Kymera's Eczema Drug Gets Fast Track Designation in the United States

Kymera Therapeutics, Inc. KYMR recently announced that the FDA granted Fast Track designation to pipeline candidate KT-621 for the treatment of moderate to severe atopic dermatitis (AD), the most common form of eczema.

KYMR stock was up 4.23% in after-hours trading yesterday.

KT-621 is an investigational, first-in-class, once-daily, oral degrader of STAT6 — the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation.

The designation from the FDA facilitates the development and expedites the review of drugs intended to treat serious conditions and address unmet medical needs. The designation allows for frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review if relevant criteria are met.

More on KYMR’s KT-621

KYMR recently reported positive results from the phase Ib study, BroADen AD, in which KT-621 demonstrated the potential to provide a once-daily oral treatment for Type 2 inflammatory diseases across every measure evaluated, including STAT6 degradation, biomarker modulation, clinical activity, impact on comorbid Type 2 diseases and safety. Shares gained on the same.

A phase IIb study, BROADEN2, in moderate to severe AD patients on KT-621 is ongoing, with data expected to be released by mid-2027. Kymera also plans to initiate a phase IIb study, BREADTH, of KT-621 in asthma in the first quarter of 2026. These studies aim to speed KT-621’s development and determine optimal dosing for upcoming subsequent parallel phase III registration studies in several Type 2 dermatology, gastroenterology and respiratory conditions.

KYMR Raises Funds

Kymera also announced the closing of its upsized underwritten public offering of $602 million of shares of its common stock.

Kymera sold and issued 8,050,000 shares of its common stock at a public offering price of $86 per share. The gross proceeds from the offering were approximately $692.3 million.

KYMR’s Impressive Performance in 2025

Kymera has put up a stellar performance so far in 2025.

In fact, shares of this clinical-stage biotechnology company have surged 64.1% year to date compared with the industry’s gain of 17.7%. The stock has also outperformed the sector and the S&P 500 Index during this period.

KYMR Outperforms Industry, Sector & S&P 500 Index

Kymera is deploying targeted protein degradation (TPD) to develop drugs for critical health problems, and the company has advanced the first degrader into the clinic for immunological diseases. Kymera’s novel TPD approach is promising, and the pipeline progress is encouraging.

In June 2025, Kymera entered into an exclusive option and license agreement with Gilead Sciences, Inc. GILD to accelerate the development and commercialization of a novel molecular glue degrader program targeting cyclin-dependent kinase 2 (CDK2) with broad oncology treatment potential in breast cancer and other solid tumors.

Kymera is advancing preclinical activities for its CDK2 molecular glue program aimed at treating breast cancer and solid tumors. If Gilead exercises its option, which includes an option payment to Kymera, it would assume all development, manufacturing and commercialization responsibilities for any products resulting from the collaboration.

Kymera also has a collaboration with Sanofi SNY to advance its pipeline. In June 2025, Sanofi informed Kymera that it had selected KT-485/SAR447971, an oral, highly potent and selective development candidate targeting IRAK4 for immuno-inflammatory diseases, to advance into clinical studies.

KYMR currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
 

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research