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Biotech Stock Roundup: VRTX Q4 Earnings, GILD, INCYs Regulatory Updates & More

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The biotech sector has been in focus over the past week as bigwig Vertex VRTX came out with Q4 earnings. Also, pipeline and regulatory updates grabbed the spotlight in the sector.

Recap of the Week’s Most Important Stories:

Q4 Results From Vertex: Vertex kick-started fourth-quarter earnings in the biotech sector. The company reported adjusted earnings per share of $3.37, which comfortably beat the Zacks Consensus Estimate of $3.28. Earnings rose 34% year over year. Revenues in the quarter came in $2.07 billion, which surpassed the Zacks Consensus Estimate of $2 billion. Strong cystic fibrosis (CF) product revenues led to higher earnings in the reported quarter. Total product revenues rose 27% year over year, primarily driven by the strong launches of Kaftrio in Europe and the performance of Trikafta in the United States. The company expects total revenues from CF products in the range of $8.4-$8.6 billion for 2022.

Vertex currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Regulatory Updates From Gilead: Gilead Sciences, Inc. GILD announced that the FDA has approved the label expansion of antiviral treatment Veklury (remdesivir) for COVID-19. The regulatory body has granted expedited approval to a supplemental new drug application (sNDA) for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression. The phase III PINETREE study results were the basis of label expansion of Veklury, pediatric EUA expansion and recently updated National Institutes of Health Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings.

Gilead also announced that the FDA has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine. The combination is being evaluated in various studies across a range of indications. The studies impacted by this partial clinical hold include phase III ENHANCE study in myelodysplastic syndrome (MDS), phase III ENHANCE-2 study in acute myeloid leukemia (AML), phase III ENHANCE-3 study in unfit AML, phase Ib study in MDS and phase II study in myeloid malignancies. The hold was placed due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms.