$PYPD

PolyPid Ltd.

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No SEC Form 4 filings for $PYPD in the last 30 days.

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PolyPid Ltd.: PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results

PolyPid Ltd. (Nasdaq: PYPD) said the FDA accepted its D-PLEX100 NDA for priority review for preventing surgical site infections in abdominal colorectal surgery, with a PDUFA goal date of Nov. 28, 2026. PolyPid entered an exclusive U.S. and Canada commercialization partnership with Azurity, receiving $30 million upfront and near-term milestones, plus tiered mid-teen to mid-twenties royalties. Q2 2026 net loss was $7.8M.

PolyPid Ltd.: PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX100

PolyPid (Nasdaq: PYPD) said the FDA accepted its NDA for D-PLEX100 to prevent surgical site infections in abdominal colorectal surgery and granted Priority Review. The PDUFA target action date is Nov. 28, 2026. FDA found no filing review issues. Acceptance triggers a $15 million milestone from Azurity, completing $30 million in upfront and near-term milestones.

Antibacterial Drug Partnership Accelerates PolyPid Commercial Path

PolyPid Ltd. (PYPD) said it signed an exclusive commercialization deal with Azurity Pharmaceuticals for D-PLEX100 to prevent abdominal surgical site infections in the U.S. and Canada. PolyPid gets $15M upfront, $15M on FDA NDA acceptance, and up to $300M in milestones. Deal follows Phase 3 SHIELD II results; U.S. launch targeted Q1 2027. Analysts at Roth and H.C. Wainwright set Buy ratings and $9 and $13 targets.

PYPD sentiment & insider activity

Over the past 7 days, alphai's AI scored 1 news story mentioning PYPD (PolyPid Ltd.). Coverage has skewed bullish: 1 bullish, 0 neutral, and 0 bearish.

Recent PYPD coverage spans financial news, regulation and mergers & acquisitions.

What's driving PYPD

  • Priority Review acceptance and an earlier-than-guidance PDUFA date materially de-risks the regulatory timeline and improves near-term financing optics via Azurity milestones.

    finanznachrichten.de · Aug 12, 2026

  • Priority Review acceptance and an earlier-than-guidance PDUFA date increase the probability-weighted path to an FDA decision and can re-rate near-term regulatory risk.

    finanznachrichten.de · Jul 29, 2026

  • The deal meaningfully de-risks commercialization and improves near-term funding visibility ahead of FDA NDA acceptance and a targeted 2027 launch.

    streetwisereports.com · Jul 24, 2026

  • The positive topline results from PolyPid's Phase 3 SHIELD II trial are likely to bolster investor confidence and could lead to a short-term increase in stock price.

    Benzinga · Sep 30, 2025

  • PolyPid's positive Phase 3 SHIELD II topline results suggest potential for stock appreciation upon clinical validation and conference presentation.

    GlobeNewswire · Sep 30, 2025

alphai scores every news story that mentions PYPD with an AI model for sentiment and relevance, and aggregates insider trades from PolyPid Ltd.'s SEC EDGAR Form 4 filings. Figures refresh continuously.

News on $PYPD

Score
$PYPDHighAI 9/10

PolyPid Ltd.: PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results

PolyPid Ltd. (Nasdaq: PYPD) said the FDA accepted its D-PLEX100 NDA for priority review for preventing surgical site infections in abdominal colorectal surgery, with a PDUFA goal date of Nov. 28, 2026. PolyPid entered an exclusive U.S. and Canada commercialization partnership with Azurity, receiving $30 million upfront and near-term milestones, plus tiered mid-teen to mid-twenties royalties. Q2 2026 net loss was $7.8M.

$PYPDMedAI 8/10

PolyPid Ltd.: PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX100

PolyPid (Nasdaq: PYPD) said the FDA accepted its NDA for D-PLEX100 to prevent surgical site infections in abdominal colorectal surgery and granted Priority Review. The PDUFA target action date is Nov. 28, 2026. FDA found no filing review issues. Acceptance triggers a $15 million milestone from Azurity, completing $30 million in upfront and near-term milestones.

$PYPDMedAI 8/10

Antibacterial Drug Partnership Accelerates PolyPid Commercial Path

PolyPid Ltd. (PYPD) said it signed an exclusive commercialization deal with Azurity Pharmaceuticals for D-PLEX100 to prevent abdominal surgical site infections in the U.S. and Canada. PolyPid gets $15M upfront, $15M on FDA NDA acceptance, and up to $300M in milestones. Deal follows Phase 3 SHIELD II results; U.S. launch targeted Q1 2027. Analysts at Roth and H.C. Wainwright set Buy ratings and $9 and $13 targets.

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