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The approval is based on phase-3 data reported one year ago, in which Breyanzi showed statsig-superior EFS compared to SoC (#msg-164317285).
Breyanzi will compete in this newly approved indication with GILD’s Yescarta (#msg-167110232).
Breyanzi was initially FDA-approved for third-line LBCL in Feb 2021 (#msg-161552697). This is the drug at the heart of the lawsuit by former CELG shareholders (#msg-169238809).
The Company could not appropriately address the U.S. Food and Drug Administration’s questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial.
As a result of the acquisition, BMY is reducing 2022 non-GAAP EPS guidance by $0.08 plus a charge for in-process R&D to be determined later. (BMY’s prior 2022 non-GAAP EPS guidance was $7.44-7.74.)
• New multi-program collaboration to develop allogeneic TCR-T/CAR-T programs brings together Immatics’ allogeneic gamma delta T cell therapy platform ACTallo with Bristol Myers Squibb’s technologies and oncology drug development expertise
• Immatics to receive upfront payment of $60 million and additional milestone payments of up to $700 million per program plus tiered royalty payments of up to low double-digit percentages on net product sales across multiple programs under the new collaboration
• Per 2019 agreement, Bristol Myers Squibb to also add one additional autologous TCR-T target where Immatics will receive an upfront payment of $20 million and be eligible for milestone payments and royalties
$BMY's LAG-3 result in first-line melanoma looks like a fairly modest medical advance, but one that will probably make serious money for the company in the coming years. (I'm long.)
Under the terms of the agreement, BridgeBio will receive an upfront payment of $90 million, up to $815 million in development, regulatory and sales milestone payments, and tiered royalties in the low- to mid-teens. BridgeBio will retain the option to acquire higher royalties in the United States in connection with funding a portion of development costs upon the initiation of registrational studies.
Based on the terms of the agreement, BridgeBio will continue to lead its ongoing Phase 1 monotherapy and combination therapy trials. Bristol Myers Squibb will lead and fund all other development and commercial activities.
2022 non-GAAP EPS was lowered by $0.21 due to an FASB accounting change regarding in-process R&D (i.e. accounting for acquisitions). The updated range for 2022 non-GAP EPS (unchanged other than the item described above) is $7.44-7.74.
BMY thinks Camzyos will have peak annual sales of at least $4B. This is the drug BMY got in the $13.1B acquisition of MYOK in Oct 2020 (#msg-158698900).
Nektar Therapeutics and Bristol Myers Squibb (NYSE: BMY) today announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued.
Bempeg previously failed in a phase-3 trial in combination with Opdivo in melanoma (#msg-168191364), so today’s news is three strikes and you’re out!
Rarely has a cancer drug failed so utterly and completely to live up to initial expectations (#msg-138532013). NKTR’s share price is down 96%(!) from its 2018 high.
Certainly BMY never would've parted with China franchise.
[BMY] may be eligible to receive regulatory and sales milestone payments of up to $147.5 million, as well as tiered double-digit royalties on the sale of mavacamten in the [China] territories outlined as part of the collaboration.
Lian is happy to let BMY do all the heavy lifting. Go BMY!
… [BMY] may be eligible to receive regulatory and sales milestone payments of up to $147.5 million, as well as tiered double-digit royalties on the sale of mavacamten in the [China] territories outlined as part of the collaboration. LianBio will fund all development and commercial expenses in the collaboration territory.
Bristol Myers Squibb today announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline. Study participants were on maximally tolerated background regimens when they entered the trial and remained on them through the duration of the study. These data were presented today as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session.
At 16 weeks the primary and all secondary endpoints were met. Of patients treated with mavacamten, 82% had not proceeded with SRT and no longer met the criteria for SRT according to the 2011 ACC/AHA Guidelines compared to 23% of patients receiving placebo.
I just grabbed a few puts for September. Looking at 10 year chart, every time it hit new highs there was a pull back. Just a little gamble. Definitely a good company to own shares in.
The approval is based on the RELATIVITY-047 trial, which tested Opdivo + relatlimab against Opdivo monotherapy and had a PFS HR=0.75 (#msg-163914232).
In first-line melanoma, Opdulag offers comparable efficacy to Opdivo + Yervoy with less toxicity.
My abbreviated take:
$BMY's LAG-3 result in first-line melanoma looks like a fairly modest medical advance, but one that will probably make serious money for the company in the coming years. (I'm long.)
Curiously, in the pre-specified subgroup with PD-L1>=50%, Keytruda’s DFS compared to placebo had a non-statsig HR=0.82—a worse result than in the overall trial.
The HR for OS, a secondary endpoint that is not yet mature, was 0.87.
All told, this is not a great dataset, IMO, but it may be enough for FDA approval. These data may put Keytruda at a competitive disadvantage to Tecentriq and Opdivo in early-stage NSCLC.
Bristol Myers Squibb and Nektar Therapeutics today announced an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.
Given there was no additional clinical benefit in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint.
Additionally, based on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma, which is evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma.
TEVA launches first US generic Revlimid—but the generic volume is constrained by a prior patent settlement between CELG and Allergan (#msg-119362355):
The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license[i.e. Apr 2026-Apr 2027] under this agreement.
This is why BMY’s guidance for 2022 Revlimid sales is still $9.5-10B (vs $12.8B in 2021: #msg-167758757), declining about $1.5B per year during 2023 and beyond.
This is a large potential market and Opdivo is the only FDA-approved immunotherapy in the NSCLC neoadjuvant setting (i.e. before surgical resection).
The approval is based on the CHECKMATE-816 study, where Opdivo/chemo bested chemo alone with the HR for EFS=0.63. Additionally, 24% of patients in the Opdivo/chemo arm had a pathological complete response (no detectable cancer) vs 2% in the chemo-only arm.
OS, which was not a primary endpoint in this trial, had an impressive HR=0.57; however, so little alpha was allocated to OS in the statistical analysis plan that the HR=0.57 result was not deemed statsig.
Under the terms of the agreement, Biohaven will receive worldwide rights to taldefgrobep and Bristol Myers Squibb will be eligible for regulatory approval milestone payments, as well as tiered, sales-based royalties beginning in the high teens.
This drug previously failed in clincial trials run by BMY/Roche, so BHVN must have a new angle.
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