一次情報の記録
決定級申請提出
Teva、トゥレット症候群向けecopipam（EBS-101）のNDAを提出
Tevaは2026年6月に、Emalex Biosciencesの7億ドル買収を受けて、トゥレット症候群向けのファーストインクラスの治療薬であるecopipam（EBS-101）について、米国FDAに新薬承認申請を提出しました。このNDA提出により、申請前段階から規制当局による審査段階へ移行し、Tevaの神経科学領域パイプラインにおける重要な規制マイルストーンとなります。
主要事実
出典の抜粋
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling EXHIBIT 99.1 Teva Delivers Strong Q2 Results and Raises Outlook for All Three Key Innovative Brands, Reflecting Continued Execution of Its Pivot to Growth Strategy Q2 2026 revenues of $4.1 billion decreased by 1% in U.S. dollars year-over-year (YoY) and by 3% in local currency (LC) terms, mainly due to lower generics revenues. Our key innovative brands collectively grew 43% YoY in LC, to over $1 billion in revenues, and we raised our 2026 outlook for all three, highlighting Teva’s continued execution of its Pivot to Growth strategy. Key Innovative brands continued to drive growth while transforming Teva’s portfolio mix and financial profile: AUSTEDO ® continued to grow rapidly, with global revenues of $696 million, growing 40% YoY in LC