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.
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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 >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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