Definium Reports Positive Phase 3 EMERGE Results for DT120 ODT in MDD; AbbVie to Buy Apogee Therapeutics; TrueLab Announces Strategic Antibody Licensing Collaboration with Bionyra Pharma; Nura Bio Secures Series B Financing to Advance SARM1 Programs; Moderna’s mRNA-1010 Earns Unanimous FDA Advisory Committee Backing on Benefit-Risk Profile

Definium Therapeutics Advances DT120 ODT with Positive Results from Pivotal Phase 3 EMERGE Study

Definium Therapeutics, Inc. reported positive topline findings from Emerge, its first Phase 3 randomized, double-blind, placebo-controlled trial assessing a single 100 µg dose of DT120 (lysergide) orally disintegrating tablet (ODT) in adults with major depressive disorder (MDD).

The study successfully achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in depressive symptoms versus placebo, as measured by the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Patients treated with DT120 ODT 100 µg experienced a Least Squares (LS) mean reduction of 13.3 points in MADRS score from baseline, compared with a 5.2-point reduction in the placebo arm, resulting in an LS mean difference of 8.1 points in favor of DT120 (p<0.0001).

In addition to meeting the primary endpoint, DT120 showed a rapid onset of action, with a placebo-adjusted LS mean reduction in MADRS score of 14.2 points observed as early as Week 1 (p<0.0001). The antidepressant effect also remained durable, with a placebo-adjusted LS mean reduction of 7.3 points maintained through Week 12 (p<0.0001).

“The topline results from Emerge demonstrate a highly differentiated efficacy profile, showing that a single dose of DT120 ODT can provide rapid, substantial, and sustained symptom relief for patients with MDD,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “As the first Phase 3 study in our development program to report results, Emerge represents a significant milestone and reinforces our confidence in DT120 as a potential best-in-class therapy for mental health conditions. These findings may pave the way for a novel treatment paradigm for MDD, addressing important unmet needs among patients and healthcare providers. We thank the patients and investigators whose participation made this study possible. Supported by decades of scientific research, these results bring us closer to a potential FDA submission and the opportunity to introduce a transformative treatment option.”

DT120 ODT demonstrated a favorable safety and tolerability profile. Approximately 99% of treatment-emergent adverse events were mild to moderate in severity, temporary in nature, and occurred primarily on the dosing day. No new safety concerns were identified, including no increased incidence of suicidal ideation or behavior. Treatment discontinuation rates were low and comparable between the DT120 and placebo groups.

Participants underwent hourly assessments between five and eight hours after dosing using a structured End of Session Checklist (EoSC). In Part A of the study, the average time required to meet EoSC criteria among DT120-treated participants was 5.8 hours, with a median time of 5.1 hours. All participants receiving DT120 satisfied the EoSC criteria within eight hours of dosing.

AbbVie Deepens Immunology Capabilities with Apogee Therapeutics Acquisition

AbbVie and Apogee Therapeutics have entered into a definitive agreement under which AbbVie will acquire Apogee and its portfolio of clinical-stage candidates targeting inflammatory and immunological disorders, including atopic dermatitis and asthma. The transaction is intended to strengthen AbbVie’s immunology franchise and expand its footprint in respiratory diseases.

According to the agreement, AbbVie will purchase all outstanding Apogee shares for $135.11 per share in cash, valuing the company at approximately $10.9 billion in total equity. The boards of both companies have unanimously approved the deal, which is anticipated to close in the third quarter of 2026, subject to customary closing requirements, including shareholder and regulatory approvals.

Commenting on the acquisition, Robert A. Michael stated that AbbVie has spent more than 20 years advancing the field of immunology and believes the addition of Apogee’s pipeline will further reinforce its leadership position. He noted that the transaction broadens AbbVie’s portfolio with differentiated clinical-stage assets addressing significant unmet needs in conditions such as atopic dermatitis and asthma, while leveraging AbbVie’s scientific and development capabilities to accelerate these programs and improve treatment standards for patients with inflammatory diseases.

The acquisition is expected to offer meaningful long-term value creation opportunities, supported by the blockbuster potential of Apogee’s pipeline. Key assets include zumilokibart (APG777), a subcutaneously administered, half-life–extended anti-IL-13 monoclonal antibody being developed for atopic dermatitis, and APG273, a combination of zumilokibart and APG333, an anti-TSLP half-life–extended monoclonal antibody, currently under development for asthma.

TrueLab and Bionyra Enter Strategic Licensing Agreement for Monoclonal and Bispecific Antibody Assets

TrueLab Biopharmaceutical, an immunology-focused biotechnology company utilizing a proprietary AI-enabled research and development platform to create innovative treatments for immune-mediated inflammatory disorders, has announced an exclusive licensing agreement with Bionyra Pharma. The deal covers two of TrueLab’s assets: TL-001, an anti-TL1A monoclonal antibody, and TL-003, a TL1A × IL-23p19 bispecific antibody.

Under the agreement, Bionyra receives exclusive global rights, excluding Greater China, to research, develop, manufacture, and commercialize both candidates. In return, TrueLab may receive up to $985 million in potential payments, including upfront consideration and development, regulatory, and commercial milestones, along with tiered royalties on future net sales. The company will also obtain a single-digit equity stake in Bionyra upon the completion of the latter’s Series A financing round.

The partnership additionally gives Bionyra the option to further develop other preclinical assets from TrueLab under a similar licensing structure. As part of the transaction, Bionyra has closed a $165 million Series A financing round co-led by Jeito Capital and Sofinnova Partners, with participation from Arkin Capital, Sanofi Ventures, Sixty Degree Capital, Vives Partners, and Apollo Health Ventures.

Nura Bio Secures $73.8M Series B to Accelerate SARM1 Inhibitor Development

Nura Bio Inc. has secured $73.8 million in Series B financing and announced progress across its two clinical-stage SARM1 inhibitor programs. The funding round was led by The Column Group, with participation from Euclidean Capital, Samsara BioCapital, and Sanofi Ventures. The proceeds will support the advancement of Nura Bio’s clinical pipeline, including the ongoing Phase 1b/2a trial of NB-4746, an orally administered, brain-penetrant SARM1 inhibitor that has recently begun dosing patients with amyotrophic lateral sclerosis (ALS).

“ALS remains a devastating neurodegenerative disorder with limited treatment options and no cure,” said Prof. Jeremy Shefner, MD, PhD, Professor of Neurology at Barrow Neurological Institute and neurologist at the Gregory W. Fulton ALS & Neuromuscular Disease Center. “Nura Bio has pioneered the development of neuroprotective therapies targeting SARM1, a key driver of axonal degeneration. Advancing this program marks a significant step toward evaluating the therapeutic potential of SARM1 inhibition in ALS.”

NB-4746 is designed to block SARM1-mediated axonal degeneration and has demonstrated neuroprotective effects in multiple preclinical models of nerve injury and neurodegenerative diseases, including ALS. In a Phase 1 study involving healthy volunteers, the candidate exhibited a favorable safety and tolerability profile while achieving targeted exposure levels in both plasma and cerebrospinal fluid.

In parallel, Nura Bio has initiated dosing in a first-in-human study of NB-9402, an oral covalent allosteric SARM1 inhibitor. The candidate has shown potent activity and durable efficacy in preclinical models of neurological disorders, further strengthening the company’s leadership in the development of SARM1-targeted therapies.

Moderna’s mRNA-1010 Wins Unanimous FDA Advisory Committee Support

Moderna, Inc. announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted (9-0) that the benefits of mRNA-1010, the company’s investigational seasonal influenza vaccine, outweigh its risks for preventing influenza in adults aged 50–64 years, as well as in individuals aged 65 years and older.

“We are grateful for the comprehensive evaluation conducted by VRBPAC and for its acknowledgment of the clinical data supporting mRNA-1010,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Seasonal influenza continues to place a considerable health burden on older adults, leading to significant illness and hospitalizations each year. We believe mRNA-1010 could offer a valuable new preventive option and further highlight the adaptability of our mRNA technology platform. We look forward to continued engagement with the FDA throughout the review process.”

Data reviewed by VRBPAC included findings from Moderna’s Phase 3 clinical development program, notably the primary analysis from the pivotal Phase 3 study (NCT06602024). These results, first reported in June 2025 and subsequently published in The New England Journal of Medicine, reinforce the vaccine’s potential as a differentiated, non-egg-based influenza prevention option for older adults.

The safety findings observed across the Phase 3 program were consistent with those reported in earlier studies of Moderna’s influenza vaccine candidate. As part of its ongoing evaluation of Moderna’s Biologics License Application (BLA) for mRNA-1010, the FDA will consider VRBPAC’s recommendations. However, advisory committee recommendations are not binding, and the FDA retains sole authority over the final approval decision.

mRNA-1010 is currently under regulatory review in the United States, the European Union, Canada, and Australia. Moderna has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 5, 2026, by the FDA. The company also plans to expand regulatory filings to additional countries throughout 2026.