Protocols

Lilly, Incyte’s baricitinib wins fast-track status for hard-to-treat lupus; Synthorx hammers out $150M+ IPO

→ Rheumatoid arthritis drug Olumiant — approved for a narrower-than-expected patient population earlier this year to the dismay of its manufacturer Eli Lilly $LLY and Incyte $INCY which had blockbuster dreams for the drug — may be worth its weight in gold if approved for lupus, a disease in which the immune system attacks its host, and has seen a solitary approved treatment in the last 50 years. The companies announced on Thursday that the drug, known chemically as baricitinib, had been granted fast-track status by the FDA for lupus. Two doses of baricitinib, which is also being investigated as a treatment for atopic dermatitis, are currently in Phase III trials in patients with systemic lupus erythematosus.

→ Avalon-controlled Nektar $NKTR rival Synthorx $THOR — which began trading on December 7 — has closed its IPO of about 13.7 million shares priced at $11 per share. Gross proceeds from the offering were about $150.7 million, the La Jolla, CA-based company said on Wednesday.

→ Novartis $NVS and Roche’s blockbuster biologic Xolair, which is approved for hives as well as allergic asthma, is vulnerable to competition after losing patent protection, with a few competitors working on biosimilars. Originally approved as an injectable prescription medicine, the drug is also available in certain regions as a liquid formulation. Novartis, on Thursday, announced the EC had granted the company approval for a pre-filled syringe of Xolair for self-administration, potentially reducing the number of regular clinic visits a patient would have previously undertaken.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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