RLAY Relay Therapeutics, Inc.
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Executive Summary
Relay Therapeutics announced plans to advance its zovegalisib + atirmociclib + endocrine therapy triplet into a Phase 3 trial for frontline HR+/HER2- metastatic breast cancer based on strong early data showing a 44% ORR in heavily pre-treated patients. The combination demonstrated favorable tolerability, with low discontinuation and dose reduction rates, supporting its potential as a best-in-class regimen. A supply agreement with Pfizer secures access to atirmociclib for the planned trial.
Actionable Insight
This data significantly de-risks the zovegalisib program and supports its potential as a frontline therapy in a large market. Traders should monitor upcoming regulatory interactions and the initiation of the Phase 3 trial as key value inflection points. The strong tolerability profile differentiates it from prior PI3K inhibitors and increases commercial viability.
Key Facts
- Zovegalisib + atirmociclib + fulvestrant showed a 44% objective response rate (ORR) in 34 evaluable, heavily pre-treated patients with PI3Kα-mutated HR+/HER2- metastatic breast cancer.
- Only 3% of patients discontinued due to treatment-related adverse events (TRAEs), and grade 3+ TRAEs occurred in 40%, with no febrile neutropenia.
- Phase 3 trial in frontline patients is expected to start in early 2027, pending regulatory feedback, with a randomized design comparing the triplet to standard CDK4/6 inhibitor + AI.
- Pfizer will supply both atirmociclib (for the experimental arm) and palbociclib (for the control arm) under a clinical supply agreement.
- 77% of patients (48/62) remain on treatment as of the April 13, 2026 data cutoff, with a median follow-up of 7.4 months.
Financial Impact
High-value late-stage clinical catalyst: potential blockbuster in a ~140,000-patient U.S. frontline market; deal value not disclosed but de-risked development via Pfizer supply agreement.
Risk Factors
- Phase 3 trial has not yet started; regulatory feedback could delay or alter the design.
- Interim data may not predict final outcomes; longer follow-up needed for progression-free survival.
- Competition from existing CDK4/6 inhibitors and emerging PI3Kα therapies remains intense.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3281389 |
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May 21, 2026
19d ago
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8-K
| $13.53 $14.26 | ▼ −5.40% | ▼ −3.74% | $14.09 (−4.14%) |
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May 21, 2026
20d ago
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Press Release
| $13.66 $14.05 | ▼ −2.86% | ▼ −1.01% | $14.09 (−3.15%) |
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May 19, 2026
21d ago
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424B5
| $13.02 $13.90 | ▼ −6.76% | ▼ −4.96% | $14.09 (−8.22%) |
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May 19, 2026
21d ago
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Press Release
| $13.02 $14.43 | ▼ −10.83% | ▼ −9.59% | $14.09 (−8.22%) |
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May 19, 2026
21d ago
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Press Release
| $12.07 $14.43 | ▲ +19.55% | ▲ +17.26% | $14.09 (+16.74%) |
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Apr 27, 2026
6w ago
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8-K
| $14.95 $13.09 | ▼ −12.44% | ▼ −12.84% | $14.09 (−5.75%) |
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Apr 27, 2026
6w ago
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Press Release
| $14.95 $13.09 | ▼ −12.44% | ▼ −12.84% | $14.09 (−5.75%) |
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Mar 16, 2026
12w ago
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Press Release
| $10.13 $9.82 | ▼ −3.06% | ▼ −1.02% | $14.09 (+39.09%) |
US Market Status
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