Web0 votes and 0 comments so far on Reddit WebI'm currently watching BYSI, which has a PDUFA decision for its drug plinabulin coming up on November 30th. The phase 3 trial met primary and secondary endpoints, but a concern I'm seeing is that it had relatively low US enrollment - 20% out of 559 total patients, with the rest being in Russia and China. Is this a major factor in FDA decisions?
FDA Calendar, FDA Drug Approval, PDUFA Calendar – …
WebDec 18, 2024 · Tenapanor for chronic kidney disease. On September 15, 2024, the FDA accepted Ardelyx Inc.’s NDA of tenapanor for controlling serum phosphorus in adult patients with chronic kidney disease on dialysis. The FDA has set a PDUFA target date of April 29, 2024. The drug’s application is supported by three phase 3 trials of more than 1,000 … WebOct 7, 2024 · This document provides fee rates for FY 2024 for an application requiring covered clinical data [ 1] ($3,242,026), for an application not requiring covered clinical data ($1,621,013), and for the prescription drug program fee ($393,933). These fees are effective on October 1, 2024, and will remain in effect through September 30, 2024. thom starke
PDUFA Date Calendar for Biotech Stocks • BioPharmCatalyst
WebEYEN has Oct 28th PDUFA 🐊. ETON has Nov 6th PDUFA 🐊. LQDA has Nov 7th PDUFA 🐊. ADMP has Nov 12th PDUFA 🐊. AADI has Nov 26th PDUFA 🐊. BYSI has Nov 30th PDUFA 🐊. CHRS has Dec 17th PDUFA 🐊. ITCI has Dec 17th PDUFA 🐊. AQST has Dec 23rd PDUFA 🐊. GBT has Dec 25th PDUFA 🐊. XERS has Jan 1st PDUFA 🐊. OPK has January PDUFA 🐊. … WebFor those of you not familiar with $BYSI - BYSI (BeyondSpring) is a Pharmaceutical company listed on Nasdaq with a major potential catalyst upcoming the 30th of … WebBeyondSpring Subsidiaries: 1) Dalian Wanchunbulin Pharmaceuticals Ltd., which owns China rights to Plinabulin, and 2) Seed Therapeutics, a target protein degradation company. uln where to find