As of Nov 2, 2026: 6 PDUFA dates in January 2027. The first is on Jan 4, 2027. Scores as of 7:14 PM ET, 15 minutes behind.

FDA decisions in January 2027

PDUFA dates and FDA panels

Next FDA dateJan 4NUVB, in 63 days Decision dates6in January Companies6with a date

FDA dates in January 2027

A drug's name opens its date's page

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FDA decision dates and panels in January 2027, each with the company's Quality Score and cash runway
Date	Stock	Drug	Cash runway	Quality Score
January 20276
January 20276
January 20276
	NUVBNuvation BioTaletrectinibRunway not counted	TaletrectinibPDUFA date · in 63 days · 10-Q	Not countedBalance Jun 30	0
	IBRXImmunityBioAnktiva · 8-KCash: 5 quarters	AnktivaPDUFA date · in 65 days · 8-K	About 5 quartersBalance Jun 30	3
	DYNDyne TherapeuticsDrug not… · 8-KCash: 7 quarters	Drug not namedPDUFA date · in 80 days · 8-K	About 7 quartersBalance Jun 30	-4
	INSMInsmedDrug not… · 8-KCash: 6 quarters	Drug not namedPDUFA date · in 87 days · 8-K	About 6 quartersBalance Jun 30	1
	PRAXPraxis Precision MedicinesDrug not… · 8-KCash: into 2028	Drug not namedPDUFA date · in 88 days · 8-K	Into 2028The company's words	-3
	PHARPharmingDrug not… · 6-KRunway not counted	Drug not namedPDUFA date · in 89 days · 6-K	Not countedBalance Dec 2025	Not scored

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Pro members also see whether each company's cash lasts past its date, how its stock moved on past FDA news, and filters by area, phase, and size, with an optional alert before each date.

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January 2027, by week

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Kept by Andrew Gomes, Breakaway's founder, from the companies' filings on the SEC's EDGAR, each date's filing linked on its row. Updated Nov 2, 2026.

Download the month's dates (CSV)Download the month's dates (PNG)Free to reuse with a link to this page.

How to cite

Breakaway, FDA decisions in January 2027, Nov 2, 2026, getbreakaway.com/biotech/2027-01

Journalists: email support@getbreakaway.com for the data behind this page.

The FDA calendar.