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Biotech Stock Roundup: NERV, RLMD Down on Updates, MRNA, NVAX's News & More
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It was a busy week for the volatile biotech sector, with important regulatory and pipeline updates from several companies. COVID-19 vaccine updates are back in the spotlight, with the winter season around the corner.
Recap of the Week’s Most Important Stories:
NERV Down on Regulatory Update: Shares of Minerva Neurosciences, Inc. (NERV - Free Report) were down after the company announced the receipt of a refusal to file letter from the FDA regarding the company’s new drug application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. Minerva is seeking approval for the 64 mg dose of roluperidone. The regulatory body has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter. The delay in NDA acceptance will lead to a postponement in potential approval, and hence investors were clearly disappointed. The NDA was submitted in August 2022 and was supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (Studies MIN-101C03 and MIN-101C07).
Regulatory Update From Biogen: Biogen (BIIB - Free Report) announced that the FDA extended the review period for its new drug application (NDA) seeking approval for antisense drug tofersen in patients with amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutation. The agency accepted the tofersen NDA in July 2022 under the accelerated pathway and granted priority review with a target action date of January 2023. Following the extension in the NDA review, the new target action date is Apr 25, 2023. Biogen had submitted responses to information requests by the FDA as part of the ongoing review, which the latter considered a major amendment to the application, and hence the extension.
Vaccine Updates From Moderna: Moderna (MRNA - Free Report) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommended approving the use of a 50-µg booster dose of its mRNA-based bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 12 years of age and older. This Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (original vaccine) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5).
The CHMP recommendation is supported by data based on preclinical studies conducted on mRNA-1273.222 and data from the phase II/III study, which evaluated mRNA-1273.214, another bivalent candidate developed by Moderna to target the Omicron BA.1 subvariant. mRNA-1273.214 was authorized by European Commission last month for use in individuals aged 12 years and above.
EUA for Novavax Booster: Novavax, Inc. (NVAX - Free Report) announced that the FDA has granted emergency use authorization (EUA) to Adjuvanted (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older. Consequently, Novavax’s COVID-19 vaccine can now be administered as a booster dose, irrespective of whether or not the primary vaccine regimen series was completed with NVX-CoV2373. The EUA allows the vaccine to be administered to adults who are not suited to receiving an mRNA-based bivalent or those adults who want to be administered with Novavax’s vaccine. The EUA was granted based on data from the phase III Prevent-19 clinical study and from the U.K.-sponsored COV-BOOST trial.
Relmada Tanks on Study Failure: Shares of Relmada Therapeutics, Inc. (RLMD - Free Report) plunged after the company announced that its RELIANCE III evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD) failed. The study did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on day 28. While the REL-1017 treatment arm achieved a MADRS reduction of 14.8 points, the placebo arm achieved a reduction of 13.9 points. Relmada also reported paradoxical results in certain sites where the study was conducted. In these sites, the placebo arm outperformed the REL-1017 treatment arm. The company is currently evaluating the results.
Performance
The Nasdaq Biotechnology Index lost 0.85% in the past five trading sessions. Among the biotech giants, Biogen has gained 4.25% during the period. Over the past six months, shares of Biogen have soared 18.58%. (See the last biotech stock roundup here: Biotech Stock Roundup: DICE Up on Study Data, GILD, BIIBs Updates & More)
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What's Next in Biotech?
Stay tuned for other updates.
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Biotech Stock Roundup: NERV, RLMD Down on Updates, MRNA, NVAX's News & More
It was a busy week for the volatile biotech sector, with important regulatory and pipeline updates from several companies. COVID-19 vaccine updates are back in the spotlight, with the winter season around the corner.
Recap of the Week’s Most Important Stories:
NERV Down on Regulatory Update: Shares of Minerva Neurosciences, Inc. (NERV - Free Report) were down after the company announced the receipt of a refusal to file letter from the FDA regarding the company’s new drug application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. Minerva is seeking approval for the 64 mg dose of roluperidone. The regulatory body has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter. The delay in NDA acceptance will lead to a postponement in potential approval, and hence investors were clearly disappointed. The NDA was submitted in August 2022 and was supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (Studies MIN-101C03 and MIN-101C07).
Regulatory Update From Biogen: Biogen (BIIB - Free Report) announced that the FDA extended the review period for its new drug application (NDA) seeking approval for antisense drug tofersen in patients with amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutation. The agency accepted the tofersen NDA in July 2022 under the accelerated pathway and granted priority review with a target action date of January 2023. Following the extension in the NDA review, the new target action date is Apr 25, 2023. Biogen had submitted responses to information requests by the FDA as part of the ongoing review, which the latter considered a major amendment to the application, and hence the extension.
Vaccine Updates From Moderna: Moderna (MRNA - Free Report) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommended approving the use of a 50-µg booster dose of its mRNA-based bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 12 years of age and older. This Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (original vaccine) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5).
The CHMP recommendation is supported by data based on preclinical studies conducted on mRNA-1273.222 and data from the phase II/III study, which evaluated mRNA-1273.214, another bivalent candidate developed by Moderna to target the Omicron BA.1 subvariant. mRNA-1273.214 was authorized by European Commission last month for use in individuals aged 12 years and above.
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
EUA for Novavax Booster: Novavax, Inc. (NVAX - Free Report) announced that the FDA has granted emergency use authorization (EUA) to Adjuvanted (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older. Consequently, Novavax’s COVID-19 vaccine can now be administered as a booster dose, irrespective of whether or not the primary vaccine regimen series was completed with NVX-CoV2373. The EUA allows the vaccine to be administered to adults who are not suited to receiving an mRNA-based bivalent or those adults who want to be administered with Novavax’s vaccine. The EUA was granted based on data from the phase III Prevent-19 clinical study and from the U.K.-sponsored COV-BOOST trial.
Relmada Tanks on Study Failure: Shares of Relmada Therapeutics, Inc. (RLMD - Free Report) plunged after the company announced that its RELIANCE III evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD) failed. The study did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on day 28. While the REL-1017 treatment arm achieved a MADRS reduction of 14.8 points, the placebo arm achieved a reduction of 13.9 points. Relmada also reported paradoxical results in certain sites where the study was conducted. In these sites, the placebo arm outperformed the REL-1017 treatment arm. The company is currently evaluating the results.
Performance
The Nasdaq Biotechnology Index lost 0.85% in the past five trading sessions. Among the biotech giants, Biogen has gained 4.25% during the period. Over the past six months, shares of Biogen have soared 18.58%. (See the last biotech stock roundup here: Biotech Stock Roundup: DICE Up on Study Data, GILD, BIIBs Updates & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.