The Week Ahead In Biotech (Feb. 13-19): Agios FDA Meeting, Avenue Adcom, Earnings And More

The Week Ahead In Biotech Feb. 13-19: Agios FDA Meeting, Avenue Adcom, Earnings And More

Biotech stocks moved back and forth amid some volatility before finishing the week ending Feb. 11 modestly lower, reversing the gains from the previous week. Earnings news flow continued to dominate proceedings, although the week also witnessed presentations at conferences and a couple of initial public offerings.

Pfizer, Inc.'s (PFE) fourth-quarter topline growth trailed expectations, exerting downward pressure on the stock. Modular Medical, Inc. (MODD) and TC BioPharm (Holdings) plc American Depositary Shares (TCBP) debuted on Wall Street following their IPOs.

Novavax, Inc. (NVAX) came under pressure midweek after a report suggested that the company is lagging very much behind its COVID-19 delivery commitments.

Here are the key catalysts that can move stocks in the biotech space in the coming week.


  • SVB Leerink Global Healthcare Conference (virtual event): Feb. 14-18.
  • 17th Congress Of European Crohn's and Colitis Organization, or ECCO (virtual event): Feb. 16-19.
  • ASCO Genitourinary Cancers Symposium (hybrid event): Feb. 17-19, in Moscone Center, San Francisco, California, and online.


The Food and Drug Administration is scheduled to rule on Agios Pharmaceuticals, Inc.'s (AGIO) new drug application for mitapivat, its most advanced drug candidate, as a treatment option for pyruvate kinase deficiency. PKD is a rare, inherited disease that presents as chronic hemolytic anemia, which is the accelerated destruction of red blood cells.

Adcom Calendar

A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Avenue Therapeutics, Inc.'s (ATXI) NDA for tramadol hydrochloride injections for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting.

The issues for the committees to discuss include the clinical relevance of tramadol hydrochloride injections, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing being a fixed-dosing regimen.

Clinical Readouts/Presentations

BioCardia, Inc. (BCDA) has a catalyst in the form of an announcement regarding the outcome of the Data Safety Monitoring Board review in the CardiAMP cell therapy heart failure trial in early February.

ASCO GU Symposium Presentations

AstraZeneca plc. (AZN) is to present results from the PROpel Phase 3 trial of Lynparza plus abiraterone, which showed the combination significantly delayed disease progression in 1st-line metastatic castration-resistant prostate cancer regardless of biomarker status, on Thursday, 4:00 p.m.-4:10 p.m. 

As well, AstraZeneca is to present results of the BAYOU Phase 2 trial evaluating the combination of Lynparza and Imfinzi in unresectable, Stage IV bladder cancer on Friday, 5:42 p.m.–5:52 p.m.

ECCO Congress Presentations

Galapagos NV (GLPG) & Gilead Sciences, Inc. (GILD) are to present new analyses from Phase 2/3 SELECTION and Phase 3 SELECTION long-term extension studies of Jyseleca (filgotinib) in ulcertative colitis.

Earnings - Monday

  • Aethlon Medical, Inc. (AEMD): Reporting after the market close.
  • Medpace Holdings, Inc. (MEDP): Reporting after the market close.


  • AtriCure, Inc. (ATRC): Reporting after the market close.
  • Pacific Biosciences of California, Inc. (PACB): Reporting after the market close.
  • Adaptive Biotechnologies Corporation (ADPT): Reporting after the market close.


  • Blueprint Medicines Corporation (BPMC): Reporting before the market open.
  • Alkermes plc (ALKS): Reporting before the market open.
  • 10x Genomics, Inc. (TXG): Reporting after the market close.


  • West Pharmaceutical Services, Inc. (WST): Reporting before the market open.
  • Insmed Incorporated (INSM): Reporting before the market open.
  • Repligen Corporation (RGEN): Reporting before the market open.
  • T2 Biosystems, Inc. (TTOO): Reporting after the market close.
  • Quidel Corporation (QDEL): Reporting after the market close.
  • Coherus BioSciences, Inc. (CHRS): Reporting after the market close.
  • Prothena Corporation plc (PRTA): Reporting after the market close.
  • Globus Medical, Inc. (GMED): Reporting after the market close.
  • Ligand Pharmaceuticals Incorporated (LGND): Reporting after the market close.
  • Ironwood Pharmaceuticals, Inc. (IRWD): Reporting after the market close.

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