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.
Bayer Initiates Late-Stage Study on Investigational NSCLC Drug
Read MoreHide Full Article
Bayer AG (BAYRY - Free Report) announced that the first patient has been enrolled in the late-stage SOHO-02 study on pipeline candidate BAY 292708.
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR) with high selectivity for mutant versus wild-type EGFR.
The phase III SOHO-02 study is an open-label, randomized, multicenter study evaluating the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations.
Year to date, shares of Bayer have lost 16.4% against the industry’s growth of 27.2%.
Image Source: Zacks Investment Research
BAYRY’s BAY 2927088 Holds Potential
Enrolled patients will be randomized to receive either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival measured by a blinded, independent, central review. Additional endpoints include the overall response rate, duration of response and evaluation of the safety of investigational agent BAY 2927088.
Results from the phase I/II SOHO-01 trial will be presented next month.
The FDA granted Breakthrough Therapy designation to BAY 2927088 in the second-line setting in February 2024. In June 2024, the Center for Drug Evaluation in China also granted Breakthrough Therapy designation to the candidate for the same patient population.
Bayer is also evaluating BAY 2927088 as a second-line therapy in adult patients with unresectable or metastatic NSCLC, whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to revive its pharmaceutical portfolio amid generic competition for Xarelto and challenges for its Crop Science division.
Lung cancer is one of the leading causes of cancer-related deaths worldwide. As of now, there is no approved targeted first-line therapy for patients with NSCLC harboring HER2 activating mutations.
Hence, the successful development of BAY 2927088 for NSCLC should be a significant boost for the company, given the market potential.
Last week, the company announced the initiation of the phase II ALPINE-1 study on pipeline candidate BAY3283142 for patients with chronic kidney disease (CKD).
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and CKD drug Kerendia. Eylea also continues to perform well.
Bayer currently has quite a few phase III studies ongoing on new candidates as well as label expansion of the existing drugs.
The company is working to get a higher dose of Eylea approved. Bayer is also working on the label expansion of Nubeqa and Kerendia in various indications.
BAYRY recently submitted a new drug application for the investigational compound elinzanetant to the FDA for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.
However, the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. In light of these challenges, Bayer is implementing a new operating model to reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. The company is also undertaking significant job cuts.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 61.8%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.7%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Bayer Initiates Late-Stage Study on Investigational NSCLC Drug
Bayer AG (BAYRY - Free Report) announced that the first patient has been enrolled in the late-stage SOHO-02 study on pipeline candidate BAY 292708.
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR) with high selectivity for mutant versus wild-type EGFR.
The phase III SOHO-02 study is an open-label, randomized, multicenter study evaluating the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations.
Year to date, shares of Bayer have lost 16.4% against the industry’s growth of 27.2%.
Image Source: Zacks Investment Research
BAYRY’s BAY 2927088 Holds Potential
Enrolled patients will be randomized to receive either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival measured by a blinded, independent, central review. Additional endpoints include the overall response rate, duration of response and evaluation of the safety of investigational agent BAY 2927088.
Results from the phase I/II SOHO-01 trial will be presented next month.
The FDA granted Breakthrough Therapy designation to BAY 2927088 in the second-line setting in February 2024. In June 2024, the Center for Drug Evaluation in China also granted Breakthrough Therapy designation to the candidate for the same patient population.
Bayer is also evaluating BAY 2927088 as a second-line therapy in adult patients with unresectable or metastatic NSCLC, whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to revive its pharmaceutical portfolio amid generic competition for Xarelto and challenges for its Crop Science division.
Lung cancer is one of the leading causes of cancer-related deaths worldwide. As of now, there is no approved targeted first-line therapy for patients with NSCLC harboring HER2 activating mutations.
Hence, the successful development of BAY 2927088 for NSCLC should be a significant boost for the company, given the market potential.
Last week, the company announced the initiation of the phase II ALPINE-1 study on pipeline candidate BAY3283142 for patients with chronic kidney disease (CKD).
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and CKD drug Kerendia. Eylea also continues to perform well.
Bayer currently has quite a few phase III studies ongoing on new candidates as well as label expansion of the existing drugs.
The company is working to get a higher dose of Eylea approved. Bayer is also working on the label expansion of Nubeqa and Kerendia in various indications.
BAYRY recently submitted a new drug application for the investigational compound elinzanetant to the FDA for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.
However, the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. In light of these challenges, Bayer is implementing a new operating model to reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. The company is also undertaking significant job cuts.
BAYRY’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the pharma/biotech industry are Eli Lilly (LLY - Free Report) and Exelixis (EXEL - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 61.8%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.7%.