RLAY PRESS-RELEASE SEC Filing Analysis

Final — all horizons settled through T+60d

RLAY ▲ +34.85% at T+60d

LONG call ✓ call won +34.85% · α vs SPY +24.36% · entry $10.13 → $13.66

Last close $13.66 (close Jun 8) · +34.85% from $10.13 entry

Entry anchored
Mar 13, 03:59 PM ET
via Databento tick

T+1d

+1.28%

call +1.28% · α +1.01%

$10.26

settled 3mo ago

T+5d

-3.06%

call -3.06% · α -1.02%

$9.82

settled 3mo ago

T+20d

+45.61%

call +45.61% · α +41.83%

$14.75

settled 8w ago

T+60d

+34.85%

call +34.85% · α +24.36%

$13.66

settled in 6h

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Executive Summary

Relay Therapeutics announced updated Phase 1/2 data for zovegalisib (400mg BID fed) in PI3Kα-mutated HR+/HER2- metastatic breast cancer, showing a median progression-free survival (PFS) of 11.1 months and a 43% confirmed objective response rate. The FDA has granted Breakthrough Therapy designation for this indication, supporting the ongoing Phase 3 ReDiscover-2 trial.

Actionable Insight

The strong efficacy and clean safety profile at a lower, food-affected dose de-risks the Phase 3 ReDiscover-2 trial. Breakthrough Therapy designation may accelerate approval timeline. Monitor upcoming enrollment updates and next data readout for confirmatory signals.

Key Facts

Zovegalisib 400mg BID fed regimen showed 11.1-month median PFS in heavily pre-treated patients with PI3Kα-mutated HR+/HER2- metastatic breast cancer
Confirmed objective response rate (ORR) was 43% (15/35) in patients with measurable disease, rising to 52% in second-line only patients
Safety profile was favorable, with only four patients discontinuing due to treatment-related adverse events
FDA granted Breakthrough Therapy designation for zovegalisib in the ReDiscover-2 trial population
Pharmacokinetic data show 400mg fed achieves exposures comparable to 600mg fasted, supporting dosing strategy

Financial Impact

Potential blockbuster opportunity; targets ~140,000 US patients with PI3Kα-mutated HR+/HER2- breast cancer

revenuevaluationpipeline value

Risk Factors

Phase 3 trial may not replicate Phase 1/2 results
Competitive landscape includes capivasertib (being tested in the same trial arm) and other AKT/PI3K inhibitors
Forward-looking statements are subject to clinical and regulatory uncertainty

Market Snapshot

Exchange

Nasdaq

Documents Analyzed

This report is based on 1 press release from GlobeNewswire.

Document	Accession Number
PRESS-RELEASE Data (Synthetic)	press-3256120

8 reports for RLAY

T+1T+5T+20T+60

29% Hit rate 2 of 7 directional calls best @ T+5▲ +19.55%May 19, 2026

Filters

Reports for RLAY — sortable, filterable
	Type				Now
May 21, 2026 19d ago	8-K BEARISH ★ 6/10	$13.53 $14.26	▼ −5.40%	▼ −3.74%	$13.66 (−0.96%)
May 21, 2026 20d ago	Press Release BEARISH ★ 7/10	$13.66 $14.05	▼ −2.86%	▼ −1.01%	$13.66 (+0.00%)
May 19, 2026 21d ago	424B5 BEARISH ★ 6/10	$13.02 $13.90	▼ −6.76%	▼ −4.96%	$13.66 (−4.92%)
May 19, 2026 21d ago	Press Release BEARISH ★ 7/10	$13.02 $14.43	▼ −10.83%	▼ −9.59%	$13.66 (−4.92%)
May 19, 2026 21d ago	Press Release BULLISH ★ 7/10	$12.07 $14.43	▲ +19.55%	▲ +17.26%	$13.66 (+13.17%)
Apr 27, 2026 6w ago	8-K BULLISH ★ 8/10	$14.95 $13.09	▼ −12.44%	▼ −12.84%	$13.66 (−8.63%)
Apr 27, 2026 6w ago	Press Release BULLISH ★ 8/10	$14.95 $13.09	▼ −12.44%	▼ −12.84%	$13.66 (−8.63%)
Mar 16, 2026 12w ago	Press Release BULLISH ★ 8/10	$10.13 $9.82	▼ −3.06%	▼ −1.02%	$13.66 (+34.85%)

US Market Status

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