The Week Ahead In Biotech: FDA Decision On G1 Therapeutics, Earnings In The Mix For Light Calendar Week

Biotech stocks advanced in the week ended Feb. 12, thanks to broader market strength and company-specific catalysts. Small and mid-cap earnings, multiple conference presentations, data readouts and a slew of IPOs were all part of the week's news flow.

Regeneron Pharmaceuticals Inc REGN received two FDA approvals during the week. Immunotherapy Libtayo, which the company co-developed with Sanofi SA SNY, got a label expansion as a treatment option for basal cell carcinoma. Regeneron also received the nod for its Evkeeza, as an adjunctive treatment option for ultra-rare cholesterol disease.

Ocugen Inc OCGN and Kalvista Pharmaceuticals Inc KALV were among the best performing stocks of the week. The former moved on momentum gathered on the back of a U.S. COVID-19 vaccine deal with Bharat Biotech and the news of an offering priced at a premium. Kalvista gained on a positive data readout.

Conferences

BIO CEO & Investor Digital Conference: Feb. 16-18

PDUFA Dates

The FDA is set to rule on G1 Therapeutics Inc's GTHX new drug application for trilaciclib as a treatment option for mitigating the impact of chemotherapy in small-cell lung cancer. The PDUFA date by which the verdict has to be issued is Monday, Feb. 15.

Related Link: Pharma Stock Ideas: Why BMO Is Recommending Regeneron, Constellation

Earnings

Monday

Medpace Holdings Inc MEDP

Tuesday

Zoetis Inc ZTS (before the market open)
EXACT Sciences Corporation EXAS (after the market close)

Wednesday

Royalty Pharma plc RPRX (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
Blueprint Medicines Corp BPMC (before the market open)
10X Genomics Inc TXG (after the close)
Invitae Corp NVTA (after the close)
Globus Medical Inc GMED (after the close)
Shockwave Medical Inc SWAV (after the close)
Veracyte Inc VCYT (after the close)
Viking Therapeutics Inc VKTX (after the close)

Thursday

West Pharmaceutical Services Inc. WST (before the market open)
Syneos Health Inc SYNH (before the market open)
Avanos Medical Inc AVNS (before the market open)
Integra Lifesciences Holdings Corp IART (before the market open)
Emergent Biosolutions Inc EBS (after the close)
Quidel Corporation QDEL (after the close)
Opko Health Inc. OPK (after the close)

Related Link: Novavax Shares Pass The $300 Mark: Is The Rally Sustainable?