等待开盘 04-01 09:30:00 美东时间
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PolyPid Ltd. has initiated the submission of its New Drug Application (NDA) to the FDA for D-PLEX₁₀₀, aimed at preventing surgical site infections (SSIs) in colorectal surgery patients. The submission, under the FDA’s Fast Track designation, includes the Chemistry, Manufacturing and Controls (CMC) and nonclinical sections, with the clinical section expected in the second quarter of 2026. D-PLEX₁₀₀, which uses PolyPid’s Kynatrix technology, provid...
03-31 12:30
PolyPid Ltd. announced that the FDA has granted a $4.3 million small business waiver for its New Drug Application (NDA) for D-PLEX₁₀₀, aimed at preventing surgical site infections in abdominal colorectal surgeries. This waiver supports the company's commercialization efforts and enables it to focus on submitting the first sections of its rolling NDA by the end of this month. D-PLEX₁₀₀ demonstrated a 60% relative risk reduction in infections in th...
03-17 12:30
PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced the appointment of Brooke Story as Chairman of the Board of Directors,
2025-12-16 21:33
PolyPid Ltd. announced the appointment of Brooke Story as Chairman of its Board of Directors. With over 25 years of leadership experience in the MedTech industry, Story will enhance the company’s strategic, commercial, and transaction capabilities. Her expertise in surgical solutions and infection prevention will support PolyPid in advancing its lead product, D-PLEX₁₀₀, which is expected to submit its New Drug Application in early 2026. Story’s l...
2025-12-16 13:30
PolyPid Ltd. has received FDA support for rolling NDA submission of D-PLEX100, its lead product for preventing surgical site infections in colorectal surgeries. The FDA agreed the company's existing clinical data, including Phase 3 results, is adequate for submission. PolyPid plans to submit the first sections in early 2026, with the Breakthrough Therapy designation further validating its regulatory strategy.
2025-12-03 13:30
PolyPid ( ($PYPD) ) has shared an announcement. PolyPid Ltd. announced its thir...
2025-11-12 20:56
PolyPid's D-PLEX₁₀₀, designed to prevent surgical site infections (SSIs) via extended, localized antibiotic delivery, has been named "Therapeutics Solution of the Year" by BioTech Breakthrough. With Phase 3 results showing a 58% relative risk reduction in SSIs, the product, leveraging PolyPid's PLEX technology, delivers doxycycline for 30 days directly at the surgical site. Widespread SSIs remain a critical issue, causing extended hospital stays ...
2025-11-06 13:30
预测市场平台Polymarket即将向美国用户重新开放,并推出POLY代币和空投;Securitize将通过SPAC合并上市。加密货币市场整体跌幅明显。美国加密PAC筹资超能源行业,挪威加密申报激增。香港金管局计划将数字港元推广至个人用户。以太坊Fusaka硬分叉预计12月上线,提升可扩展性和安全性。 Mellon Prefix = synonym
2025-10-28 23:47
Can truth be tokenized?
2025-10-24 20:55