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Home › PDUFA Calendar › RHHBY

RHHBY PDUFA Date: Giredestrant (evERA, with everolimus)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
FDA decision (PDUFA) target 2026-12-18 · Roche Holding AG ADR · ER-positive advanced breast cancer

Also under FDA review from Roche Holding AG, as a separate application: Giredestrant (lidERA), Nov 30, 2026. One application, one page; this page is the evERA application with the Dec 18, 2026 goal date.

Genentech said on February 19, 2026 that the FDA accepted the NDA for giredestrant in combination with everolimus and is expected to make a decision on the approval by December 18, 2026. A separate NDA for giredestrant alone in early breast cancer (lidERA) has a November 30, 2026 goal date. (Genentech, February 19, 2026)

More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

Giredestrant in combination with everolimus is under FDA review to treat ER-positive advanced breast cancer.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapEXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

RHHBY run-up into the PDUFA (last ~120 days)

$60.58$47.39
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-18
Drug / candidateGiredestrant in combination with everolimus
IndicationER-positive advanced breast cancer
CompanyRoche Holding AG ADR
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05306340

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

When is the RHHBY PDUFA date?
The FDA PDUFA target date for RHHBY (Roche Holding AG ADR) is 2026-12-18 for Giredestrant in combination with everolimus. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is RHHBY's drug Giredestrant in combination with everolimus?
Giredestrant in combination with everolimus is Roche Holding AG ADR's candidate under FDA review for ER-positive advanced breast cancer.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.