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

 

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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 (GTHX)'s 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.

Earnings

Monday, Feb. 15:

• Medpace Holdings Inc (MEDP).

Tuesday, Feb. 16:

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

Wednesday, Feb. 17:

• 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, Feb. 18:

• 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).