Biotech stocks came under pressure in the week ended Aug. 14 amid mixed earnings news flow from the sector. FDA decisions scheduled for the week also produced adverse outcomes. Eagle Pharmaceuticals Inc (NASDAQ: EGRX) and Fennec Pharmaceuticals Inc (NASDAQ: FENC) received complete response letters for their respective regulatory applications, while a decision on Eton Pharmaceuticals Inc's (NASDAQ: ETON) eye inflammation drug hadn't come by the Aug. 10 decision date.
The week, however, saw a signing spree by coronavirus vaccine developers, which stitched up manufacturing as well as supply deals.
Here are the key catalysts for the unfolding week.
Conferences
Virtual Keystone Symposia: Advances in Cancer Immunotherapy: Aug. 17-19
PDUFA Dates
Gilead Sciences, Inc. (NASDAQ: GILD) and licensing partner GALAPAGOS NV/S ADR (NASDAQ: GLPG) await FDA decision on the NDA for filgotinib in moderate-to-severe rheumatoid arthritis. (estimated date of Wednesday, Aug. 19, assuming priority review)
The FDA is set to rule on BioMarin Pharmaceutical Inc.'s (NASDAQ: BMRN) BLA for valoctocogene roxaparvovec, its investigational AAV5 gene therapy for treating adults with hemophilia A. (Friday)
Tricida Inc (NASDAQ: TCDA) has a Aug. 22 PDUFA date for the NDA for its TRC 101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. With FDA's communication to the company in mid-July, stating that it has identified deficiencies in the application, it is less likely the investigational drug is approved by the D-day. (Saturday)