There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things hampering psychiatric drug development. Institutions including the European Congress of Neuropsychopharmacology (ECNP) and the American Psychiatric Association (APA) are developing Roadmaps to find the biomarkers that can enable more biologically based diagnostic framework. But such a framework is likely at least a decade away from being broadly feasible. In the meantime, companies are innovating in psychiatric drug development in multiple ways. Even without biomarkers, they are finding ways to conduct more precise trials on more precise groups of patients.
Immutep stock plummets 90% on efti phase III failure in NSCLC
Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility. The data monitoring committee determined the trial should be stopped following an interim futility analysis as part of the study protocol. “We are very disappointed and surprised with the outcome of the futility analysis, in light of efti’s performance in every other clinical trial,” said Immutep CEO Marc Voigt. The company is still analyzing the data to better understand the results and to figure out the next steps, he said. Whether Immutep can survive the fall remains to be seen. The TACTI-004 was the most advanced trial to date, and all data seemed to point to success.
Kyron-Servier deal focused on programmable glycoprotein platform
Newco Kyron Bio is showing its colors after sealing a research agreement with Servier SA, underpinning a claim that it has overcome one of the longest-running challenges of the biotech industry, and developing technology to precisely control the glycosylation of therapeutic proteins. The founder and CEO of Kyron, Emilia McLaughlin, said a number of approaches to modifying glycoproteins have now been linked to precise analytical tools for detecting their exact composition, opening the way for the company to develop its programming glycoengineering platform.
Kanaph, Imbiologics to kick off 2026 Korea biotech, med-tech IPOs
Two biotech and three med-tech companies are slated for Kosdaq debuts this month, signaling a potential rebound for Korea financings in 2026. Kanaph Therapeutics Inc. will open with a ₩40 billion (US$26.99 million) raise March 16. Antibody drugmaker Imbiologics Corp. will debut March 20 with ₩52 billion, marking the largest raise so far this year. In med tech, wearable monitoring device-maker Mezoo Co. Ltd. will launch its IPO March 26, offering 1.34 million shares at ₩16,700 to ₩21,600 each. Rehabilitation robot developer Cosmo Robotics Co. Ltd. is slated to list March 27. Recensmedical Inc. will follow on March 31.
Otsuka’s repinatrabit shows phase II efficacy in PKU adolescents
Otsuka Pharmaceutical Co. Ltd. reaped positive results from an open-label phase II study of repinatrabit (JNT-517) in adolescents with phenylketonuria (PKU), a rare disease marked by the inability to break down the amino acid phenylalanine. Tokyo-headquartered Otsuka gained the small-molecule asset through its $1.1 billion acquisition of Boston-based Jnana Therapeutics Inc. in 2024. Repinatrabit is an oral phenylalanine transporter solute carrier family 6 member 19 (SLC6A19) inhibitor, derived from Jnana’s RAPID (Reactive Affinity Probe Interaction Discovery) platform.
Biopharma deals hit record value early in 2026
Biopharma deal value reached $61.17 billion in the first two months of 2026, far exceeding the openings recorded in previous years. The January-to-February total represents a roughly 60% increase from the $38.11 billion logged in the same period of 2025. February’s largest deal was an $8.5 billion agreement between Innovent Biologics Inc. and Eli Lilly and Co.
Also in the news
4basebio, Abbott, Atara Biotherapeutics, Beaubrain Healthcare, Biogene, Biomarin, Bridgebio, C2N Diagnostics, Capricor, Circle, Combat Medical, Cullgen, Curanex, Edgeone Medical, Eli Lilly, Enodia, Fujifilm Biotechnologies, Gyre, Halozyme, Helus, Insulet, Intensity, Ipsen, Johnson & Johnson, Kenai, Kezar Life Sciences, Mesoblast, Mindmaze, Monteris, Noah Medical, Otsuka, Personalis, Poolbeg, Preludedx, Ratio, Regenxbio, Solid Biosciences, Tenon, Toro Neurovascular, Trinity Biotech, Ultragreen.ai, United, Valanx Biotech, Verano, Xspray, Zuellig Pharma