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Home › PDUFA Calendar › RHHBY

RHHBY PDUFA Date: Giredestrant

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
FDA decision (PDUFA) target 2026-11-30 · Roche Holding AG ADR · Early breast cancer

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

Genentech said on June 1, 2026 that the FDA accepted the NDA for giredestrant in early breast cancer (lidERA) and is expected to make a decision on the approval by November 30, 2026. A separate NDA for giredestrant with everolimus in advanced breast cancer (evERA) has a December 18, 2026 goal date. (Genentech, June 1, 2026)

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

The story

Giredestrant is under FDA review to treat Early 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 . TruqapBTAI . 2026-11-14Same month decision . IGALMI® (dexmedetomidine)
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 date2026-11-30
Drug / candidateGiredestrant
IndicationEarly breast cancer
CompanyRoche Holding AG ADR
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04961996

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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 2026-11-30 for Giredestrant. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is RHHBY's drug Giredestrant?
Giredestrant is Roche Holding AG ADR's candidate under FDA review for Early 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.