Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.

Private Company Edition: The Paragon Biosciences-founded Emalex previously raised $35m when ecopipam was in Phase II. Also, Catalio Capital launches a “special situations” fund, Zenas raises $118m to develop a pipeline of autoimmune disease treatments and Lusaris emerges with $60m.

It does not look like the Norwegian biotech can recover from the discontinuation of its lead candidate, the lymphoma drug Betalutin, and the ‘for sale’ signs are likely to be erected soon as a strategic review gets underway.

Despite a seemingly sound mechanism and promising early data, the Swedish firm’s sole clinical asset has flunked a mid-stage prostate cancer trial, prompting a search for responsive subgroups.