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.

The federal government must address the failure of Silicon Valley Bank (SVB) with speed and clarity before it metastasizes into a national crisis, so the ecosystem of institutions in which SVB has operated, including other banks and investors, can help bridge companies so that they can continue to operate while they wait for their deposits.

The run-on-the-bank panic around SVB would have been quelled if everyone was dissuaded from succumbing to mass hysteria. Understanding what happened can help prevent further bank runs.

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.

We’ve suffered a protracted downturn in general interest in biotech. That downturn has been compounded by rising interest rates undercutting equities in general. Now we must determine 1) how much worse this downturn might be and 2) how we’ll do things differently once we reboot. Here, Peter Kolchinsky explains why he believes we’ve emerged from the downturn but must reboot biotech with more honest and efficient processes and better defend our industry’s value proposition to policymakers and the public.

Our year-end wrap of the site’s most popular articles of 2022 reflects a challenging year for the biotech sector, featuring tumultuous markets and the shifting drug pricing policy landscape. But those pieces also reflect the ingenuity, hopefulness, and opportunity that is inherent in drug discovery and development.

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.

Thanks to the selfless efforts of a handful of smart and dedicated volunteers from a few tech transfer offices (TTOs), law firms, and investment firms, the fraught process by which technology licenses are extricated from universities is getting a significant upgrade.

Outgoing Forma Therapeutics CEO Frank Lee talks with Rapport about bringing a patient-centric mindset to a biotech steeped in science and Forma’s acquisition by Novo Nordisk.

The recent announcement by Alnylam Pharmaceuticals that it was holding off on a planned Phase 3 pivotal study for vutrisiran (marketed as Amvuttra in its sole approved indication so far, hATTR amyloidosis with polyneuropathy) in Stargardt disease illustrates how the Inflation Reduction Act is already having a negative impact on small molecule and orphan drug R&D prioritization. Alnylam’s announcement also brought out skeptics of the biotech industry, who argue the new law is being scapegoated by innovators who want to overturn its Medicare drug-negotiation provisions.

As the founder of two biotech companies in Arizona that are currently fundraising to support drug development, it’s clear to me that the Inflation Reduction Act will steer me away from developing cancer drugs for older Americans. This is a problem that can be fixed.

The biotech sector is experiencing the most severe downturn of at least the last 20 years. There have been many other downturns in the more recent past, but this one is different. Here Peter Kolchinsky discusses why - and how we’ll rebound.

When a biotech company is valued at around the same amount of cash it has sitting in the bank, is it a safe investment? Some investors might think so - and so we looked at the data. The answer might surprise you.

Created through the fusion of parallel efforts at RA Capital and Atlas Venture, TRIANA is a newly launched biotech that is building its pipeline using a target-first, rational approach to molecular glue discovery.

Gateway is RA Capital’s new board-building tool. It’s free to use, so give it a try. And if you’re on a biotech board or aspire to be on one, please take a minute to fill out a profile.

Take a few minutes at the beginning of a board meeting to give the board the big picture before asking them to analyze individual pieces of your narrative. At RA Capital, we encourage our companies to use a tool called the Elephant Slide. This slide helps visualize a company’s value proposition, goals, challenges, and upcoming decisions in one place - allowing you to address the elephant in the room.

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.

Covid has flooded a barren vaccine startup landscape with capital. And that has revealed some valuable lessons for investors, company builders, Congress, and the public.

Interest in life science technologies and tools is accelerating with the advent of CRISPR and other aspects of synthetic biology. The ability to have a capital efficient way to advance these innovations is very attractive and will help drive innovation.

Interest in life science technologies and tools is accelerating with the advent of CRISPR and other aspects of synthetic biology. The ability to have a capital efficient way to advance these innovations is very attractive and will help drive innovation.