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, and 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:

Conferences

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

PDUFA Dates

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 is a fixed-dosing regimen.

Related Link: 2 Natural-Killer Cell Therapy Oncology Companies Investors Should Watch

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: 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 (Thursday, 4-4:10 pm) & results of the BAYOU Phase 2 trial evaluating the combination of Lynparza and Imfinzi in unresectable, Stage IV bladder cancer (Friday, 5:42 pm – 5:52 pm)

ECCO Congress Presentations

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

Earnings

The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule

Monday

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

Tuesday

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

Wednesday

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

Thursday

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

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates