Gilead Sciences to Acquire Arcellx in Strategic Move to Accelerate Anito-cel Development; Novo Nordisk Faces Setback as CagriSema Underwhelms Against Rival Therapy in Trial; Vanda Pharmaceuticals Secures FDA Approval for BYSANTI; All-oral Calquence + venetoclax Combo Clears in the US for First-line Treatment of CLL; Merck’s ENFLONSIA Demonstrates Strong Protection Against Severe RSV in Young Children Over Consecutive Seasons

Gilead Sciences Announces Acquisition of Arcellx to Advance Long-Term Growth of Anito-cel

Gilead Sciences announced a definitive agreement to acquire Arcellx, a clinical-stage biotechnology company, in a strategic move to strengthen its leadership in cell therapy and oncology innovation. The acquisition builds on an existing collaboration between the two companies focused on anito-cel (anitocabtagene autoleucel), a next-generation BCMA-directed CAR-T therapy being developed for patients with relapsed or refractory multiple myeloma. Under the terms of the transaction, Gilead will acquire all outstanding shares of Arcellx for a cash consideration, along with a contingent value right (CVR) tied to future commercial performance, reflecting confidence in the therapy’s long-term revenue potential.

Anito-cel has demonstrated compelling clinical data, including deep and durable responses with a favorable safety profile, addressing limitations seen in earlier CAR-T therapies such as high toxicity and manufacturing complexity. The U.S. Food and Drug Administration (FDA) has already accepted the biologics license application (BLA) for anito-cel, with regulatory decisions anticipated in 2026. Full ownership of Arcellx will allow Gilead to streamline development, manufacturing, and commercialization, while eliminating profit-sharing obligations associated with the prior partnership.

Beyond anito-cel, the acquisition provides Gilead with access to Arcellx’s proprietary D-Domain CAR platform, a differentiated technology that may enable more precise and flexible cell therapy designs across multiple oncology indications. This platform is viewed as a strategic asset that could support the development of next-generation CAR-T therapies and potentially expand into autoimmune and inflammatory diseases.

From a financial perspective, Gilead expects the transaction to be accretive to earnings by the latter part of the decade, assuming successful approval and commercialization of anito-cel. The acquisition also reinforces Gilead’s broader oncology strategy, complementing its existing cell therapy portfolio and positioning the company to compete more effectively in the rapidly evolving hematologic malignancies market. Overall, the deal underscores Gilead’s commitment to long-term growth through high-impact innovation and targeted acquisitions.

Novo’s CagriSema Fails to Match Performance of Eli Lilly’s ZEPBOUND in Trial

Novo Nordisk released a major corporate update outlining progress across its metabolic disease portfolio, alongside strategic initiatives aimed at sustaining long-term growth amid intensifying competition in diabetes and obesity care. The announcement highlighted continued strong global demand for GLP-1–based therapies, including treatments for type 2 diabetes and chronic weight management, which remain central to the company’s growth strategy.

The company emphasized advancements in both injectable and oral formulations designed to improve patient adherence and expand access. Novo Nordisk also reiterated its commitment to lifecycle management, investing heavily in next-generation molecules and combination therapies targeting obesity-related comorbidities such as cardiovascular disease, non-alcoholic steatohepatitis (NASH), and chronic kidney disease. Clinical trials across multiple late-stage assets continue to progress, reinforcing the robustness of the pipeline.

At the same time, Novo Nordisk acknowledged operational and market challenges, including capacity constraints, pricing pressures, and rising competition from peers developing alternative incretin-based therapies. In response, the company has undertaken organizational and manufacturing optimization initiatives to enhance supply reliability and cost efficiency. These efforts include investments in new production facilities and selective restructuring to prioritize high-growth therapeutic areas.

From a financial standpoint, Novo Nordisk reaffirmed its long-term outlook, citing sustained revenue growth driven by obesity and diabetes franchises, despite short-term volatility related to investment spending and competitive dynamics. Management underscored that innovation, scale, and deep therapeutic expertise remain key differentiators.

Overall, the update reflects Novo Nordisk’s dual focus on near-term execution and long-term transformation. By strengthening its pipeline, expanding manufacturing capabilities, and sharpening strategic priorities, the company aims to maintain its leadership position in metabolic diseases while navigating a rapidly evolving competitive landscape.

Vanda Pharmaceuticals Receives FDA Approval of BYSANTI for Bipolar I Disorder and Schizophrenia

Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration has approved BYSANTI (milsaperidone) for the treatment of bipolar I disorder and schizophrenia, marking a major milestone in psychiatric drug development. Notably, milsaperidone is classified as a new chemical entity, representing a rare instance of novel pharmacological innovation in a therapeutic area that has seen limited breakthroughs over the past decade.

The approval was supported by a comprehensive clinical development program demonstrating efficacy in managing both psychotic and mood symptoms, along with a safety and tolerability profile suitable for long-term use. BYSANTI is designed to address limitations of existing antipsychotic therapies, including metabolic side effects, sedation, and incomplete symptom control, which often lead to poor adherence and suboptimal outcomes.

Vanda emphasized that BYSANTI offers clinicians greater flexibility in treating complex psychiatric conditions that frequently require individualized therapy. The dual indication for bipolar I disorder and schizophrenia broadens its clinical relevance and commercial potential, positioning it as a cornerstone product in Vanda’s neuropsychiatric portfolio.

The company plans a phased commercial launch, supported by targeted physician education and patient access programs. From a strategic perspective, the approval significantly enhances Vanda’s growth outlook, diversifying revenue streams and reinforcing its reputation as an innovator in central nervous system disorders. More broadly, the approval signals renewed momentum in psychiatric drug development, highlighting the continued importance of novel mechanisms of action in addressing unmet mental health needs.

US Approves Calquence with Venetoclax as the First Fixed-duration, All-oral Frontline Option for CLL

AstraZeneca announced U.S. approval of a fixed-duration, all-oral combination regimen featuring Calquence (acalabrutinib) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). This approval represents a significant advancement in CLL care, offering patients an effective alternative to continuous, indefinite therapy.

Calquence, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, has already established a strong clinical profile as a monotherapy. The newly approved combination leverages complementary mechanisms of action to achieve deep and durable responses within a defined treatment period. Clinical trial data demonstrated high rates of progression-free survival and manageable safety, including in patients with high-risk disease features.

The fixed-duration approach is particularly meaningful for patients, as it reduces long-term toxicity, treatment burden, and healthcare costs while preserving efficacy. For AstraZeneca, the approval strengthens its hematology franchise and aligns with broader industry trends favoring time-limited regimens that improve quality of life. Strategically, the decision enhances Calquence’s competitiveness in an increasingly crowded CLL market and reinforces AstraZeneca’s commitment to patient-centric oncology innovation. The company expects rapid adoption in clinical practice, supported by established physician familiarity with Calquence.

Merck’s ENFLONSIA Exhibits Sustained Efficacy in Preventing Severe RSV in At-Risk Infants Over Two Seasons

Merck reported positive new clinical data for ENFLONSIA (clesrovimab), an investigational monoclonal antibody being developed to prevent respiratory syncytial virus (RSV) disease in infants and young children under two years of age who are at increased risk of severe illness. The data, collected across two RSV seasons, demonstrated sustained efficacy and a favorable safety profile.

RSV remains a leading cause of hospitalization in infants worldwide, particularly among premature babies and those with underlying health conditions. ENFLONSIA is designed to provide passive immunity through a single dose, offering season-long protection without the need for repeated administration.

Merck highlighted that clesrovimab could complement existing preventive strategies, including maternal vaccination, and expand options for protecting vulnerable pediatric populations. The consistency of protection across multiple seasons strengthens the case for regulatory submission and potential broad clinical use. From a public health perspective, the data underscore the potential impact of long-acting monoclonal antibodies in reducing RSV-related hospitalizations and healthcare burden. For Merck, ENFLONSIA represents a strategically important asset within its infectious disease portfolio, reinforcing the company’s focus on preventive innovation and pediatric care.