Biotech Values

[Mufaso]

VKTX—Does today’s PR imply that VK2735’s market entry will be in late 2028 or 2029?

(Corrected response follows)

The short answer is no. "Progress payments" are negotiated by bean counters mainly to do two things: 1- to show skin in the game by the customer and 2 - to make the CDMO have some offsetting cash flow for investment. (It's likely that Corden will have to invest more than $150 mill for "early product payment" to provide the capacity that they committed to for Viking. This is one of the reasons I believe this deal was so good for Viking.)

WRT to when VK2735 will hit the market, here is my current guess.
-Initiate both Ph3 (Obesity and T2D) studies by May 2025
-Complete enrollment by Dec 2025
-Complete studies by Mar 2027 (15 month /64 week study based on 12 week titration and 52 week maintenance per FDA guidance)
-Submit NDA by Sept 2027 (6 months to create docs)
-PDUFA Date of Jul 2028 (10 months is normal)

So I'm guessing approval by Jul 31, 2028 on everything proceeding "normally". Add 6 months for minor issues and you have a range of mid to late 2028. Note that it's possible they could complete enrollment quicker or use AI to shorten NDA creation (NVO claims to be able to do this now) so that a late 2027 market entry is possible as is some unforeseen circumstance that could push out the market entry.