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Translate (TBIO) Down on Unsatisfactory CF Drug Study Results
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Translate Bio, Inc. (TBIO - Free Report) announced results from the second interim analysis from a phase I/II study which is evaluating its mRNA product candidate, MRT5005, for the treatment of patients with cystic fibrosis (“CF”).
The above-mentioned first-in-human study investigated the safety and tolerability of single- and multiple-ascending doses of inhaled MRT5005 in the given patient population.
Data from the multiple-ascending dose portion of the study showed that treatment with multiple doses of MRT5005 was generally safe and well tolerated. However, the candidate failed to improve lung function in CF patients as there was no pattern of increases in percent predicted forced expiratory volume in 1 second (ppFEV1), a measure of lung function. Also, no clear pattern of new or increasing levels of immunogenicity markers was observed with repeat dosing of MRT5005.
Shares of the Translate Bio were down 23.2% in after-hours trading on Wednesday following the announcement of the news. However, the stock has rallied 39.4% so far this year compared with the industry’s increase of 2.1%.
Notably, MRT5005 is designed to treat the underlying cause of CF regardless of the patients’ genetic mutation. The company plans to continue with ongoing and additional studies on MRT5005. The candidate has received Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA.
Translate Bio remains focused on providing innovative mRNA therapeutics for all CF patients. Meanwhile, the company has identified a next-generation CF candidate for which investigational new drug-enabling studies are expected to begin in the second half of 2021. The candidate has demonstrated positive results in pre-clinical studies.
Please note that Translate Bio has a collaboration and license agreement with French pharma giant Sanofi (SNY - Free Report) , related to the development of mRNA vaccines for infectious diseases. The companies are working together to develop novel mRNA vaccines aimed at broadly addressing all current and future infectious diseases.
Catalent’ earnings estimates have been revised 10.1% upward for 2021 and 9% for 2022 over the past 60 days. The stock has inched up 1.9% year to date.
Zoetis’ earnings estimates have been revised 4.8% upward for 2021 and 4.2% for 2022 over the past 60 days.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Translate (TBIO) Down on Unsatisfactory CF Drug Study Results
Translate Bio, Inc. (TBIO - Free Report) announced results from the second interim analysis from a phase I/II study which is evaluating its mRNA product candidate, MRT5005, for the treatment of patients with cystic fibrosis (“CF”).
The above-mentioned first-in-human study investigated the safety and tolerability of single- and multiple-ascending doses of inhaled MRT5005 in the given patient population.
Data from the multiple-ascending dose portion of the study showed that treatment with multiple doses of MRT5005 was generally safe and well tolerated. However, the candidate failed to improve lung function in CF patients as there was no pattern of increases in percent predicted forced expiratory volume in 1 second (ppFEV1), a measure of lung function. Also, no clear pattern of new or increasing levels of immunogenicity markers was observed with repeat dosing of MRT5005.
Shares of the Translate Bio were down 23.2% in after-hours trading on Wednesday following the announcement of the news. However, the stock has rallied 39.4% so far this year compared with the industry’s increase of 2.1%.
Notably, MRT5005 is designed to treat the underlying cause of CF regardless of the patients’ genetic mutation. The company plans to continue with ongoing and additional studies on MRT5005. The candidate has received Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA.
Translate Bio remains focused on providing innovative mRNA therapeutics for all CF patients. Meanwhile, the company has identified a next-generation CF candidate for which investigational new drug-enabling studies are expected to begin in the second half of 2021. The candidate has demonstrated positive results in pre-clinical studies.
Please note that Translate Bio has a collaboration and license agreement with French pharma giant Sanofi (SNY - Free Report) , related to the development of mRNA vaccines for infectious diseases. The companies are working together to develop novel mRNA vaccines aimed at broadly addressing all current and future infectious diseases.
Zacks Rank & Stocks to Consider
Translate Bio currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Catalent, Inc. (CTLT - 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.
Catalent’ earnings estimates have been revised 10.1% upward for 2021 and 9% for 2022 over the past 60 days. The stock has inched up 1.9% year to date.
Zoetis’ earnings estimates have been revised 4.8% upward for 2021 and 4.2% for 2022 over the past 60 days.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
AccessZacks Top 10 Stocks for 2021 today >>