Unicycive gets a CRL Read in browser

Thank you for reading, dupa dupackia! basic Subscription UPGRADE

Mon T W Th F 30 June, 2025

The biotech companies everyone will be talking about in 2025 get revealed live in Boston this September. Endpoints 11 isn’t just any list — it’s where industry insiders gather to see which bold bets might pay off. Find out who wins in real time at the State Room — reserve your spot now and save with the Early Bird rate.

news Moderna's Phase 3 flu vaccine efficacy in line with competitors, teeing up new submissions OpenAI-backed startup releases new AI models, claiming top performance in making antibodies Unicycive gets a CRL for chronic kidney disease pill as third-party production issues linger Hikma pledges $1B to expand US manufacturing presence

Jul 10 11:00am ET Beyond the data deluge: Immune profiling in early immuno-oncology trials sponsored by Precision for Medicine Jul 22 2:00pm ET New data from ASCO 2025 & clinical performance of Natera’s ultra-sensitive MRD platform sponsored by Natera Jul 24 12:00pm ET Predict tumor response and identify more patients for therapy with epigenomic biomarkers sponsored by Guardant

Post-Hoc Live is now available to stream. Catch full episodes on YouTube or listen on Spotify and Apple Podcasts. Be sure to subscribe so you don’t miss what’s next.

endpoints pharma J&J dealt blow in fight over its 340B rebate model FDA loosens safety requirements for CAR-Ts in move to boost access CEOs push EU to include cell, gene therapy incentives in Biotech Act FDA gives drugmakers more time to submit impurity data

in case you missed it 1. A dinner in Paris revived talks for Sanofi's $9.5B deal for Blueprint 2. FDA head Makary’s short-lived CRL ask on KalVista’s drug raises more concerns of political intervention 3. News Briefing BioCryst sells Orladeyo business in Europe; UCB gets a Phase 3 win for Fintepla 4. Innovent brings a new mechanism to obesity market with China approval 5. Alphabet’s Calico inks $25M licensing deal for Mabwell’s IL-11 programs 6. Peer Review Bill Meury brings new perspective to Incyte as Hoppenot retires; Ex-MorphoSys CEO leads revitalized Vor Bio 7. Kennedy v. Braidwood: The Supreme Court Upheld ACA Preventive Services but That’s Not the End of the Story KFF 8. Avadel Shareholder Seeks Ousting Drugmaker’s Entire Board