Sept. 24 Company Quick Takes: FDA approves smallpox vaccine; plus Epidyolex, Vitrakvi, Oral semaglutide, Takeda-Evotec, Guerbet- IBM Watson

FDA approves Bavarian Nordic’s smallpox/monkeypox vaccine
FDA approved Jynneos MVA-BN from Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) to prevent smallpox and monkeypox, making the vaccine the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine in the world. FDA also awarded Bavarian Nordic a Priority Review voucher as part of the approval. The third-generation modified vaccinia Ankara (MVA) virus is approved in the EU as Imvanex and in Canada as Imvamune.

Epidyolex, Vitrakvi garner European approvals
Vitrakvi larotrectinib from Bayer AG (Xetra:BAYN) became the EU’s first tissue-agnostic cancer therapy as the European Commission approved the inhibitor of TrkA, TrkB and TrkC to treat adult and pediatric patients with NTRK fusion-positive solid tumors. Epidyolex cannabidiol from GW Pharmaceuticals plc (NASDAQ:GWPH) also gained the EC’s approval Monday. It’s approved as an adjunct to clobazam for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome -- two rare forms of epilepsy -- in patients ages 2 and older. ...