UCB to Acquire Candid Therapeutics; Pfizer’s ELREXFIO Sets New Benchmark in PFS for Hard-to-Treat Multiple Myeloma Patients; Axsome Therapeutics Wins FDA Approval for AUVELITY to Address Alzheimer’s Agitation; FDA Advisory Panel Backs Truqap for PTEN-Deficient mHSPC; Bepirovirsen Receives FDA Priority Review Alongside Breakthrough Therapy Tag

UCB Bets on Candid Therapeutics to Boost Immunology Pipeline with T-cell Engagers

UCB has entered into a definitive agreement to acquire Candid Therapeutics, strengthening its immunology pipeline and advancing its capabilities in next-generation biologics, particularly T-cell engagers (TCEs). The deal aligns with UCB’s strategy to expand innovative treatments for severe immune-mediated diseases and reinforce its position in immunology.

A key component of the acquisition is cizutamig, Candid’s lead investigational asset. This bispecific antibody targets B-cell maturation antigen (BCMA) on plasma cells and CD3 on T-cells, enabling targeted immune responses to eliminate pathogenic cells. Designed to balance efficacy with reduced cytokine release, cizutamig has already been studied in over 100 patients across multiple myeloma and autoimmune conditions and is currently being evaluated in several early-stage clinical trials spanning more than 10 autoimmune diseases.

This acquisition complements UCB’s broader strategy of diversifying its immunology platform, including its recent collaboration with Antengene. By integrating Candid’s multi-specific TCE pipeline, UCB aims to enhance its approach to treating antibody-mediated autoimmune diseases through targeted and mechanism-driven therapies rather than relying on single modalities.

According to Jean-Christophe Tellier, the deal represents a significant milestone in UCB’s innovation strategy and introduces a potentially transformative therapy capable of redefining treatment standards. Ken Song emphasized that UCB’s expertise in immunology development and commercialization will accelerate the clinical progress of Candid’s pipeline.

The transaction is valued at up to $2.2 billion, including $2 billion upfront and up to $200 million in milestone payments. Pending regulatory approvals, the deal is expected to close between late Q2 and early Q3 2026.

Pfizer’s ELREXFIO Demonstrates Marked PFS Benefit in Double-Class Exposed RRMM Patients

Pfizer Inc. has reported positive topline results from its Phase 3 MagnetisMM-5 trial evaluating ELREXFIO as a standalone treatment for adults with relapsed or refractory Multiple Myeloma who had received at least one prior therapy. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival compared to the standard regimen of daratumumab, pomalidomide, and dexamethasone. The safety profile of ELREXFIO remained consistent with previous findings.

The progression-free survival results surpassed the predefined interim efficacy threshold, with a majority of patients treated with ELREXFIO experiencing no disease progression during the analysis period. While the trial is ongoing to evaluate overall survival as a secondary endpoint, these data are not yet mature. Pfizer plans to share detailed findings with global regulatory authorities and present them at an upcoming medical conference.

Multiple myeloma is an aggressive and currently incurable cancer affecting plasma cells in the bone marrow. It is the second most common blood cancer globally, with a high rate of relapse despite advances in treatment. Many patients require multiple lines of therapy, and long-term survival remains limited. The disease also significantly affects quality of life due to symptoms such as fatigue, bone pain, and increased susceptibility to infections.

According to Jeff Legos, early intervention remains critical to improving outcomes. He emphasized that ELREXFIO has already demonstrated strong clinical benefits in heavily pretreated patients and now shows promise earlier in treatment. The therapy is approved in over 35 countries and continues to be evaluated across multiple treatment settings through ongoing clinical studies.

Axsome Therapeutics Secures FDA Nod for AUVELITY in Alzheimer’s-Related Agitation

Axsome Therapeutics has announced that the U.S. Food and Drug Administration has approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer’s disease. This marks the first approved therapy specifically targeting this condition, offering a novel mechanism of action through NMDA and sigma-1 receptor modulation.

The approval represents a significant advancement for patients, caregivers, and clinicians managing Alzheimer’s-related agitation, a condition affecting up to 76% of individuals with the disease. Symptoms such as restlessness, aggression, and emotional distress often place a heavy burden on both patients and caregivers. According to Herriot Tabuteau, this milestone highlights the company’s commitment to addressing serious neurological disorders and delivering innovative treatment options for underserved conditions.

The decision is supported by robust clinical evidence from the Phase 3 ADVANCE-1 and ACCORD-2 trials. In ADVANCE-1, AUVELITY demonstrated statistically significant improvement in agitation symptoms compared to placebo, while ACCORD-2 showed that continued treatment significantly delayed symptom relapse. The drug also exhibited a favorable safety and tolerability profile, with low discontinuation rates and adverse events comparable to placebo.

Experts, including Jeffrey Cummings, emphasized that agitation is one of the most challenging aspects of Alzheimer’s disease, often linked to faster cognitive decline and increased care needs. AUVELITY’s approval addresses a long-standing unmet need and is expected to play an important role in improving patient care.

Previously granted Breakthrough Therapy designation and Priority Review, AUVELITY is also approved for major depressive disorder and has already been used by over 300,000 patients.

Truqap Moves Closer to Approval in PTEN-Deficient mHSPC After FDA Panel Backing

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) has expressed a positive benefit-risk assessment for AstraZeneca’s Truqap when used in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). The committee supported the regimen with a 7–1 vote, with one abstention, based on data from the Phase III CAPItello-281 trial.

The FDA had previously accepted a supplemental New Drug Application (sNDA) for this combination therapy following encouraging trial results presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. Patients with PTEN-deficient mHSPC typically face aggressive disease progression, poor prognosis, and limited treatment options, highlighting the need for more effective therapies.

Clinical findings from the CAPItello-281 study demonstrated a statistically significant 19% reduction in the risk of disease progression or death compared to standard treatment. The combination also improved median radiographic progression-free survival by 7.5 months, extending it to 33.2 months versus 25.7 months in the control group. Additional benefits included delayed progression to castration resistance, reduced prostate-specific antigen (PSA) progression, and improved skeletal event-free survival outcomes.

Although overall survival data remain immature, early analyses suggest a favorable trend for the Truqap combination. The safety profile was consistent with known effects of the therapies, though higher rates of Grade 3 or above adverse events were observed in the combination arm, including rash, hyperglycemia, and hypertension.

The FDA will consider ODAC’s recommendation during its review process, while a similar regulatory application is currently under evaluation in the European Union.

US FDA Grants Priority Review and Breakthrough Therapy Designation to Bepirovirsen

GSK plc has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for priority review for bepirovirsen, an investigational antisense oligonucleotide (ASO) being developed to treat adults with Chronic Hepatitis B. The therapy has also been granted Breakthrough Therapy Designation, highlighting its potential to offer significant improvements over existing treatment options. This designation builds upon its earlier Fast Track status, which supports faster development and regulatory review for therapies addressing serious unmet medical needs.

Chronic hepatitis B remains a major global health concern, affecting more than 250 million people worldwide. Current treatment options, such as nucleos(t)ide analogues, often require lifelong use and achieve very low functional cure rates. A functional cure is defined as sustained absence of viral DNA and hepatitis B surface antigen (HBsAg) in the blood after stopping therapy, which significantly reduces the risk of long-term complications like liver cancer.

The regulatory submission is supported by positive Phase III results from the B-Well 1 and B-Well 2 trials. In these studies, bepirovirsen, when combined with standard of care, demonstrated statistically significant and clinically meaningful improvements in functional cure rates compared to standard treatment alone. The therapy showed particularly strong efficacy in patients with lower baseline HBsAg levels and maintained a safety profile consistent with earlier studies.

Detailed findings from these trials are expected to be presented at the European Association for the Study of Liver Congress and published in 2026. The FDA has set a target decision date of October 26, 2026, under the Prescription Drug User Fee Act (PDUFA).