Company Product Description Indication Status
89bio Inc., of San Francisco BIO89-100 Glycopegylated FGF21 analogue Fibrosis stage 2 or 3 nonalcoholic steatohepatitis Based on written guidance from the FDA, the company plans to run the 200-patient Enliven phase IIb study comparing 2 dose levels of BIO89-100 to placebo; primary endpoints are NASH resolution without worsening of fibrosis and the improvement of fibrosis ≥ 1 stage without worsening of NASH, both at week 24
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) JAK inhibitor Moderate to severe atopic dermatitis FDA extended the review period for the supplemental NDA by 3 months to review an updated assessment of the drug’s benefit-risk profile; new PDUFA action date is early in the third quarter of 2021
Acadia Pharmaceuticals Inc., of San Diego Nuplazid (pimavanserin) 5-HT 2a receptor inverse agonist Dementia-related psychosis FDA issued a complete response letter
Exelixis Inc., of Alameda, Calif. XB-002 Antibody-drug conjugate targeting tissue factor Advanced solid tumors FDA accepted the IND for a phase I study testing the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB-002; study scheduled to start in the second quarter of 2021
Eli Lilly and Co., of Indianapolis Taltz (ixekizumab) Monoclonal antibody targeting interleukin 17A Moderate to severe plaque psoriasis Health Canada issued a notice of compliance to treat pediatric patients from age 6 to under 18
Passage Bio Inc., of Philadelphia PBKR-03 Gene therapy expressing GALC Krabbe disease European Commission granted orphan designation
Supernus Pharmaceuticals Inc., of Rockville, Md. Qelbree (viloxazine extended-release capsules) Norepinephrine reuptake inhibitor Attention-deficit hyperactivity disorder FDA approved the NDA
Tetra Bio-Pharma Inc., of Ottawa, Ontario ARDS-003 Cannabinoid CB2 receptor agonist Severe COVID-19 FDA reviewed the preclinical data package and clinical development plan and acknowledged that the preclinical safety data are acceptable to file an IND

Notes

For more information about individual companies and/or products, see Cortellis.