SEC filing terms, in plain language

SEC terms in our research (8-K, 10-K, 10-Q, press releases, materiality, Regulation FD, class actions) explained simply, with the SEC's own definitions.

Half of every deep research answer comes from what a company told investors, and companies tell investors through filings with the U.S. Securities and Exchange Commission (SEC). This page explains the filings and terms you will meet, in the same three parts as the FDA approval terms: our explanation, the SEC's words in a shaded box with a link, and an example from our research.

Most SEC definitions here come from Investor.gov, the SEC's website for individual investors, and from the SEC's investor bulletins.

Where filings live#

EDGAR: The SEC's free public database of company filings. Every SEC document our research quotes links to its copy on EDGAR, at sec.gov/Archives/edgar/….

“The SEC’s EDGAR database provides free public access to corporate information, allowing you to quickly research a company’s financial information and operations by reviewing registration statements, prospectuses and periodic reports filed on Forms 10-K and 10-Q.”Investor.gov (SEC) · EDGAR

The 8-K: news, within days#

Form 8-K current report

A short filing a company must make when something important happens. When a company receives a Complete Response Letter, the 8-K and its press release are usually how investors first hear about it, often within a few days.

“Public companies file Form 8-K, known as the "current report," to the SEC to announce major events that shareholders should know about, including bankruptcy proceedings, a change in corporate leadership (such as a new director or officer) and preliminary earnings announcements.”Investor.gov (SEC) · 8-K

“Companies are required to make most 8-K disclosures within four business days of the triggering event and in some cases even earlier.”Investor.gov (SEC) · Investor Bulletin: How to Read an 8-K

The FDA's second letter to Replimune is dated April 10, 2026; Replimune's 8-K reporting it was filed April 13. Read it →

Material

Important enough that a sensible investor would want to know before deciding to buy or sell. Companies must disclose material events; deciding what is material involves judgement, which is one reason two companies can describe similar letters very differently.

“The types of information required to be disclosed on Form 8-K are generally considered to be “material.” That means that, in general, there is a substantial likelihood that a reasonable investor would consider the information important in making an investment decision.”Investor.gov (SEC) · How to Read an 8-K

8-K items

An 8-K is organised by numbered items, one per kind of event. The ones you will see most in our research:

Item	What it is for	The SEC's words
2.05	Restructuring, such as job cuts	“This item requires disclosure of restructuring plans under which the company will incur material charges.”
7.01	Regulation FD disclosure (see below)	“The purpose of Regulation FD—for “fair disclosure”—is to prevent companies from selectively disclosing material, non-public information.”
8.01	Other events, often an FDA letter	“This is the place where companies may report anything that they believe is important but is not specifically required elsewhere in the 8-K.”
9.01	Financial statements and exhibits	“Under this item, a company must file certain financial statements and list the exhibits that it has filed as part of the 8-K.”

Source for all four: Investor.gov (SEC) · How to Read an 8-K.

Replimune's 8-K on its second letter also announced job cuts. Read it →

Exhibit 99.1 and the press release

An 8-K is often a short cover form with the company's press release attached as an exhibit, usually numbered 99.1. Most of what a company says about an FDA letter is in that press release. Our citations link to the exhibit itself, so the address often ends in something like ex99-1.htm.

“If the registrant makes available to its stockholders or otherwise publishes, within the period prescribed for filing the report, a press release or other document or statement containing information meeting some or all of the requirements of this Form, the information called for may be incorporated by reference to such published document or statement … provided copies thereof are filed as an exhibit to the report on this Form.”SEC · Form 8-K, General Instructions

“Replimune disagrees with the FDA about whether the data set … is sufficient” is quoted from Exhibit 99.1 of Replimune's April 2026 8-K.

Furnished and filed

A technical but useful distinction. Information filed with the SEC carries certain legal liabilities; information furnished under some items (including Item 7.01) does not, unless the company says otherwise. It does not make furnished information less accurate; it is one of the things a company weighs when it chooses between Item 7.01 and Item 8.01 for a press release.

“The information in a report furnished pursuant to Item 2.02 (Results of Operations and Financial Condition) or Item 7.01 (Regulation FD Disclosure) shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, unless the registrant specifically states that the information is to be considered “filed” …”SEC · Form 8-K, General Instructions

Regulation FD fair disclosure

The rule that a company cannot tell important news to some people (such as analysts) before telling everyone. It is why FDA letters are announced publicly, usually by press release and 8-K, rather than shared privately.

“Regulation FD addresses the selective disclosure of information by publicly traded companies and other issuers.”Investor.gov (SEC) · Fair Disclosure, Regulation FD

The 10-K and 10-Q: the fuller picture#

Form 10-K annual report

The company's yearly, detailed report: its business, its risks, its finances (audited), and its lawsuits. Because it is longer and more careful than an 8-K, the 10-K often describes an FDA letter differently from the press release that announced it.

“The annual report on Form 10-K provides a comprehensive overview of the company's business and financial condition and includes audited financial statements.”Investor.gov (SEC) · Form 10-K

Verrica's 8-Ks between 2020 and 2026 do not mention an ampule-crushing device; its 2026 10-K lists a design patent on an “ampule crush tool”. Read it →

Sections of a 10-K

A 10-K follows a fixed order, so you can go straight to the part you need:

Section	The SEC's words
Item 1 · Business	“… requires a description of the company’s business, including its main products and services, what subsidiaries it owns, and what markets it operates in.”
Item 1A · Risk Factors	“… includes information about the most significant risks that apply to the company or to its securities.”
Item 3 · Legal Proceedings	“… requires the company to include information about significant pending lawsuits or other legal proceedings, other than ordinary litigation.”
Item 7 · MD&A	“… gives the company’s perspective on the business results of the past financial year. This section, known as the MD&A for short, allows company management to tell its story in its own words.”

Source: SEC · How to Read a 10-K.

An FDA letter usually appears in Item 1 (the product's status), Item 1A (the risk it creates), and sometimes Item 3 (if lawsuits follow).

Form 10-Q quarterly report

A shorter report filed for each of the first three quarters of the company's year, with unaudited figures. It updates the 10-K.

“The Form 10-Q includes unaudited financial statements and provides a continuing view of the company's financial position during the year.”Investor.gov (SEC) · Form 10-Q

Event date and filing date

A letter is dated when the FDA signs it; the 8-K is filed days later; a press release may go out in between. Filings sometimes give the date the company announced the letter, not the date on it. Our research always cites each document's own date. (Our explanation.)

Outlook's letters are signed August 27 and December 30, 2025; some of its filings give August 28 and December 31, the days its press releases went out. Read it →

Forward-looking statements

Statements about the future (“we expect to resubmit in the first quarter”, “we believe the data support approval”). Filings mark them as such and list risks that could make them wrong. Read them as the company's plans and beliefs, not as facts. (Our explanation.)

When investors sue#

Securities class action

A lawsuit brought by some shareholders on behalf of all shareholders who bought during a certain time, claiming the company misled them. After a Complete Response Letter, these suits often argue the company knew of problems before it disclosed them. Filing a suit is an allegation, not a finding.

“A federal securities class action is a court action filed on behalf of a group of shareholders under Rule 23 of the Federal Rules of Civil Procedure.”Investor.gov (SEC) · Class Actions

Class actions followed letters to Replimune, CorMedix and Verrica. Verrica's →

Class period

The window of time covered by a class action: shareholders who bought in it are part of the class. It often ends on the day the bad news came out.

“In a securities class action, shareholders who purchased or sold the company’s securities during a specific period of time, known as the class period, usually allege the company and its officers and directors violated the federal and state securities laws.”Investor.gov (SEC) · Class Actions

The class period in CorMedix's securities class action ends on the day it announced its second letter. Read it →

Motion to dismiss, and derivative suit

Early in a class action, the company usually asks the court to throw the case out (a motion to dismiss). If the court denies it, the case goes on. A derivative suit is different: shareholders sue the company's own directors on the company's behalf, and settlements often take the form of governance changes. (Our explanation; these are court terms rather than SEC definitions.)

A court denied the motion to dismiss CorMedix's class action in 2025; a derivative settlement built on governance reforms followed. Read it →

Sources#

All SEC quotations were checked against the Investor.gov and sec.gov pages linked beside them on October 7, 2026. Investor.gov is the SEC's site for individual investors. Entries marked “our explanation” have no single SEC definition; read them as a starting point.