The Week Ahead In Biotech: Focus On Mallinckrodt FDA Decision, Conference Presentations

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).