Incyte Corp Stock Price, News & Analysis

Incyte (INCY) announced results from Phase 3 TRuE-PN clinical trials evaluating ruxolitinib cream 1.5% (Opzelura®) for prurigo nodularis (PN) treatment. The TRuE-PN1 study met its primary endpoint, with 44.6% of patients achieving significant itch improvement versus 20.6% in the vehicle control group at Week 12.

Key secondary endpoints were also met, including:

• 15.8% vs 3.9% achieved Investigator's Global Assessment Treatment Success
• 11.9% vs 2.9% achieved overall treatment success
• 29.7% vs 12.7% showed significant itch improvement at Week 4

In the TRuE-PN2 study, while showing positive trends across secondary endpoints, the primary endpoint did not reach statistical significance due to high placebo response. The safety profile remained consistent with previous data. These results will inform upcoming regulatory discussions.

Incyte (INCY) has announced the granting of restricted stock unit awards (RSUs) to 16 new employees, totaling 13,351 shares of company 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 March 3, 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 (NASDAQ: INCY) announces multiple data presentations at the upcoming 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, March 7-11, 2025. The presentations will feature new data from their dermatology portfolio, including:

- Late-breaking Phase 3 data for ruxolitinib cream (Opzelura®) in prurigo nodularis from the TRuE-PN1 study

- Multiple presentations on ruxolitinib cream in atopic dermatitis, including long-term safety data from TRuE-AD1 and TRuE-AD2 Phase 3 studies, treatment patterns, and 52-week disease control in children aged 2-11 years

- Data for axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD)

Incyte (INCY) and Genesis Therapeutics have announced a strategic collaboration focused on developing novel small molecule medicines using Genesis' GEMS artificial intelligence platform. The partnership grants Incyte exclusive rights to develop and commercialize collaboration products.

Under the agreement, Genesis will receive a $30 million upfront payment and could earn up to $295 million in milestone payments per target. The collaboration initially focuses on two targets, with Incyte having the option to add a third target for a predetermined fee. Genesis is also eligible for tiered royalties on sales of approved collaboration products.

The partnership aims to leverage Genesis' proprietary AI technology, GEMS (Genesis Exploration of Molecular Space), to accelerate the discovery and optimization of small molecule compounds for Incyte-selected targets.

Incyte (INCY) has announced its participation in two major healthcare investor conferences in March 2025. The company will present at the Cowen 45th Annual Health Care Conference on Monday, March 3, at 11:10 am EST, and at the Leerink Partners 2025 Global Healthcare Conference on Tuesday, March 11, at 9:20 am EST.

Both presentations will be accessible through live webcasts on Investor.Incyte.com and will remain available for replay for 30 days following the events.

Incyte (INCY) reported strong financial results for Q4 and full-year 2024, with total revenues reaching $1.2B (+16% Y/Y) in Q4 and $4.2B (+15% Y/Y) for FY2024. Key revenue drivers included Jakafi, with net revenues of $773M (+11% Y/Y) in Q4 and $2.8B (+8% Y/Y) for FY2024, and Opzelura, with net revenues of $162M (+48% Y/Y) in Q4 and $508M (+50% Y/Y) for FY2024.

The company provided 2025 guidance for Jakafi ($2,925-$2,975M) and Opzelura ($630-$670M). 2025 is expected to be a transformative year with four new product launches, four pivotal study readouts, at least three Phase 3 study initiations, and seven proof of concept study readouts. A key development includes ruxolitinib extended-release meeting FDA bioequivalence criteria, with submission planned by year-end 2025.

Incyte (INCY) has announced the granting of restricted stock unit awards (RSUs) to 24 new employees, totaling 16,301 shares of 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 February 3, 2025. The compensation committee approved these awards as inducement for new employees joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over four years, with 25% of the shares vesting annually on each anniversary of the vesting commencement date, contingent upon continued employment with the company.

Incyte (Nasdaq:INCY) has announced its schedule for the fourth quarter and year-end 2024 financial results conference call and webcast. The event is set for 8:00 a.m. ET on Monday, February 10, 2025. The related press release will be issued at 7:00 a.m. ET on the same day.

The call will be accessible via domestic dial-in at 877-407-3042 and international dial-in at 201-389-0864, using the conference ID number 13751174. For those unable to attend, a replay will be available for thirty days. The U.S. replay dial-in number is 877-660-6853 and the international replay dial-in number is 201-612-7415, also using the conference ID number 13751174. Additionally, a live webcast with slides will be accessible at Investor.Incyte.com and available for replay for ninety days.

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.