Paratek's Antibiotic Candidate Gets FDA Committee Date
Paratek Pharmaceuticals, Inc. PRTK 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 AGN.
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 and Genomic Health Inc GHDX, 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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