Dualitas partners with Roche for bispecific antibody screen worth up to $1B. Sep. 17, 2026 A year after launching with a $65 million series A investment, Dualitas Therapeutics Inc. has signed up its first partner to use its Dualscreen Bispecific Discovery Engine to screen bispecific antibody combinations. The partnership with Roche Holding AG calls for screening more than 300,000 bispecific combinations to look for pairs of antibodies that have synergistic effects on immunology and inflammation diseases when tethered together compared to the effect of the antibodies individually and when combined as two separate antibodies. Dualitas will receive $36.5 million in up-front payments and is eligible for research, development and commercial milestone payments as well as tiered royalties with a potential total deal value of up to $1 billion. Orbis, Novo in $1.4B cardiometabolic deal for macrocycles. After its investment arm seeded Orbis Medicines ApS in 2021 and participated in a €90 million (US$92.8 million) series A round at the start of 2025, Novo Nordisk A/S entered a $1.4 billion multitarget partnership with the oral macrocycle drug discovery company to find next-generation drugs for cardiometabolic diseases. The companies, both based in Denmark, Orbis in Copenhagen and Novo in Bagsvaerd, did not disclose the breakdown of the $1.4 billion, which involves both up-front and milestone payments, including those tied to development and commercial achievements, as well as tiered royalties on potential sales. In addition, Novo is making a strategic investment in Orbis, supporting its [n] Gen platform, which develops synthetic macrocycles it calls [n] Cycles that are optimized for oral bioavailability and membrane permeability. Orbis' pipeline is initially focused on targets already validated by injectable blockbuster biologics. Realheart artificial heart shows sixfold reduction in hemolysis. A new total artificial heart (TAH) being developed by Scandinavian Real Heart AB saw six times less blood damage compared to the Syncardia Systems LLC's Total Artificial Heart (TAH), the only U.S. FDA-approved system to bridge patients awaiting heart transplants in a lab-based study. Although the findings, published in Nature Scientific Reports, were generated in an in vitro mock circulation model, rather than real patients, the significantly lower hemolysis using Realheart highlights its potential advantage if replicated clinically. GLP-1s, gene editing make 2026 Citation Laureates list. Even as the treatment potential for GLP-1 drugs continues to expand beyond metabolic indications, recognition grows for the scientific breakthroughs that led to the blockbuster peptide hormone, with Clarivate plc naming three key GLP-1 researchers among its Citation Laureates 2026. Regcell adds $66M to take Nobel-winning Tregs to clinic. Regcell Inc. has raised $66 million in new financing and Japanese government support to move its Nobel-linked regulatory T-cell (Treg) platform toward the clinic, advancing an epigenetic reprogramming approach designed to convert disease-driving immune cells into antigen-specific Tregs. The financing includes a $44 million series A led by Playground Global and a second grant from Japan's AMED. Regcell said the funding will support an IND submission, clinical development across autoimmune indications and advancement of a second-generation platform program through phase II proof of concept. SK Biopharm takes 1st Bio's LRRK2/c-Abl inhibitor in $315M deal. SK Biopharmaceuticals Co. Ltd. signed a licensing and equity deal agreement to acquire global rights to 1ST-104, a preclinical type II LRRK2/c-Abl tyrosine kinase inhibitor, for Parkinson's disease from 1st Biotherapeutics Inc. The asset belongs, in part, to the challenged class of leucine-rich repeat kinase 2 inhibitors, which recently suffered a high-profile setback when Biogen Inc. and Denali Therapeutics Inc. discontinued the phase IIb Luma study of BIIB-122 (DNL-151) in May 2026. 1ST-104 is a next-generation, LRRK2-selective type II inhibitor, which 1st Bio said was designed to address limitations reported with some existing type I LRRK2 inhibitors, including lung-related abnormalities in preclinical studies. Longeveron plummets on phase IIb failure in infant heart syndrome. Shares of Longeveron Inc. (NASDAQ: LGVN) were trading at $2.87, down $3.81, or 57%, on word of top-line results from Elpis II, the phase IIb trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome. The study fell short in the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at month 12. In the intent-to-treat population, the least-squares mean RVEF difference between treatment groups was −0.7 percentage points. Longeveron has begun "a process of optimizing cost containment and will explore all options" with shareholder value in mind, the company said in a press release. No 510(k) exemption for CAD, CADt devices. The final answer is no, the U.S. FDA said in denying a citizen petition requesting partial exemption from premarket notification requirements for certain software used in radiology computer-aided detection or diagnosis (CAD) and computer-aided triage and notification (CADt) devices. In publishing its final order in today's Federal Register, the FDA said neither the petition, filed last year on behalf of Harrison.ai, nor the comments it received demonstrated that premarket notification isn't necessary to assure the safety and effectiveness of the devices. That's one of the factors the agency considers when determining if a 510(k) exemption is appropriate for a Class II device. SEC settlement resolves charges against Ubiome founders. The U.S. SEC reached a settlement with the co-founders of Ubiome Inc., a defunct private San Francisco-based medical testing company. The settlement will resolve charges the SEC brought more than five years ago against the company's CEO, Jessica Richman, and its chief scientific officer, Zachary Apte, regarding Ubiome's fundraising tactics. While the settlement includes no admission of guilt, Richman and Apte will each have to pay $125,000 and face a three-year bar on serving as an officer or director. Med-tech M&A value nears $80B, best pace since 2022. Med-tech M&A hit $79.5 billion through July, more than double 2025's pace and the second-highest seven-month opening in BioWorld's records, behind 2022. Novanta Inc.'s $1.45 billion buy of Riverpoint Medical and American Industrial Partners' $1.27 billion acquisition of Avanos Medical Inc. led the month's M&As. Regulatory: approvals for bayer, scholar rock, telix, abbott and more. Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations. To read more on related topics, click on one of the words below.

Dualitas Therapeutics appoints Karim Dabbagh as Chief Executive Officer to advance novel bispecific antibody pipeline toward the clinic. 0 3 minutes read * Karim Dabbagh, Ph.D., joins as CEO, bringing leadership experience in advancing immunology and inflammation therapies through clinical trials; Rich Murray, Ph.D., former interim CEO, remains on the Board of Directors * Dualitas announces the nomination of DTX-102 as its lead development candidate, a bispecific antibody powered by a novel immune proximity engager mechanism, for the treatment of rheumatoid arthritis; clinical studies are anticipated to begin in 2027 * Dualitas announces two additional preclinical programs - enabled by its proprietary proximity engager - across large population indications including allergy, dermatology and gastrointestinal diseases SOUTH SAN FRANCISCO, Calif., June 8, 2026 /PRNewswire/ - Dualitas Therapeutics, Inc., a biotechnology company developing next-generation bispecific antibody therapies for immunology and inflammation ("I&I") indications, has appointed Karim Dabbagh, Ph.D., as chief executive officer to lead the company as it advances its lead development candidate, DTX-102, a bispecific antibody incorporating Dualitas' immune proximity engager, for autoimmune indications including rheumatoid arthritis. IND-enabling studies have begun for DTX-102 and it is anticipated to enter the clinic in 2027. Appointment of Karim Dabbagh as Chief Executive Officer "This is a pivotal time for Dualitas, as we begin advancing the first of our differentiated bispecific antibody therapies for immune and inflammatory diseases into the clinic next year," Dabbagh said. "Our unique proximity engager technology with I&I applications has the potential to set a new standard in efficacy for millions of patients who are underserved by existing treatments." Dabbagh has spent more than two decades in biotech and pharma leadership, specializing in I&I. He joins Dualitas from Silver Creek Pharmaceuticals, where he was President and CEO. Prior to that, he served as President and CEO of Second Genome, helping build the company's R&D platform and advancing its pipeline from discovery into the clinic, while also securing collaborations with Gilead Sciences and Bayer. Earlier in his career, he led Pfizer's immunoregulation department as well as external R&D innovation efforts in autoimmune and inflammatory diseases and previously held leadership roles in Inflammation Discovery Research at Roche. "Karim's deep experience advancing immunology therapies from the lab to clinical trials and establishing high-value collaborations across the drug discovery ecosystem makes him exceptionally well-suited for Dualitas at this critical juncture of pipeline maturation," said Neil Weir, Ph.D., Chairman of the Board of Directors. "Rich Murray, Ph.D., who served as interim CEO from January 2025, has shown tremendous leadership through the Series A financing and alignment of the science to product development. We are delighted he will remain on the Board of Directors." DTX-102 and Dualitas "Proximity Engager" Technology Dualitas' bispecific antibodies pair an internally discovered novel immune proximity engager arm with an antibody against a validated target. Unlike traditional bispecific approaches that seek incremental gains by combining two separate inhibitors, Dualitas' proximity engager pairs synergistically with diverse immune targets. This interaction drives amplified pharmacological effects that are achievable only in a bispecific format and cannot be achieved with monospecific agents. Dualitas is applying its bispecific proximity engager across multiple validated immune pathways, starting with the CD28 pathway for its DTX-102 program. In vitro and in vivo preclinical studies of DTX-102 demonstrated significantly greater potency and more durable immune modulation than currently approved therapies targeting the same pathways. In addition to DTX-102, Dualitas announces two additional programs using its proprietary proximity engager. DTX-103 is an anti-FcεRI bispecific antibody that targets the IgE pathway to treat allergic diseases like asthma, food allergy, chronic spontaneous urticaria, among others. DTX-101 targets IL-2Rβ to substantially suppress both IL-15 and IL-2 pathways and is designed for initial indications in dermatologic and gastrointestinal disease. Dualitas' $65 million Series A financing, announced in September 2025, will fund DTX-102 into the clinic and the ongoing development of its pipeline assets. About Dualitas Therapeutics Dualitas Therapeutics, Inc. is a biotechnology company pioneering next-generation bispecific antibody (BsAb) therapies for immunology and inflammation (I&I). Dualitas' portfolio, built from its DualScreen discovery engine, includes development candidate DTX-102 in rheumatoid arthritis, DTX-103 in allergic disease and DTX-101 in dermatologic and gastrointestinal autoimmune disease, alongside additional discoveries based on cell-surface proximity biology and novel co-target pairing. While advancing its own pipeline, Dualitas offers a variety of strategic collaboration opportunities to extend the impact of its DualScreen discovery engine, ranging from existing pipeline programs to identifying de novo BsAbs to establishing programs in disease areas beyond I&I. For more information, please visit https://www.dualitastx.com/ and follow The AI Journal Ltd. on LinkedIn. SOURCE Dualitas Therapeutics 5 seconds ago 33 seconds ago 52 seconds ago

Dualitas Therapeutics has appointed Karim Dabbagh as chief executive officer to lead development of its bispecific antibody pipeline. Dabbagh joins from Silver Creek Pharmaceuticals, bringing over two decades of experience in immunology and inflammation, including previous leadership roles at Pfizer and Roche. The company has nominated DTX-102, a bispecific antibody targeting rheumatoid arthritis, as its lead development candidate. IND-enabling studies have begun, with clinical trials anticipated to start in 2027. DTX-102 uses Dualitas' proprietary immune proximity engager technology, which the company says demonstrated significantly greater potency than approved therapies in preclinical studies. Dualitas also announced two additional preclinical programmes: DTX-103 for allergic diseases and DTX-101 for dermatologic and gastrointestinal conditions. The company raised $65 million in Series A funding in September 2025.