Q3 2026 Biotech Catalyst Calendar: PDUFA Dates and Readouts to Watch

Why a Catalyst Calendar Matters

In biotech, the stock rarely moves on the quarter — it moves on the event. An FDA decision date, a Phase 3 topline readout, or an advisory committee meeting can re-rate a company overnight. Knowing which of those dates fall in the weeks ahead is the difference between watching a catalyst and being surprised by one.

This is a snapshot of the confirmed and expected catalysts across the rest of Q3 2026 (through September 30), drawn from FDA action dates and ClinicalTrials.gov records that BioSniper tracks and updates hourly. Every date below is anchored to a primary source — you can click any ticker through to the company's full timeline on our event calendar.

A note on precision: PDUFA target dates are set by the FDA and are the most concrete catalysts on the calendar, though they can shift with a review extension. Clinical readout windows are inferred from trial completion dates and are best read as "expected around" a month or quarter, not a guaranteed day.

The Five Confirmed PDUFA Dates

These are the FDA decision dates with a specific target set for the remainder of Q3. Each is a binary, high-conviction catalyst:

Target date	Company	Candidate	Setting
Jul 29	Outlook Therapeutics (OTLK)	ONS-5010	Ophthalmology
Aug 22	Capricor Therapeutics (CAPR)	Deramiocel	DMD cardiomyopathy
Aug 23	Ultragenyx (RARE)	DTX401 (AAV gene therapy)	Glycogen Storage Disease Type Ia
Sep 22	Ionis (IONS)	Zilganersen	Rare neurology
Sep 27	Praxis Precision Medicines (PRAX)	Relutrigine	SCN2A / SCN8A DEEs

Two of these are worth flagging for the risk they carry. Capricor's deramiocel decision on August 22 is a small-cap, single-asset event — the kind where the PDUFA outcome dominates the whole thesis. Ultragenyx's DTX401 on August 23 is a gene-therapy filing for an ultra-rare metabolic disease; gene-therapy reviews have historically carried more manufacturing and CMC uncertainty than small-molecule NDAs. For how the FDA's review clock actually works and what a Complete Response Letter would mean, see our complete guide to PDUFA dates.

Clinical Readouts on the Calendar

Beyond the FDA decisions, the quarter is dense with data. A few of the readouts that could move their sponsors:

• Cytokinetics (CYTK) — Phase 3 topline in symptomatic non-obstructive hypertrophic cardiomyopathy, expected early September. Cytokinetics is expanding aficamten's story beyond the obstructive setting; a positive non-obstructive result would widen the addressable population.
• MoonLake Immunotherapeutics (MLTX) — Phase 3 topline for sonelokimab in hidradenitis suppurativa, expected late September. A large-indication readout for a single-asset immunology name.
• Arrowhead (ARWR) — Phase 3 topline for plozasiran in severe hypertriglyceridemia, expected early September, extending the program's cardiometabolic data set.
• UroGen (URGN) — Phase 3 topline for UGN-103 in bladder cancer, expected in September.
• Alumis (ALMS) — Phase 2 readout for ESK-001 in systemic lupus erythematosus, expected by quarter-end.

These are a curated slice. Across the full window, BioSniper is tracking roughly 50 Phase 3 topline reads and 30 Phase 2 readouts in the quarter — from large-cap label expansions (AbbVie, AstraZeneca, Sanofi, Amgen all have Phase 3 data in the window) to single-asset smid-cap events where the readout is the company.

How to Use This — and Verify It Yourself

The value of a catalyst calendar is not the headline; it's the ability to trace each date back to the record and size the event against the balance sheet. A PDUFA is only as interesting as the company's cash runway into it, and a Phase 3 readout only matters if you know the primary endpoint it's powered to show.

That's the workflow BioSniper is built for: every catalyst on the calendar links to the company's filings, financials, and trial records, so you can go from "there's a PDUFA on August 22" to "here's the runway, the trial design, and the precedent" in a couple of clicks. To learn how to mine the underlying trial records directly, see How to Read ClinicalTrials.gov Like an Analyst.

Dates reflect FDA action dates and trial-record estimates as of July 19, 2026, and are subject to change. This is research information, not investment advice.