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

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Shanthi Rexaline
·2 min read
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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 (NASDAQ: REGN) received two FDA approvals during the week. Immunotherapy Libtayo, which the company co-developed with Sanofi SA (NASDAQ: 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 (NASDAQ: OCGN) and Kalvista Pharmaceuticals Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: MEDP)

Tuesday

View more earnings on IBB

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

Wednesday

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

Thursday

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

Related Link: Novavax Shares Pass The 0 Mark: Is The Rally Sustainable?

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