On July 21, 2025 iTeos Therapeutics, Inc. ("iTeos") (Nasdaq: ITOS) reported that it has entered into a definitive merger agreement whereby Concentra Biosciences, LLC ("Concentra") will acquire iTeos for $10.047 in cash per share of iTeos common stock par value $0.001 per share ("iTeos Common Stock"), plus one non-transferable contingent value right ("CVR"), which represents the right to receive: (i) 100% of the closing net cash of iTeos in excess of $475 million; and (ii) 80% of any net proceeds received from any disposition of certain of iTeos’ product candidates that occurs within six months following the closing (such cash and CVR consideration, the "Offer Consideration") (Press release, iTeos Therapeutics, JUL 21, 2025, View Source [SID1234654452]).

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Following a strategic review process conducted with the assistance of iTeos’ management and legal and financial advisors, the iTeos board of directors has unanimously determined that the acquisition by Concentra is in the best interests of all iTeos stockholders and has approved the merger agreement and related transactions.

Pursuant and subject to the terms of the merger agreement, Concentra will commence a tender offer by August 1, 2025, to acquire all outstanding shares of iTeos common stock for the Offer Consideration. The closing of the offer is subject to certain conditions, including the tender of a number of shares of iTeos common stock that, together with shares of iTeos Common Stock owned by Concentra or its affiliates, represents at least a majority of the total number of outstanding shares, the availability of at least $475 million of cash (net of transaction costs and other liabilities) at closing, and other customary closing conditions. Immediately following the closing of the offer, iTeos will be acquired by Concentra, and all remaining shares not tendered in the offer, other than shares owned directly or indirectly by iTeos, Concentra or a subsidiary thereof, or a holder who properly demands appraisal, will be converted into the right to receive the same Offer Consideration per share of iTeos Common Stock as is provided in the offer. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close in the third quarter of 2025.

Advisors

TD Cowen is acting as exclusive financial advisor to iTeos and Ropes & Gray LLP is acting as legal counsel to iTeos. Gibson, Dunn & Crutcher LLP is acting as legal counsel to Concentra.

On July 21, 2025, Nuvalent, Inc. reported the initiation of ALKAZAR, its Phase 3 clinical trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell lung cancer, versus ALECENSA, a front-line standard of care, with the dosing of the first patient in the trial (Press release, Nuvalent, JUL 21, 2025, View Source [SID1234654453]).

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On July 21, 2025 Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported the appointment of Gilad Mamlok to serve as the Company’s new Senior Vice President and Chief Financial Officer, effective August 24, 2025, succeeding Eyal Rubin (Press release, Protalix, JUL 21, 2025, View Source [SID1234654454]). To ensure a seamless transition, Mr. Mamlok has joined the company and is working alongside Mr. Rubin. After his tenure as Chief Financial Officer ends, Mr. Rubin will continue to be available to the Company as necessary until October 2025.

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"With his three decades of experience in healthcare and technology companies, Gilad will play a pivotal role in the execution of our growth strategy, and I am delighted to welcome him to the Protalix team," said Dror Bashan, Protalix’s President and Chief Executive Officer. "I also want to thank Mr. Rubin, both personally and on behalf of Protalix and its Board of Directors, for his unwavering dedication and leadership. Over the last six years, Eyal and I have worked in a close, collaborative manner in the management of the Company. He contributed significantly to Protalix’s transformation, strengthening the Company’s capital and financial status and preparing the Company for growth. We wish Eyal success in his future endeavors."

Mr. Mamlok is a seasoned financial executive with three decades of experience in healthcare and technology companies. He has an extensive background in capital markets transactions, mergers and acquisitions, business development and investor relations as well as in corporate governance matters. Most recently, he served as the Chief Financial Officer of TytoCare Ltd., a privately-held company in the remote healthcare space. Prior to his role at TytoCare, Mr. Mamlok served as the Chief Financial Officer of Sol-Gel Technologies Ltd. In this role, he was responsible for an initial public offering and other capital markets transactions, as well as in-licensing and out-licensing transactions. Prior to his role at Sol-Gel, he served in other medical device companies, including Given Imaging which was acquired by Covidien plc in 2014. Mr. Mamlok holds a BA in Economics, magna cum laude, and a Master’s degree in Business/Managerial Economics, both from the Tel Aviv University.

On July 21, 2025 Astrazeneca reported positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, JUL 21, 2025, View Source [SID1234654456]).​

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The final OS analysis demonstrates consistent survival benefit as previously reported in the interim OS results, and builds on the previously presented primary endpoint data, which demonstrated the longest-reported median progression-free survival (PFS) in this setting.

Pasi A. Jänne, MD, PhD, Senior Vice President for Translational Medicine and thoracic medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: "When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in 1st-line where treatment duration can be long and many patients remain active. These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. The observed survival benefit is particularly impressive given that FLAURA2 did not impose any restrictions on the choice of subsequent treatment after disease progression."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the 1st-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease. With its strong survival benefit and tolerable safety profile, this combination has the potential to help patients live longer while maintaining their quality of life on treatment."

With longer follow up, the safety profile of Tagrisso plus chemotherapy continues to be manageable and consistent with the established profiles of the individual medicines. Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates due to AEs and on-target toxicities were low in both arms of the trial.

These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Tagrisso plus chemotherapy is approved in more than 80 countries, including the US, EU, China and Japan, based on the FLAURA2 Phase III trial.

Notes

NSCLC
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.1-2 Approximately 75% of people are diagnosed with advanced NSCLC.3 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4-6

While EGFR-tyrosine kinase inhibitors (TKI) have significantly improved outcomes in the 1st-line setting, mechanisms of resistance and disease progression are extremely common, and a significant unmet need exists in later-line settings for effective and well-tolerated treatment options.7-10

FLAURA2
FLAURA2 is a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with Tagrisso 80mg QD oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.

The trial enrolled 557 patients in more than 150 centres across more than 20 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS with OS as the key secondary endpoint.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy (CRT). Tagrisso plus chemotherapy is approved in more than 80 countries, including the US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC. Tagrisso is the only targeted therapy shown to improve patient outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials, locally advanced stages in the LAURA Phase III trial and late-stage disease in the FLAURA and FLAURA2 Phase III trials.

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

On July 21, 2025 Orion’s collaboration partner Bayer reported that the European Commission has granted marketing authorization in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Orion, JUL 21, 2025, View Source [SID1234654457]). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC.

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Darolutamide, under the brand name Nubeqa, is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. Darolutamide is developed jointly by Orion and Bayer.

Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.1 In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. 2 Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.3

About the ARANOTE trial

The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is radiological progression free survival (rPFS), measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial presented at ESMO (Free ESMO Whitepaper) 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in rPFS were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of adverse events in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT.

About darolutamide

Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and the growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide’s low potential for blood-brain barrier penetration.

Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were roughly similar to the respective comparator arm. Darolutamide is a treatment option for doctors and patients, considering its tolerability and low risk of drug interaction.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy.

About metastatic hormone-sensitive prostate cancer

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.4,5,6 For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi).

Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.