On February 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that it has entered into a definitive agreement to acquire Arcellx (Nasdaq: ACLX) for $115 per share in cash at closing and one contingent value right of $5 per share, which represents an implied equity value of $7.8 billion payable at closing. Arcellx is a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases.

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Kite, a Gilead company, and Arcellx have an existing collaboration to co-develop and co-commercialize Arcellx’s lead pipeline candidate, anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for patients with multiple myeloma. Despite advancements in treatment, many patients with multiple myeloma eventually relapse and require additional lines of therapy. As disease progresses, patients often experience diminishing responses, increasing toxicity and fewer viable options, especially those who are heavily pretreated or unable to tolerate existing therapies.

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, addressing key challenges associated with current CAR T-cell therapies in multiple myeloma.

The BLA for anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma is supported by results from the Phase 1 study (NCT04155749) and the pivotal Phase 2 iMMagine1 study (NCT05396885) and has been accepted by the U.S. Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.

"This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy. In addition, the anito-cel D-domain BCMA binder could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation."

In addition to anito-cel, Arcellx’s D-Domain CAR technology platform has generated proprietary, target-binding domains with improved specificity and enhanced binding affinity that could potentially be used for next-generation CAR T-cell and bispecific therapies. There is potential to leverage the D-domain BCMA binder in vivo cell therapy efforts.

"The story of Arcellx is one of innovation, passion, resilience and teamwork. I could not be prouder of our team, our contribution to the myeloma field, and the impact anito-cel and our D-Domain platform are poised to have for patients and clinicians," said Rami Elghandour, Chairman and Chief Executive Officer, Arcellx. "We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy. Kite is well-positioned to maximize access to anito-cel, benefiting more patients, and the company’s commitment to be the leader in cell therapy is one I admire. I’m grateful to our Board of Directors for this opportunity, our shareholders who supported our journey, our partners who believed in us, the patients and physicians who participated in our studies, and most of all, our team members who did the impossible and left an indelible mark on the future of medicine."

Terms of the Transaction

The transaction was approved by both the Gilead and Arcellx Boards of Directors and is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions. Gilead currently owns approximately 11.5 percent of Arcellx’s outstanding common stock.

Under the terms of the merger agreement entered into in connection with the transaction, a wholly-owned subsidiary of Gilead will commence a tender offer to acquire all of the outstanding shares of Arcellx’s common stock that Gilead does not already own for an offer price of (1) $115 per share in cash, which represents a 68 percent premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026, plus (2) one non-transferable contingent value right (CVR) that entitles the holder to receive an additional $5 per CVR upon the achievement of cumulative global net sales of anito-cel of at least $6.0 billion from launch through year-end 2029. If the tender offer is successfully completed, Gilead will acquire all remaining shares of Arcellx not tendered in the offer through a second step merger for the same consideration as is paid in the tender offer.

Upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.

BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Ropes & Gray LLP is serving as legal counsel to Gilead. Centerview Partners LLC is acting as exclusive financial advisor to Arcellx. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Arcellx.

(Press release, Arcellx, FEB 23, 2026, View Source [SID1234662839])

On February 23, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Jose Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine and the co-inventor of Anixa’s CAR-T technology, will be a keynote speaker at the South Carolina Clinical & Translational Research (SCTR) Institute 2026 Retreat: Cell-Based Therapies from Discovery to Translation, on Friday, March 6, 2026.

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Dr. Conejo-Garcia’s keynote presentation will include a discussion of Anixa’s ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, which utilizes the FSHR-mediated CAR-T therapy first discovered by Dr. Conejo-Garcia and his team at The Wistar Institute.

The SCTR 2026 Retreat will bring together pioneers in research, clinical care, and industry to showcase breakthrough innovations in advanced cell therapy, immune therapy, oncology, and cellular product manufacturing, and engage in empowering collaboration across the vibrant ecosystem, driving the future of medicine.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, FEB 23, 2026, View Source [SID1234662838])

On February 23, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).

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DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands.

Planned DURIPANC milestones:

July 2026 – Complete subject enrollment.
August 2026 – Complete full Ampligen dosing for all subjects.
December 2026 – Evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.
June 2027 – Evaluation of the Secondary Endpoints once last subject reaches week 49
Progression-Free Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of progression or death, whichever occurs first.
Overall Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of death,
Immunogenic efficacy, defined as >50% increase in circulating Ki67+ CD 8+ T cell in peripheral blood evaluated 12 weeks after start of combination therapy.
Infiltrating immune profile, defined as the change in infiltrating immune profile after start of combination therapy.
Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy.
AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.

According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting "high quality of life" during treatment.

See: DURIPANC, Year-End Interim Clinical Progress Update

Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders.

(Press release, AIM ImmunoTech, FEB 23, 2026, View Source [SID1234662837])

On February 22, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC. Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."

Dr. Qingmei Shi, Chief Medical Officer of CStone, added, "The MHRA’s approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential. We are proud of CStone’s clinical development and regulatory affairs teams for their’ effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK. Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future. CStone will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The EC and MHRA have approved sugemalimab for two indications:

In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.

(Press release, CStone Pharmaceauticals, FEB 22, 2026, View Source [SID1234662833])

On February 22, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that yet another participant with mCRPC in the Cohort Expansion Phase (Phase II) of the SECuRE trial achieved undetectable PSA and negative PSMA PET. The undetectable PSA was measured following the first cycle and the negative PSMA PET was reported following the second cycle of 67Cu-SAR-bisPSMA (8 GBq each cycle).

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The participant is a 76-year-old man who was initially diagnosed with prostate cancer 15 years ago. He had radical prostatectomy to treat the primary disease and radiotherapy for local recurrence, having progressed to metastatic disease in 2020. Previous systemic anti-cancer treatments included an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT). In 2025, the disease progressed further, and he was enrolled into the Cohort Expansion Phase of the SECuRE study with a baseline PSA of 3.25 ng/mL. Seven weeks after his first cycle of 67Cu-SAR-bisPSMA, this participant achieved undetectable PSA levels. He proceeded to receive one more cycle of 67Cu-SAR-bisPSMA, and no disease was observed on PSMA PET following the second dose (Figure 1). This participant exhibited mild (Grade 1) related AEs, including altered taste, dry eyes, eye pain, fatigue and salivary gland soreness (all resolved except fatigue). No haematological or renal AEs were observed to date.

This new case represents the fifth participant to achieve undetectable disease by radiographic assessment following 67Cu-SAR-bisPSMA treatment in Clarity’s SAR-bisPSMA theranostic program (3 participants who received up to four cycles of 8 GBq, and 2 participants who received up to three cycles of 12 GBq)2,3,4.

Update on previously reported participant with no detectable disease following 67Cu-SAR-bisPSMA treatment
Follow-up on the previously reported participant from the Cohort Expansion Phase (no detectable disease and absence of prior bone metastasis following three cycles of 8 GBq 67Cu-SAR-bisPSMA treatment)2, demonstrated that his PSA remains undetectable, with no disease identified on his latest PET conducted 1 month after the administration of the fourth cycle (Feb 2026; Figure 2). Following the first three cycles of 67Cu-SAR-bisPSMA, the participant exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs2. Notably, no new safety signals have been observed during and since the administration of the fourth cycle to date.The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of SECuRE3 and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The momentum of data we are generating with our lead SAR-bisPSMA product in both theranostic and diagnostic trials is strong, with excellent results to date on all fronts. We are beyond excited to see yet another patient achieve undetectable disease following their 67Cu-SAR-bisPSMA treatments. What is particularly outstanding is that this new patient presented with undetectable PSA just 7 weeks after his first 8 GBq cycle, with a negative PSMA PET being reported after the second cycle. This result is particularly impressive given this participant has been battling prostate cancer for 15 years and is now free of any detectable disease based on PSA and PET assessments with only mild (Grade 1) AEs.

"While this outcome is extraordinary, we now know this is not just luck or coincidence. Despite the number of participants in the SECuRE trial being relatively small, this is now the fifth time we have seen a patient present with undetectable disease following their 67Cu-SAR-bisPSMA treatments2,3,4, and study recruitment is still ongoing. We are also excited to see that the previous participant in the Cohort Expansion Phase of the SECuRE trial to achieve undetectable disease observed by anatomical and molecular imaging2 continues to show undetectable disease during his last follow up in February 2026, following the fourth 67Cu-SAR-bisPSMA cycle. This is especially encouraging as this participant had bone metastasis at study entry and now continues to report excellent quality of life after his treatment with 67Cu-SAR-bisPSMA."

"Our methodical commitment to science and the highest standard of clinical development underpins our achievements to date. Combining the optimised bivalent "bis" structure with the benefits offered by the copper isotope pairing, enabled by the proprietary sarcophagine (SAR) chelating technology, is key to the benefits we are seeing from the SAR-bisPSMA products. The most recent data released from the Co-PSMA study clearly establishes that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence and sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management5. Our registrational diagnostic AMPLIFY6 and CLARIFY7 trials with 64Cu-SAR-bisPSMA are also nearing the end of recruitment, getting us closer to commercialisation. We now look forward to progressing the SECuRE trial recruitment and have already initiated the planning for a registrational Phase III trial, as we hope to see more people benefit from our unique theranostic product. Having three Fast Track Designations (FTDs) for SAR-bisPSMA gives us confidence to persevere harder than ever, and positive interactions with the US Food and Drug Administration (FDA) confirm that we are on the right track. Our team is motivated and driven to progress SAR-bisPSMA to the market through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease. As we continue to generate exceptional data, we believe SAR-bisPSMA is well positioned to fully exploit the current treatment and diagnostic challenges in radiopharmaceuticals and improve treatment outcomes for patients with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3.

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)3. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, 61.5% (8/13) of participants achieved PSA reductions greater than 50%, and 46.2% (6/13) of participants achieved PSA reductions of 80% or more3. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial8 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, FEB 22, 2026, View Source [SID1234662832])