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Form 6-K PolyPid Ltd. For: Jun 01

Mon, 01 Jun 2026 08:35:00 -0400

si-local-file:///var/storage/secattach/20260601/26579944.html

Form 6-K PolyPid Ltd. For: Jun 01

Mon, 01 Jun 2026 08:35:00 -0400

si-local-file:///var/storage/secattach/20260601/26579944.html

PolyPid completes FDA submission for surgical infection prevention drug

Mon, 01 Jun 2026 08:32:16 -0400

PolyPid Ltd. (NASDAQ: PYPD) announced it has completed its New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100, a drug candidate designed to prevent surgical site infections in patients undergoing colorectal surgery.

The company submitted the application on a rolling review basis and expects a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act review timeline.

The application is supported by results from the company's Phase 3 SHIELD II trial, which met its primary endpoint and demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care

PolyPid completes FDA submission for surgical infection prevention drug

Mon, 01 Jun 2026 08:32:16 -0400

The company submitted the application on a rolling review basis and expects a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act review timeline.

PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀

Mon, 01 Jun 2026 08:30:00 -0400

If approved, D-PLEX₁₀₀ would address a critical unmet medical need in the prevention of surgical site infections

PDUFA target action date currently planned for the first quarter of 2027

PETACH TIKVA, Israel, June 01, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced the successful completion of its New Drug Application (“NDA”) submission on a rolling review basis to the U.S. Food and Drug Administration (“FDA”) for D-PLEX₁₀₀, the Company’s

PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀

Mon, 01 Jun 2026 08:30:00 -0400

If approved, D-PLEX₁₀₀ would address a critical unmet medical need in the prevention of surgical site infections

PDUFA target action date currently planned for the first quarter of 2027

PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference

Wed, 20 May 2026 08:30:00 -0400

PETACH TIKVA, Israel, May 20, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that the Company’s management will participate in investor meetings at the Craig-Hallum 23rd Annual Institutional Investor Conference on Thursday, May 28, 2026, at the Depot Renaissance Hotel in Minneapolis, MN.

Investors interested in meeting with PolyPid should contact their Craig Hallum representative directly.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating

PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference

Wed, 20 May 2026 08:30:00 -0400

Investors interested in meeting with PolyPid should contact their Craig Hallum representative directly.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating

PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference

Wed, 20 May 2026 08:30:00 -0400

Investors interested in meeting with PolyPid should contact their Craig Hallum representative directly.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating

PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference

Wed, 20 May 2026 08:30:00 -0400

Investors interested in meeting with PolyPid should contact their Craig Hallum representative directly.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating

Form 6-K PolyPid Ltd. For: May 13

Wed, 13 May 2026 07:35:00 -0400

si-local-file:///var/storage/secattach/20260513/26481810.html

Form 6-K PolyPid Ltd. For: May 13

Wed, 13 May 2026 07:35:00 -0400

si-local-file:///var/storage/secattach/20260513/26481810.html

PolyPid Ltd. (PYPD) Tops Q1 EPS by 70c

Wed, 13 May 2026 07:30:48 -0400

PolyPid Ltd. (NASDAQ: PYPD) reported Q1 EPS of $0.35, $0.70 better than the analyst estimate of ($0.35).

For earnings history and earnings-related data on PolyPid Ltd. (PYPD) click here.

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

Wed, 13 May 2026 07:30:00 -0400

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently

U.S. Commercial Partnership Discussions in Late Stages

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026.

Recent Corporate Highlights:

Initiated NDA Submission to the