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Fourth-quarter results continue to be in the spotlight in the biotech sector. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Moderna’s Q4 Earnings: Shares of Moderna (MRNA - Free Report) were down after the company reported fourth-quarter results. Earnings of $3.61 per share missed Zacks Consensus Estimate and our model estimates of $4.66 and $4.48, respectively. Earnings declined year over year due to lower revenues and higher operating expenses. Revenues in the quarter were $5.08 billion, which also missed the Zacks Consensus Estimate of $5.09 billion. Total revenues were down 29.5% year over year due to declining COVID-19 vaccine sales during the quarter.
Moderna reiterated its product revenue guidance for 2023. Management expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals.
Updates From Regeneron: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi obtained FDA approval for Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. It was earlier approved for moderately to severely active rheumatoid arthritis (RA).
Regeneron also announced the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for Libtayo (cemiplimab) in combination with platinum-based chemotherapy for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients with no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
Regeneron’s biologics license application (BLA) seeking FDA approval for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy has also been accepted for Priority Review by the agency.The FDA target action date is Jun 27, 2023, following the use of a priority review voucher.
Incyte’s Opzelura Gets Positive CHMP Opinion: Incyte (INCY - Free Report) announced that EMA’s CHMP has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. The CHMP recommendation was based on two pivotal phase III trials (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of ruxolitinib cream versus vehicle (non-medicated cream). Data showed treatment with ruxolitinib cream improved facial and total body repigmentation.
Setback for Cytokinetics: Cytokinetics, Incorporated (CYTK - Free Report) received a Complete Response Letter (CRL) from the FDA regarding the new drug application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF). The regulatory body stated that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations. In addition, the FDA stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks.
Performance
The Nasdaq Biotechnology Index has lost 1.76% in the past five trading sessions. Among the biotech giants, Moderna has lost 13.29% during the period. Over the past six months, shares of Biogen have soared 36.91%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Q4 Results, EBS and BPMC Offer Updates)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.
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Biotech Stock Roundup: MRNA Q4 Earnings, REGN's Updates, CYTK Receives Setback
Fourth-quarter results continue to be in the spotlight in the biotech sector. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Moderna’s Q4 Earnings: Shares of Moderna (MRNA - Free Report) were down after the company reported fourth-quarter results. Earnings of $3.61 per share missed Zacks Consensus Estimate and our model estimates of $4.66 and $4.48, respectively. Earnings declined year over year due to lower revenues and higher operating expenses. Revenues in the quarter were $5.08 billion, which also missed the Zacks Consensus Estimate of $5.09 billion. Total revenues were down 29.5% year over year due to declining COVID-19 vaccine sales during the quarter.
Moderna reiterated its product revenue guidance for 2023. Management expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals.
Updates From Regeneron: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi obtained FDA approval for Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. It was earlier approved for moderately to severely active rheumatoid arthritis (RA).
Regeneron also announced the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for Libtayo (cemiplimab) in combination with platinum-based chemotherapy for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients with no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
Regeneron’s biologics license application (BLA) seeking FDA approval for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy has also been accepted for Priority Review by the agency.The FDA target action date is Jun 27, 2023, following the use of a priority review voucher.
Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Incyte’s Opzelura Gets Positive CHMP Opinion: Incyte (INCY - Free Report) announced that EMA’s CHMP has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. The CHMP recommendation was based on two pivotal phase III trials (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of ruxolitinib cream versus vehicle (non-medicated cream). Data showed treatment with ruxolitinib cream improved facial and total body repigmentation.
Setback for Cytokinetics: Cytokinetics, Incorporated (CYTK - Free Report) received a Complete Response Letter (CRL) from the FDA regarding the new drug application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF). The regulatory body stated that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations. In addition, the FDA stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks.
Performance
The Nasdaq Biotechnology Index has lost 1.76% in the past five trading sessions. Among the biotech giants, Moderna has lost 13.29% during the period. Over the past six months, shares of Biogen have soared 36.91%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Q4 Results, EBS and BPMC Offer Updates)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.