INCY — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-07-28

• The FDA has granted JAKAFI orphan drug status for MF, PV and GVHD. Because of these orphan designations, the ORPHAN Cures Act extended the period before ruxolitinib phosphate becomes eligible for selection for Medicare drug price negotiation under the Inflation Reduction Act.

• In May 2026, the FDA approved JAKAFI XR (ruxolitinib) extended release tablets for the treatment of adults with intermediate- or high-risk MF, adults with PV who have had an inadequate response to or are intolerant to hydroxyurea, as well as adults and children aged 12 years and older with steroid-r…

• INCB160058 is an Incyte-discovered, novel JAK2V617F mutant-specific inhibitor for patients with MPNs harboring a JAK2V617F mutation. Following a comprehensive review of available data, we discontinued further development of INCB160058 to prioritize our next-generation JAK2V617F-targeted pipeline.

• In July 2026, we completed the acquisition of Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, which has been developing latarcibart, a novel investigational monoclonal antibody that modulates Protein S to restore hemostasis. Latarcibart has received Breakthrough Therapy, Fast Trac…

• In July 2026, data from the Phase 1/2 multidose study of latarcibart in patients with VWD were presented at the 2026 International Society on Thrombosis and Haemostasis (ISTH) Congress, demonstrating that once-monthly SC treatment with latarcibart resulted in an 81% median reduction in annualized bl…

Text removed vs the prior filing · source: 10-Q · 2026-04-28

• The FDA has granted JAKAFI orphan drug status for MF, PV and GVHD. In addition, ruxolitinib phosphate qualifies for the Small Biotech Exception from the Centers for Medicare and Medicaid Services (“CMS”) under the Inflation Reduction Act.

• We are developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and in combinations. Bioavailability and bioequivalence data were published for ruxolitinib’s once-daily (“QD”) extended release (“XR”) formulation at the European Hematology Association Virtual Congress in Ju…

• INCB160058 is an Incyte-discovered, novel JAK2V617F mutant-specific inhibitor being evaluated in patients with MPNs harboring a JAK2V617F mutation. In the first quarter of 2026, we initiated dosing of the amorphous solid dispersion (“ASD”) formulation of INCB160058 in the Phase 1 trial. Results from…

• Prurigo Nodularis. In January 2026, we received FDA feedback indicating that an additional clinical study would be required to support registration in mild to moderate prurigo nodularis (“PN”). Based on this feedback we have decided to pause further development of ruxolitinib cream in PN at this tim…

• In April 2026, we entered into an agreement granting a third party worldwide commercialization rights for zilurgisertib.

Text added vs the prior filing · source: 10-Q · 2026-07-28

• Third-party payors are increasingly challenging the prices charged for medical products and services, and payors and employers are adopting benefit plan changes that shift a greater portion of prescription drug costs to patients. Third party pharmacy benefit managers (PBMs), other similar organizati…

• •prepare and execute our commercial product launch strategies;

• Healthcare reform measures, including federal and state drug pricing reforms, could impact the pricing and profitability of pharmaceuticals and adversely affect the commercial viability of our or our collaborators’ products and drug candidates.

• In recent years, the U.S. federal government has enacted significant healthcare and drug pricing reforms through legislation and regulation. These reforms include modifications to Medicare reimbursement, increased manufacturer rebate obligations under certain government healthcare programs and the e…

• In addition, the Inflation Reduction Act of 2022 (the “IRA”) introduced several significant changes to Medicare, including: requiring CMS to negotiate prices for certain high-expenditure, single source Medicare drugs; imposing inflation-based rebates on manufacturers whose prices increase faster tha…

Text removed vs the prior filing · source: 10-Q · 2026-04-28

• Third-party payors are increasingly challenging the prices charged for medical products and services, and payors and employers are adopting benefit plan changes that shift a greater portion of prescription drug costs to patients. Third party pharmacy benefit managers (PBMs), other similar organizati…

• Healthcare reform measures could impact the pricing and profitability of pharmaceuticals, and adversely affect the commercial viability of our or our collaborators’ products and drug candidates. If recent proposals for changes to Medicare and Medicaid reimbursement of drug prices are adopted into la…

• In recent years, through legislative and regulatory actions and executive orders, the U.S. federal government has made substantial changes to various payment systems under the Medicare and other federal healthcare programs. Comprehensive reforms to the U.S. healthcare system were enacted, including …

• In addition, there has been an increasing legislative and enforcement interest in the United States with respect to drug pricing practices. This has resulted in significant legislative activity and proposals from the prior and current administrations relating to prescription drug prices and reimburs…

• Further, if we become the subject of any governmental or other regulatory hearing or investigation with respect to the pricing of our products or other business practices, we could incur significant expenses and could be distracted from the operation of our business and execution of our business str…

Text added vs the prior filing · source: 10-Q · 2026-07-28

• (c) During the three months ended June 30, 2026, the following officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934 (the “Exchange Act”)) of our Company adopted a prearranged trading plan relating to our common stock and intended to satisfy the affirmative defense of Rule …

• Pablo Cagnoni, our President and Global Head of Research and Development, adopted a trading plan on April 30, 2026 providing for the sale of up to an aggregate of 139,381 shares of our common stock until May 1, 2028.

• Patrick Mayes, our Executive Vice President, Chief Scientific Officer, adopted a trading plan on April 29, 2026 providing for the sale of up to an aggregate of 52,131 shares of our common stock until April 29, 2027.

• During the three months ended June 30, 2026, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of our Company adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities, whether or not intended to satisfy the affirmative defen…

Text removed vs the prior filing · source: 10-Q · 2026-04-28

• (a) On April 28, 2026, the Company announced that it has appointed Suketu Upadhyay as Executive Vice President and Chief Financial Officer of the Company, effective as of May 4, 2026.

• Mr. Upadhyay, age 57, previously served as Chief Financial Officer and Executive Vice President, Finance, Operations & Supply Chain of Zimmer Biomet, a medical device company. He was appointed to this role in August 2023, having first joined Zimmer Biomet in 2019 as Executive Vice President and Chie…

• Mr. Upadhyay’s employment will be on an at-will basis. As Executive Vice President and Chief Financial Officer of the Company, Mr. Upadhyay will receive a base salary of $850,000 and will have a target cash bonus opportunity under the Company’s annual incentive compensation plan equal to 60% of his …

• Upon employment, in accordance with the Company’s customary practice, Mr. Upadhyay will enter into an employment agreement on the same form as the Company’s employment agreements with its other Executive Vice Presidents. Mr. Upadhyay’s employment agreement will provide for certain payments and benef…

• There are no arrangements or understandings between Mr. Upadhyay and any other persons pursuant to which he was selected as Executive Vice President and Chief Financial Officer. Mr. Upadhyay has no family relationships with any of the Company’s directors or executive officers, and he has no direct o…