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Biotech Stock Roundup: REGN, SAGE, NMRA Down on Updates, ITCI Gains on Study Success
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It was a busy week in the biotech sector with lots of important regulatory and pipeline updates. Among these, biotech giant Regeneron (REGN - Free Report) was in the news on a complaint alleging fraudulent drug pricing practices related to its lead drug, Eylea. Sage Therapeutics (SAGE - Free Report) took a beating on the failure of its Parkinson's Disease study, while Intra-Cellular Therapies, Inc (ITCI - Free Report) surged on positive study data.
Recap of the Week’s Most Important Stories:
Lawsuit Against Regeneron: Shares of Regenerontumbled following a complaint filed by the U.S. Department of Justice against the company, alleging fraudulent drug pricing practices related to its lead drug, Eylea. The Department filed a complaint under the False Claims Act (FCA) against Regeneron, which manufactures and sells the ophthalmology drug, Eylea. The complaint alleged that Regeneron fraudulently raised Medicare reimbursement rates for its leading drug, Eylea, by knowingly submitting false average sales price reports to the Centers for Medicare and Medicaid Services, excluding certain price concessions.
Regeneron allegedly manipulated Medicare’s drug pricing process by knowingly failing to report its payment of credit card processing fees as price concessions to its customers. Per the complaint, Regeneron paid these credit card fees so that distributors would accept credit cards for Eylea's purchases and simultaneously charge a lower cash price for the drug.
Per the complaint, Regeneron significantly inflated the cost of its drug to Medicare over many years by resorting to these fraudulent practices and, in turn, boosted its revenues. As a result, the higher average sales price cost the Medicare system hundreds of millions of dollars.
These practices likely enabled Eylea to become the market leader in this space and seize market share from its competitors. If Regeneron is found guilty, the government would be eligible to recover three times the amount of its losses from the company plus fines under the FCA. In response, Regeneron stated that it would defend itself against the lawsuit.
ITCI Up on Study Data: Intra-Cellular Therapies announced positive top-line results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Its shares hit a new 52-week high on the success of the study.
Results showed that lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints. Lumateperone 42 mg met the primary endpoint of change from the baseline at week six on the Montgomery-Åsberg Depression Rating Scale total score versus placebo.
ITCI also reported that the key secondary endpoint was achieved by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale score, which is a measure of severity of illness compared with placebo at week six.
Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
Additionally, feedback from MDD patients, as measured by the Quick Inventory of Depressive Symptomatology Self Report, demonstrated that lumateperone 42 mg robustly improved depressive symptoms. Lumateperone was generally safe and well-tolerated in this study.
Lumateperone 42 mg is approved in the United States under the brand name, Caplyta, for the treatment of schizophrenia in adults. Later in 2021, Caplyta’s label was expanded to treat depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
SAGE Down on Study Results: Shares of Sage Therapeutics lost 20% after the company announced top-line results from the phase II PRECEDENT study. This double-blind, placebo-controlled study evaluated investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD). The study is designed to evaluate the safety and efficacy of dalzanemdor dosed over six weeks. The study failed to achieve its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor as compared to placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42.
The candidate was generally well-tolerated and did not exhibit any new safety signal. A total of 48 participants experienced treatment emergent adverse events, which were mild to moderate in severity. Further analysis did not suggest any meaningful difference versus placebo in the other exploratory endpoints, such as SCOPA-Cog. Consequently, SAGE does not plan any further development of dalzanemdor in PD.
Setback for Neumora: Neumora Therapeutics, Inc. (NMRA - Free Report) announced that the FDA has placed a clinical hold on the phase I study on NMRA-266. The study evaluated NMRA-266, a positive allosteric modulator (PAM) of the M4 muscarinic receptor, for treating some types of neuropsychiatric disorders. The regulatory body placed the clinical hold after pre-clinical data showed convulsions in rabbits following treatment with NMRA-266. NMRA’s shares were down on the setback.
Following the FDA’s clinical hold, the phase I single ascending dose/multiple ascending dose study investigating NMRA-266 has been paused. However, around 30 participants who were already dosed in the above-mentioned early-stage study have not experienced any evidence of convulsions as of now. Neumora is currently working closely with the FDA to resolve the clinical hold.
Regulatory Update From GSK: GSK plc (GSK - Free Report) announced that the FDA has accepted its biologics license application (BLA), seeking approval for its 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY. The regulatory body granted a standard review to the BLA and a decision is expected on Feb 14, 2025.
The MenABCWY vaccine candidate combines the antigenic components of GSK’s two popular licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The MenABCWY combination targets the five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which are primarily responsible for the most invasive meningococcal disease cases globally. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections compared to current FDA-approved meningitis vaccines. This is because it has been designed to protect against all five vaccine-preventable serogroups with one combined product.
GSK also announced positive results from the EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior to the leading combination treatment.
Performance
The Nasdaq Biotechnology Index has lost 5.39% in the past five trading sessions and Moderna’s shares have risen 7.31% during the same time frame. Over the past six months, shares of MRNA have risen 19.82%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA Up on Vaccine Data, BMYs Updates & More News)
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What's Next in Biotech?
Stay tuned for pipeline updates.
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Biotech Stock Roundup: REGN, SAGE, NMRA Down on Updates, ITCI Gains on Study Success
It was a busy week in the biotech sector with lots of important regulatory and pipeline updates. Among these, biotech giant Regeneron (REGN - Free Report) was in the news on a complaint alleging fraudulent drug pricing practices related to its lead drug, Eylea. Sage Therapeutics (SAGE - Free Report) took a beating on the failure of its Parkinson's Disease study, while Intra-Cellular Therapies, Inc (ITCI - Free Report) surged on positive study data.
Recap of the Week’s Most Important Stories:
Lawsuit Against Regeneron: Shares of Regeneron tumbled following a complaint filed by the U.S. Department of Justice against the company, alleging fraudulent drug pricing practices related to its lead drug, Eylea. The Department filed a complaint under the False Claims Act (FCA) against Regeneron, which manufactures and sells the ophthalmology drug, Eylea. The complaint alleged that Regeneron fraudulently raised Medicare reimbursement rates for its leading drug, Eylea, by knowingly submitting false average sales price reports to the Centers for Medicare and Medicaid Services, excluding certain price concessions.
Regeneron allegedly manipulated Medicare’s drug pricing process by knowingly failing to report its payment of credit card processing fees as price concessions to its customers. Per the complaint, Regeneron paid these credit card fees so that distributors would accept credit cards for Eylea's purchases and simultaneously charge a lower cash price for the drug.
Per the complaint, Regeneron significantly inflated the cost of its drug to Medicare over many years by resorting to these fraudulent practices and, in turn, boosted its revenues. As a result, the higher average sales price cost the Medicare system hundreds of millions of dollars.
These practices likely enabled Eylea to become the market leader in this space and seize market share from its competitors. If Regeneron is found guilty, the government would be eligible to recover three times the amount of its losses from the company plus fines under the FCA. In response, Regeneron stated that it would defend itself against the lawsuit.
ITCI Up on Study Data: Intra-Cellular Therapies announced positive top-line results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Its shares hit a new 52-week high on the success of the study.
Results showed that lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints. Lumateperone 42 mg met the primary endpoint of change from the baseline at week six on the Montgomery-Åsberg Depression Rating Scale total score versus placebo.
ITCI also reported that the key secondary endpoint was achieved by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale score, which is a measure of severity of illness compared with placebo at week six.
Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
Additionally, feedback from MDD patients, as measured by the Quick Inventory of Depressive Symptomatology Self Report, demonstrated that lumateperone 42 mg robustly improved depressive symptoms. Lumateperone was generally safe and well-tolerated in this study.
Lumateperone 42 mg is approved in the United States under the brand name, Caplyta, for the treatment of schizophrenia in adults. Later in 2021, Caplyta’s label was expanded to treat depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
SAGE Down on Study Results: Shares of Sage Therapeutics lost 20% after the company announced top-line results from the phase II PRECEDENT study. This double-blind, placebo-controlled study evaluated investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD). The study is designed to evaluate the safety and efficacy of dalzanemdor dosed over six weeks. The study failed to achieve its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor as compared to placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42.
The candidate was generally well-tolerated and did not exhibit any new safety signal. A total of 48 participants experienced treatment emergent adverse events, which were mild to moderate in severity. Further analysis did not suggest any meaningful difference versus placebo in the other exploratory endpoints, such as SCOPA-Cog. Consequently, SAGE does not plan any further development of dalzanemdor in PD.
Setback for Neumora: Neumora Therapeutics, Inc. (NMRA - Free Report) announced that the FDA has placed a clinical hold on the phase I study on NMRA-266. The study evaluated NMRA-266, a positive allosteric modulator (PAM) of the M4 muscarinic receptor, for treating some types of neuropsychiatric disorders. The regulatory body placed the clinical hold after pre-clinical data showed convulsions in rabbits following treatment with NMRA-266. NMRA’s shares were down on the setback.
Following the FDA’s clinical hold, the phase I single ascending dose/multiple ascending dose study investigating NMRA-266 has been paused. However, around 30 participants who were already dosed in the above-mentioned early-stage study have not experienced any evidence of convulsions as of now. Neumora is currently working closely with the FDA to resolve the clinical hold.
NMRA currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Update From GSK: GSK plc (GSK - Free Report) announced that the FDA has accepted its biologics license application (BLA), seeking approval for its 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY. The regulatory body granted a standard review to the BLA and a decision is expected on Feb 14, 2025.
The MenABCWY vaccine candidate combines the antigenic components of GSK’s two popular licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The MenABCWY combination targets the five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which are primarily responsible for the most invasive meningococcal disease cases globally. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections compared to current FDA-approved meningitis vaccines. This is because it has been designed to protect against all five vaccine-preventable serogroups with one combined product.
GSK also announced positive results from the EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior to the leading combination treatment.
Performance
The Nasdaq Biotechnology Index has lost 5.39% in the past five trading sessions and Moderna’s shares have risen 7.31% during the same time frame. Over the past six months, shares of MRNA have risen 19.82%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA Up on Vaccine Data, BMYs Updates & More News)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for pipeline updates.