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Biotech Stock Roundup: GSK's Litigation Update, BIIB's Drug Approval & Other Updates
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It was a busy week for the biotech sector, with numerous data presentations by biotech companies at healthcare conferences. Regular pipeline news was also in the spotlight.
Recap of the Week’s Most Important Stories:
GSK Down on Zantac Litigation: GSK (GSK - Free Report) suffered a setback in the ongoing Zantac litigation. The company issued a statement disagreeing with the ruling by the Delaware State Court that allows the numerous lawsuits related to Zantac to move forward for jury trials. The lawsuits claim that the heartburn drug Zantac (ranitidine) causes cancer. The Delaware State Court’s decision also contradicts the Federal Court’s multidistrict litigation (MDL) ruling (in December 2022), which dismissed all cases alleging five cancer types.
In the MDL, plaintiffs identified five different types of cancers (liver, bladder, pancreatic, esophageal and stomach). The court dismissed all MDL cases alleging the five cancers. GSK stated that as per scientific consensus, there was no consistent or reliable evidence to show that ranitidine increases the risk of any cancer. GSK said that it will continue to vigorously defend itself against all claims.
The company also announced positive results from an interim analysis of the phase III DREAMM-8 head-to-head trial. The trial is evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone, compared to a combination of bortezomib and pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma, previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The patients had documented disease progression during or after their most recent therapy. Results showed statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival.
Biogen’s Drug Approval: Biogen (BIIB - Free Report) announced that the European Commission (EC) has granted marketing approval to Qalsody (tofersen) for treating patients with amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutation. The marketing authorization was granted to Qalsody under exceptional circumstances, wherein a treatment is deemed to have a positive benefit/risk assessment but gathering comprehensive data is difficult due to the rarity of the condition. The EC has also maintained an orphan designation for Qalsody.
The approval was based on data from the phase III VALOR study. It was expected as the Committee for Medicinal Products for Human Use (CHMP) of the EMA rendered a positive opinion recommending a marketing authorization under exceptional circumstances for Qalsody for SOD1-ALS in February. Biogen in-licensed rights to tofersen from Ionis Pharmaceuticals under a collaborative development and license agreement.
VIR Up on Study Results: Vir Biotechnology, Inc.’s (VIR - Free Report) shares rose after it announced new preliminary data from its phase II SOLSTICE study. The study is evaluating the safety, tolerability and efficacy of tobevibart and investigational small interfering ribonucleic acid elebsiran for the treatment of people living with chronic hepatitis delta.
Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, and reduce the level of virions and subviral particles in the blood. Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid. One cohort is evaluating the combination of tobevibart and elebsiran, dosed every four weeks with a second cohort evaluating tobevibart monotherapy every two weeks. Approximately 50% of the participants have compensated cirrhosis.
The preliminary data from this mid-stage study showed treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. Vir Biotechnology is on track to report additional 24-week treatment data for approximately 60 SOLSTICE participants in the fourth quarter of 2024.
Amgen Study Updates: Amgen (AMGN - Free Report) announced that its late-stage study on Uplizna (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD) was successful.
The randomized, double-blind, placebo-controlled, parallel-group, multicenter MITIGATE study was designed to evaluate the efficacy and safety of Uplizna compared to placebo in reducing the risk of flares in adults with IgG4-RD.
After a screening period of up to 28 days, patients were randomized (1:1) to receive 300 mg intravenous of Uplizna or placebo on days 1, 15, and week 26 after premedication, and followed for the 52-week randomized control period. This drug is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States, EU and many other countries.
The study met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints (annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission) were also achieved. Consequently, Amgen is planning to file for approval of the drug in the United States.
Viking’s NASH Data: Viking Therapeutics (VKTX - Free Report) announced positive 52-week histologic data from the phase IIb VOYAGE study that evaluated VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The VOYAGE study achieved its secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment with VK2809 when compared with placebo. This study evaluated four different doses of VK2809 — 1 mg, 2.5 mg, 5 mg and 10mg.
Results showed that roughly 63-75% patients who took VK2809 achieved NASH resolution (meaning the disease symptoms disappeared) while experiencing no worsening of fibrosis. In contrast, only 29% of patients who received a placebo achieved similar results. 44-57% of the patients who took the drug showed at least a one-stage improvement in fibrosis without worsening of NASH compared to 34% for placebo. Overall, 40-50% of patients who received VK2809 achieved NASH resolution and at least a one-stage improvement in fibrosis compared to 20% in the placebo group.
This study has already achieved its primary endpoint – NASH patients who received VK2809 achieved a statistically significant reduction in liver fat content following 12 weeks of treatment. However, the company’s shares were down despite the upbeat data.
Performance
The Nasdaq Biotechnology Index has gained 5.47% in the past five trading sessions and Biogen’s shares have risen 10.41% during the same time frame. In the past six months, shares of MRNA have rallied 97.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIBs Acquisition, PTCT, LRMR Gain on Updates & More News)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: GSK's Litigation Update, BIIB's Drug Approval & Other Updates
It was a busy week for the biotech sector, with numerous data presentations by biotech companies at healthcare conferences. Regular pipeline news was also in the spotlight.
Recap of the Week’s Most Important Stories:
GSK Down on Zantac Litigation: GSK (GSK - Free Report) suffered a setback in the ongoing Zantac litigation. The company issued a statement disagreeing with the ruling by the Delaware State Court that allows the numerous lawsuits related to Zantac to move forward for jury trials. The lawsuits claim that the heartburn drug Zantac (ranitidine) causes cancer. The Delaware State Court’s decision also contradicts the Federal Court’s multidistrict litigation (MDL) ruling (in December 2022), which dismissed all cases alleging five cancer types.
In the MDL, plaintiffs identified five different types of cancers (liver, bladder, pancreatic, esophageal and stomach). The court dismissed all MDL cases alleging the five cancers. GSK stated that as per scientific consensus, there was no consistent or reliable evidence to show that ranitidine increases the risk of any cancer. GSK said that it will continue to vigorously defend itself against all claims.
The company also announced positive results from an interim analysis of the phase III DREAMM-8 head-to-head trial. The trial is evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone, compared to a combination of bortezomib and pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma, previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The patients had documented disease progression during or after their most recent therapy. Results showed statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival.
Biogen’s Drug Approval: Biogen (BIIB - Free Report) announced that the European Commission (EC) has granted marketing approval to Qalsody (tofersen) for treating patients with amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutation. The marketing authorization was granted to Qalsody under exceptional circumstances, wherein a treatment is deemed to have a positive benefit/risk assessment but gathering comprehensive data is difficult due to the rarity of the condition. The EC has also maintained an orphan designation for Qalsody.
The approval was based on data from the phase III VALOR study. It was expected as the Committee for Medicinal Products for Human Use (CHMP) of the EMA rendered a positive opinion recommending a marketing authorization under exceptional circumstances for Qalsody for SOD1-ALS in February. Biogen in-licensed rights to tofersen from Ionis Pharmaceuticals under a collaborative development and license agreement.
Biogen Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
VIR Up on Study Results: Vir Biotechnology, Inc.’s (VIR - Free Report) shares rose after it announced new preliminary data from its phase II SOLSTICE study. The study is evaluating the safety, tolerability and efficacy of tobevibart and investigational small interfering ribonucleic acid elebsiran for the treatment of people living with chronic hepatitis delta.
Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, and reduce the level of virions and subviral particles in the blood. Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid. One cohort is evaluating the combination of tobevibart and elebsiran, dosed every four weeks with a second cohort evaluating tobevibart monotherapy every two weeks. Approximately 50% of the participants have compensated cirrhosis.
The preliminary data from this mid-stage study showed treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. Vir Biotechnology is on track to report additional 24-week treatment data for approximately 60 SOLSTICE participants in the fourth quarter of 2024.
Amgen Study Updates: Amgen (AMGN - Free Report) announced that its late-stage study on Uplizna (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD) was successful.
The randomized, double-blind, placebo-controlled, parallel-group, multicenter MITIGATE study was designed to evaluate the efficacy and safety of Uplizna compared to placebo in reducing the risk of flares in adults with IgG4-RD.
After a screening period of up to 28 days, patients were randomized (1:1) to receive 300 mg intravenous of Uplizna or placebo on days 1, 15, and week 26 after premedication, and followed for the 52-week randomized control period. This drug is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States, EU and many other countries.
The study met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints (annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission) were also achieved. Consequently, Amgen is planning to file for approval of the drug in the United States.
Viking’s NASH Data: Viking Therapeutics (VKTX - Free Report) announced positive 52-week histologic data from the phase IIb VOYAGE study that evaluated VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The VOYAGE study achieved its secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment with VK2809 when compared with placebo. This study evaluated four different doses of VK2809 — 1 mg, 2.5 mg, 5 mg and 10mg.
Results showed that roughly 63-75% patients who took VK2809 achieved NASH resolution (meaning the disease symptoms disappeared) while experiencing no worsening of fibrosis. In contrast, only 29% of patients who received a placebo achieved similar results. 44-57% of the patients who took the drug showed at least a one-stage improvement in fibrosis without worsening of NASH compared to 34% for placebo. Overall, 40-50% of patients who received VK2809 achieved NASH resolution and at least a one-stage improvement in fibrosis compared to 20% in the placebo group.
This study has already achieved its primary endpoint – NASH patients who received VK2809 achieved a statistically significant reduction in liver fat content following 12 weeks of treatment. However, the company’s shares were down despite the upbeat data.
Performance
The Nasdaq Biotechnology Index has gained 5.47% in the past five trading sessions and Biogen’s shares have risen 10.41% during the same time frame. In the past six months, shares of MRNA have rallied 97.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIBs Acquisition, PTCT, LRMR Gain on Updates & More News)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.