Oruka Therapeutics, Inc. 8-K

What Happened

• On May 29, 2026, Oruka Therapeutics, Inc. (Oruka) entered into a First Amendment to the IL-23 License Agreement with Paragon Therapeutics, Inc., amending the December 17, 2024 License Agreement. The Amendment expands the License Agreement’s defined “Field” to include inflammatory bowel disease (IBD).
• The Amendment imposes timing restrictions on human dosing of Oruka’s candidate ORKA-001 for IBD: no dosing in clinical trials as part of a combination therapy until June 1, 2028, and no monotherapy dosing until June 1, 2030. The Amendment is filed as Exhibit 10.1 to the 8-K (filed June 1, 2026).

Key Details

• Amendment date: May 29, 2026; original License Agreement dated December 17, 2024.
• Field expansion: IBD was not included previously; the Amendment adds all therapeutic, prophylactic, palliative and diagnostic uses for IBD.
• Dosing restrictions: combination trials restricted until June 1, 2028; monotherapy trials restricted until June 1, 2030.
• Change-of-control/material-transaction clause: if Oruka (or a Paragon licensee of its retained rights) completes a material transaction (including change of control), remaining restrictions outside the initial Field definition will terminate on June 1, 2028.

Why It Matters

• This contractual change allows Oruka to pursue IBD indications for ORKA-001 but establishes firm timelines delaying human dosing for combination and monotherapy trials. That affects the near-term clinical-development timeline and when Oruka might generate clinical data and related investor milestones for an IBD indication.
• The change-of-control clause means a material transaction could accelerate the end of some restrictions (effective June 1, 2028), which could be relevant to strategic deals or corporate transactions. The filing does not disclose any financial terms.