidence in its portfolio.
Incyte's strategic focus is on high-impact clinical programs, with positive Phase 3 results for retifanlimab in SCAC and NSCLC. The acquisition of Escient Pharmaceuticals added promising assets to its R&D pipeline.
However, the company faced a GAAP net loss of $444.6 million for Q2 2024, driven by high R&D expenses, including costs from the Escient acquisition.
Incyte raised the lower end of its full-year Jakafi revenue guidance to $2,710-2,750 million and adjusted R&D expense guidance to reflect ongoing investments.
Incyte (Nasdaq: INCY) will release its Q2 2024 financial results on July 30, 2024, at 7:00 a.m. ET. A conference call and webcast to discuss these results will follow at 8:00 a.m. ET. Domestic participants can dial in at 877-407-3042, while international participants can use 201-389-0864, with the conference ID 13747471. For those unable to attend, a replay will be available for thirty days by dialing 877-660-6853 (U.S.) or 201-612-7415 (international) and using the same conference ID. The live webcast and slides can be accessed at Investor.Incyte.com and will be available for replay for ninety days.
Incyte (Nasdaq: INCY) announced the issuance of restricted stock unit (RSU) awards and stock options to 27 new employees under the 2024 Inducement Stock Incentive Plan. The total RSUs granted represent 14,577 shares, and stock options represent 18,149 shares of the company's common stock. The grants were approved by the compensation committee and set to begin vesting on July 1, 2024. Each RSU will vest 25% annually over four years, contingent on continued employment. The stock options have a $60.87 exercise price, with a ten-year term, and will vest 25% after one year, with the remaining 75% vesting monthly over the next three years.