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])

On September 18, 2026 IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer.

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Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will be authorized for marketing in all EU Member States and European Economic Area (EEA) countries.

The positive opinion from CHMP is primarily based on the results of the pivotal Phase III FLAMES1 study. The FLAMES study is a Phase III, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of senaparib versus placebo as the maintenance treatment for subjects with advanced (FIGO Stage III-IV) Ovarian Cancer (OC) who are in response (complete or partial) following first-line (1L) platinum-based chemotherapy. In the FLAMES study, senaparib as 1L maintenance monotherapy reduced the risk of progression or death versus placebo in a broad patient population with advanced OC, irrespective of BRCA mutation status and with consistent benefits observed between homologous recombination subgroups. Notably, at the prespecified interim analysis, the median PFS was NR with senaparib versus 13.6 months with placebo (HR = 0.43, 95% CI 0.32-0.58; p<0.0001). Senaparib was associated with a 57% reduction in the risk of progression or death compared with placebo.

In July 2026, IMPACT entered into an exclusive partnership with Pharmanovia. Under the licensing agreement, IMPACT has granted Pharmanovia exclusive manufacturing, development and commercialisation rights for senaparib as maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer across 66 countries, including all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa.

Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT, commented: "The positive opinion from EMA CHMP is a critical step towards market authorization by the EC, marking a significant milestone not only for senaparib and IMPACT Therapeutics, but also for the global footprint of innovative Chinese-originator biotech companies. We look forward to the final decision by the EC, and we will continue to work closely with our partner Pharmanovia to efficiently advance access to senaparib across the licensed territories in Europe, the Middle East, North Africa, Australia and New Zealand, accelerating the global reach of this innovative Chinese-originated drug to benefit more patients worldwide."

Dr. Stephan Eder, Chief Executive Officer, Pharmanovia, added: "Our partnership combines IMPACT’s scientific expertise with our launch and market expertise. The CHMP’s positive opinion marks an important next step in the regulatory process for this medicine. Our focus is now on using our market access, medical and launch capabilities to bring senaparib as a novel treatment option to patients in our territories.

(Press release, Impact Therapeutics, SEP 18, 2026, View Source [SID1234670954])