Kymera Therapeutics, Inc. KYMR announced its business goals for 2025, along with anticipated progress on its pipeline of immunology programs.
The stock rose 8% on the announcement.
Shares of KYMR have surged 47.2% in a year against the industry’s decline of 16%.
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Kymera is developing KT-621, an investigational, first-in-class, once-daily oral degrader of STAT6. The candidate has demonstrated dupilumab-like activity and very good safety data in preclinical models.
Recruitment is ongoing in a phase I study with multiple single ascending dose and multiple ascending dose cohorts completed. KT-621 has the potential to address numerous Th2 diseases, including atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, chronic spontaneous urticaria and prurigo nodularis, among others.
Kymera expects to complete this phase I study and report data in the second quarter of 2025. It will also advance the candidate in a phase lb study in AD patients in the second quarter of 2025 and report data in the fourth quarter of the year.
A phase IIb study in AD is planned for the fourth quarter, followed by a mid-stage study in asthma in early 2026.
Kymera is also evaluating KT-295, an investigational, first-in-class, once-daily oral degrader of TYK2, a member of the Janus kinase (JAK) family required for Type I IFN, IL-12 and IL-23 signaling.
The company expects to file an investigational new drug application for the candidate and initiate dosing in the phase I healthy volunteer clinical study in the second quarter of 2025. Data from the study is expected in the fourth quarter.
KT-474 (SAR444656) is a first-in-class IRAK4 degrader in development for the treatment of immune-inflammatory diseases with significant patient needs, such as hidradenitis suppurativa (HS) and AD.
In July 2024, partner Sanofi SNY informed Kymera about its intention to rapidly expand the ongoing mid-stage studies on KT-474 (SAR444656) toward pivotal studies. Sanofi informed Kymera about the decision to expand the studies after an independent data review committee reviewed preliminary safety and efficacy data in these studies.
Kymera, in collaboration with Sanofi, plans to advance KT-474 in phase IIb dose-ranging clinical studies in HS and AD, with primary completion expected in the first half of 2026 for HS and mid-2026 for AD.
In addition, Kymera plans to announce the next immunology program, a first-in-class development candidate addressing an undrugged transcription factor, in the first half of 2025. Clinical testing is targeted in early 2026.
Last year, Kymera decided not to continue developing KT-333 (STAT3) and KT-253 (MDM2) beyond phase I based on an overall assessment of its clinical oncology programs and given progress across the immunology pipeline.
Kymera has a sound cash position. As of Dec. 31, 2024, KYMR had an estimated $850 million in cash, which should fund its operations into mid-2027.
Kymera currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the biotech sector are Castle Biosciences CSTL and BioMarin Pharmaceutical BMRN, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share estimates for 2025 have remained constant at $1.84.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
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