We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Biotech Stock Roundup: KDNY Up on NVS Buyout, BIIB & Eisai's AD Drug Update & More
Read MoreHide Full Article
It was a busy week for the biotech sector. Key regulatory and pipeline updates from bigwigs like Biogen (BIIB - Free Report) were in the spotlight during the week. Mergers and Acquisitions are back in focus too.
Recap of the Week’s Most Important Stories:
Chinook Surges on Novartis Acquisition: Shares of Chinook Therapeuticssurged on Jun 12 after an acquisition announcement by pharma giant Novartis. Per the terms of the deal, Novartis will acquire Chinook for $3.5 billion. Shareholders of Chinook would receive $3.2 billion ($40.00 per share) in cash upon closing, plus a contingent value right with up to $0.3 billion ($4.00 per share) payable in cash upon achieving certain regulatory milestones. The transaction is expected to close in the second half of 2023. The offer price of $40 represents a 66.7% premium to Chinook’s closing price of $23.99 on Jun 9.
The acquisition will add two late-stage candidates, atrasentan and zigakibart (BION-1301), for immunoglobulin A nephropathy (IgAN), to Novartis’ pipeline. Atrasentan, an oral endothelin A receptor antagonist (ERA), is currently in phase III development for IgAN, with a readout expected in the fourth quarter. Zigakibart is a targeted biologic therapy with the potential to address the root cause of IgAN, the production of abnormal galactose-deficient IgA and preserve kidney function. IgAN is a progressive, rare kidney disease that generally affects young adults and currently lacks targeted treatment options.
Regulatory Update From Biogen: Biogen and partner Eisai announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously recommending approval of their supplementary biologics license application (sBLA) for Alzheimer’s disease (AD) drug Leqembi (lecanemab). The sBLA is seeking full approval for Leqembi. Per the committee, Eisai’s phase III Clarity AD clinical study confirms the clinical benefit of Leqembi 100 mg/mL injection for intravenous use for treating AD.
The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months. Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid beta (Aβ), obtained accelerated approval on Jan 6, 2023. The committee confirmed the overall risk-benefit profile of Leqembi.
Biogen also announced that the Nasdaq halted trading of its common shares on Jun 9.
2seventy bio Down on Study Update: Shares of immuno-oncology cell therapy company 2seventy bio, Inc. (TSVT - Free Report) were down after it announced that the phase I trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has been stopped. The study has been halted by 2seventy bio’s partner and the regulatory sponsor of the study - Seattle Children’s. The pause came in response to a recent grade 5 (fatal) serious adverse event (SAE) and was followed by the required notification to the FDA. PLAT-08 utilizes 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology cell therapies. The primary cause of this SAE and its potential relationship to the study drug is currently under investigation.
IRWD, AbbVie Linzess Update: Ironwood (IRWD - Free Report) announced that the FDA has approved a label expansion of Linzess (linaclotide) as a once-daily treatment for pediatric patients aged 6-17 years with functional constipation. The drug is developed and marketed by AbbVie and Ironwood in the United States for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). The FDA had earlier granted a six-month priority review to the companies’ supplemental new drug application (sNDA), four months earlier than the standard review timeline.
The FDA approval was based on the results of a large, multicenter, double-blind, phase III study. Results showed that treatment with linaclotide resulted in a statistically significant and clinically meaningful improvement compared to placebo in 12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week), the primary endpoint.
Journey Medical Gains on Study Data: Shares of Journey Medical Corporation (DERM - Free Report) gained 22.2% on Jun 13 after the company reported that the phase I study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) in healthy adults achieved its primary endpoints. The phase I study assessed the impact of DFD-29 on the microbial flora of healthy adults. The study also assessed the safety and tolerability of the treatment.
The study enrolled healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple time points throughout the study. The study achieved all its primary objectives and no significant safety issues were noted during the study. Data showed that treatment with DFD-29 for 16 weeks had no significant negative impact on the normal microbial flora and did not induce significant bacterial resistance.
Additionally, treatment with DFD-29 did not cause any major proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or the development of resistance. DFD-29 is being developed for treating severe papulopustular rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Performance
The Nasdaq Biotechnology Index has gained 1.04% in the past five trading sessions. Among the biotech giants, Vertex has gained 5.02% during the period. Over the past six months, shares of MRNA have declined 39.67%. (See the last biotech stock roundup here: Biotech Stock Roundup: GSK Provides Updates, Biogen to Discontinue Study & More).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Biotech Stock Roundup: KDNY Up on NVS Buyout, BIIB & Eisai's AD Drug Update & More
It was a busy week for the biotech sector. Key regulatory and pipeline updates from bigwigs like Biogen (BIIB - Free Report) were in the spotlight during the week. Mergers and Acquisitions are back in focus too.
Recap of the Week’s Most Important Stories:
Chinook Surges on Novartis Acquisition: Shares of Chinook Therapeutics surged on Jun 12 after an acquisition announcement by pharma giant Novartis. Per the terms of the deal, Novartis will acquire Chinook for $3.5 billion. Shareholders of Chinook would receive $3.2 billion ($40.00 per share) in cash upon closing, plus a contingent value right with up to $0.3 billion ($4.00 per share) payable in cash upon achieving certain regulatory milestones. The transaction is expected to close in the second half of 2023. The offer price of $40 represents a 66.7% premium to Chinook’s closing price of $23.99 on Jun 9.
The acquisition will add two late-stage candidates, atrasentan and zigakibart (BION-1301), for immunoglobulin A nephropathy (IgAN), to Novartis’ pipeline. Atrasentan, an oral endothelin A receptor antagonist (ERA), is currently in phase III development for IgAN, with a readout expected in the fourth quarter. Zigakibart is a targeted biologic therapy with the potential to address the root cause of IgAN, the production of abnormal galactose-deficient IgA and preserve kidney function. IgAN is a progressive, rare kidney disease that generally affects young adults and currently lacks targeted treatment options.
Chinook 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 Biogen: Biogen and partner Eisai announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously recommending approval of their supplementary biologics license application (sBLA) for Alzheimer’s disease (AD) drug Leqembi (lecanemab). The sBLA is seeking full approval for Leqembi. Per the committee, Eisai’s phase III Clarity AD clinical study confirms the clinical benefit of Leqembi 100 mg/mL injection for intravenous use for treating AD.
The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months. Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid beta (Aβ), obtained accelerated approval on Jan 6, 2023. The committee confirmed the overall risk-benefit profile of Leqembi.
Biogen also announced that the Nasdaq halted trading of its common shares on Jun 9.
2seventy bio Down on Study Update: Shares of immuno-oncology cell therapy company 2seventy bio, Inc. (TSVT - Free Report) were down after it announced that the phase I trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has been stopped. The study has been halted by 2seventy bio’s partner and the regulatory sponsor of the study - Seattle Children’s. The pause came in response to a recent grade 5 (fatal) serious adverse event (SAE) and was followed by the required notification to the FDA. PLAT-08 utilizes 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology cell therapies. The primary cause of this SAE and its potential relationship to the study drug is currently under investigation.
IRWD, AbbVie Linzess Update: Ironwood (IRWD - Free Report) announced that the FDA has approved a label expansion of Linzess (linaclotide) as a once-daily treatment for pediatric patients aged 6-17 years with functional constipation. The drug is developed and marketed by AbbVie and Ironwood in the United States for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). The FDA had earlier granted a six-month priority review to the companies’ supplemental new drug application (sNDA), four months earlier than the standard review timeline.
The FDA approval was based on the results of a large, multicenter, double-blind, phase III study. Results showed that treatment with linaclotide resulted in a statistically significant and clinically meaningful improvement compared to placebo in 12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week), the primary endpoint.
Journey Medical Gains on Study Data: Shares of Journey Medical Corporation (DERM - Free Report) gained 22.2% on Jun 13 after the company reported that the phase I study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) in healthy adults achieved its primary endpoints. The phase I study assessed the impact of DFD-29 on the microbial flora of healthy adults. The study also assessed the safety and tolerability of the treatment.
The study enrolled healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple time points throughout the study. The study achieved all its primary objectives and no significant safety issues were noted during the study. Data showed that treatment with DFD-29 for 16 weeks had no significant negative impact on the normal microbial flora and did not induce significant bacterial resistance.
Additionally, treatment with DFD-29 did not cause any major proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or the development of resistance. DFD-29 is being developed for treating severe papulopustular rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Performance
The Nasdaq Biotechnology Index has gained 1.04% in the past five trading sessions. Among the biotech giants, Vertex has gained 5.02% during the period. Over the past six months, shares of MRNA have declined 39.67%. (See the last biotech stock roundup here: Biotech Stock Roundup: GSK Provides Updates, Biogen to Discontinue Study & More).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.