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.
Other News of Note:
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)