A year ago we published the first “Semper Maior” piece, making the case that biotech was on firm ground and ready for a reboot. We put out the second piece last summer, when it felt like the rebound was underway. Had the year ended in October or even November… well, you know. But here we are after a general market and XBI surge feeling like biotech is now truly recovering from its prolonged downturn. So let’s mine the data, as we have before, to get a sense of what happened in 2023 and what lessons to take with us into 2024.

On February 22, CMS announced that they would not be reconsidering the National Coverage Determination (NCD) that effectively denies Medicare patients access to lecanemab, a drug with accelerated approval for Alzheimer’s disease. CMS’s rationale was that “there is not yet evidence meeting the criteria for reconsideration.” It’s worth pausing to consider the highly unusual CMS precedent that is playing out in Alzheimer’s.

In today’s FutureCast discussion, RA’s Raj Shah, Jake Simson, Tess Cameron, and Peter Kolchinsky revisit one of our most talked-about articles: Time to Reboot Biotech. Fresh financial analysis and actionable board room advice abound.

2020 and 2021 were the heyday for special purpose acquisition companies, or SPACs. We got in on the act ourselves – twice! – and we’ve learned a lot about why SPACs can sometimes work for a biotech in very particular circumstances, but also why mostly they don’t. We would also note that in certain market conditions, chasing merger targets with a SPAC can be extremely challenging. So we pulled the plug on our second SPAC. Here’s the story.

Biotech board members and management teams are increasingly asking how their companies can benefit from what RA Capital and others call a “Series I” IPO process (also known as a data-driven or logic-based IPO). Here we’ve compiled common questions and answers.