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The Zacks Analyst Blog Highlights Bristol Myers, Turning Point Therapeutics, Regeneron, Novavax, and Mirati Therapeutics
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For Immediate Release
Chicago, IL – June 9, 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: Bristol Myers (BMY - Free Report) , Turning Point Therapeutics , Regeneron (REGN - Free Report) , Novavax (NVAX - Free Report) , and Mirati Therapeutics, Inc. .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Acquisitions and More
The biotech sector has been in the spotlight in the past week, with acquisition, pipeline and regulatory updates.
Recap of the Week's Most Important Stories:
Bristol Myers Announces Acquisition: Bristol Myers has announced that it will acquire clinical-stage precision oncology company Turning Point Therapeutics for $76.00 per share, which equates to a total transaction value of $4.1 billion. The offer price of $76 represents a 122% premium to Turning Point's closing price of $34.16 on Jun 2.
Shares of Turning Point surged on the same. The acquisition is expected to close in the third quarter of 2022. The acquisition will add Turning Point's lead asset, repotrectinib, a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors.
Concurrently, Bristol Myers announced that the company has withdrawn the supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
Regeneron to Buy Sanofi's Stake in Libatyo: Regeneronannounced that it will acquire partner Sanofi's stake in their collaboration agreement for the oncology drug Libtayo (cemiplimab). Shares were down on the same as investors most likely viewed the deal as overpriced and buying out Libtayo from Sanofi might not reap rewards in the future for the former.
Both companies entered into an immuno-oncology license and collaboration agreement in 2015 whereby they divide worldwide operating profits equally from the drug and co-commercialize Libtayo in the United States. Sanofi is solely responsible for the commercialization of the drug outside the country. Libtayo is approved in the United States as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced NSCLC.
Per the terms of the deal, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron worldwide over the course of a defined transition period. In return, Regeneron will make an upfront payment of $900 million to Sanofi. Sanofi will also be entitled to receive an 11% royalty on the worldwide net sales of Libtayo.
Additionally, Sanofi will be entitled to a regulatory milestone payment of $100 million upon the first approval by either the FDA or the European Commission of Libtayo in combination with chemotherapy for the first-line treatment of certain patients with NSCLC as well as sales-related milestone payments of up to $100 million in total over the next two years.
Novovax Vaccine Gets FDA Committee Recommendation: Novavax announced that its COVID-19 vaccine has received a positive vote from the FDA Vaccines and Related Biological Products Advisory Committee. The Committee voted 21 to 0, with one abstention recommending the agency grant Emergency Use Authorization (EUA) to Novavax' COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.
The recommendation was based on positive data from the phase III study, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the United States and Mexico, wherein the vaccine demonstrated 90.4% efficacy. The FDA will take the recommendation into account when making decisions on EUA.
Mirati Gains on Positive Study Data: Mirati Therapeutics, Inc. announced positive results from an early stage KRYSTAL-1 study on investigational candidate adagrasib for lung cancer. The KRYSTAL study is evaluating intracranial (IC) responses of adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
Results of a prospective analysis from the phase Ib cohort of the KRYSTAL-1 study showed that one-third of the patients had an IC response in patients with CNS metastases, consistent with what was observed systemically in this cohort. Three patients achieved a complete response and three achieved a partial response in this analysis. The IC disease control rate was 84% (16/19, including 10 patients with stable disease).
The median IC duration of response was not reached. With a median follow up of 6.6 months, these early and positive data show adagrasib demonstrated a meaningful overall intracranial response rate with early indications for overall survival. Shares gained on the same.
The Nasdaq Biotechnology Index has gained 0.80% in the past four trading sessions. Among the biotech giants, Bristol Myers has gained 1.51% during the period. Over the past six months, shares of Moderna have lost 48.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY's Opdivo Updates, Pipeline Updates From REGN, BIIB)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Why Haven't You Looked at Zacks' Top Stocks?
Our 5 best-performing strategies have blown away the S&P's impressive +28.8% gain in 2021. Amazingly, they soared +40.3%, +48.2%, +67.6%, +94.4%, and +95.3%. Today you can access their live picks without cost or obligation.
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 Bristol Myers, Turning Point Therapeutics, Regeneron, Novavax, and Mirati Therapeutics
For Immediate Release
Chicago, IL – June 9, 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: Bristol Myers (BMY - Free Report) , Turning Point Therapeutics , Regeneron (REGN - Free Report) , Novavax (NVAX - Free Report) , and Mirati Therapeutics, Inc. .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Acquisitions and More
The biotech sector has been in the spotlight in the past week, with acquisition, pipeline and regulatory updates.
Recap of the Week's Most Important Stories:
Bristol Myers Announces Acquisition: Bristol Myers has announced that it will acquire clinical-stage precision oncology company Turning Point Therapeutics for $76.00 per share, which equates to a total transaction value of $4.1 billion. The offer price of $76 represents a 122% premium to Turning Point's closing price of $34.16 on Jun 2.
Shares of Turning Point surged on the same. The acquisition is expected to close in the third quarter of 2022. The acquisition will add Turning Point's lead asset, repotrectinib, a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors.
Concurrently, Bristol Myers announced that the company has withdrawn the supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
Regeneron to Buy Sanofi's Stake in Libatyo: Regeneron announced that it will acquire partner Sanofi's stake in their collaboration agreement for the oncology drug Libtayo (cemiplimab). Shares were down on the same as investors most likely viewed the deal as overpriced and buying out Libtayo from Sanofi might not reap rewards in the future for the former.
Both companies entered into an immuno-oncology license and collaboration agreement in 2015 whereby they divide worldwide operating profits equally from the drug and co-commercialize Libtayo in the United States. Sanofi is solely responsible for the commercialization of the drug outside the country. Libtayo is approved in the United States as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced NSCLC.
Per the terms of the deal, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron worldwide over the course of a defined transition period. In return, Regeneron will make an upfront payment of $900 million to Sanofi. Sanofi will also be entitled to receive an 11% royalty on the worldwide net sales of Libtayo.
Additionally, Sanofi will be entitled to a regulatory milestone payment of $100 million upon the first approval by either the FDA or the European Commission of Libtayo in combination with chemotherapy for the first-line treatment of certain patients with NSCLC as well as sales-related milestone payments of up to $100 million in total over the next two years.
Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Novovax Vaccine Gets FDA Committee Recommendation: Novavax announced that its COVID-19 vaccine has received a positive vote from the FDA Vaccines and Related Biological Products Advisory Committee. The Committee voted 21 to 0, with one abstention recommending the agency grant Emergency Use Authorization (EUA) to Novavax' COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.
The recommendation was based on positive data from the phase III study, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the United States and Mexico, wherein the vaccine demonstrated 90.4% efficacy. The FDA will take the recommendation into account when making decisions on EUA.
Mirati Gains on Positive Study Data: Mirati Therapeutics, Inc. announced positive results from an early stage KRYSTAL-1 study on investigational candidate adagrasib for lung cancer. The KRYSTAL study is evaluating intracranial (IC) responses of adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
Results of a prospective analysis from the phase Ib cohort of the KRYSTAL-1 study showed that one-third of the patients had an IC response in patients with CNS metastases, consistent with what was observed systemically in this cohort. Three patients achieved a complete response and three achieved a partial response in this analysis. The IC disease control rate was 84% (16/19, including 10 patients with stable disease).
The median IC duration of response was not reached. With a median follow up of 6.6 months, these early and positive data show adagrasib demonstrated a meaningful overall intracranial response rate with early indications for overall survival. Shares gained on the same.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 0.80% in the past four trading sessions. Among the biotech giants, Bristol Myers has gained 1.51% during the period. Over the past six months, shares of Moderna have lost 48.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMY's Opdivo Updates, Pipeline Updates From REGN, BIIB)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Why Haven't You Looked at Zacks' Top Stocks?
Our 5 best-performing strategies have blown away the S&P's impressive +28.8% gain in 2021. Amazingly, they soared +40.3%, +48.2%, +67.6%, +94.4%, and +95.3%. Today you can access their live picks without cost or obligation.
See Stocks Free >>
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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.