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Biotech Stock Roundup: MRNA's Q4 Results, RAPT Down on Study Results & Other Updates
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Earnings updates continue to be in focus in the biotech sector as we move through the last leg of the earnings cycle. Concurrently, pipeline and regulatory updates continue to be in the spotlight as well.
Recap of the Week’s Most Important Stories:
Moderna’s Q4 Earnings: Moderna (MRNA - Free Report) reported earnings of 55 cents per share in the fourth quarter of 2023, which beat the Zacks Consensus Estimate of a loss of 78 cents per share. Revenues of $2.8 billion beat the Zacks Consensus Estimate of $2.5 billion. Revenues primarily comprise COVID-19 Vaccine Spikevax sales. Moderna reaffirmed its product sales guidance of approximately $4 billion for 2024.
Moderna continues to expect initial regulatory approvals for its RSV vaccine (mRNA-1345), starting in the first half of 2024.
RAPT Crashes on Study Failure: RAPT Therapeutics, Inc. (RAPT - Free Report) announced that the FDA notified that a clinical hold has been placed on the company’s phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and phase IIa trial in asthma. Shares of this clinical-stage, immunology-based biopharmaceutical company crashed on the news. While the FDA informed RAPT verbally, the latter is yet to receive a formal clinical hold letter from the agency.
The hold was placed due to a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but has been characterized as potentially related to zelnecirnon. Dosing of zelnecirnon has been halted in both clinical trials. Enrollment of new trial participants has also been paused. The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.
Per the company, approximately 350 patients have been enrolled across three clinical studies evaluating zelnecirnon — the two phase II trials and an earlier phase Ia/Ib study. No evidence of liver toxicity has been observed with any other trial participant. Additionally, no evidence of liver toxicity was observed in nonclinical studies.
IOVA Surges on Drug Approval: Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) surged after the company obtained FDA-granted accelerated approval to lifileucel suspension for intravenous infusion under the brand name Amtagvi.
Lifileucel is a tumor-derived autologous T cell immunotherapy, indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
The FDA’s accelerated approval was based on safety and efficacy data from the phase II C-144-01 study, which evaluated Amtagvi in patients with advanced melanoma, previously treated with anti-PD-1 therapy and targeted therapy. Treatment with Amtagvi led to deep and durable responses in the given patient population. The accelerated nod from the regulatory body was based on the overall response rate and duration of response. Iovance is evaluating Amtagvi in frontline advanced melanoma in the phase III confirmatory study, TILVANCE-301, as well as additional solid tumor types.
Sarepta Up on Regulatory Update: Sarepta Therapeutics’ (SRPT - Free Report) shares rose after the FDA accepted its efficacy supplement to the biologics license application (BLA), seeking to expand the treatment label for its Duchenne muscular dystrophy (DMD) drug, Elevidys. The FDA has assigned the Priority Review status to the company’s Elevidys filing with a review goal date of Jun 21, 2024.
Elevidys was initially approved by the FDA in June 2023 under the accelerated pathway to treat ambulatory pediatric patients aged between four and five years with DMD.
The efficacy supplement seeks to expand the labeled indication for Elevidys to treat all DMD patients, irrespective of age and ambulation status. Subject to approval, it will also convert the Elevidys accelerated approval to a traditional approval.
Sarepta also reported that the regulatory body has confirmed that it will not hold any advisory committee meeting to discuss the efficacy supplement to the Elevidys BLA.
Regeneron’s Myeloma Drug Gets Priority Review: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that its biologics license application (BLA), seeking approval of linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies has been accepted by the FDA. The regulatory body has granted Priority Review to the same with a target action date of Aug 22, 2024.
The BLA is supported by data from a phase I/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM.
The linvoseltamab clinical development program includes a phase III confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a phase I/II study in the first-line setting, a phase II trial in high-risk smoldering MM and a phase II trial in monoclonal gammopathy of undetermined significance. A phase I study of linvoseltamab, in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM, is also planned.
Image: Bigstock
Biotech Stock Roundup: MRNA's Q4 Results, RAPT Down on Study Results & Other Updates
Earnings updates continue to be in focus in the biotech sector as we move through the last leg of the earnings cycle. Concurrently, pipeline and regulatory updates continue to be in the spotlight as well.
Recap of the Week’s Most Important Stories:
Moderna’s Q4 Earnings: Moderna (MRNA - Free Report) reported earnings of 55 cents per share in the fourth quarter of 2023, which beat the Zacks Consensus Estimate of a loss of 78 cents per share. Revenues of $2.8 billion beat the Zacks Consensus Estimate of $2.5 billion. Revenues primarily comprise COVID-19 Vaccine Spikevax sales. Moderna reaffirmed its product sales guidance of approximately $4 billion for 2024.
Moderna continues to expect initial regulatory approvals for its RSV vaccine (mRNA-1345), starting in the first half of 2024.
RAPT Crashes on Study Failure: RAPT Therapeutics, Inc. (RAPT - Free Report) announced that the FDA notified that a clinical hold has been placed on the company’s phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and phase IIa trial in asthma. Shares of this clinical-stage, immunology-based biopharmaceutical company crashed on the news. While the FDA informed RAPT verbally, the latter is yet to receive a formal clinical hold letter from the agency.
The hold was placed due to a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but has been characterized as potentially related to zelnecirnon. Dosing of zelnecirnon has been halted in both clinical trials. Enrollment of new trial participants has also been paused. The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.
Per the company, approximately 350 patients have been enrolled across three clinical studies evaluating zelnecirnon — the two phase II trials and an earlier phase Ia/Ib study. No evidence of liver toxicity has been observed with any other trial participant. Additionally, no evidence of liver toxicity was observed in nonclinical studies.
IOVA Surges on Drug Approval: Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) surged after the company obtained FDA-granted accelerated approval to lifileucel suspension for intravenous infusion under the brand name Amtagvi.
Lifileucel is a tumor-derived autologous T cell immunotherapy, indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
The FDA’s accelerated approval was based on safety and efficacy data from the phase II C-144-01 study, which evaluated Amtagvi in patients with advanced melanoma, previously treated with anti-PD-1 therapy and targeted therapy. Treatment with Amtagvi led to deep and durable responses in the given patient population. The accelerated nod from the regulatory body was based on the overall response rate and duration of response. Iovance is evaluating Amtagvi in frontline advanced melanoma in the phase III confirmatory study, TILVANCE-301, as well as additional solid tumor types.
IOVA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Up on Regulatory Update: Sarepta Therapeutics’ (SRPT - Free Report) shares rose after the FDA accepted its efficacy supplement to the biologics license application (BLA), seeking to expand the treatment label for its Duchenne muscular dystrophy (DMD) drug, Elevidys. The FDA has assigned the Priority Review status to the company’s Elevidys filing with a review goal date of Jun 21, 2024.
Elevidys was initially approved by the FDA in June 2023 under the accelerated pathway to treat ambulatory pediatric patients aged between four and five years with DMD.
The efficacy supplement seeks to expand the labeled indication for Elevidys to treat all DMD patients, irrespective of age and ambulation status. Subject to approval, it will also convert the Elevidys accelerated approval to a traditional approval.
Sarepta also reported that the regulatory body has confirmed that it will not hold any advisory committee meeting to discuss the efficacy supplement to the Elevidys BLA.
Regeneron’s Myeloma Drug Gets Priority Review: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that its biologics license application (BLA), seeking approval of linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies has been accepted by the FDA. The regulatory body has granted Priority Review to the same with a target action date of Aug 22, 2024.
The BLA is supported by data from a phase I/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM.
The linvoseltamab clinical development program includes a phase III confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a phase I/II study in the first-line setting, a phase II trial in high-risk smoldering MM and a phase II trial in monoclonal gammopathy of undetermined significance. A phase I study of linvoseltamab, in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM, is also planned.
Performance
The Nasdaq Biotechnology Index has gained 0.73% in the past four trading sessions. Among the biotech giants, Incyte has gained 4.21% during the period. Over the past six months, shares of GSK have surged 22.6%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB’s Q4 Results, CBAY Up on GILD’s Acquisition & Other Updates)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.