[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  quantumup [@Quantumup1](/creator/twitter/Quantumup1) on x 3529 followers Created: 2025-07-23 18:20:33 UTC H.C. Wainwright reit'd $ORKA Buy/$45 after Oruka📰that the FDA had cleared its IND application for its Phase 2a trial of ORKA-001 (the company's long-acting anti-IL-23p19 antibody) in moderate-to-severe PsO, called EVERLAST-A. $ABBV $PTGX - $JNJ #EDAV25 H.C. Wainwright said in its note: "This program is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately XX patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI XXX at Week XX. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This "no-dose" arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI XXX at Week XX will receive ORKA-001 every six months. Additional details on the EVERLAST-A design, as well as interim data from the ORKA-001 Phase X study, will be presented at the European Academy of Dermatology and Venereology ( #EADV) Congress in September. Oruka expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. Psoriasis trials historically have had low placebo rates and good reproducibility across phases of development, making this Phase 2a readout particularly impactful for risk-mitigating ORKA-001. We reiterate our Buy rating and 12-month target of $45." XXXXX engagements  **Related Topics** [$ucbjy](/topic/$ucbjy) [$orkas](/topic/$orkas) [$jnj](/topic/$jnj) [hc](/topic/hc) [$orka](/topic/$orka) [$abbv](/topic/$abbv) [stocks healthcare](/topic/stocks-healthcare) [$ptgx](/topic/$ptgx) [Post Link](https://x.com/Quantumup1/status/1948085842020590074)
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quantumup @Quantumup1 on x 3529 followers
Created: 2025-07-23 18:20:33 UTC
H.C. Wainwright reit'd $ORKA Buy/$45 after Oruka📰that the FDA had cleared its IND application for its Phase 2a trial of ORKA-001 (the company's long-acting anti-IL-23p19 antibody) in moderate-to-severe PsO, called EVERLAST-A. $ABBV $PTGX - $JNJ #EDAV25 H.C. Wainwright said in its note: "This program is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately XX patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI XXX at Week XX. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This "no-dose" arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI XXX at Week XX will receive ORKA-001 every six months.
Additional details on the EVERLAST-A design, as well as interim data from the ORKA-001 Phase X study, will be presented at the European Academy of Dermatology and Venereology ( #EADV) Congress in September. Oruka expects to share efficacy and response duration data from EVERLAST-A in 2H 2026.
Psoriasis trials historically have had low placebo rates and good reproducibility across phases of development, making this Phase 2a readout particularly impactful for risk-mitigating ORKA-001. We reiterate our Buy rating and 12-month target of $45."
XXXXX engagements
Related Topics $ucbjy $orkas $jnj hc $orka $abbv stocks healthcare $ptgx