Public Company Edition: Denali, Crinetics and Ocular Therapeutix grossed $500m, $350m and $325m, respectively, in private placements ahead of data readouts. Also, Viking raised $550m after its positive Phase II obesity data and Abingworth invested $210m in Gilead’s Trodelvy NSCLC trials.

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Govorestat could soon be filed for a second indication after impressing as a potential treatment for SORD deficiency, one of the most common forms of recessive hereditary neuropathy for which there are no approved therapies.

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.