PolyPid’s Promising Outlook: Buy Rating Affirmed Amidst SHIELD II Trial Progress and Strategic FDA Engagement

JMP Securities analyst Roy Buchanan reiterated a Buy rating on PolyPid (PYPD – Research Report) today and set a price target of $13.00.

Roy Buchanan has given his Buy rating due to a combination of factors that highlight PolyPid’s promising outlook. The company has successfully enrolled the final patient in its SHIELD II trial, maintaining its timeline for a top-line release in the second quarter. This trial was expanded from an initial target of approximately 630 to 800 subjects, following a recommendation from the data safety monitoring board based on interim analysis results.
PolyPid is preparing for a pre-NDA meeting with the FDA, aiming for a rolling NDA submission under the Breakthrough Therapy designation for D-PLEX100. Additionally, the company is in discussions with potential commercial partners, focusing on the U.S. market. With approximately $33 million in potential warrant proceeds contingent on positive SHIELD II results, PolyPid is well-positioned financially to proceed through the approval process. The analyst remains optimistic about the SHIELD II trial’s outcome, citing an 80% probability of approval based on previous positive results and the mechanistic rationale for D-PLEX100.