Funding & Financings
Alethio raises $90M for MPNs
Sofinnova and RA Capital co-led the Oxford spinout's Series A. Its G6B antibody, ATX-011, goes after the cells that start the disease and is expected in the clinic in the first half of 2028.
Read the full story →Specific Biologics raises $35M to edit out ALS repeats
Hatteras led the Toronto company's Series A. Its Dualase editor fits in a single AAV, and the money runs to a first-cohort biomarker readout in C9ORF72 ALS.
Read the full story →Regulatory & Clinical
FDA finalises potency rules for cell and gene therapies
Sponsors now need a potency assurance strategy from the IND onwards, and thin potency data can be grounds for a clinical hold. It replaces guidance from 2011.
Read the full story →Leadership Moves
ARTHEx hires Christian Freitag as CMO
The former Azafaros and Dynacure CMO joins the Valencia RNA company as its Fast Track DM1 drug, ATX-01, runs in a Phase I/IIa trial.
Read the full story →Talent Insight
The first trial changes the org chart
- A new Series A that funds a first trial usually brings first hires in clinical development, regulatory affairs and CMC.
- With potency expected at IND, analytical and regulatory CMC people with viral vector experience become early hires for cell and gene therapy teams.
- Worth watching: Rare disease companies moving from early to registrational trials tend to hire a CMO with late-stage experience first, then build underneath them.
Building a team in Biotech, R&D & Clinical?
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