On February 24, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that Japan’s Ministry of Health, Labour and Welfare ("MHLW") has granted regulatory (Shonin) marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.

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In Japan, the Shonin approval process is the most rigorous pathway for medical devices, conducted after a review and recommendation by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This marks the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan. The PMS study is intended to further evaluate the safety and clinical performance of Alpha DaRT in real-world clinical settings and to generate additional real-world clinical evidence in collaboration with Japanese physicians and treatment centers.

"Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform," said Uzi Sofer, Chief Executive Officer of Alpha Tau. "Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types."

Robert E. Claar, CEO of HekaBio K.K., said, "The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we got strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan."

Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital, said, "Through this domestic clinical trial, Alpha DaRT has demonstrated promise, representing a major advance in the fight against cancer. Demonstrating the efficacy of intratumoral alpha-particle radiation therapy, a modality long considered difficult to implement, for patients who have not responded to conventional therapies is a highly meaningful achievement, offering a new treatment option.

By confirming both safety and efficacy in this study, we have opened the door to delivering this therapy in real-world clinical practice, thereby expanding the range of treatment options available to patients. This outcome also provides important insights for future clinical research aimed at broadening indications.

Bringing hope to patients and their families by offering ‘a new treatment option’ is not only clinically valuable but also provides psychological support in the care setting. Alpha DaRT holds the potential to turn that hope into reality.

Further validation and long-term safety evaluation will be necessary, but we are confident that these results represent a major step forward in advancing discussions toward broader clinical application."

(Press release, Alpha Tau Medical, FEB 24, 2026, View Source [SID1234662897])

On February 24, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive early data from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy.

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Among the first six evaluable patients treated with lifileucel monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%. All evaluable patients had advanced disease, were refractory to prior therapy, and had significant disease burden, with a mean sum of diameters of 117 millimeters at baseline and a mean of more than two prior lines of therapy. Patients experienced deep responses that improved over time, consistent with lifileucel in melanoma, non-small-cell lung cancer, and other solid tumors. The safety profile was favorable and consistent with lifileucel therapy in other indications. Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the U.S. Food and Drug Administration (FDA) on an accelerated path to expedite approval. Iovance also plans to explore lifileucel in other high grade soft tissue sarcoma subtypes with high unmet need as part of its clinical development program.

UPS and DDLPS are high grade, aggressive soft tissue sarcomas associated with poor prognosis that impact more than 3,000 patients in the U.S. and more than 5,000 patients in Europe annually, including more than 3,500 patients with advanced disease.1-3 There is a high unmet medical need for new treatment options for second-line patients with recent clinical studies reporting ORRs of less than 5%, median progression-free survival (mPFS) of ~2-3 months, and median overall survival (mOS) of ~9-10 months.4-6

Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist, MSKCC, stated, "In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care. Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026."

Dr. Brian Gastman, EVP Translational Medicine and Research at Iovance, stated, "The exciting clinical results show that lifileucel could offer a new, highly efficacious, and durable immunotherapy option in two aggressive forms of advanced sarcoma and further illustrate the promise of our TIL cell therapy platform to offer meaningful clinical benefit in multiple solid tumor cancers. Chemotherapy with extremely poor efficacy remains the second-line standard of care for these patients after progression on front-line chemotherapy. We look forward to bringing lifileucel to UPS and DDPLS patients as quickly as possible."

(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662917])

On February 24, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that Dr. James Bianco, President and Chief Executive Officer, will participate in the following upcoming investor conferences:

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Citizens Life Science Conference
Date: Tuesday, March 10, 2026
Time: 4:00 pm ET
Links: To register and view presentation, click HERE. A live and archived webcast of the presentation will also be available through the investors page of TuHURA’s corporate website at View Source

Leerink Global Healthcare Conference
Date: Wednesday, March 11, 2026
Time: TuHURA will be available to meet 1×1 with investors
Links: To request a meeting, please contact your Leerink representative

(Press release, TuHURA Biosciences, FEB 24, 2026, View Source [SID1234662939])

On February 24, 2026 MiraDx, a molecular diagnostics company focused on genetic testing to personalize cancer treatment, reported the U.S. commercial launch of PROSTOX Standard, a new, clinically validated genetic test that expands access to personalized radiation therapy for patients with localized prostate cancer. The test identifies those at increased risk of developing long-term urinary side effects following conventionally fractionated or moderately hypofractionated radiation therapy (CFRT or MHFRT), and complements the company’s existing PROSTOX Ultra offering, for patients being considered for stereotactic body radiation therapy (SBRT). By offering both tests, MiraDx is expanding access to toxicity risk assessment testing to a broader group of prostate cancer patients at risk for genitourinary (GU) toxicity following external beam radiation therapy (EBRT).

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While EBRT is an effective and widely used treatment for localized prostate cancer, more than 20% of patients treated with radiation therapy experience persistent urinary side effects, referred to as late GU toxicity.1 PROSTOX tests help predict late-onset genitourinary (GU) toxicity—side effects such as urinary urgency, leakage, or discomfort—that can appear months or years after radiation treatment and significantly impact quality of life.

Localized prostate cancer has an excellent prognosis with a five-year survival rate of over 99%.2 Although SBRT, CFRT, and MHFRT have similar efficacy in this population, individual responses to each treatment method can vary due to a patient’s genetics. Until now, clinicians have lacked a biology-driven tool to identify which patients are most at risk for GU toxicity from each EBRT method. PROSTOX tests address this gap by analyzing inherited genetic variants in microRNAs and their pathways that influence how individual patients tolerate radiation. Using a simple cheek swab, PROSTOX delivers actionable results in 5-7 days, enabling physicians and patients to make more personalized radiation treatment decisions based upon each patient’s individual side effect risk profile.

"PROSTOX tests bring precision medicine to radiation oncology by shifting the focus from the tumor alone to determining the most effective treatment approach for each patient based upon their unique biology and resulting treatment risks," said Melissa C. Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "Having information about which type of radiation each patient will tolerate best allows clinicians to better tailor radiation treatments to patients, helping them avoid future long-term side effects."

Each PROSTOX test evaluates genetic risk across a different radiation therapy regimen. A result that a patient is at high risk with PROSTOX Standard does not imply a high-risk result for PROSTOX Ultra, and vice versa. In rare cases (less than 2% of patients), PROSTOX tests will identify that a patient has a high risk for late GU side effects with both SBRT and CFRT/MHFRT. For these patients, other interventions may be available.

"Being diagnosed with prostate cancer is life altering and comes with many decisions and so much uncertainty," said Ron Stewart, a patient who received PROSTOX testing. "The PROSTOX test helped me feel more confident about my treatment plan and more optimistic that my cancer treatment would not hamper my quality of life down the road."

PROSTOX Standard and PROSTOX Ultra are commercially available in the U.S. and performed at MiraDx’s CLIA-certified and CAP-accredited molecular diagnostics laboratory in Los Angeles, Calif. Coverage may vary by insurance plan. MiraDx offers a financial assistance program to help ensure patient access to PROSTOX tests.

About PROSTOX Tests

PROSTOX tests are clinically validated diagnostic tests used to predict genitourinary toxicity following external beam radiation therapy (EBRT). The tests analyze inherited genetic variants in microRNAs and their pathways that influence how individual patients tolerate radiation, delivering actionable insights to enable clinicians to make informed therapeutic choices with their families. The PROSTOX Standard test is designed to predict toxicity following CFRT (37-45 fractions over 7-9 weeks) or MHFRT (20-28 fractions over 4-5 weeks). The PROSTOX Ultra test is designed to predict toxicity following SBRT (5–7 fractions over approximately 10 days).

(Press release, MiraDx, FEB 24, 2026, View Source [SID1234662956])

On February 24, 2026 Amgen (NASDAQ:AMGN) reported it will present at the 46th Annual TD Cowen Health Care Conference at 1:10 p.m. ET on Monday, March 2, 2026. Kave Niksefat, senior vice president of Global Marketing and Access at Amgen, and Justin Claeys, senior vice president of Finance at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, FEB 24, 2026, View Source [SID1234662898])