PolyPid (NASDAQ:PYPD) Issues Earnings Results

PolyPid (NASDAQ:PYPD) announced its earnings results on Wednesday. The company reported ($0.24) earnings per share for the quarter, missing analysts’ consensus estimates of $0.91 by ($1.15), FiscalAI reports.

Here are the key takeaways from PolyPid’s conference call:

• FDA review is nearing a key decision: D-PLEX100’s priority-review PDUFA date is November 28, with labeling discussions underway and scheduled FDA interactions described as on track. Approval and the planned early-2027 launch remain subject to FDA action; the company did not discuss inspection details.
• PolyPid and Azurity are preparing for a U.S. launch, with Azurity building its commercial teams and targeting hospitals. The company cautioned that formulary reviews happen account by account and adoption may take several months; a CMS decision on NTAP reimbursement is expected in August 2027.
• Label expansion is a potential growth driver: PolyPid plans to begin FDA discussions this quarter on expanding D-PLEX100 beyond colorectal surgery to broader abdominal procedures. The company has not yet received FDA feedback on what evidence or requirements would be needed.
• The EMA validated PolyPid’s D-PLEX100 application and began its review, with a decision expected in the second half of 2027. After ending its European agreement with ADVANZ PHARMA, PolyPid regained commercialization rights and said it is discussing potential partnerships.
• PolyPid reported $15.5 million in cash and short-term deposits at quarter-end and said it received a further $15 million Azurity payment in early October; management expects resources to fund operations into 2028. The company also plans PD01B’s pre-IND meeting and first-in-human study in the second half of 2027, while the program remains in development.

PolyPid Stock Performance

PYPD traded up $0.30 during trading on Wednesday, reaching $6.62. The stock had a trading volume of 359,090 shares, compared to its average volume of 125,961. The stock has a market cap of $126.21 million, a PE ratio of -4.47 and a beta of 1.43. PolyPid has a one year low of $3.50 and a one year high of $7.15. The business has a 50-day moving average of $5.30 and a 200-day moving average of $4.77.

Wall Street Analyst Weigh In

A number of brokerages have recently issued reports on PYPD. HC Wainwright reiterated a “buy” rating and set a $13.00 price target on shares of PolyPid in a research report on Tuesday, July 21st. Weiss Ratings restated a “sell (d-)” rating on shares of PolyPid in a research report on Friday, September 18th. Oppenheimer started coverage on shares of PolyPid in a research report on Tuesday, October 27th. They issued an “outperform” rating and a $10.00 price objective on the stock. Craig Hallum set a $12.00 target price on shares of PolyPid in a research note on Wednesday, July 22nd. Finally, Wall Street Zen upgraded shares of PolyPid from a “hold” rating to a “buy” rating in a research report on Saturday, October 31st. Four research analysts have rated the stock with a Buy rating and one has assigned a Sell rating to the stock. According to data from MarketBeat, PolyPid presently has a consensus rating of “Moderate Buy” and an average price target of $11.00.

About PolyPid

PolyPid Ltd. (NASDAQ: PYPD) is a clinical-stage biopharmaceutical company focused on developing locally administered therapies designed to provide controlled and sustained drug release at treatment sites. The company’s technology is intended to maintain therapeutic drug concentrations over extended periods while limiting systemic exposure. PolyPid’s lead product candidate is D-PLEX100, an investigational formulation based on doxycycline and the company’s proprietary PLEX polymeric matrix. It is being developed for the prevention of surgical-site infections, initially in patients undergoing colorectal surgery.