BMY takes global license to IMTX’s TCR-bispecific program—$150M up-front:
GILD vs BMY in LBCL CAR-T—who has the edge?
Both Yescarta and Breyanzi are poised to take share from stemcell transplants.
BMY boosts dividend—authorizes $15B share buyback:
The new annualized dividend is $2.16 (up from $1.96); at the current share price, the new payout is a yield of 3.8%.
The $15B buyback authorization does not have a time limit. (Inasmuch as BMY had $200K remaining on the old buyback authorization, the total buyback authorization is now $15.2B.)
Reblozyl sBLA in beta thalassemia—>3/27/22 PDUFA date—(with FDA priority review):
BMY is now partnered with MRK on Reblozyl development and commercialization as a result of MRK’s buyout of XLRN, which makes for an odd working relationship.
Deucravacitinib for psoriasis has 9/10/22 PDUFA date (with standard FDA review):
The Deucra MAA in psoriasis has also been validated by the EMA.
Mavacamten PDUFA extended 3mo to 4/28/22:
The FDA simply needs more time to complete the NDA review—it has not requested any new data or analyses from BMY.
Mavacamten is the drug BMY got in the $13.1B acquisition of MYOK in Oct 2020 (#msg-158698900).
BMY presents phase-2 Milvexian data at AHA:
Milvexian is an oral anticoagulant that inhibits Factor XIa, a new MoA. Compared to FXa inhibitors such as Eliquis and Xarelto, Milvexian may be able to offer comparable efficacy with less bleeding risk.
BMY is developing Milvexian with JNJ, pursuant to a 2018 collaboration (#msg-140083631). BMY hopes Milvexian can replace some or all of the revenue from Eliquis, which loses exclusivity in 2028. Phase-3 trials for Milvexian are slated to start in 2022.
BMY reports statsig DFS in neoadjuvant* NSCLC:
These data are from the phase-3 CHECKMATE-816 study. BMY reported stellar pCR (complete pathological response) data from this trial in Apr 2021 (#msg- 163102660), but the DFS (primary endpoint) data were not yet mature then.
This result should enable Opdivo to compete with Tecentriq use in adjuvant NSCLC.
See #msg-163102660 for background info.
*Stage Ib to IIIa.
well, this stock is sure driving me crazy. goes down on decent earnings. i've felt this stock has been undervalued for years. ibd writer keeps saying patent cliffs coming soon , isn't that true for all pharma stocks? i know bmy is rumored to be buying ?aurina? for roughly $35 or 4.5B which im tired of this ceo not paying down current massive debt of $45B. with guidance around $7.50 this year and probably much higher next year wheres the wallstreet luv? my fav part of this stock is the free cash flow of 15B and growing. whats the reason any of you have invested in this stock? cheers
BMY 3Q21 results:
2021 non-GAAP EPS guidance is now $7.40-7.55 (up slightly from the prior guidance of $7.35-7.55.
BMY’s Deucravacitinib fails phase-2 trial in UC:
FDC of Opdivo/Relatimab—(anti-LAG-3)—has 3/19/22 PDUFA date for 1L-melanoma (with FDA priority review):
Nimbus Therapeutics (private) starts phase-2b of TYK2 inhibitor in psoriasis:
This is potential competition for BMY’s Deucravacitinib.
FDA approves Opdivo monotherapy in adjuvant MIUC:
Confirmed on today’s CC that the Opdivo/Yervoy arm in CHECKMATE-649 did not show a statsig benefit vs chemo. (See bottom paragraph of the post this is replying to.)
BMY 2Q21 results—2021_non-GAAP_EPS_guidance remains $7.35-7.55:
BMY, BBIO ink clinical-trial collaboration to test Opdivo + BBP-398 (SHP2 inhibitor) in NSCLC and other solid cancers:
Opdivo/Yervoy fails to show statsig OS benefit compared to Erbitux/chemo in first-line SCCHN:
These results are from the CHECKMATE-651 study.
BMY opys-in_for PRTA's anti-tau_compound, PRX005:
PRTA gets $80M from BMY for the opt-in and is eligible to receive as much as $2.2B in regulatory/commercial milestone payments.
BMY inherited this collaboration from CELG (#msg-139431013).
BMY settles US Revlimid-patent case with another challenger—Sun Pharma—on similar terms to prior settlements—(e.g. #msg-158350306):
The basic framework of these settlements is: a) the generic-drug companies who settled can launch limited quantities their Revilimid generics in the US market in 2022 (Mar 2022 for Natco [the first company to settle with BMY]; and somewhat later in 2022 for RDY, Cipla, and Sun Pharma); and 2) the generic-drug companies who settled can launch unlimited quantities of their Revlimid generics starting on 1/31/26.
BMY, Eisai ink global collaboration for MORAb-202 ADC:
Breyanzi shows phase-3 statsig-superior EFS compared to SoC (high-dose chemo followed by stem-cell transplant) in second-line, large B-cell lymphoma:
Bryanzi’s existing label includes only the third-line setting (#msg-161552697).
BMY releases additional Opdivo/chemo and Opdivo/Yervoy data from the CHECKMATE-648 study in certain GI cancers:
In Apr 2021, BMY announced that this study hit its OS primary endpoint for both the Opdivo/chemo and Opdivo/Yervoy arms, compared to chemo alone (#msg-163050617), but no details were available until now.
The dataset is complex and you need a scorecard to understand all of it; fortunately, Evaluate Vantage has provided one:
Note: Opdivo/chemo is already FDA-approved in a different kind of metastatic GI cancer, based on the CHECKMATE-649 (rather than -648) study (#msg-163247972); and Opdivo monotherapy is already FDA-approved in adjuvant esophageal cancer, based on the CHECKMATE-577 study (#msg-163936079).
FDA approves Zeposia for_moderate/severe ulcerative colitis:
Zeposia was approved in 2020 by FDA and EMA for relapsing MS (#msg-154586608, #msg-154614638). The label expansion to UC is BMY’s first GI-immunology approval.
FDA approves Opdivo monotherapy in adjuvant esophageal cancer (for patients who have residual pathological disease following chemo/radiation in the neoadjuvant setting and a complete resection):
The approval was based on the CHECKMATE-577 study. Today was the PDUFA date.
This is Opdivo’s second approval in an adjuvant setting—the other is in melanoma.
PDUFA for Opdivo in adjuvant MUIC is 9/3/21 (with priority review):
The sBLA is based on the CHECKMATE-274 study.