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Bayer Wins FDA Acceptance for KERENDIA CKD Filing Without Diabetes
Bayer reported that the U.S. FDA accepted its supplemental New Drug Application for KERENDIA for chronic kidney disease patients without diabetes. The filing is backed by Phase III trial data that Bayer says showed kidney and cardiovascular benefits in non diabetic CKD patients, and KERENDIA is already approved in the U.S. for adults with chronic kidney disease associated with type 2 diabetes. The sNDA covers adults with CKD without diabetes on standard care, a population not included in KERENDIA's current U.S. approvals, and the FIND CKD trial enrolled 1,584 such patients and showed a statistically significant 0.7 mL/min/1.73 m²/year difference in eGFR decline versus placebo, plus a benefit on a kidney cardiovascular composite outcome. Bayer, a €41.8 billion life science group active across Europe, the Americas and Asia, has been pushing deeper into prescription therapies, and the company's narrative highlights new labels and approvals for KERENDIA as a key pharmaceutical catalyst that can help offset patent losses. The critical signpost now is the FDA's decision on this sNDA, including the timing and any label wording around the kidney and cardiovascular endpoints from FIND CKD.
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Aging Population › Chronic-Disease Pharma Franchises ▲Regulation
BAYN.XETRA · Regulation · Positive FDA accepted Bayer's sNDA for KERENDIA in non-diabetic CKD, advancing a key label expansion toward approval.
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Johnson & Johnson Q3 Earnings Preview: Estimates Cut, Stelara Biosimilar Pressure Looms
Johnson & Johnson will report its third-quarter 2026 results on Oct. 13, with the Zacks Consensus Estimate pegged at $25.37 billion in sales and $2.66 per share in earnings. Over the past 60 days, the consensus estimate for 2026 earnings has declined from $11.48 to $11.21 per share, while the 2027 estimate has fallen from $12.81 to $12.17. J&J has an Earnings ESP of +2.10% and a Zacks Rank #3 (Hold), and it exceeded earnings expectations in each of the trailing four quarters, delivering an average surprise of 1.39%. Within the Innovative Medicine segment, consensus estimates stand at $4.33 billion for Darzalex, $2.24 billion for Tremfya and $1.07 billion for Erleada, while Stelara sales are seen at $634.0 million and Imbruvica at $602.0 million, with Stelara's loss of exclusivity having cut the segment's growth by 760 basis points in the second quarter. The MedTech segment carries a consensus estimate of $8.77 billion, and J&J still expects to generate more than $100 billion in revenues in 2026 after $49.4 billion in the first half.
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Aging Population › Chronic-Disease Pharma Franchises ▼Demand
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Demand
Biotech & Genomic Medicine › Oncology Therapeutics Demand
JNJ · Capital · Negative Consensus 2026/2027 EPS estimates cut ahead of Q3 report, with Stelara loss of exclusivity dragging Innovative Medicine growth.
AbbVie Revenue Rises 10.2% as Skyrizi and Rinvoq Offset Humira's 35.9% Decline
AbbVie grew total revenue 10.2% to $16.99 billion last quarter even as Humira sales fell 35.9% to $756 million, with the company's newer immunology drugs carrying the growth. Skyrizi brought in $5.505 billion, up 24.4%, and Rinvoq added $2.525 billion, up 24.5%, lifting total immunology sales to $8.786 billion, up 15.1%. Neuroscience contributed $3.228 billion, up 20.3%, while oncology slipped 1.5% to $1.650 billion and aesthetics edged up 0.3% to $1.282 billion. Adjusted earnings per share came in at $3.65, up 22.9%, against GAAP earnings of $2.03, and management guides to full-year adjusted EPS of $13.87 to $14.07. AbbVie recently closed its purchase of Apogee Therapeutics at $135.11 per share in cash, for a total equity value of $10.9 billion, a deal the company says will reduce adjusted EPS by $0.14 this year and approximately $0.46 in 2027, with accretion beginning in 2032. At a forward P/E of 18.97 as of October 6, AbbVie trades essentially in line with the sector's 18.84 but above its own five-year average of 14.51, a premium that leans on expected EPS growth of 16.14% in 2027.
About megatrends
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Demand
Aging Population › Chronic-Disease Pharma Franchises Demand
ABBV · Capital · Positive AbbVie grew total revenue 10.2% to $16.99B with adjusted EPS up 22.9% to $3.65 and raised full-year EPS guidance.
ABBV · Demand · Positive Skyrizi and Rinvoq sales rose ~24% each, lifting total immunology revenue 15.1% and offsetting Humira's 35.9% decline.
3impact 4
Novo Nordisk Raises 2026 Outlook, Targets Peer-Level Growth Through 2030
Novo Nordisk raised its 2026 outlook while telling investors at a London strategy day that it aims to grow revenue through 2030 at roughly the pace of large drugmaker peers. In the second quarter of 2026, adjusted sales rose 7% at constant exchange rates and adjusted operating profit rose 11%, though reported operating profit fell 16%, dragged down by a DKK 6.3 billion non-cash impairment on pipeline assets and by a year-ago rebate reversal. The raised 2026 outlook now puts adjusted sales and operating profit between flat and down 6% at constant exchange rates, while the longer view promises more than five multi-blockbuster launches by 2030, over DKK 150 billion in pipeline sales in 2035, and revenue growth in line with peers from 2026 to 2030, which management stressed are ambitions rather than guidance. The company's Wegovy pill topped 265,000 weekly prescriptions in a single week this summer and total prescriptions have passed 5 million since launch, but Eli Lilly's Mounjaro and Zepbound have overtaken Ozempic and Wegovy in the US, and Novo's next-generation shot CagriSema missed its goal of proving it was not inferior to Lilly's tirzepatide. At a forward P/E of 10.97 as of October 6, against 18.77 for the sector and a five-year average of 27.91, Novo trades well below peers, with 59 hedge funds holding the stock in the most recent quarter, up from 55, and short interest at just 0.83% of the float.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
Aging Population › Chronic-Disease Pharma Franchises Competition
Longevity & Life Extension › GLP-1 Healthspan Proxies Competition
NVO · Capital · Neutral Novo raised its 2026 outlook and reported Q2 adjusted sales +7% and operating profit +11%, but reported operating profit fell 16% on a DKK 6.3bn impairment and the outlook still implies flat-to-down adjusted sales/profit.
NVO · Competition · Negative Eli Lilly's Mounjaro and Zepbound have overtaken Ozempic and Wegovy in the US, and Novo's next-gen CagriSema missed its non-inferiority goal versus Lilly's tirzepatide.
LLY · Competition · Positive Eli Lilly's Mounjaro and Zepbound have overtaken Ozempic and Wegovy in the US, and CagriSema missed its non-inferiority goal versus Lilly's tirzepatide.
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Eli Lilly Trades at 30.94 Times Forward Earnings Despite 48% Revenue Growth
Eli Lilly reported 48% revenue growth for the second quarter of 2026 and raised its full-year outlook, yet the stock trades at 30.94 times forward earnings, well below its five-year average of 45.59. Mounjaro brought in $9.9 billion in the quarter, up 91%, and Zepbound added $4.9 billion, up 46%, while non-GAAP gross margin reached 86.3% and revenue outside the US rose 80% to $8.6 billion. The once-daily weight-loss pill Foundayo booked $98 million in its first quarter of sales, and Medicare's new coverage pathway now lets eligible patients get Foundayo or Zepbound for $50 a month, with Lilly estimating about 20 million Medicare patients may meet the clinical criteria. Management lifted 2026 revenue guidance to between $85 billion and $87 billion from $82 billion to $85 billion, and plans to file retatrutide with the FDA in the first quarter of 2027. Growth was volume-led, with volume up 60% against a 13% decline in realized prices, and second-quarter EPS of $8.38 absorbed $3.03 per share of acquired research charges, while reported EPS was $7.94 and full-year guidance stands at $35.50 to $36.50.
About megatrends
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Demand
Aging Population › Chronic-Disease Pharma Franchises ▲Demand
Longevity & Life Extension › GLP-1 Healthspan Proxies ▲Demand
LLY · Capital · Positive Lilly reported 48% Q2 revenue growth, 86.3% gross margin, and raised full-year 2026 revenue guidance to $85-87B.
LLY · Demand · Positive Mounjaro sales rose 91% to $9.9B, Zepbound rose 46% to $4.9B, and Medicare's new coverage pathway opens Foundayo/Zepbound to ~20M eligible patients.
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Eli Lilly Consensus Estimates Rise as Zacks Rank Holds at #3
Eli Lilly is expected to post earnings of $9.83 per share for the current quarter, a year-over-year change of +40%, with the Zacks Consensus Estimate edging up +0.1% over the last 30 days. For the current fiscal year, the consensus earnings estimate of $36.64 points to a change of +51.3% from the prior year and has risen +0.3% over the past month, while the next fiscal year's consensus estimate of $46.8 indicates a change of +27.7% and has moved +1.4% higher. On the revenue side, the consensus sales estimate of $22.14 billion for the current quarter points to a year-over-year change of +25.8%, with the $88.88 billion and $102.02 billion estimates for the current and next fiscal years indicating changes of +36.4% and +14.8%, respectively. In the last reported quarter, Lilly posted revenues of $22.97 billion, up +47.7% year over year, and EPS of $8.38 versus $6.31 a year ago, beating the Zacks Consensus revenue estimate of $20.26 billion by +13.38% and the EPS estimate by +39.43%. The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Lilly, and the stock is graded D on the Zacks Value Style Score, indicating it trades at a premium to its peers.
About megatrends
Aging Population › Chronic-Disease Pharma Franchises ▲Capital
Longevity & Life Extension › GLP-1 Healthspan Proxies Capital
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Capital
LLY · Capital · Positive Consensus earnings and revenue estimates for Eli Lilly rose, with current-quarter EPS seen up 40% YoY and full-year EPS up 51.3%.