On September 18, 2026 Johnson & Johnson, a worldwide leader in multiple myeloma, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI (teclistamab) for the treatment of adult patients with RRMM who have received at least one prior therapy.

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Addressing evolving treatment needs in relapsed or refractory multiple myeloma
Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes such as anti-CD38 monoclonal antibodies and lenalidomide.3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options, particularly in earlier lines of therapy.3,4

Expert and company perspectives support teclistamab use earlier in the treatment pathway
"Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs," said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "This positive CHMP opinion reflects the importance of teclistamab in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment. By providing steroid-sparing combination and monotherapy regimens, teclistamab has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma."

"Today’s recommendation reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as teclistamab, into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure."

Teclistamab monotherapy demonstrated significant improvements in progression-free and overall survival compared to standard of care
The CHMP recommendation is supported by data from the Phase 3 MajesTEC-9 study (NCT05572515), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.5

Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS).1 Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p<0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared to standard of care.1 Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR, 65.9% vs. 16.8%; p<0.001).1

Safety profile consistent with that established in prior studies
The safety profile for teclistamab in the study was consistent with its known safety profile.6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%).1 Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively.1 Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time.1

This regulatory milestone builds on the recent European Commission approval of teclistamab in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, based on the results of the MajesTEC-3 study published in The New England Journal of Medicine.7 Together, these two Phase 3 studies help establish the potential of teclistamab-based regimens as an important treatment option across a broad second-line population.7

About the MajesTEC-9 study
MajesTEC-9 (NCT05572515) is an ongoing, randomised Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines including lenalidomide and an anti-CD38 monoclonal antibody.5 The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), overall survival (OS), safety and patient-reported outcomes.1

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.8 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.9 In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.6,10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.6 Teclistamab is currently being evaluated in several combination studies.11,12,13,14

To date, more than 30,700 patients have been treated worldwide with teclistamab.15

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.6

About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.16,17 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.18,19 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.20 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.21,22,23 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, SEP 18, 2026, View Source [SID1234670959])

On September 18, 2026 PHP Biotech International Inc., a US-based biotechnology company developing intracellular nanobody therapeutics for aggressive solid tumors, reported that it has identified the urokinase plasminogen activator receptor (uPAR) as the entry point for its investigational lead candidate, PHP53-nb. uPAR is the cell-surface protein that mediates the binding and internalization of the nanobody into the tumor cell, where PHP53-nb is designed to restore the p53 pathway. The identification answers one of the central questions for any intracellular therapeutic: not only what the molecule does once inside the cell, but how it gets there.

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The finding matters well beyond a single molecule. For three decades, uPAR has been one of the most consistent markers of aggressiveness in cancer: the more a tumor expresses it, the more it invades, spreads and recurs. It is found in breast, pancreatic, colorectal and brain tumors, and not only on malignant cells but on the supporting stroma around them — the tissue that feeds and protects the tumor.

What has changed recently is how the field regards the receptor. Rather than attempting to block uPAR, researchers increasingly use it as a delivery address. More than 450 patients have already been imaged with uPAR-directed PET agents across nine Phase 2 trials, making uPAR one of the rare oncology targets to be visualized in humans before being treated therapeutically at scale.

The same pathway is now being pursued by CAR T cell programs. In 2026, teams at Memorial Sloan Kettering and Columbia published in Cell, and an independent group at McMaster University and King’s College London published in Science Translational Medicine, both directing engineered T cells against uPAR — in lung, pancreatic and ovarian models, and in recurrent glioblastoma, respectively.

For PHP53-nb, the identification opens three avenues. First, it supports the nanobody’s tumor selectivity documented in prior research, offering a molecular explanation for why the molecule concentrates its activity on tumor cells rather than healthy tissue. Second, it raises the prospect of patient selection using a uPAR imaging agent that already exists at clinical grade and is currently used in clinical trials — a companion-imaging logic that most early-stage programs cannot borrow from day one. Third, it defines a dual profile: p53 pathway restoration inside the cell, with uPAR on the cell surface serving as the route of internalization. This is a sharper logic than the single-antigen approach prevailing in much of the field, in which one target must carry the burden of both recognition and therapeutic effect.

The company’s internalization model describes a four-step cascade. PHP53-nb binds uPAR at the cell surface, forms a ternary complex with the LRP receptor, enters the cell through clathrin-mediated endocytosis, and is released from the early endosome into the cytoplasm for intracellular activity. Each step represents a checkpoint that a purely extracellular therapeutic never has to pass, and each is now mapped.

PHP53-nb is a first-in-class humanized camelid nanobody designed to restore the p53 axis, which is lost in roughly half of all human cancers. Beyond that therapeutic objective, nanobodies are highly modular by nature — small, stable, easily conjugated and readily engineered into multispecific formats. A binder with confirmed uPAR-mediated internalization is, in principle, a valuable delivery mechanism. The same molecule that carries a p53-restoring mechanism today could be developed into a radioligand or an antibody-drug conjugate, combining biological tumor-suppressor restoration with a cytotoxic payload against the most aggressive tumors.

PHP53-nb is investigational and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.

(Press release, PHP Biotech, SEP 18, 2026, View Source [SID1234670958])

On September 18, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported that on September 17, 2026 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 179,750 shares of Iovance’s common stock to eighteen new, non-executive employees.

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The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $10.02, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the "First Vesting Date") and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.

(Press release, Iovance Biotherapeutics, SEP 18, 2026, View Source [SID1234670957])

On September 18, 2026 Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ: AMRX) reported that the U.S. Food and Drug Administration (FDA) has approved its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product references SOMATULINE Depot and will launch immediately. The product received Competitive Generic Therapy (CGT) designation from the FDA.

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"The approval and launch of lanreotide adds another material growth driver to our Affordable Medicines business," said Srinivas Kone, Ph.D., Senior Vice President and Chief Scientific Officer – Affordable Medicines. "Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities. With dedicated, large-scale in-house manufacturing capacity, we are well positioned to reliably supply the market, broaden access to this important medicine and create meaningful long-term value for patients, providers, and shareholders."

U.S. annual sales for SOMATULINE Depot for the 12 months ended July 2026 were $983 million, per IQVIA.

Lanreotide Injection is indicated for: the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. It helps control hormone levels in acromegaly, improves progression-free survival in eligible GEP-NET patients, and reduces the need for rescue therapy in patients with carcinoid syndrome.

(Press release, Amneal Pharmaceuticals, SEP 18, 2026, View Source [SID1234670956])

On September 18, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported new data that was recently presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea. Natera and its collaborators presented four abstracts, including two oral presentations.

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A mini-oral presentation featured the largest molecular residual disease (MRD) dataset ever presented in lung cancer. This analysis of 1,129 patients with resected stage 1-3 non-small cell lung cancer (NSCLC) spanned an observation period from 2016 to 2025. Signatera MRD detection was evaluated in the early post-surgical window and throughout surveillance, with the following key findings:

Early post-surgical Signatera-status was strongly prognostic of recurrence-free survival. Signatera-positivity in the early post-surgical window (7–90 days after surgery) was associated with significantly worse recurrence-free survival (RFS), with a 25% higher absolute 3-year RFS for Signatera-negative patients.
Signatera-positive patients had approximately 5X the risk of recurrence or death during surveillance.
Findings were consistent across both the primary surgical and perioperative cohorts, supporting broad applicability of Signatera monitoring across resected stage 1-3 NSCLC.
"One of the pressing challenges in early-stage lung cancer is knowing which patients are truly at risk of recurrence and our standard clinical tools don’t reliably give us that answer," said Charu Aggarwal, M.D., MPH, FASCO, the Leslye Heisler Professor for Lung Cancer Excellence at the University of Pennsylvania’s Perelman School of Medicine and principal investigator of the study. "This dataset showed, across more than 1,100 patients, that Signatera MRD status, in the early post-surgical window and throughout surveillance, is a powerful and consistent predictor of recurrence-free and overall survival. That kind of evidence, at this scale, can meaningfully change how we think about adjuvant treatment decisions in lung cancer."

"Lung cancer touches more patients globally than any other cancer, and WCLC is a powerful reminder of the collective commitment to doing better for them," said Caitlin Schonewolf, M.D., MS, senior medical director, oncology, Natera. "Earlier and more precise answers can mean more time and better quality of life for patients with lung cancer."

Full list of presentations at WCLC 2026 included:

Abstract P2.192
Presenter: Deborah Doroshow, M.D., Ph.D.
Poster: ctDNA After Definitive Therapy ± Immunotherapy and Association with Survival Outcomes in Locally Advanced Unresectable NSCLC

Abstract P2.200
Presenter: Seohee Shim, M.D.
Poster: ctDNA-based Molecular Residual Disease as a Predictive Biomarker for Treatment Stratification in Unresectable Stage 3 NSCLC

Abstract MO05.07
Presenter: David Gandara, M.D.
Mini Oral: KRAS G12C Predicts Superior Outcomes with 1L Cemiplimab for Non-Squamous aNSCLC With PD-L1 ≥ 50%: Data From EMPOWER-Lung 1

Abstract MO11.09
Presenter: Charu Aggarwal, M.D., MPH, FASCO
Mini Oral: Post-Surgical Molecular Residual Disease Detection, Adjuvant Treatment Patterns, and Overall Survival in Resected Stage 1-3 NSCLC

(Press release, Natera, SEP 18, 2026, View Source [SID1234670955])