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Biotech week ahead, Sept. 8

September 6, 2020

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 5.7% 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

PDUFA Dates

The FDA is set to rule on Mallinckrodt PLC’s MNK 4.95% NDA for terlipressin that is being evaluated for treating hepatorenal syndrome type 1. (Saturday)

Clinical Readouts/Presentations

Standalone Releases:

Applied Genetic Technologies Corp AGTC 0.69% 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 0.56% 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 0.07% 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 0.94%: 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 2.09% and Ligand Pharmaceuticals Inc. LGND 0.34%: new subgroup analysis from Phase 2b trials with nebulized ensifentrine in chronic obstructive pulmonary disease. (Tuesday)

Lyra Therapeutics Inc LYRA 4.89%: Poster presentation for lead asset LYR-210 for the treatment of chronic rhinosinusitis.

IGCS Presentations:

Sutro Biopharma IncSTRO 3.54%: 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 0.64%: 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 2.89%: 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 1.6% (Wednesday after the close)

IPO Quiet Period Expiry

CureVac BV CVAC 11.47%

https://www.benzinga.com/general/biotech/20/09/17389314/the-week-ahead-in-biotech-focus-on-mallinckrodt-fda-decision-conference-presentations

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