BofA/ML - BMY: Positive CM-9LA top-line win ahead of expectations; potential filing 1H20 | BMY Message Board Posts

Bristol-Myers Squibb Co.

  BMY website

BMY   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  756 of 836  at  10/22/2019 9:24:46 AM  by

JBWIN


BofA/ML - BMY: Positive CM-9LA top-line win ahead of expectations; potential filing 1H20

 

CM-9LA hits in 1L NSCLC ahead of expected; filing likely 1H20

We look for strength in BMY shares today given a major win for its Opdivo franchise with a positive interim top-line readout from its high-profile phase 3 CheckMate-9LA study (Opdivo + Yervoy + chemotherapy) in 1L NSCLC, which comes ahead of the expected early 2020 timeframe. While we view the companys recent data from CM-227 (Opdivo + Yervoy) at ESMO as an important step for Opdivo, the CM-9LA study represents a potentially much larger opportunity for its overall I/O positioning in the lung marketwhich represents by far the largest indication across solid tumors. While questions over the trial will remain until we get detailed results at a meeting (likely AACR in April, or ASCO in June at the latest), wed highlight todays announcement as a much needed win for the company on the back of the controversial Celgene pending acquisition, and an important catalyst that in our view represents the start to a re-rating of shares. Reiterate Buy and $60 PO. 

We had the opportunity to speak with management, who noted that while 9LA will be an important registrational dataset for the Opdivo franchise, the plan is to go ahead with the CM-227 filing imminently (rather than wait for CM-9LA) given that they only have top-line 9LA data in-house. That said, wed expect a quick regulatory turnaround for 9LA, with a likely submission in 1H20 (assuming data presented at AACR or ASCO).

Lingering questions over safety profile and subgroup analysis

While todays data will likely prompt upside to current Opdivo/Yervoy expectations, we recognize that several questions are likely to remain before the Street fully warms up to Opdivo as a player in 1L lung. Top of mind questions include: 1) how will the safety profile look given the three regimen combo, 2) strength of data in subgroups given the primary analysis was in all-comers (PD-L1 high, low, and negative expressers), and 3) durability profile (though we note that the follow up will be much shorter than CM-227).

 
 


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 13     Views: 247
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board


About Us  •  Contact Us  •  Follow Us on Twitter  •  Members Directory  •  Help Center  •  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
© 2003-2019 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...