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The Zacks Analyst Blog Highlights Ocugen, Voyager Therapeutics, BioNTech, Regeneron and Gilead Sciences
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For Immediate Release
Chicago, IL – March 10, 2022 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Ocugen (OCGN - Free Report) , Voyager Therapeutics, Inc. (VYGR - Free Report) , BioNTech (BNTX - Free Report) , Regeneron (REGN - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: OCGN, VYGR and More
Ocugen grabbed the headlines, courtesy of its regulatory updates. Plus, other vital information dominated the biotech sector this week.
Recap of the Week’s Most Important Stories:
Ocugen Down on Regulatory Update: Shares of Ocugen tanked after it was announced that the FDA has declined to issue an Emergency Use Authorization (EUA) to its COVID-19 vaccine Covaxin. OCGN was seeking EUA for Covaxin to actively immunize COVID-19 caused by SARS-CoV-2 in individuals aged from 2 years to 18 years. As a result, OCGN stated that it will continue working with the FDA to deduce the regulatory pathway forward for vaccination of the pediatric individuals with Covaxin.
Voyager Surges on Deal with Novartis: Shares of Voyager Therapeutics, Inc. (surged after the company announced an agreement with Novartis. Per the terms of the deal, NVS receives a target-specific access to Voyager’s novel TRACER AAV capsids for potential use with three CNS targets plus options to access capsids for two additional targets. In exchange, Voyager will receive $54 million upfront and is entitled to receive up to $37.5 million of exercise fees for options related to the three initial CNS targets.
Novartis might also choose to evaluate capsids for up to two additional targets. Voyager will get $18 million upon selection of each target and a $12.5 million exercise fee for selection of a capsid for each target. Voyager is also eligible to earn up to $1.5 billion worth of potential development, regulatory and commercial milestones payments as well as mid- to high-single-digit tiered royalties based on the net sales of Novartis products incorporating the licensed capsids.
BioNTech Collaborates with Regeneron:BioNTech announced that it expanded its strategic collaboration with Regeneron. BioNTech and Regeneron plan to jointly conduct studies, evaluating FixVac candidate BNT116 in combination with Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC). Both companies will share the development costs equally.
The agreement follows BNTX’s existing collaboration whereby the combination of its FixVac candidate BNT111 with Libtayo is being evaluated for advanced melanoma. In addition, BNTX is investigating and sponsoring an early stage study, which evaluates the combination of Libtayo with its FixVac candidate BNT112 for prostate cancer.
Data on Gilead’s Trodelvy: Gilead Sciences, Inc. announced positive results from the phase II TROPiCS-02 study, which is evaluating its breast cancer drug Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy.
The trial targeted a 30% reduction in the risk of disease progression or death. The primary endpoint results were consistent with those observed in the phase I/II IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. The drug is already approved for second-line metastatic triple-negative breast cancer and second-line metastatic bladder cancer.
The study also showed a trend toward improvement in overall survival (OS), a key secondary endpoint. Final data on the OS endpoint is expected in 2024. Gilead will continue to follow up with patients for the overall survival result.
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights Ocugen, Voyager Therapeutics, BioNTech, Regeneron and Gilead Sciences
For Immediate Release
Chicago, IL – March 10, 2022 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Ocugen (OCGN - Free Report) , Voyager Therapeutics, Inc. (VYGR - Free Report) , BioNTech (BNTX - Free Report) , Regeneron (REGN - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: OCGN, VYGR and More
Ocugen grabbed the headlines, courtesy of its regulatory updates. Plus, other vital information dominated the biotech sector this week.
Recap of the Week’s Most Important Stories:
Ocugen Down on Regulatory Update: Shares of Ocugen tanked after it was announced that the FDA has declined to issue an Emergency Use Authorization (EUA) to its COVID-19 vaccine Covaxin. OCGN was seeking EUA for Covaxin to actively immunize COVID-19 caused by SARS-CoV-2 in individuals aged from 2 years to 18 years. As a result, OCGN stated that it will continue working with the FDA to deduce the regulatory pathway forward for vaccination of the pediatric individuals with Covaxin.
Voyager Surges on Deal with Novartis: Shares of Voyager Therapeutics, Inc. (surged after the company announced an agreement with Novartis. Per the terms of the deal, NVS receives a target-specific access to Voyager’s novel TRACER AAV capsids for potential use with three CNS targets plus options to access capsids for two additional targets. In exchange, Voyager will receive $54 million upfront and is entitled to receive up to $37.5 million of exercise fees for options related to the three initial CNS targets.
Novartis might also choose to evaluate capsids for up to two additional targets. Voyager will get $18 million upon selection of each target and a $12.5 million exercise fee for selection of a capsid for each target. Voyager is also eligible to earn up to $1.5 billion worth of potential development, regulatory and commercial milestones payments as well as mid- to high-single-digit tiered royalties based on the net sales of Novartis products incorporating the licensed capsids.
Voyager currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioNTech Collaborates with Regeneron: BioNTech announced that it expanded its strategic collaboration with Regeneron. BioNTech and Regeneron plan to jointly conduct studies, evaluating FixVac candidate BNT116 in combination with Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC). Both companies will share the development costs equally.
The agreement follows BNTX’s existing collaboration whereby the combination of its FixVac candidate BNT111 with Libtayo is being evaluated for advanced melanoma. In addition, BNTX is investigating and sponsoring an early stage study, which evaluates the combination of Libtayo with its FixVac candidate BNT112 for prostate cancer.
Data on Gilead’s Trodelvy: Gilead Sciences, Inc. announced positive results from the phase II TROPiCS-02 study, which is evaluating its breast cancer drug Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy.
The trial targeted a 30% reduction in the risk of disease progression or death. The primary endpoint results were consistent with those observed in the phase I/II IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. The drug is already approved for second-line metastatic triple-negative breast cancer and second-line metastatic bladder cancer.
The study also showed a trend toward improvement in overall survival (OS), a key secondary endpoint. Final data on the OS endpoint is expected in 2024. Gilead will continue to follow up with patients for the overall survival result.
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.