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.
Spero Gets Fast Track Designation for SPR994, Shares Improve
Read MoreHide Full Article
Shares of Spero Therapeutics, Inc. (SPRO - Free Report) increased about 6% after the company announced that the FDA granted Fast Track designation to SPR994, the company’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis.
Shares of the company have decreased 9.8% in the past year compared with the industry’s decline of 4.7%.
The FDA grants Fast Track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once the company files a new drug application (“NDA”).
The company has planned a phase III study, whereinoral SPR994 will be compared with an existing standard of care intravenous (IV) antibiotic, ertapenem in about 1,200 patients randomized 1:1 in each arm. The primary endpoint of the study will be the combined clinical and microbiological response at the test of cure, with a 10% non-inferiority margin versus IV ertapenem. The study will incorporate a lead-in cohort of 70 patients, with an intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero expects to receive pharmacokinetic data from the lead-in cohort in the second half of 2019.
Recently, the FDA granted approval for the label expansion of Allergan plc’s anti-infective drug, Avycaz (ceftazidime and avibactam) in pediatric patients as monotherapy for cUTI, and in combination with metronidazole for complicated intra-abdominal infections (cIAI). This is the first drug to receive approval for pediatric patients with cUTI or cIAI in more than a decade. Avycaz is jointly marketed by Allergan and Pfizer (PFE - Free Report) .
Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 1.61%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?
From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.
This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.
Image: Bigstock
Spero Gets Fast Track Designation for SPR994, Shares Improve
Shares of Spero Therapeutics, Inc. (SPRO - Free Report) increased about 6% after the company announced that the FDA granted Fast Track designation to SPR994, the company’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis.
Shares of the company have decreased 9.8% in the past year compared with the industry’s decline of 4.7%.
The FDA grants Fast Track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once the company files a new drug application (“NDA”).
The company has planned a phase III study, whereinoral SPR994 will be compared with an existing standard of care intravenous (IV) antibiotic, ertapenem in about 1,200 patients randomized 1:1 in each arm. The primary endpoint of the study will be the combined clinical and microbiological response at the test of cure, with a 10% non-inferiority margin versus IV ertapenem. The study will incorporate a lead-in cohort of 70 patients, with an intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero expects to receive pharmacokinetic data from the lead-in cohort in the second half of 2019.
Recently, the FDA granted approval for the label expansion of Allergan plc’s anti-infective drug, Avycaz (ceftazidime and avibactam) in pediatric patients as monotherapy for cUTI, and in combination with metronidazole for complicated intra-abdominal infections (cIAI). This is the first drug to receive approval for pediatric patients with cUTI or cIAI in more than a decade. Avycaz is jointly marketed by Allergan and Pfizer (PFE - Free Report) .
Zacks Rank & Stock to Consider
Spero is currently a Zacks Rank #3 (Hold) stock.
A better-ranked stock worth considering is Johnson & Johnson (JNJ - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 1.61%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?
From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.
This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.
See Stocks Today >>