The FDA can't seem to make up its mind
Two reversals in one month, both in the field's favour. uniQure regained its path to accelerated approval for its Huntington's disease gene therapy, and days later Regenxbio got the same news on its Hunter syndrome programme — both after the agency had pushed back just months earlier. The science didn't change. The agency's read on it did.
In vivo CAR-T is producing real data
Kelonia's ASCO data showed all 18 multiple myeloma patients MRD-negative one month post-treatment, and Cartesian struck a licensing deal with WestGene to push in vivo CAR-T into autoimmune disease. The thesis is starting to look like evidence.
The market is sorting winners from the rest
Sangamo filed for bankruptcy, Be Biopharma killed its lead haemophilia B programme, and Sensorion dropped its hearing loss asset days after Regeneron's rival therapy got approved — for free. Meanwhile CARsgen secured the world's first CAR-T approval in a solid tumour. Good science is no longer enough on its own.
Our team on the ground in San Diego and the start of something bigger
Last week, our President Kim Barnes and VP of Commercial Operations David Green, touched down at BIO in San Diego, and what a week it was. Between back-to-back meetings with local and international partners, they laid the groundwork for something special: a coalition of communities coming together for Advanced Therapies Week in January 2027.
We've always believed the whole is greater than the sum of its parts, and these conversations proved it. Conversations with the Emily Whitehead Foundation, BIOCHINA, California Life Sciences, CONNECT, UCSD and more left us genuinely energised about what's possible when the field unites behind a single goal: getting cell and gene therapies to patients faster.
This is just the beginning. As we formalise these partnerships and build new ideas, audiences and momentum, ATW 2027 is shaping up to be our most exciting event yet. Watch this space!
Required reading this month: The Science is proven. The systems are not
We've just published a whitepaper in collaboration with our Advisory Board, and the timing couldn't be more apt given everything above. Eight in ten eligible patients still cannot access approved advanced therapies, and this whitepaper, written by Elizabeth Figueroa PhD of Dark Horse Consulting with input from 14 Advisory Board members across clinical, investment, manufacturing and nonprofit leadership, makes the case that operational systems, not science, are now the field's defining bottleneck.
It covers five forces shaping the next phase of the industry — regulatory evolution, decentralisation and access, in vivo momentum, the shifting geography of clinical data, and business model recalibration.
Download it here.
In case you missed it: 60 Seconds with Bo Wiinberg ahead of Advanced Therapies Europe
In our newly launched ‘60 Seconds With’ series, Bo Wiinberg, Chief Business Officer at Novo Nordisk Foundation Cellerator, makes the case that fragmentation, not science, is what's really slowing Europe's CGT sector down. His view: the fix isn't more innovation, it's the industry actually showing up to the same conversations, together.
Bo will be doing exactly that at Advanced Therapies Europe 2026 (7–9 September, InterContinental Hotel, Barcelona) Watch the full clip here.
Coming up: Europe's ATMP Roadmap webinar — 15th July
We're hosting a webinar on Europe's ATMP Roadmap: From Strategy to Execution in a New Global Reality on 15th July. Given everything happening with regulatory volatility and shifting geographies this month, it's a timely one — register to join us.
Want to hear more from us?
We publish a roundup of the most important CGT news every Friday on LinkedIn - follow us so you don't miss it.
Have your say - next month we're launching a new section featuring an expert opinion on the most important themes in CGT. Think this could be you? Please contact Ingerid.sorgaard@phacilitate.com to secure your spot.
Until then…
)