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

After remaining steady in the first three sessions of the week ended Sept. 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: Sept. 8-11
• Wells Fargo 2020 Virtual Healthcare Conference: Sept. 9-10
• Baird 2020 Global Healthcare Conference: Sept. 9-10
• BTIG Virtual Biotechnology Conference: Sept. 10-11
• 66th Annual Meeting of the American Rhinologic Society, or ARS, (virtual event): Sept. 10-12
• International Gynecologic Cancer Society, or IGCS, xDigital Annual Global Meeting: Sept. 10-13
• 2020 Psych Congress (virtual event): Sept. 10-13
• MDS Virtual Congress 2020: September 12–16
• MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting: Sept. 11-13

See Also: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

PDUFA Dates

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

Clinical Readouts/Presentations

Standalone Releases:

Applied Genetic Technologies Corp AGTC said it will present an update 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. (Wednesday)

MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting Presentations:

Johnson & Johnson's JNJ 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's RHHBY 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: New 12-month data from all four cohorts in the Phase 1a study of ATA188 for the treatment of progressive forms of multiple sclerosis. (Friday)

ARS Meeting Presentations:

VERONA PHARMA P/S ADR VRNA and Ligand Pharmaceuticals Inc. LGND: new subgroup analysis from Phase 2b trials with nebulized ensifentrine in chronic obstructive pulmonary disease. (Tuesday)

Lyra Therapeutics Inc LYRA: Poster presentation for lead asset LYR-210 for the treatment of chronic rhinosinusitis.

IGCS Presentations:

Sutro Biopharma IncSTRO: 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: 24-month results from the PD-1102 trial evaluating its investigational gene therapy VY-AADC in advanced Parkinson's disease. (Friday)

Earnings

Applied Genetic Technologies (Wednesday before the market open)

MEI Pharma Inc MEIP (Wednesday after the close)

IPO Quiet Period Expiry

CureVac BV CVAC