Replies to post #245724 on Biotech Values

[DewDiligence]

BMY/JNJ—Milvexian—>FDA Fast Track designation for_all_phase-3_indications:

https://finance.yahoo.com/news/milvexian-granted-u-fda-fast-105900364.html

The three Milvexian indications BMY/JNJ are pursuing in phase-3 are: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF—see #msg-171338375.

FDA Fast Track status doesn’t mean much, but it makes a Priority Review of the NDAs somewhat more likely (if one or more of these phase-3 trials pan out).

Please see #msg-169818942 and #msg-169809402 for additional background info.

p.s. This PR was issued yesterday.

[DewDiligence]

BMY/JNJ—Milvexian phase-3 fails_in ACS—(props_to PFE):

https://www.businesswire.com/news/home/20251113242684/en/Update-on-Phase-3-Librexia-ACS-Trial

Two other phase-3 Milvexian trials continue: primary stroke prevention in patients with atrial fib; and secondary stroke prevention following a stroke or TIA.

Milvexian’s phase-2 data were murky (#msg-169809402), so this phase-3 program was relatively high-risk. It may turn out that FXIa is not a better place to intervene in the coagulation cascade than FXa. This is plainly what PFE thought when PFE declined to partner with BMY on an FXIa “successor” to Eliquis.