Milvexian—>FDA Fast Track designation for_all_indications:
The three indications BMY is pursuing in phase-3 are: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF.
IMMP +65% on interim (single-arm) phase-2 data for LAG-3 drug with Keytruda in NSCLC:
IMMP’s eftilagimod alpha is a LAG-3 protein that targets the same biologic pathway as BMY’s relatlimab, one of the component drugs (along with Opdivo) in Opdulag.
BMY’s Opdulag, which was FDA approved in Mar 2022 for first-line melanoma, is already selling at an annualized rate of $500M in the US alone (#msg-171784010).
Please see #msg-168259768 for related info.
$3.4M insider sale yesterday by BMY’s CSO, Rupert Vessey:
Unless Vessey is buying a house, a sale of this size at this price level is somewhat concerning.
BMY 1Q23 results…
2023 non-GAAP EPS guidance remains $7.95-8.25, +4% YoY at the midpoint of the range.
BMY’s CCO, Christopher Boerner—>CEO effective 11/1/23:
CEO, Giovanni Caforio will become Executive Chairman on 11/1/23. Between now and 11/1/23, Boerner will have the title of COO.
CHMP approves Breyanzi in second-line LBCL:
FDA approval in this indication came in Jun 2022 (#msg-169240243).
BMY, EVO extend/expand neurodegeneration collaboration:
The collaboration now runs for another eight years, and EVO receives an additional $50M in up-front cash.
Note that BMY and EVO are also collaborating in protein degradation (#msg-168811996).
EC approves Sotyktu for psoriasis:
Essentially same label as FDA’s.
BMY will not launch Opdualag in Germany due to pricing constraints on FDC (combination) drugs:
BMY/JNJ unveil_phase-3_program_for Milvexian—50,000 patients_across_three_ trials_in secondary stoke prevention, ACS, and AF/primary stroke prevention:
Opdivo PDUFA date for adjuvant melanoma—>10/13/23:
The corresponding MAA has been validated by the EMA, starting the review clock.
The sBLA and MAA are based on the CHECKMATE-076 study, which showed HR=0.42 for the primary RFS endpoint (#msg-170239823).
BMY/TVST report Abecma data from phase-3 KarMMa-3 study:
BMY -2.5% today—possible reason is that the CEO just sold $18M worth of stock—approximately half his holding—(the Form-4 filing hit the wires last night after the close):
It's hard to interpret a transaction of this size as non-bearish. I wonder if Giovanni Caforio is planning to retire in the next 12-18 months.
Bayer enrolls first phase-3 patients for FXIa inhibitor, Asundexian:
BMY’s Sotyktu patients are coming approximately 1/3 from treatment-naïve, 1/3 for Otezla switches, and 1/3 from biologic switches. (Source: 4Q22 CC.)
BMY 4Q22 results—2023 guidance:
2023 non-GAAP EPS guidance is $7.95-8.25; at the midpoint of the range, this is a 4% increase relative to 2022’s non-GAAP EPS of $7.70.
CHMP approves BMY’s Sotyktu for psoriasis:
Addendum—Breyanzi is the first CAR-T to show efficacy in CLL, as far as I know. rrCLL is a large market; if Breyanzi’s complete-response rate after, say, 5 years is as high as 15-20%, this indication could be a meaningful commercial contributor.
Breyanzi, which is currently approved for various forms of relapsed NHL, has annualized sales of under $200M.
BMY’s Breyanzi meets primary endpoint in rrCLL/SLL single-arm trial:
BMY’s Breyanzi continues to show robust results in second-line LBCL after longer follow-up:
Data from the same trial presented one year ago (at ASH 2021) are in #msg-164317285.
BMY boosts annualized dividend to $2.28—(from $2.16):
At the current share price ($79.88), the new annualized payout is a yield of 2.9%.
BMY 3Q22 results—2022 non-GAAP guidance unchanged:
Non-GAAP EPS guidance remains $7.44-7.74.
This PR wasn’t supposed to come out until Wednesday morning. (Somebody must have goofed.)
Camzyos sNDA for prevention of SRT* in patients with symptomatic obstructive HCM has 6/16/23 PDUFA date:
*Septal Reduction Therapy, a surgical intervention to correct a structural heart defect.
BMY—Opdivo monotherapy—>RFS HR=0.42 in adjuvant melanoma:
Opdivo monotherapy shows statsig RFS in adjuvant melanoma (fully resected Stage IIB/C):
These results are from the phase-3 CHECKMATE-76K trial. Details to be presented at a medical conference.
What is the link for that? TIA
Sotyktu: Miracle Pill for Autoimmune Diseases
"Given both deucravacitinib’s new mechanism of action and its very acceptable safety profile, it has the ability to make billions of dollars for Bristol-Myers Squibb. Well, it will give immeasurably suffering patients an extra chance for healing.
For U.S. patients, the price of Sotyktu is set at $6,146 (excluding discounts and rebates) for a one-month course of treatment. A year’s worth of therapy would cost $74,000. This is one-third more than the cost of treating psoriasis with Otezla (apremilast).
According to industry forecasts, deucravacitinib sales will reach $2.4 billion annually by 2026. Peak demand for deucravacitinib will easily reach $4 billion annually."
Perfect timing—BMY reports 2yr Sotyktu data in psoriasis at EADV conference:
FDA approves Sotyktu (deucravacitinib) for psoriasis:
The label does not include JAK-like black-box warnings or usage restrictions, validating BMY’s contention that Sotyktu's TYK2 target is well differentiated from JAK1/2/3.
BMY expects eventual Sotyktu approval in other autoimmune indications and foresees peak annual sales of at least $4B.