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Biotech Stock Roundup: APLS, NVAX Gain on Updates, INCYs Regulatory News & More
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The biotech sector has been in the spotlight in the past week with important pipeline and regulatory updates before the second-quarter earnings kickstart.
Recap of the Week’s Most Important Stories:
Incyte’s Drug Gets FDA Nod for Another Indication: Incyte (INCY - Free Report) announced that the FDA has approved Opzelura (ruxolitinib) cream for another indication. The regulatory body approved Opzelura cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. The FDA approval was based on data from the phase III TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), which evaluated the safety and efficacy of Opzelura versus vehicle in more than 600 people with nonsegmental vitiligo, aged 12 and older. Opzelura was earlier approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Apellis Up on Regulatory Update: Apellis Pharmaceuticals, Inc. (APLS - Free Report) surged after it announced that the FDA has accepted and granted Priority Review designation for the new drug application (NDA) for pipeline candidate pegcetacoplan. The NDA is seeking approval of pegcetacoplan, an investigational, targeted C3 therapy, for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The regulatory body has set a target action date of Nov 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. The NDA was submitted based on results from the phase III DERBY and OAKS studies at 12 and 18 months and the phase II FILLY study at 12 months. Apellis plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.
Novavax Surges on CDC Endorsement: Novavax (NVAX - Free Report) shares gained after the company announced that the Centers for Disease Control and Prevention (“CDC”) has endorsed its protein-based COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a primary two-dose regimen for use in adults aged 18 years and older. The endorsement follows Advisory Committee on Immunization Practices’ (“ACIP”) recommendation of using Novavax’s vaccine in adults. The CDC establishes its vaccine recommendations and schedules based on advice from ACIP. Last week, Novavax was granted emergency use authorization (EUA) for its COVID-19 vaccine as a primary two-dose regimen for use in adults.
NexImmune Application Gets Clearance: NexImmune (NEXI - Free Report) announced that the FDA has given clearance to its investigational new drug (IND) application for NEXI-003. Following the IND clearance, NexImmune can initiate a study to evaluate NEXI-003 in patients with relapsed or refractory HPV-related cancers. Shares of this clinical-stage biotechnology company jumped 23.13% in aftermarket hours trading on Jul 14 after this announcement. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.
The phase I study will enroll patients at multiple clinical sites across the United States. The proposed study is a two-part, multicenter, open-label, dose-finding, first-in-human (FIH) study to characterize the safety and clinical activity of NEXI-003 in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers (with confirmed histopathology detection of HPV-16 and/or HPV-18 expression), who have received at least one prior regimen of standard therapy according to local standard of care guidance(s).
Performance
The Nasdaq Biotechnology Index has gained 0.57% in the past five trading sessions. Among the biotech giants, Incyte has gained 1.17% during the period. Over the past six months, shares of Vertex have surged 25.45%. (See the last biotech stock roundup here: Biotech Stock Roundup: ICPTs Study Data, NVAX Vaccine Gets EUA, VERU Up on Data)
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What's Next in Biotech?
Stay tuned for earnings and other updates.
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Biotech Stock Roundup: APLS, NVAX Gain on Updates, INCYs Regulatory News & More
The biotech sector has been in the spotlight in the past week with important pipeline and regulatory updates before the second-quarter earnings kickstart.
Recap of the Week’s Most Important Stories:
Incyte’s Drug Gets FDA Nod for Another Indication: Incyte (INCY - Free Report) announced that the FDA has approved Opzelura (ruxolitinib) cream for another indication. The regulatory body approved Opzelura cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. The FDA approval was based on data from the phase III TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), which evaluated the safety and efficacy of Opzelura versus vehicle in more than 600 people with nonsegmental vitiligo, aged 12 and older. Opzelura was earlier approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Incyte currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Apellis Up on Regulatory Update: Apellis Pharmaceuticals, Inc. (APLS - Free Report) surged after it announced that the FDA has accepted and granted Priority Review designation for the new drug application (NDA) for pipeline candidate pegcetacoplan. The NDA is seeking approval of pegcetacoplan, an investigational, targeted C3 therapy, for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The regulatory body has set a target action date of Nov 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. The NDA was submitted based on results from the phase III DERBY and OAKS studies at 12 and 18 months and the phase II FILLY study at 12 months. Apellis plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.
Novavax Surges on CDC Endorsement: Novavax (NVAX - Free Report) shares gained after the company announced that the Centers for Disease Control and Prevention (“CDC”) has endorsed its protein-based COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a primary two-dose regimen for use in adults aged 18 years and older. The endorsement follows Advisory Committee on Immunization Practices’ (“ACIP”) recommendation of using Novavax’s vaccine in adults. The CDC establishes its vaccine recommendations and schedules based on advice from ACIP. Last week, Novavax was granted emergency use authorization (EUA) for its COVID-19 vaccine as a primary two-dose regimen for use in adults.
NexImmune Application Gets Clearance: NexImmune (NEXI - Free Report) announced that the FDA has given clearance to its investigational new drug (IND) application for NEXI-003. Following the IND clearance, NexImmune can initiate a study to evaluate NEXI-003 in patients with relapsed or refractory HPV-related cancers. Shares of this clinical-stage biotechnology company jumped 23.13% in aftermarket hours trading on Jul 14 after this announcement. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.
The phase I study will enroll patients at multiple clinical sites across the United States. The proposed study is a two-part, multicenter, open-label, dose-finding, first-in-human (FIH) study to characterize the safety and clinical activity of NEXI-003 in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers (with confirmed histopathology detection of HPV-16 and/or HPV-18 expression), who have received at least one prior regimen of standard therapy according to local standard of care guidance(s).
Performance
The Nasdaq Biotechnology Index has gained 0.57% in the past five trading sessions. Among the biotech giants, Incyte has gained 1.17% during the period. Over the past six months, shares of Vertex have surged 25.45%. (See the last biotech stock roundup here: Biotech Stock Roundup: ICPTs Study Data, NVAX Vaccine Gets EUA, VERU Up on Data)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for earnings and other updates.