ORION Biotech Catalyst Calendar
Menu
Skip to company dates

PolyPid (PYPD) pipeline and stated timing

PYPD · 1 program · Next stated timing: “November 28, 2026” · Earlier SEC wording is retained below.

Pipeline at a glance

ProgramEventStageStated timingFiling
D-PLEX100 target date (company stated)PDUFANovember 28, 20266-K ·

Source: ORION, orionbiotechai.com/company/PYPD, data as of Oct 29, 2026
https://www.orionbiotechai.com/company/PYPD

Nearest upcoming stated timing: D-PLEX100 · PDUFA target date (company stated) · November 28, 2026

SEC sources last checked .

No full company check on record. The date above is the newest check of a single row.

Programs and stated timing

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

D-PLEX100

Prevention of surgical site infections in patients undergoing abdominal colorectal surgery

Quote matches the filing

PDUFA target date (company stated)November 28, 2026

Stage: PDUFASEC filing · “PDUFA goal date”

Public float: Unknown (no public float found in SEC filings).

PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.

6-K · Filed · Source rechecked

founder confirmed 2026-10-30

Source details

Accession 0001213900-26-113107

SEC accepted the filing

Timing wording over time
Jun 1, 2026 · EX-99.1 · “first quarter of2027”Oct 28, 2026 · EX-99.1 · “November 28,2026”May 2026Apr 2027

Dots are filing dates. Bars show resolved calendar periods; timing wording stays as stated.

Sources: EX-99.1 filed Jun 1, 2026; EX-99.1 filed Oct 28, 2026.

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
D-PLEX100FDA decisionNovember 28, 2026
“PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.”

Filed · EX-99.1

Period not started

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

D-PLEX100FDA decisionfirst quarter of 2027
“The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline.”

Filed · EX-99.1

Period not started

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

“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.

Subscribe in your calendar

Exact dates stated in SEC filings appear as single all-day entries with the company’s sentence as written and its SEC link. Periods and date bounds remain in the company records and are not added to calendars. An entry is updated when the company’s timing wording changes; if newer wording gives no exact date, the entry is removed.

Calendar address: https://www.orionbiotechai.com/company/PYPD.ics

Steps for Google, Apple and Outlook

Google Calendar: on a computer, open Google Calendar, then Settings, Add calendar, From URL. Paste the calendar address and choose Add calendar. The phone apps cannot add a calendar by address. Google refreshes subscribed calendars on its own schedule, which can take a day or more.

Apple Calendar on a Mac: choose File, then New Calendar Subscription, and paste the address. Set Location to iCloud to see it on iPhone, and pick an Auto-refresh interval. On iPhone or iPad with iOS 18 or later: Settings, Apps, Calendar, Calendar Accounts, Add Account, Other, Add Subscribed Calendar. On iOS 17 or earlier: Settings, Calendar, Accounts, Add Account, Other, Add Subscribed Calendar.

Outlook on the web or the new Outlook: choose Add calendar, then Subscribe from web, paste the address, name it and choose Import. Classic Outlook for Windows: Home, Add Calendar, From Internet, then paste the address.

Entries are single all-day items on exact dates the company named and are marked as free time. The download link saves a copy that does not update; use the address for a subscription.

No sign-up and no email address. Links back to ORION carry ?src=ics or ?src=rss and nothing else.

Request another SEC timing statement

Suggest an SEC timing statement to add for PYPD. You can include the original filing link in your note. The founder reads each request by hand.

Or email ORION.

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 PYPD 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.