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.
Paratek's Antibiotic Candidate Gets FDA Committee Date
Read MoreHide Full Article
Paratek Pharmaceuticals, Inc. announced that an FDA advisory committee will review the new drug application (NDA) for its lead antibiotic candidate, omadacycline, on Aug 8.
The NDA, seeking approval for once-daily, oral and intravenous (IV) dosing of omadacycline, was filed with the FDA in April this year. With the regulatory body granting priority review to the NDA, a decision from the FDA is expected in early October. The candidate is also under review in the EU, with a decision is expected in the second half of this year.
Omadacycline has been developed for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin plus skin structure infections (ABSSSI). The candidate enjoys Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating CABP and ABSSSI.
The NDA was supported by data from three pivotal studies — two in ABSSSI and one in CABP. Omadacycline met primary endpoints in each of these trials and was generally safe and well-tolerated during its evaluation process in both. Omadacycline is also being developed for the therapy of urinary tract infections.
Apart from omadacycline, Paratek’s acne candidate, Seysara, is under review in the United States. It has been developed in partnership with Allergan plc .
Shares of Paratek have plunged 40.2% year to date, underperforming the industry’s decline of 5.8%.
Paratek currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 166.7% year to date.
Genomic Health’s earnings estimates have been revised 46.9% upward for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 45.5% so far this year.
Will You Make a Fortune on the Shift to Electric Cars? Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
Image: Bigstock
Paratek's Antibiotic Candidate Gets FDA Committee Date
Paratek Pharmaceuticals, Inc. announced that an FDA advisory committee will review the new drug application (NDA) for its lead antibiotic candidate, omadacycline, on Aug 8.
The NDA, seeking approval for once-daily, oral and intravenous (IV) dosing of omadacycline, was filed with the FDA in April this year. With the regulatory body granting priority review to the NDA, a decision from the FDA is expected in early October. The candidate is also under review in the EU, with a decision is expected in the second half of this year.
Omadacycline has been developed for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin plus skin structure infections (ABSSSI). The candidate enjoys Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating CABP and ABSSSI.
The NDA was supported by data from three pivotal studies — two in ABSSSI and one in CABP. Omadacycline met primary endpoints in each of these trials and was generally safe and well-tolerated during its evaluation process in both. Omadacycline is also being developed for the therapy of urinary tract infections.
Apart from omadacycline, Paratek’s acne candidate, Seysara, is under review in the United States. It has been developed in partnership with Allergan plc .
Shares of Paratek have plunged 40.2% year to date, underperforming the industry’s decline of 5.8%.
Paratek currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 166.7% year to date.
Genomic Health’s earnings estimates have been revised 46.9% upward for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 45.5% so far this year.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>