Sadly disappointing Phase 3 results 😞

Good lesson on the higher risks of biologics though. BLA (biologics license application) a relatively new classification (maybe 5 or so years?) meant to divert biologics from the NDA process that small molecule drugs go through.

In practical terms, it means they face an extra level of scrutiny and regulation because of how complicated the manufacturing process is. You can't just carry out a series of chemical reactions in test tubes (oversimplification ofc). You actually have to grow them in living cells and extract / purify proteins after. That makes it much harder to guarantee consistency in dosage, stability, etc of the final product.

Whereas a small molecule drug being made at an established GMP compliant facility might allow for laxer inspections of processing via risk analysis, every step of the biologic process is going to be combed through.

I tend to follow the same rule of thumb with biologics (which have had amazing results / potential) that I do with controlled substances drugs - expect twice the regulation to mean twice the cost and twice as long a timeline.