MimiVax Announces Data Cutoff for Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma

On July 15, 2026 MimiVax Inc., a clinical-stage biotechnology company dedicated to the development of innovative cancer immunotherapies, reported that data cutoff has been reached for the SURVIVE trial (NCT05163080), the Company’s Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating SurVaxM in patients with newly diagnosed glioblastoma (nGBM). The dataset has been transferred to the trial’s independent statistical team, who have initiated the pre-specified analysis.

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The SURVIVE trial, which completed enrollment in 2024 across 11 major cancer centers in the United States, is designed to evaluate whether adding SurVaxM to standard-of-care adjuvant temozolomide chemotherapy improves survival outcomes compared to temozolomide alone in patients with newly diagnosed glioblastoma. The study enrolled 249 patients with newly diagnosed, resected glioblastoma across institutions including Roswell Park Comprehensive Cancer Center, Dana-Farber Cancer Institute, Cleveland Clinic, Fred Hutchinson Cancer Center, UCSF, NYU, Miami Baptist Cancer Center, Northwell Health, Norton Cancer Institute, Overlook Medical Center and Texas Oncology.

"Five years ago, we began the SURVIVE trial with the conviction that SurVaxM will meaningfully extend survival for patients diagnosed with glioblastoma. Completing the data cutoff brings us one step closer to achieving that goal," said Michael Ciesielski, PhD, chief executive officer and co-founder of MimiVax. "None of this would have been possible without the patients and families who trusted us with their care, and the clinical teams who made this trial work."

"Reaching the data cutoff is a milestone our team, our investigators, and most importantly our patients have been working toward for years," said Robert Fenstermaker, MD, chief medical officer and co-founder. "With the independent analysis now underway, we look forward to sharing topline results soon."

Glioblastoma is the most common and aggressive malignant primary brain tumor in adults, with a median overall survival of approximately 16 – 18 months with standard therapy alone. The SURVIVE trial was built upon encouraging results from the preceding Phase 2a study of SurVaxM in 63 newly diagnosed glioblastoma patients, which demonstrated a median overall survival of 25.1 months. Fifty percent of patients receiving SurVaxM survived at least two years, and 19 percent survived at least five years. Individuals with the strongest immune responses had a much longer median overall survival (mOS) of 43.1 months.

About the SURVIVE Trial

SURVIVE (NCT05163080) is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating SurVaxM in combination with standard-of-care adjuvant temozolomide versus temozolomide alone in patients with newly diagnosed, resected glioblastoma. The SURVIVE trial is being conducted at 11 major cancer centers across the United States.

About SurVaxM

SurVaxM is a first-in-class, patented peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95 percent of glioblastomas. Delivered via subcutaneous injection, SurVaxM is engineered to stimulate patients’ own immune response to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Fast Track Designation for newly diagnosed glioblastoma and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancer.

(Press release, MimiVax, JUL 15, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-announces-data-cutoff-for-phase-2b-survive-trial-of-survaxm-in-newly-diagnosed-glioblastoma [SID1234669233])

KEYTRUDA® (pembrolizumab) as Monotherapy Significantly Improved Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient (dMMR) Tumors Compared to Chemotherapy

On July 15, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the Phase 3 KEYNOTE‑C93 trial evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy. KEYTRUDA is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial.

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At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for KEYTRUDA; however, these OS data were not mature at the time of this analysis. The trial is ongoing, and OS for the full study population will be evaluated at a future analysis. This analysis also showed a clinically meaningful overall response rate (ORR), as well as complete response rate (CRR) and duration of response (DOR) for KEYTRUDA. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities.

"This is the first Phase 3 trial of a PD-1 inhibitor to show improved PFS compared to platinum doublet chemotherapy when given as monotherapy in the frontline setting for these patients, potentially providing a chemo-free option," said Dr. Brian Slomovitz, director of Gynecologic Oncology and deputy director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center in Miami Beach, Florida, and the study’s overall principal investigator.

"These findings build upon the well-established role of KEYTRUDA in endometrial cancer, one of the few cancers with rising incidence rates," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "We are committed to helping women facing this disease by advancing potential treatment options. We thank the patients and investigators for their important contributions to this study and look forward to sharing these results with the medical community."

In the U.S., KEYTRUDA is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer. KEYTRUDA is indicated: in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; in combination with LENVIMA (lenvatinib), in collaboration with Eisai, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR), as determined by an FDA-authorized test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; and as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Merck has a comprehensive clinical development program evaluating KEYTRUDA (both as monotherapy and in combination with chemotherapy) and sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, in endometrial cancer. As previously announced, TroFuse-005 (NCT06132958) met its primary endpoints of PFS and OS, as well as its key secondary endpoint of ORR in patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. In addition, TroFuse-033 (NCT06952504) is enrolling patients with pMMR endometrial cancer to evaluate sac-TMT in an earlier treatment setting of first-line maintenance. The KEYNOTE-B21 trial (NCT04634877) remains ongoing for analysis in the dMMR subgroup.

About KEYNOTE-C93

KEYNOTE-C93 is a randomized, open-label Phase 3 trial (NCT05173987) evaluating KEYTRUDA monotherapy versus carboplatin plus paclitaxel in patients with dMMR advanced or recurrent endometrial cancer who have not previously been treated with prior systemic chemotherapy. The trial enrolled 299 patients who were randomized to receive either:

KEYTRUDA (400 mg) intravenously every six weeks for up to 18 cycles, or;
Combination of paclitaxel (175 mg/m2) and carboplatin (AUC 5 or 6) every three weeks for six cycles.
The trial’s dual primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS. A key secondary endpoint of the study is ORR.

About endometrial cancer

Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. Endometrial cancer is one of the few cancers with increasing mortality. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall.

(Press release, Merck & Co, JUL 15, 2026, View Source [SID1234669232])

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])