The Durham, NC-based biotech took the first $20 million of that debt, which was provided by Silicon Valley Bank, and can draw down the rest as needed. Two months after lining up a $175 million SPAC deal to jump to Nasdaq, Humacyte has added $50 million in debt financing to fuel its work on implantable bioengineered tissue. Max Gelman Humacyte picks up $50M in debt financing That stands in contrast, they say, to the approaches being taken by Canada and the EU.

In a statement, the group said the FDA is being too cautious given the extreme need for treatments, noting the agency has the ability to conditionally approve treatments based on one clinical trial but is choosing not to do so here. The news of the FDA delay has already prompted criticism from the prominent advocacy group, ALS Association. In all, the patients in the trial arm scored on average 2.32 points higher than placebo after 24 weeks, good for a p-value of p=0.03. The placebo group, meanwhile, did so at an average of 1.66 points per month. The average patient started at a baseline of 36 on the 48-point scale, and those in the active arm saw an average decline of 1.24 points per month. Amylyx’s EMA submission comes on the heels of a 137-person trial that measured the rate at which patients declined using a clinically validated test.

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