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NKTR Up on Start of Phase III Program on Rezpeg for Atopic Dermatitis

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Key Takeaways

  • NKTR launched ZENITH AD-1 and AD-2 to evaluate rezpeg in moderate-to-severe atopic dermatitis.
  • Nektar plans to begin the ZENITH AD-3 study in September for treatment-experienced patients.
  • NKTR expects initial top-line ZENITH AD data in mid-2028 and a BLA filing in 2029 if successful.

Nektar Therapeutics (NKTR - Free Report) announced that it has initiated the first two registrational studies in the phase III ZENITH AD program, which is evaluating its pipeline candidate, rezpegaldesleukin (rezpeg), for treating moderate-to-severe atopic dermatitis, also known as eczema.

The company initiated two late-stage studies – ZENITH AD-1 and ZENITH AD-2 – which are part of the phase III ZENITH AD program, investigating rezpeg, a novel regulatory T-cell biologic, in patients who are aged 12 years or above with moderate-to-severe atopic dermatitis.

Shares of Nektar were up 5.9% yesterday following the announcement of the news.

Year to date, shares of Nektar have rallied 62.5% against the industry’s decline of 4.5%.

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More on NKTR’s Phase III Program for Rezpeg

The phase III ZENITH AD program comprises three double-blind, placebo-controlled studies evaluating rezpeg in moderate-to-severe atopic dermatitis.

The newly initiated ZENITH AD-1 and ZENITH AD-2 studies will enroll patients who are systemic biologic/JAK inhibitor treatment-naïve, while the third study – ZENITH AD-3 – will enroll patients with prior systemic biologic and/or JAK inhibitor treatment experience.

The ZENITH AD-3 study is scheduled to begin in September.

Initial top-line data from the ZENITH AD program are expected to be announced in mid-2028. If successful, the company expects to file a biologics license application for rezpeg to treat moderate-to-severe atopic dermatitis in 2029.

Rezpeg selectively activates regulatory T-cells (Tregs) to calm the immune system and reduce inflammation. Unlike older IL-2 therapies that broadly stimulate both protective and aggressive immune cells, rezpeg specifically expands Tregs without harmful immune activation. This targeted approach makes it safer for treating autoimmune and inflammatory diseases.

NKTR’s Other Development Activities With Rezpeg

Besides atopic dermatitis, rezpeg is being developed as a self-administered injection for other autoimmune and inflammatory diseases, including alopecia areata and type I diabetes.

The phase IIb REZOLVE-AA study is investigating rezpeg for treating patients with severe-to-very severe alopecia areata.

In April 2026, Nektar announced new data from a blinded 16-week treatment extension period of its phase IIb REZOLVE-AA study, evaluating rezpeg in patients with severe-to-very-severe alopecia areata. The 52-week top-line data from the 16-week blinded treatment extension of the REZOLVE-AA study demonstrated deepening of responses in severe-to-very-severe alopecia areata following treatment with rezpeg.

The company plans to initiate a single registrational phase III study on rezpeg for treating alopecia areata in early 2027.

Meanwhile, initial data from the phase II study evaluating rezpeg in type I diabetes is also expected to be announced in 2027.

Nektar regained full rights to rezpeg from pharma giant Eli Lilly (LLY - Free Report) in April 2023 and took charge of its clinical development. Rezpeg was earlier developed in collaboration with LLY for several autoimmune indications.

Rezpeg is now a wholly-owned asset of Nektar, and the company owes no royalty payments to Eli Lilly.

NKTR's Zacks Rank & Stocks to Consider

Nektar currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 54% year to date.

Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 134.6% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.

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