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Cytokinetics (CYTK) pipeline and stated timing

Pipeline at a glance

ProgramEventStageStated timingFiling
aficamten target date (company stated)PDUFANovember 14, 202610-Q ·
aficamten submissionPhase 3 20268-K ·

Source: ORION, orionbiotechai.com/company/CYTK, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/CYTK

Nearest upcoming stated timing: aficamten · PDUFA target date (company stated) · November 14, 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

aficamten

Matched

NDA/BLA submissionQ4 2026

Stage: Phase 3SEC filing · “Phase 3”

Public float: $2,500,000,000 · as of · SEC filing

Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026.

8-K · Filed · Last checked

Source details

Accession 0001193125-26-372456

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
aficamtenSubmissionQ4 2026
“Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

aficamtenFDA decisionNovember 14, 2026
“The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.”

Filed · 10-Q

Period not started

The stated period has not started yet, so there is nothing to compare.

aficamtenSubmissionQ4 2026
“Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See CYTK in the calendar · Review labels and methodology

A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.