Positive Phase 2b Clinical Results in Atopic Dermatitis and Alopecia Areata
First positive 2b results reported for Respag (Rezpeg) in atopic dermatitis (AD) and alopecia areata (AA), validating the Treg mechanism and positioning the program as a late-stage novel MOA candidate.
Strong 36-Week Maintenance Durability and Deepening of Response
36-week maintenance AD data showed durable efficacy and deepening responses with continued dosing (monthly or quarterly maintenance), including increases in EASI-75 and EASI-90 and up to a fivefold (~500%) increase in EASI-100 with extended treatment.
Large Safety Database and Favorable Safety Profile
Respag safety database now exceeds 1,000 patients (≈381 patient-years exposure) with a differentiated safety profile reported and no increased risk observed for systemic adverse events such as conjunctivitis, infection, or malignancy.
Regulatory and Developmental Milestones – Phase 3 Ready
Alignment with the FDA on phase 3 dose and trial elements for AD achieved; first Phase 3 patient randomization expected in June 2026, first pivotal data anticipated mid-2028, and goal to submit a BLA in 2029.
Commercial Development Plans – Convenient Dosing and Device Strategy
Respag demonstrated potential for extended monthly/quarterly maintenance dosing and company plans commercial launch in an auto-injector with weight-banded dosing to enable self-administration similar to single-use pen devices.
Strong Cash Position After Financings
Ended 2025 with $245.8M in cash and investments and no debt; since year-end raised approximately $476M net (≈$432M from an offering + ≈$44M from ATM) and expect to end 2026 with ~$400M–$460M in cash, supporting phase 3 investment.
Portfolio Expansion and Additional Programs
Ongoing TrialNet-sponsored phase 2 in new-onset type 1 diabetes (initial data expected in 2027), NKTR-0165 and NKTR-0166 TNFR2 agonist/bispecific programs advancing preclinically with planned IND submissions in 2027, and multiple additional indication opportunities being explored (e.g., asthma, chronic rhinosinusitis, dermatomyositis).
Commercially Relevant Findings: Asthma and Patient-Reported Outcomes
Respag showed statistically significant improvements in ACQ-5 (asthma control) in AD patients with comorbid asthma (including ~75% improvement in patients with uncontrolled asthma at baseline), and demonstrated rapid itch relief and improvements on patient-reported outcomes.