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: OCGN Down on Update, VYGR Surges on Deal & Other Updates
Read MoreHide Full Article
Ocugen (OCGN - Free Report) 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. (VYGR - Free Report) 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 (BNTX - Free Report) announced that it expanded its strategic collaboration with Regeneron (REGN - Free Report) . 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. (GILD - Free Report) 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.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 2.95% in the past five trading sessions. Among the biotech giants, Vertex has gained 3.48% during the period. Over the past six months, shares of Vertex have rallied 24.74%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA's Q4 Earnings, LXRX, KOD Down on Updates & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Biotech Stock Roundup: OCGN Down on Update, VYGR Surges on Deal & Other Updates
Ocugen (OCGN - Free Report) 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. (VYGR - Free Report) 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 (BNTX - Free Report) announced that it expanded its strategic collaboration with Regeneron (REGN - Free Report) . 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. (GILD - Free Report) 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.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 2.95% in the past five trading sessions. Among the biotech giants, Vertex has gained 3.48% during the period. Over the past six months, shares of Vertex have rallied 24.74%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA's Q4 Earnings, LXRX, KOD Down on Updates & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.