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KYMR Stock Up as FDA Grants Fast Track Designation to Asthma Drug
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Key Takeaways
KYMR gains FDA Fast Track status for KT-621 to treat moderate-to-severe eosinophilic asthma.
KT-621 is a first-in-class oral STAT6 degrader in phase IIb studies, with data due starting in 2027.
KYMR is also advancing KT-621 in atopic dermatitis, with prior positive phase Ib results and Fast Track nod.
Kymera Therapeutics (KYMR - Free Report) announced that the FDA has granted a Fast Track designation to its lead candidate, KT-621, for the treatment of moderate-to-severe eosinophilic asthma. KYMR shares rose 4% following the announcement.
KT-621 is an investigational first-in-class, once-daily oral degrader of STAT6 — the central transcription factor driving IL-4/IL-13 signaling and type II inflammation. The candidate is the first STAT6-directed therapy to enter clinical development, positioning it as a potentially paradigm-shifting agent across a wide range of inflammatory diseases.
The Fast Track designation is granted by the FDA to facilitate drug development and expedite the review of therapies intended to treat serious diseases with unmet medical needs.
Year to date, shares of KYMR have risen 13.8% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Asthma is a chronic inflammatory lung disease that causes airway narrowing and breathing difficulties, with symptoms such as shortness of breath, coughing, wheezing and chest tightness. Despite available treatments like inhalers and injectable biologics, significant unmet needs for improved therapies remain.
More on KYMR’s KT-621
KT-621 is currently being evaluated in two global phase IIb studies.
In January, Kymera initiated the phase IIb BREADTH study, assessing the efficacy, safety and tolerability of three KT-621 dose levels in adults with moderate-to-severe eosinophilic asthma over a 12-week treatment period. The study’s primary endpoint is the percent change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1), with secondary endpoints encompassing a broad set of additional safety, efficacy and quality-of-life measures. Top-line data are expected to be reported in late 2027.
Besides asthma, the candidate is also being evaluated for the treatment of atopic dermatitis (AD), also known as eczema. In December, Kymera announced positive data from the phase Ib BroADen study on KT-621, which showed deep STAT6 degradation, significant biomarker reductions and meaningful clinical improvements across AD and related conditions, with favorable safety.
The company is developing KT-621 under the phase IIb BROADEN2 study for adults and adolescents with moderate-to-severe AD, with top-line data anticipated in mid-2027. The primary endpoint of the study is the percent change from baseline in the Eczema Area and Severity Index score.
In December 2025, the FDA also granted Fast Track designation to KT-621 for the treatment of moderate-to-severe AD.
These studies (BREADTH and BROADEN2) are expected to accelerate KT-621’s development and inform dose selection for subsequent parallel phase III registration trials across multiple type II inflammatory diseases.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 8.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 11.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $8.99. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.10. Year to date, shares of ANIP have declined 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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KYMR Stock Up as FDA Grants Fast Track Designation to Asthma Drug
Key Takeaways
Kymera Therapeutics (KYMR - Free Report) announced that the FDA has granted a Fast Track designation to its lead candidate, KT-621, for the treatment of moderate-to-severe eosinophilic asthma. KYMR shares rose 4% following the announcement.
KT-621 is an investigational first-in-class, once-daily oral degrader of STAT6 — the central transcription factor driving IL-4/IL-13 signaling and type II inflammation. The candidate is the first STAT6-directed therapy to enter clinical development, positioning it as a potentially paradigm-shifting agent across a wide range of inflammatory diseases.
The Fast Track designation is granted by the FDA to facilitate drug development and expedite the review of therapies intended to treat serious diseases with unmet medical needs.
Year to date, shares of KYMR have risen 13.8% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Asthma is a chronic inflammatory lung disease that causes airway narrowing and breathing difficulties, with symptoms such as shortness of breath, coughing, wheezing and chest tightness. Despite available treatments like inhalers and injectable biologics, significant unmet needs for improved therapies remain.
More on KYMR’s KT-621
KT-621 is currently being evaluated in two global phase IIb studies.
In January, Kymera initiated the phase IIb BREADTH study, assessing the efficacy, safety and tolerability of three KT-621 dose levels in adults with moderate-to-severe eosinophilic asthma over a 12-week treatment period. The study’s primary endpoint is the percent change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1), with secondary endpoints encompassing a broad set of additional safety, efficacy and quality-of-life measures. Top-line data are expected to be reported in late 2027.
Besides asthma, the candidate is also being evaluated for the treatment of atopic dermatitis (AD), also known as eczema. In December, Kymera announced positive data from the phase Ib BroADen study on KT-621, which showed deep STAT6 degradation, significant biomarker reductions and meaningful clinical improvements across AD and related conditions, with favorable safety.
The company is developing KT-621 under the phase IIb BROADEN2 study for adults and adolescents with moderate-to-severe AD, with top-line data anticipated in mid-2027. The primary endpoint of the study is the percent change from baseline in the Eczema Area and Severity Index score.
In December 2025, the FDA also granted Fast Track designation to KT-621 for the treatment of moderate-to-severe AD.
These studies (BREADTH and BROADEN2) are expected to accelerate KT-621’s development and inform dose selection for subsequent parallel phase III registration trials across multiple type II inflammatory diseases.
Kymera’s Zacks Rank & Stocks to Consider
KYMR currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 8.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 11.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $8.99. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.10. Year to date, shares of ANIP have declined 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.