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PolyPid Gains FDA Support for D-PLEX100 NDA Submission

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PolyPid Gains FDA Support for D-PLEX100 NDA Submission

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An announcement from PolyPid ( (PYPD) ) is now available.

On December 3, 2025, PolyPid announced receiving positive feedback from the FDA regarding its pre-NDA meeting for D-PLEX100, a product designed to prevent surgical site infections. The FDA’s agreement on the adequacy of PolyPid’s clinical data package, including successful Phase 3 trial results, supports the company’s plan to submit a rolling NDA in early 2026. This development validates PolyPid’s regulatory strategy and positions the company to potentially bring a transformative treatment to market, enhancing its standing in the biopharmaceutical industry.

The most recent analyst rating on (PYPD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on PolyPid stock, see the PYPD Stock Forecast page.

Spark’s Take on PYPD Stock

According to Spark, TipRanks’ AI Analyst, PYPD is a Neutral.

PolyPid’s score reflects significant financial challenges, including consistent losses and negative equity. While the company’s clinical advancements and financing efforts are promising, they are not sufficient to offset the financial risks. The stock exhibits neutral technical indicators and an unattractive valuation, limiting its appeal to investors.

To see Spark’s full report on PYPD stock, click here.

More about PolyPid

PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics. Its proprietary PLEX technology enables precise drug delivery over extended durations. The company is advancing its lead product candidate, D-PLEX100, for preventing surgical site infections in abdominal colorectal surgeries, with a broader pipeline in oncology, obesity, and diabetes.

Average Trading Volume: 72,606

Technical Sentiment Signal: Hold

Current Market Cap: $61.68M

See more data about PYPD stock on TipRanks’ Stock Analysis page.

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