Benzinga - by Vandana Singh, Benzinga Editor.
Monday, Bayer AG (OTC: BAYRY) (OTC: BAYZF) stopped the OCEANIC-AF Phase 3 study early after asundexian showed inferiority to Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc's (NYSE: PFE) apixaban (Eliquis).
William Blair writes that the trial's unexpected outcome after an 11-month initiation period contrasts with recent positive study results that indicated similar rates of stroke or systemic embolism but with a significant decrease in bleeding risk.
Data from milvexian, an oral Factor XIa inhibitor by Bristol Myers, and privately held Anthos Therapeutics Inc's abelacimab in total knee replacement showed promising effectiveness and safety trends, suggesting potential implications for atrial fibrillation.
The setback of OCEANIC-AF is likely to diminish investor confidence in Factor XIa inhibitors' capability to outperform Eliquis in atrial fibrillation, impacting ongoing trials such as the Phase 3 Librexia-AF trial with milvexian (anticipated results in 2027).
Success in other medical indications like acute coronary syndrome and secondary stroke prevention could validate milvexian's blockbuster potential, though beating Eliquis specifically in atrial fibrillation holds a significant market opportunity exceeding $10 billion.
This success could bolster Bristol Myers' long-term prospects, especially if potential competition from asundexian is now eliminated.
The analyst also notes that since asundexian was only being dosed once daily, it is possible asundexian was being underdosed.
In contrast, Bristol Myers' management highlights that milvexian was evaluated across a much wider dose range, including once and twice daily.
The analyst's rating for BMY is Market Perform ahead of additional clarity with the company's commercial portfolio.
Price Action: BMY shares are down 4.01% at $48.80 on the last check Monday.
Photo Via Company
Latest Ratings for BMY
| Mar 2022 | Wells Fargo | Maintains | Equal-Weight | |
| Dec 2021 | Goldman Sachs | Initiates Coverage On | Buy | |
| Dec 2021 | Wells Fargo | Initiates Coverage On | Equal-Weight |
View the Latest Analyst Ratings
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.