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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

Ernexa Therapeutics Receives Independent Validation of ERNA-101 with Complete Tumor Clearance and Durable Survival in Ovarian Cancer Models Ahead of Planned Clinical Entry

On July 15, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101’s mechanism of action and provide important third-party validation as the Company advances toward its planned Investigational New Drug (IND) submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter.

In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals (67%). Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy.

"This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "Independent reproduction of these findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming IND submission. Perhaps most importantly, complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically ‘cold’ solid tumors. With IND submission planned this quarter and our first clinical study expected later this year, we believe Ernexa is entering one of the most important value-creating periods in the Company’s history."

Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors.

The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone.

"One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "These independently generated results provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate T cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors. Independent confirmation of these findings is particularly meaningful because reproducibility is one of the strongest indicators supporting successful clinical translation. We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically ‘cold’ solid tumors where today’s checkpoint inhibitors have produced limited clinical benefit."

The study was conducted by an independent contract research organization using expanded treatment groups in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. Tumor burden was monitored longitudinally through bioluminescence imaging to evaluate treatment response and confirm complete tumor clearance.

The study included four treatment arms:

ERNA-101 plus anti-PD-1
ERNA-101 monotherapy
Anti-PD-1 monotherapy
Untreated control

Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade.

With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.

(Press release, Ernexa Therapeutics, JUL 15, 2026, View Source [SID1234669245])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

Senti Biosciences Holdings, Inc. Announces a Strategic Transaction to Unlock Value for its Gene-Circuit-Enabled Pipeline, Including SENTI-202, and to Sharpen its Focus on Next-Generation Controllable Genetic Medicines Powered by its Regulator Dial™ Technology Platform

On July 15, 2026 Senti Biosciences Holdings, Inc. (NASDAQ: SNTI) ("SBH" or the "Company") reported a strategic transaction designed to sharpen its focus on next-generation controllable genetic medicines powered by its Regulator Dial technology platform (the "Retained Assets") and unlock value for its Gene-Circuit-enabled pipeline, including SENTI-202, currently being advanced by its wholly owned subsidiary, Senti Biosciences, Inc.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of this transaction, a newly formed privately held biotechnology company ("NewCo") controlled by affiliates of Celadon, the Company’s largest investor, will acquire the Company’s assets relating to its Gene-Circuit-enabled pipeline, including the rights to SENTI-202 in exchange for a contingent value right (a "CVR"), which will be distributed to equity holders providing up to $60 million in milestone payments over a seven-year period tied to the future success of SENTI-202.

After the closing of the transaction, SBH plans to seek additional financing to allow its team to focus on advancing early-stage programs built around its proprietary Regulator Dial platform, including a controllable gene therapy for Rett Syndrome and controllable, armored tumor-infiltrating lymphocytes ("TILs") for solid tumors designed to improve efficacy and safety. SBH believes this technology addresses one of the most important challenges in modern biotechnology—the ability to dynamically control powerful genetic medicines after they have been administered to patients. Both retained SBH programs build upon the Company’s foundation at the intersection of synthetic biology and artificial intelligence to accelerate and optimize Regulator-Dial-powered therapies.

As previously announced here, SENTI-202 was granted Regenerative Medicine Advanced Therapies (RMAT) designation by FDA and exhibited durable Measurable Residual Disease (MRD)-negative responses from a 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for relapsed/refractory acute myeloid leukemia (AML). In addition, the Company has identified a specific attribute in its NK donors ("Donor X characteristic") that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a composite CR (cCR) when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1. The Donor X characteristic is found in ~50% of adult donors, is independent of HLA or KIR matching, and will be used in all future SENTI-202 manufacturing, thus supporting SENTI-202’s allogeneic off-the-shelf usage.

NewCo intends to continue development of SENTI-202, an FDA Regenerative Medicine Advanced Therapy (RMAT)-designated clinical stage asset for AML and other blood cancers, as well as other Logic Gate-enabled therapies for solid tumors and Gene-Circuit-powered programs, such as in vivo CAR.

The CVR milestone structure consists of:

$10 million upon filing and acceptance of a Biologics License Application (BLA) for SENTI-202;
$20 million upon FDA approval of a BLA for SENTI-202; and
$30 million upon achievement of $200 million in cumulative net sales of SENTI-202.

The CVR structure is intended to give SBH’s stockholders value in connection with future development, regulatory, and commercial achievements while enabling the NewCo to focus resources on advancing SENTI-202 and the Gene Circuits franchise.

"This transaction will allow the two companies to focus their resources and accelerate the delivery of powerful new genetic medicines to patients across multiple categories and diseases while allowing the SBH stockholders to potentially benefit from the success of both entities," said Timothy Lu, M.D., Ph.D, the Company’s CEO.

The transaction has been approved by SBH’s board of directors and remains subject to customary closing conditions, including approval by SBH’s stockholders and other conditions set forth in the definitive agreement.

Additional information regarding the proposed transaction, including a copy of the definitive transaction agreement and the form of agreement governing the CVRs, will be provided in a Current Report on Form 8-K filed by SBH with the U.S. Securities and Exchange Commission and available at sec.gov.

(Press release, Senti Biosciences, JUL 15, 2026, View Source [SID1234669246])