Kairos Pharma Reports Breakthrough Interim Safety Data in Phase 1 Trial of ENV-105

On July 15, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, reported compelling interim safety data from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (AstraZeneca’s Tagrisso) in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). The data represent a pivotal milestone in Kairos Pharma’s lead program: resensitizing patients who have acquired resistance to osimertinib, the global standard-of-care for EGFR-mutated NSCLC. With no serious adverse events (Grade 3 or higher) observed across 13 treated patients to date from ENV-105 treatment, the safety profile supports continued progression toward an early efficacy readout.

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Non-small cell lung cancer is the dominant form of lung cancer, accounting for approximately 85% of all lung cancer diagnoses globally. Within NSCLC, EGFR-mutated patients represent the most commercially important and genetically actionable subpopulation. The EGFR-NSCLC market alone is valued at approximately $10 billion across leading current markets, growing at a CAGR of 10.5%, projected to be over $13 billion by 2030.1-3 Osimertinib (Tagrisso) is the gold-standard, first-line therapy for this patient population with about $6 billion in sales annually.4,5 Despite osimertinib’s initial efficacy, resistance to the drug is inevitable. Once a patient progresses on osimertinib, therapeutic options are limited with a significant clinical setback with inferior survival outcomes. Currently, there is no FDA-approved agent specifically designed to reverse or overcome osimertinib resistance and restore drug sensitivity.

Kairos Pharma’s scientific thesis is grounded in a precision oncology insight of restoring sensitivity to standard of care cancer therapies. CD105 (endoglin) is pathologically elevated in patients who develop osimertinib resistance, and its overexpression drives one of the core resistance signaling pathways.6, 7 ENV-105 (carotuximab) is a first-in-class CD105 antibody that blocks the signaling of this overexpressed protein, mechanistically dismantling the resistance phenotype and creating the biological conditions for osimertinib sensitivity. This strategy support extending progression-free survival, preserving quality of life, and fundamentally increasing the clinical utility of the world’s most prescribed EGFR-targeted therapy. If successful, ENV-105 would not compete with osimertinib — it would extend its commercial life across the entire EGFR-mutated patient population.

"Our goal is not simply to complete a Phase 1 trial; it is to deliver a resensitization solution that changes the post-progression treatment paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed across 13 patients" said Dr. John Yu, Chief Executive Officer of Kairos Pharma.

The scientific rationale for targeting CD105 is well-established: CD105 is a validated driver of resistance and disease relapse across multiple cancer types, including EGFR-driven NSCLC, and pre-clinical models have already confirmed ENV-105’s capacity to sensitize tumors to both radiation and hormone therapy. Critically, ENV-105’s clinical validation extends beyond lung cancer with an ongoing Phase 2 trial for castrate-resistant prostate cancer, ENV-105 delivered median progression-free survival exceeding 13 months, a significant improvement over standard of care. We believe that this demonstrated that the CD105 suppression mechanism translates into durable clinical benefit across fundamentally different tumor types and resistance contexts.

"ENV-105 continues to be extremely well tolerated, now across two very different indications," said Dr. Neil Bhowmick, Chief Science Officer of Kairos Pharma. "As we continue to showcase ENV-105’s potential for targeting drug resistance, this data is another important milestone in achieving our goal to ultimately provide better patient care over a longer term."

Interim Phase 1 Safety Data: Clinical Highlights

The interim safety analysis of the Phase 1 trial evaluating ENV-105 + osimertinib in EGFR-mutated advanced NSCLC patients demonstrates a clean early safety profile in the 13 patients treated with combination therapy. The trial is intended to assess safety, tolerability, and recommended Phase 2 dose, with adverse events evaluated under Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and dose-limiting toxicities monitored during the initial treatment cycles. All side effects were manageable with standard supportive care.

(Press release, Kairos Pharma, JUL 15, 2026, View Source [SID1234669231])

Johnson & Johnson reports Q2 2026 results, raises 2026 outlook

On July 15, 2026 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2026. "Johnson & Johnson delivered strong second-quarter results, demonstrating the power of our innovation, the depth of our portfolio and the momentum in our pipeline as we advance transformative treatments that address the world’s toughest health challenges," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "With raised guidance and quarterly sales surpassing $25 billion, we are on track to meet our 2026 target of more than $100 billion in annual revenue for the first time in our Company’s 140-year history."

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Overall financial results
Q2
($ in Millions, except EPS)
2026
2025
% Change
Reported Sales
$25,310
$23,743
6.6%
Net Earnings
$5,534
$5,537
-0.1%
EPS (diluted)
$2.27
$2.29
-0.9%
Q2
Non-GAAP* ($ in Millions, except EPS)
2026
2025
% Change
Operational Sales1,2
5.6%
Adjusted Operational Sales1,3
5.7%
Adjusted Net Earnings1,4
$7,081
$6,699
5.7%
Adjusted EPS (diluted)1,4
$2.90
$2.77
4.7%
Free Cash Flow5,6
~$8,700
$6,214

Regional sales results
Q2
% Change
($ in Millions)
2026
2025
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$14,533
$13,544
7.3%
7.3

7.4
International
10,777
10,199
5.7
3.4
2.3
3.5
Worldwide
$25,310
$23,743
6.6%
5.6
1.0
5.7

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q2
% Change
($ in Millions)
2026
2025
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$16,384
$15,202
7.8%
6.8
1.0
6.9
MedTech
8,926
8,541
4.5
3.6
0.9
3.7
Worldwide
$25,310
$23,743
6.6%
5.6
1.0
5.7

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Second-Quarter 2026 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 6.8%*, with divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by DARZALEX, CARVYKTI, TECVAYLI and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and Other Immunology in Immunology, and SPRAVATO and CAPLYTA in Neuroscience. Growth was partially offset by STELARA (an approximate 760 basis points impact) and REMICADE in Immunology, as well as IMBRUVICA and ZYTIGA in Oncology.
MedTech
MedTech worldwide operational sales grew 3.6%*, with net acquisitions and divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by wound closure products and biosurgery products in Surgery, electrophysiology products and Shockwave in Cardiovascular, contact lenses in Vision, and trauma in Orthopaedics.

Full-year 2026 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
July 2026
April 2026
Adjusted Operational Sales1,2
Change vs. Prior Year / Mid-point
6.2% – 6.8% / 6.5%
5.6% – 6.6% / 6.1%
Operational Sales2 / Mid-point
Change vs. Prior Year / Mid-point
$100.3B – $100.9B / $100.6B
6.5% – 7.1% / 6.8%
$99.7B – $100.7B / $100.2B
5.9% – 6.9% / 6.4%
Estimated Reported Sales3/ Mid-point
Change vs. Prior Year / Mid-point
$100.8B – $101.4B / $101.1B
7.0% – 7.6% / 7.3%
$100.3B – $101.3B / $100.8B
6.5% – 7.5% / 7.0%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$11.50 – $11.65 / $11.58
6.6% – 8.0% / 7.3%
$11.30 – $11.50 / $11.40
4.7% – 6.7% / 5.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$11.60 – $11.75 / $11.68
7.5% – 8.9% / 8.2%
$11.45 – $11.65 / $11.55
6.1% – 8.1% / 7.1%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: July 2026 = $1.15 and April 2026 = $1.17 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast.
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform1
Press Release
CHMP recommendation advances Johnson & Johnson’s TECVAYLI (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma
Press Release
FDA approves label expansion, cementing TREMFYA as the only IL‑23 inhibitor proven to help stop further joint damage
Press Release
FDA approves CAPLYTA (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
Press Release
Johnson & Johnson Announces CE Mark Approval for the New ETHICON 4000 Stapler
Press Release
FDA grants Priority Review for IMAAVY (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)
Press Release
Data Releases
Johnson & Johnson presents new IMAAVY (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis
Press Release

New TALVEY (talquetamab-tgvs) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma
Press Release
IMAAVY (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies
Press Release
Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study
Press Release
Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren’s disease
Press Release
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited
Press Release
Johnson & Johnson’s Phase 3 prostate cancer study shows ERLEADA (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer
Press Release
New TECVAYLI (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma
Press Release
Johnson & Johnson study shows TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn’s disease
Press Release
Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease
Press Release
Johnson & Johnson Announces Pivotal Clinical Study Results for a New Soft-Tissue Surgical Robotic System
Press Release
CAPLYTA (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis
Press Release
IMAAVY (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)
Press Release
Product Launch
Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave C2 Aero Coronary IVL Catheter
Press Release
Other
DePuy Synthes Appoints Christina Zamarro as Chief Financial Officer1
Press Release
Johnson & Johnson Invests more than $1 Billion to Strengthen U.S. Vision Manufacturing in Jacksonville, Florida
Press Release
Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and Patients
Press Release
Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform
Press Release
DePuy Synthes Announces Agreement to Acquire Miniature Radiofrequency Tracking Technology Across its Joint Reconstruction Portfolio
Press Release
DePuy Synthes Enters Exclusive U.S., Canada and Australia Distribution Agreement for CGBIO’s NOVOSIS
Press Release

Groundbreaking global survey captures the significant patient burden experienced with current standard-of-care bladder cancer treatments, underscoring urgency for continued innovation
Press Release
Johnson & Johnson Appoints Ryan Koors as Vice President, Investor Relations
Press Release
Johnson & Johnson Launches Landmark Head-to-Head Pulsed Field Ablation Trial in Persistent Atrial Fibrillation
Press Release
Johnson & Johnson Showcases CARTO-Powered Innovation, Including Debut of CARTOSOUND SONATA, to Advance Arrhythmia Care at HRS 2026
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

(Press release, Johnson & Johnson, JUL 15, 2026, View Source [SID1234669230])

GSK completes acquisition of Nuvalent, Inc.

On July 15, 2026 GSK plc (LSE/NYSE: GSK) reported completion of its acquisition of Nuvalent, Inc.1, a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies.

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The acquisition adds three lung cancer assets to GSK’s oncology portfolio. Zidesamtinib (NVL-520) and neladalkib (NVL-655) are considered potential best-in-class assets, based on clinical data, and are under FDA review for ROS1-positive and ALK-altered non-small cell lung cancer (NSCLC) with target decision dates later this year. Both have received FDA Breakthrough Therapy and Orphan Drug Designations. If approved, they are expected to launch in 2026 with multi-blockbuster potential. The acquisition also includes NVL-330 in phase I development for HER2-altered NSCLC.

Luke Miels, Chief Executive Officer, GSK, said: "Today’s deal completion accelerates our entry into lung cancer with zidesamtinib and neladalkib and a platform for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III development. There is a clear need for these medicines in defined patient populations, consistent with our approach of acquiring validated assets that aim to improve standard of care."

Financial considerations
Under the terms of the agreement, GSK completed a tender offer to acquire all of Nuvalent’s outstanding shares. The aggregate equity value of the transaction is approximately $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is approximately $9.4 billion (£7.1 billion).

About NSCLC
NSCLC is the most common form of lung cancer and is often characterised by specific genetic alterations, such as those in ALK, ROS1, or HER2. It can often metastasise (i.e. spread) to the central nervous system. It primarily affects working-age individuals. Current treatments are associated with mutation resistance and side effects, including metabolic and neurologic events, that can adversely impact patients’ quality of life.

(Press release, GlaxoSmithKline, JUL 15, 2026, View Source [SID1234669229])

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2026

On July 15, 2026 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 4,207 million in the second quarter of 2026. Net trade sales were USD 2,435 million in the U.S. and USD 1,772 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, JUL 15, 2026, View Source [SID1234669228])

Cellectar Biosciences Announces Publication of Phase 1 Study of Iopofosine I 131 in Peer-Reviewed Journal Cancers

On July 15, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the publication of results from a Phase 1 dose-escalation study evaluating iopofosine I 131 in combination with low-dose dexamethasone in 31 patients with heavily pretreated relapsed/refractory multiple myeloma (r/r MM). The manuscript, titled "A Phase I Trial of Iopofosine I 131 and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma," was published in the peer-reviewed journal, Cancers.

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"Iopofosine I 131 represents a differentiated therapeutic approach for patients with relapsed or refractory multiple myeloma who have limited remaining treatment options," said Sikander Ailawadhi, M.D., professor of medicine, division of hematology/oncology, Mayo Clinic, Jacksonville, Florida and lead author of the publication. "The study demonstrated manageable toxicity with adverse events being essentially limited to cytopenias, encouraging disease control, and evidence of antitumor activity in a heavily pretreated population, supporting the potential of this novel targeted radiotherapeutic in these most fragile patients. The predictability and recovery of the cytopenias support its potential for repeat dosing strategies in future clinical development."

Highlights of the Data:

The study evaluated both single-dose and fractionated-dose regimens of iopofosine I 131 in 31 heavily pretreated r/r MM patients, many of whom had exhausted available treatment options.

Among 26 efficacy-evaluable patients:

Clinical activity appeared more pronounced in patients receiving higher total administered doses
84.6% achieved stable disease or better following treatment
30% overall response rate observed among evaluable patients (n=10) receiving at least 60 mCi of iopofosine I 131
The overall response rate was 15.4%, with four patients achieving partial responses
Investigators reported a favorable and manageable safety profile, with adverse events primarily consisting of predictable and reversible hematologic toxicities
No new safety signals were identified, and non-hematologic adverse events were generally low grade
"Publication of these data in Cancers further validate the potential of iopofosine as a differentiated targeted radiopharmaceutical and underscore the promise of our phospholipid drug conjugate platform as a novel targeted radiotherapeutic platform," said Jarrod Longcor, Cellectar’s chief operating officer and co-author of the publication. "Importantly, the mechanism of action is not dependent on a single target or mutation, creating the opportunity to address a broad range of B-cell-mediated malignancies. We believe iopofosine has the potential to serve patients across multiple indications, including Waldenström macroglobulinemia, multiple myeloma, diffuse large B-cell lymphoma and other difficult-to-treat hematologic cancers where new therapeutic options remain urgently needed."

The authors further noted that iopofosine’s limited impact on renal and hepatic function, coupled with its predictable and manageable safety profile, may make it particularly attractive for older, frail, or heavily pretreated patients who may not be candidates for more intensive therapies. The study also demonstrated recovery of treatment-related cytopenias over time, supporting the potential for repeat dosing strategies in future clinical development.

The full article can be accessed here.

About the Phase 1 Study
The Phase 1 dose escalation and safety study was conducted as an open-label, multi-center trial, which enrolled 31 patients with relapsed or refractory multiple myeloma who had received a median of four prior lines of therapy. Patients received either a single dose or fractionated doses of iopofosine I 131 plus low-dose dexamethasone. The study established 31.25 mCi/m² as the maximum tolerated single dose and identified 20 mCi/m² administered twice, one week apart, as the highest evaluated fractionated dose regimen. The authors recommended a fractionated Phase 2 regimen of 15 mCi/m² administered on days 1 and 7 in combination with weekly low-dose dexamethasone.

(Press release, Cellectar Biosciences, JUL 15, 2026, View Source [SID1234669227])