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Paratek (PRTK) Gets FDA Approval for Nuzyra and Seysara

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Paratek Pharmaceuticals, Inc. (PRTK - Free Report) announced that the FDA has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Shares of the company rose 8.2% in pre-market on Oct 3, following the news. However, shares of the company have decreased 48.3% year to date compared with the industry’s decline of 3.1%.

Nuzyra, a modernized tetracycline, is approved as a once-daily intravenous (IV) and oral antibiotic that is specifically designed to overcome tetracycline resistance. The drug exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains. 

The approval of Nuzyra is supported by multiple clinical trials within the company's global development program. Almost 2,000 adult patients received Nuzyra, and it was found to be efficacious and generally safe, and well tolerated.  As part of the approval, Paratek agreed to conduct post marketing studies in CABP and pediatrics. The company plans to launch Nuzyra in the first quarter of 2019.

As per Centers for Disease Control and Prevention (CDC), drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The increase of antibiotic resistance continues to drive the need for new, effective therapies. 

Separately, the company also announced that the FDA has approved Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular, moderate to severe acne vulgaris in patients 9 years of age or older. It is a new once-daily oral therapy for the treatment of acne.

The company has exclusively licensed U.S. development and commercialization rights of Seysara for the treatment of acne to Allergan PLC (AGN - Free Report) . Again, Allergan assigned these rights to Almirall SA. Paratek, however, retains development and commercialization rights in the rest of the world. Paratek earned a $12-million milestone payment upon the FDA approval and is now entitled to receive tiered royalties at rates ranging from high-single to low-double digits on net sales of Seysara.

Zacks Rank & Stocks to Consider

Paratek is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the biotech sector are Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Merus N.V.(MRUS - Free Report) . Both Ligand and Merus sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 95.8% year to date.

Merus’ loss per share estimates have narrowed from $3.09 to $2.60 for 2018 and from $4.22 to $4.01 for 2019 over the past 60 days. Share price of the company has increased 2.1% year to date.

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