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Pfizer (PFE) Gets Unfavorable Votes from FDA Panel for Tanezumab
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Pfizer Inc. (PFE - Free Report) along with partner Eli Lilly (LLY - Free Report) announced that the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted against their investigational candidate, tanezumab, which was being developed for the treatment of adult patients with moderate-to-severe osteoarthritis (“OA”) pain, for whom use of other analgesics is ineffective or not appropriate.
Per the press release, there was a single voting question focused on whether tanezumab’s benefits outweigh its risks. The FDA committee voted one in favor and 19 against tanezumab, as the candidate’s risk profile outweighs its benefits for addressing the given indication.
The committee’s discussions were based on the Biologics License Application (“BLA”) for tanezumab, which is currently under review in the United States. The BLA included data from 20 clinical studies, including three late-stage studies, which evaluated tanezumab in patients with moderate-to-severe OA.
Per the company, despite the unfavorable outcome for tanezumab, it will continue to work with the FDA authorities as the regulatory body continue its review of the BLA.
Shares of Pfizer have declined 3.1% so far this year compared with the industry’s decrease of 1.9%.
We note that Pfizer has a collaboration with Eli Lilly for the development and commercialization of tanezumab. The candidate is also being evaluated in phase III studies for treating cancer-associated pain.
If successfully developed and upon potential approval, the companies will equally share profits and certain expenses related to tanezumab in the United States.
Johnson & Johnson’s earnings estimates have been revised 6.6% upward for 2021 and 4.9% for 2022 over the past 60 days. The stock has inched up 2.9% year to date.
Zoetis’ earnings estimates have been revised 5.2% upward for 2021 and 4.2% for 2022 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
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Pfizer (PFE) Gets Unfavorable Votes from FDA Panel for Tanezumab
Pfizer Inc. (PFE - Free Report) along with partner Eli Lilly (LLY - Free Report) announced that the FDA Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted against their investigational candidate, tanezumab, which was being developed for the treatment of adult patients with moderate-to-severe osteoarthritis (“OA”) pain, for whom use of other analgesics is ineffective or not appropriate.
Per the press release, there was a single voting question focused on whether tanezumab’s benefits outweigh its risks. The FDA committee voted one in favor and 19 against tanezumab, as the candidate’s risk profile outweighs its benefits for addressing the given indication.
The committee’s discussions were based on the Biologics License Application (“BLA”) for tanezumab, which is currently under review in the United States. The BLA included data from 20 clinical studies, including three late-stage studies, which evaluated tanezumab in patients with moderate-to-severe OA.
Per the company, despite the unfavorable outcome for tanezumab, it will continue to work with the FDA authorities as the regulatory body continue its review of the BLA.
Shares of Pfizer have declined 3.1% so far this year compared with the industry’s decrease of 1.9%.
We note that Pfizer has a collaboration with Eli Lilly for the development and commercialization of tanezumab. The candidate is also being evaluated in phase III studies for treating cancer-associated pain.
If successfully developed and upon potential approval, the companies will equally share profits and certain expenses related to tanezumab in the United States.
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Johnson & Johnson (JNJ - Free Report) and Zoetis Inc. (ZTS - 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.
Johnson & Johnson’s earnings estimates have been revised 6.6% upward for 2021 and 4.9% for 2022 over the past 60 days. The stock has inched up 2.9% year to date.
Zoetis’ earnings estimates have been revised 5.2% upward for 2021 and 4.2% for 2022 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>