Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.

While Moderna plans preclinical studies and Tonix Pharma’s candidate is to enter trials in H1, Bavarian Nordic is seeking US and Indian manufacturing partners for its approved monkeypox vaccine. Scrip examines if the disease presents an opportunity for vaccine makers, like COVID-19 did or it could go the H1N1 way

Public Company Edition: MAIA launches a $10m initial public offering, the first in the US since May, but NewAmsterdam opts for the SPAC route to the stock market. Also, Legend raises $350m in a follow-on offering, Iveric obtains access to $250m in debt and Otonomy cuts costs after a Phase II failure.

Public Company Financings: Theravance sold its 85% interest in Trelegy royalties from GSK and Innoviva sold its 15% interest for up to $1.8bn in total. Also, ProKidney grossed $597m from its SPAC merger, Pliant raised $200m in a post-Phase IIa offering and Marinus earned $110m in a PRV sale.