Key Takeaways
- Oruka Therapeutics shares rose 12% after ORKA-001, its drug for psoriasis, completely cleared the skin of 61% of patients on the high dose at Week 16 of its Phase 2b EVERLAST-B trial.
- The results closely match the earlier EVERLAST-A trial, so the drug’s efficacy looks much more solid now.
- The bigger prize is dosing: Oruka is aiming for one or two shots a year. AbbVie’s Skyrizi is given every 12 weeks and Johnson & Johnson’s Tremfya every 8.
- The next test is the 52-week EVERLAST-A data due in December, and Phase 3 is planned for the first half of 2027.
Oruka Therapeutics (ORKA) is up 12% today after its psoriasis drug passed its second big test, with results that look a lot like the first.
Round two looks like round one
Early this morning, Oruka reported Week 16 results from EVERLAST-B, its Phase 2b trial of ORKA-001. These are the results for the 600 mg group, the dose it plans to take into Phase 3:
- 61% of patients reached PASI 100, or completely clear skin (the trial’s main goal), against 0% on placebo.
- 86% reached PASI 90.
- 39% had at least one adverse event, against 43% on placebo, and none had a serious one.
That’s right in line with the earlier EVERLAST-A trial, where 63% of high-dose patients reached PASI 100 at Week 16.
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One or two shots a year
Oruka is aiming to dose ORKA-001 just once or twice a year. Skyrizi, from AbbVie (ABBV), is given every 12 weeks, and Tremfya, from Johnson & Johnson (JNJ), every 8.
Dr. Joel Gelfand, a University of Pennsylvania dermatology professor and EVERLAST-B’s lead investigator, said in Oruka’s release:
“The potential for these effects to be long lasting, with just one or two doses a year, would be a paradigm shift in moderate-to-severe psoriasis management.”
Plus: Oruka says ORKA-001’s PASI 100 rate across its two trials runs about 20 points above what the leading IL-23 drugs have shown in their own trials. (That comparison is across separate trials; no head-to-head study has been run.) And by Oruka’s count, psoriasis has already produced several drugs with $5 billion or more in yearly sales.
December is the next big test
Oruka expects 52-week EVERLAST-A results in December, a first look at whether the response can last on a shot once a year. Phase 3 should start in the first half of 2027.
And it has the cash to get there…
That pile more than doubled in the June quarter, and Oruka says it should last through filing ORKA-001 for approval. Meanwhile, the burn has run $21 million to $24 million a quarter lately…
Phase 3 will cost more, though. (And I wouldn’t be surprised to see Oruka pad that cushion after a result like this.)
My take: Two trials now back up ORKA-001’s clear-skin numbers. If December shows the response holds on a once-a-year shot, that’s Gelfand’s “paradigm shift,” and there’s plenty of upside from here for a company valued at a little over $5 billion before today.
Of course, these are 16-week results, and Phase 3 hasn’t started yet.
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