After remaining steady in the first three sessions of the week ended September 4, biotech stocks pulled back along with the broader market in a tech-induced sell-off. Barring anything COVID-19-related, the news flow was fairly light ahead of the Labor Day holiday.

Amarin Corporation plc. (AMRN) took a severe beating after losing a patent appeal related to its synthetic fish oil pill Vascepa. The stock lost over 40% during the week, attributable primarily to the adverse ruling and to a smaller extent to the market sell-off.

Here are the key catalysts for the unfolding week.

Conferences

• Citi's 15th Annual BioPharma Conference: September 8-11.
• Wells Fargo 2020 Virtual Healthcare Conference: September 9-10.
• Baird 2020 Global Healthcare Conference: September 9-10.
• BTIG Virtual Biotechnology Conference: September 10-11.
• 66th Annual Meeting of the American Rhinologic Society, or ARS, (virtual event): September 10-12.
• International Gynecologic Cancer Society, or IGCS, xDigital Annual Global Meeting: September 10-13.
• 2020 Psych Congress (virtual event): September 10-13.
• MDS Virtual Congress 2020: September 12–16.
• MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting: September 11-13.

PDUFA Dates

The FDA is set to rule on Mallinckrodt PLC (MNK)'s NDA for terlipressin, which is being evaluated for treating hepatorenal syndrome type 1 on Saturday, September 12.

Clinical Readouts/Presentations

Standalone Releases:

• Applied Genetic Technologies Corp. (AGTC) said it will present an update on Wednesday, September 9 on its planned Phase 2/3 X-Linked Retinitis Pigmentosa clinical trial design, a re-analysis of dose Groups 2 and 4 data, and new preliminary visual sensitivity data from Group 5.

MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting Presentations:

• Johnson & Johnson (JNJ)'s Janssen unit: additional data on the effect of treatment with ponesimod versus teriflunomide on disability measures in patients with relapsing multiple sclerosis.
• Roche Holdings AG (RHHBY)'s Genentech unit: New analyses from the two-year open-label Phase 3b CASTING study of Ocrevus in patients with relapsing-remitting multiple sclerosis, and new data from the SAkura Phase 3 studies of Enspryng in neuromyelitis optica spectrum disorder.
• Atara Biotherapeutics Inc. (ATRA): Presenting new 12-month data from all four cohorts in the Phase 1a study of ATA188 for the treatment of progressive forms of multiple sclerosis on Friday, September 11.

ARS Meeting Presentations:

• VERONA PHARMA P/S ADR (VRNA) and Ligand Pharmaceuticals Inc. (LGND): Presenting new subgroup analysis from Phase 2b trials with nebulized ensifentrine in chronic obstructive pulmonary disease on Tuesday, September 8.
• Lyra Therapeutics Inc. (LYRA): Poster presentation for lead asset LYR-210 for the treatment of chronic rhinosinusitis.

IGCS Presentations:

• Sutro Biopharma Inc. (STRO): updated data from the Phase 1 study of STRO-002, its FRα-targeting antibody-drug conjugate, in ovarian cancer; The company will hold a conference call Wednesday to discuss the updated data.

MDS Virtual Congress Presentations:

• Neurocrine Biosciences, Inc. (NBIX): new Phase 3 data analyses of Ongentys capsules as an add-on therapy to levodopa/carbidopa in patients with Parkinson's disease experiencing motor "off" episode, and new Phase Ib data of an investigational gene therapy, NBIb-1817, in advanced Parkinson's disease.
• Voyager Therapeutics Inc. (VYGR): Presenting 24-month results from the PD-1102 trial evaluating its investigational gene therapy VY-AADC in advanced Parkinson's disease on Friday, September 11.

Earnings

• Applied Genetic Technologies (Wednesday, before the market open).
• MEI Pharma Inc. (MEIP) (Wednesday, after the close).

IPO Quiet Period Expiry

• CureVac BV (CVAC).