Zolbetuximab

Takeda's first-in-class orexin treatment won an FDA nod in narcolepsy. Daiichi Sankyo faced investor pushback after admitting to an accounting error. Astellas booked a new quarterly revenue record. And more. 1. Takeda gains FDA nod for first-in-class narcolepsy treatment Orzeyful Takeda’s Orzeyful (oveporexton) has become the first orexin treatment to reach the market. Approved by the FDA for narcolepsy type 1, the drug is also the first medicine to address the root cause of the disease, rather than its symptoms. Takeda has pegged Orzeyful’s peak sales at between $2 billion and $3 billion. 2. Daiichi Sankyo flags accounting error, as shares tank despite revenue beat Daiichi Sankyo’s stock price tanked 11% after the company reported $182 million in extra expenses that it had missed in its fiscal year 2025 report. The Japanese pharma attributed the incident to “booking errors in accounts payable for suppliers.” Meanwhile, despite major antibody-drug conjugate sales growth, questions remain around the firm’s profitability. 3. Astellas’ revenue hits new record as strategic brands drive major beat (release, PDF) Astellas’ quarterly revenue hit a new high. At 640.9 billion Japanese yen ($4.05 billion) for the three months ended in June, it marked 26.7% growth year over year, crushing analysts’ consensus by 15%. Sales from key brands, including Pfizer-partnered Padcev, eye drug Izervay, stomach cancer therapy Vyloy and menopause med Veozah, all topped expectations. 4. AstraZeneca, CSPC to form joint venture for biologics manufacturing AstraZeneca has teamed up with CSPC Pharmaceutical again, this time on a new manufacturing joint venture in China. The new 51-49 joint venture, located in Shijiazhuang, will initially focus on producing “mutually agreed biologics drug substances for the global markets,” CSPC said. The two firms have multiple ongoing R&D collaborations. 5. From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech Asian countries are vying to build out their own biopharma ecosystems. “South Korea stands out as a reliable and fully compliant alternative that offers operational continuity without regulatory friction,” James Choi, chief marketing officer at Samsung Biologics, told Fierce. 6. In a first, Otsuka’s Voyxact stabilizes IgAN patients’ kidney function decline to normal levels Otsuka’s Voyxact has become the first drug to stabilize kidney function decline to the normal rate in a phase 3 trial among patients with IgA nephropathy. Results from the phase 3 Visionary trial linked Voyxact to an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, versus a 4.2 mL/min/1.73m² decline for placebo. 7. Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety (Stat) 8. Braveheart charges past expectations with $382.5M IPO to fund cardio drug from Hengrui 9. Sanofi-backed Expedition uses $115M series B to advance COPD drug on phase 2 journey 10. Shionogi makes the call on COVID pill Xocova TV spot 11. Ono, Mediar enter antibody discovery pact for fibro-inflammatory diseases (release)

Japan-based PeptiDream Inc. (Tokyo Stock Exchange: 4587) has announced the first patient dosing in a first-in-human radiopharmaceutical clinical trial of 64Cu-PD-29875, a macrocyclic peptide conjugate targeting Claudin 18.2 (CLDN18.2) in patients with gastric or gastroesophageal junction (GEJ) cancer. The PeptiDream claudin18.2 radiopharmaceutical program is structured as a Phase 0 imaging study, using copper-64 (⁶⁴Cu) labelling to generate PET/CT imaging data on safety, pharmacokinetics, tumor uptake, and dosimetry. The study’s diagnostic data are intended to inform the development of a companion ²²⁵Ac-labeled therapeutic, forming an integrated radiotheranostic pair. Patient enrollment numbers and a projected completion date were not disclosed. Endpoints center on diagnostic performance characterization and dosimetry, with the imaging data expected to support the design of subsequent therapeutic trials. The program received funding from Japan’s Agency for Medical Research and Development (AMED) under its Practical Research for Innovative Cancer Control initiative in 2024. CLDN18.2 is a tight-junction transmembrane protein whose normal expression is tightly restricted to differentiated gastric epithelial cells, where it remains physically inaccessible to circulating agents. In gastric and GEJ cancer specifically, CLDN18.2 expression is retained through metastatic progression, making it relevant across disease stages rather than only at diagnosis. The clinical validation of this target arrived with the 2024 FDA approval of zolbetuximab-clzb (Vyloy), a CLDN18.2-directed monoclonal antibody from Astellas Pharma, in first-line HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma — the first approved therapy directed at this target. PD-29875 is a macrocyclic peptide discovered using PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) technology and further optimized through in vivo imaging and efficacy studies at PDRadiopharma, PeptiDream’s wholly owned subsidiary. In its diagnostic configuration, the peptide is conjugated to ⁶⁴Cu, a positron emitter with a 12.7-hour half-life suited to the timescale of peptide biodistribution and tumor accumulation. The claudin18.2 PET imaging data generated in this Phase 0 study are designed to confirm tumor uptake, establish dosimetry parameters, and identify patients most likely to benefit from the therapeutic counterpart — a ²²⁵Ac-labeled version of the same peptide scaffold delivering targeted alpha-particle radiation. This theranostic strategy mirrors the PSMA paradigm in prostate cancer, where ⁶⁸Ga-PSMA PET imaging and ¹⁷⁷Lu-PSMA-617 (Pluvicto) therapy operate as a diagnostic-therapeutic pair. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.