Recent financings, including the $150m launch of Pathalys and a planned $100m IPO for Mineralys, illustrate the reality of biopharma funding in 2023 – that having near-term clinical trial milestones are key to fundraising this year. Companies with dwindling cash are conserving the funds they have left.

The US biotech’s candidate, ALTO-100, has hit the mark in a Phase IIa depression trial, de-risking the firm’s novel precision approach to psychiatry R&D and triggering the start of a Phase IIb study.

From 2013 to November 2022, Chinese pharma companies as a single sponsor started a total of 35 international Phase III clinical studies for innovative drugs in the US, indicating a continuing push by the biopharma sector in the country to leverage increasing innovation to access this huge and lucrative market. Led by BeiGene, 20 firms have placed their bets on such studies and some are planning similar new moves despite an ongoing downturn in industry funding, this infographic analysis shows.

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.