Sibeprenlimab

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)

Otsuka Pharmaceutical Development and Commercialisation and Otsuka Pharmaceutical have announced positive two-year results from the Phase 3 VISIONARY trial, demonstrating that Voyxact (sibeprenlimab-szsi) significantly stabilised kidney function in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. The findings, presented during a late-breaking oral session at the GlomCon Hawaii 2026 conference, showed that the study met its key secondary endpoint by significantly improving the annual rate of kidney function decline, measured by estimated Glomerular Filtration Rate (eGFR). Patients treated with Voyxact achieved an annualised eGFR slope of +0.3 mL/min/1.73 m²/year, compared with -4.2 mL/min/1.73 m²/year in the placebo group, representing a statistically significant treatment benefit. According to Otsuka, Voyxact is the first therapy for IgA nephropathy to achieve the Kidney Disease: Improving Global Outcomes (KDIGO) therapeutic goal of slowing kidney function decline to a near-physiological rate of less than one mL/min/1.73 m² per year for most adults. The study also reported sustained improvements in overall kidney function after 24 months. Patients receiving Voyxact experienced a least-square mean increase of 1.3 mL/min/1.73 m² in eGFR from baseline, while those receiving placebo recorded a decline of 7.9 mL/min/1.73 m², resulting in a treatment difference of 9.2 mL/min/1.73 m². The safety profile remained favourable throughout the two-year study period. Overall adverse events, infections and injection-site reactions occurred at rates comparable to placebo, while serious infections, severe adverse events and treatment discontinuations were reported less frequently in the Voyxact arm. No new safety concerns were identified. Dr. Dana Rizk, Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham and co-chair of the VISIONARY steering committee, said the results represent a major advance in the treatment of IgA nephropathy. She noted that achieving the KDIGO treatment goal has the potential to fundamentally alter disease progression and improve long-term outcomes for patients. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, said the VISIONARY trial represents the largest Phase 3 study conducted in IgA nephropathy, with 24 months of follow-up in a patient population representative of real-world clinical practice. He added that the magnitude of kidney function preservation observed in the study supports Voyxact's potential to redefine the treatment landscape by addressing the underlying drivers of the disease rather than only managing symptoms. Voyxact received accelerated approval from the US Food and Drug Administration (FDA) in November 2025 after meeting the VISIONARY trial's primary endpoint of significantly reducing proteinuria at nine months. The newly reported two-year data build on earlier evidence demonstrating reductions in proteinuria, galactose-deficient IgA1 (Gd-IgA1) and haematuria, further supporting the therapy's disease-modifying potential. Otsuka said the complete two-year Phase 3 analysis will be presented at an upcoming scientific congress and will form part of its rolling supplemental Biologics License Application (sBLA) seeking traditional FDA approval for Voyxact. IgA nephropathy is a chronic immune-mediated kidney disease that primarily affects adults between 20 and 40 years of age and can progressively lead to kidney failure. Voyxact is a humanised monoclonal antibody that selectively inhibits APRIL (A Proliferation-Inducing Ligand), an immune pathway involved in the production of pathogenic galactose-deficient IgA1, a key driver of IgAN. Administered as a once-every-four-weeks subcutaneous injection, Voyxact is currently the first and only FDA-approved selective APRIL inhibitor for adults with primary IgA nephropathy at risk of disease progression.