Biotech Values

[Whalatane]

RGLS.

In January, the Company announced that it held a meeting with U.S. Food and Drug Administration (FDA) and had confirmed alignment with the FDA on the acceptability of the program's CMC, non-clinical and clinical pharmacology plans and the key elements of a Phase 3 trial design as a single pivotal study, including a 12-month htTKV endpoint planned to support Accelerated Approval and a 24-month eGFR endpoint to support Full Approval.

Impressive that they can go straight to a P3 ....and a single pivotal trial ...trial to start Q3 ....12 month end pt for accelerated approval .
They are going to need $
By the way ...Vivo Capital is also invested here

. In March 2024, Regulus Therapeutics announced an oversubscribed $100 million private placement of equity, and Vivo Capital was among the institutional investors participating in this financing round.

JMO
Kiwi