Paratek Pharma

Paratek Pharmaceuticals, Inc. engages in the development and commercialization of therapies based upon tetracycline chemistry. Its products include omadacycline and sarecycline, which are used for the treatment of community-acquired bacterial infections, including community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections and urinary tract infections. The company was founded by Walter Gilbert and Stuart B. Levy in 1996 and is headquartered in Boston, MA.

Earnings data Q2 2024

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Paratek Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is a new tetracycline-derived, broad-spectrum antibiotic being developed in both oral tablet and intravenous formulations for use as a first-line monotherapy antibiotic for ABSSSI, CABP, urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Paratek has Special Protocol Assessment agreements with the FDA for the phase 3 trials planned in ABSSSI and CABP.

BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for NUZYRA® (omadacycline) for the treatment of infections caused by Nontuberculous Mycobacteria (NTM). This orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex (MABc), which is the focus of an ongoing Phase 2b study initiated by Paratek. The FDA's Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides Paratek with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved. “The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA, a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, as a potential therapy option for patients afflicted with M. abscessus pulmonary disease, an orphan disease for which there are no approved therapies,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “Earlier this year, we initiated our Phase 2b clinical study that is designed to examine the efficacy and safety of NUZYRA in patients with M. abscessus pulmonary disease. These clinical data will continue to build upon the expanding data and publications about NUZYRA and its potential utility in NTM abscessus. About NTM Abscessus Pulmonary infections caused by M. abscessus, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the United States. Patients with pulmonary disease caused by M. abscessus have a myriad of symptoms including severe fatigue, fever, cough, and shortness of breath. The standard of care typically involves a combination of multiple antibiotics, most of which are intravenous, which can often require life-long treatment that is complicated by long-term tolerability challenges and multiple adverse events. About the Phase 2b NTM Study The Phase 2b study is a placebo-controlled, randomized monotherapy study of NUZYRA in patients with M. abscessus pulmonary disease who are in the early treatment phase and are not receiving other antibiotic treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this orphan disease, Paratek expects the study will take about two years to complete enrollment. More information can be found at clinicaltrials.gov under the study ID number (NCT04922554). About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world. In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter. About NUZYRA NUZYRA® (omadacycline) is a novel once-daily antibiotic with both oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains. Indications and Usage NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Safety Information Contraindications NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. Warnings and Precautions Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. Drug Interactions Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. Use in Specific Populations Lactation: Breastfeeding is not recommended during treatment with NUZYRA. To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch. Please see full Prescribing Information for NUZYRA at www.NUZYRA.com. Forward Looking Statements This press release contains forward-looking statements related to our overall strategy, products, prospects, NTM disease, our clinical studies for NTM, real world data of NUZYRA for NTM patients and the potential for NUZYRA to fill an unmet medical need for NTM patients. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

Paratek Pharmaceuticals Announces FDA Orphan Drug Designation for NUZYRA® (omadacycline) for the Treatment of Infections Caused by Nontuberculous Mycobacteria

The stock price of Paratek Pharmaceuticals Inc (NASDAQ: PRTK) increased by over 4% pre-market. This is why it happened.

PRTK Stock Price Increases Over 4% Pre-Market: Why It Happened

Paratek Pharmaceuticals' (PRTK) CEO Evan Loh on Q2 2021 Results - Earnings Call Transcript

Paratek (PRTK) delivered earnings and revenue surprises of -31.03% and -3.94%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?

Paratek Pharmaceuticals (PRTK) Q2 Earnings and Revenues Miss Estimates

Shares of Paratek Pharmaceuticals (NASDAQ:PRTK) rose in after-market trading after the company reported Q2 results. Quarterly Results Earnings per share increased 137.74% over the past year to $0.20, which missed the estimate of $0.31.

Paratek Pharmaceuticals: Q2 Earnings Insights

-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $14.9 Million from the Core Commercial Business, a 13% Increase over the Prior Quarter

Paratek Pharmaceuticals Announces Total Revenue of $57.5 Million in the Second Quarter 2021

The stock price of Paratek Pharmaceuticals Inc (NASDAQ: PRTK) increased by over 10% pre-market. This is why it happened.

PRTK Stock Price Increases Over 10% Pre-Market: Why It Happened

The Center for Disease Control and Prevention (CDC) has added Paratek Pharmaceuticals Inc's (NASDAQ: PRTK) antibiotic Nuzyra (omadacycline) as an alternative agent for pre-exposure prophylaxis and postexposure prophylaxis of primary bubonic and pharyngeal plague infections in adults 18 years of age and over. According to the CDC, Yersinia pestis (Y.

Paratek Stock Is Trading Higher As CDC Adds Nuzyra As Recommended Antibiotic For Plague Treatment

BOSTON, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the Company's novel, once-daily oral and intravenous antibiotic NUZYRA®  (omadacycline) has recently been added to the Center for Disease Control and Prevention's (CDC) updated report, “Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response”. NUZYRA was added as an alternative agent for the treatment, pre-exposure prophylaxis, and postexposure prophylaxis of primary bubonic and pharyngeal plague infections in adults 18 years of age and over.

Paratek Pharmaceuticals Announces NUZYRA® (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague

BOSTON, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that Adam Woodrow, President and Chief Commercial Officer, will participate in a panel discussion at the Wedbush PacGrow Healthcare Conference 2021. The discussion will take place on August 11, 2021 at 4:40 p.m. E.T. and focus on Infectious Personality: Challenges and Optimism in Infectious Diseases: A Discussion of Impactful Drug Development, Innovation, and Regulatory Trends in the Space.

Paratek Pharmaceuticals to Present at Wedbush PacGrow Healthcare Conference 2021

Paratek (PRTK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Paratek Pharmaceuticals (PRTK) Earnings Expected to Grow: What to Know Ahead of Q2 Release

BOSTON, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, August 9, 2021 at 4:30 p.m. EDT to provide a corporate update and report its financial results for the second quarter ended June 30, 2021.

Paratek Pharmaceuticals to Report Second Quarter 2021 Financial Results on August 9, 2021

-- First BARDA Procurement has been Delivered and Revenue will be Recognized in Second Quarter 2021 -- First BARDA Procurement has been Delivered and Revenue will be Recognized in Second Quarter 2021

Paratek Pharmaceuticals Announces First BARDA Project BioShield Procurement of NUZYRA® (omadacycline) Valued at ~$38 Million

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The company reduced its 2021 revenue outlook.

Why Paratek Pharmaceuticals Stock Is Sinking Today

Paratek Pharmaceuticals Inc (NASDAQ: PRTK) has initiated Phase 2b trial evaluating Nuzyra (omadacycline) for Nontuberculous Mycobacterial (NTM) Pulmonary Disease caused by Mycobacterium abscessus complex (MABc). The placebo-controlled, randomized monotherapy study will include 75 patients in the early treatment phase who are not receiving other treatments.

Paratek Launches Mid-Stage NTM Program With Nuzyra, Second Procurement Under BARDA Pact Expected In 2H 2022

-- U.S.-Based Sites Ready to Begin Enrolling Patients, Placebo-Controlled Study Evaluating NUZYRA Efficacy at 12 Weeks of Treatment

Paratek Pharmaceuticals Announces Initiation of Phase 2b Study in Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc) with NUZYRA® (omadacycline)

BOSTON, June 10, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that it will host an investor webinar on Wednesday, June 16, 2021, at 10:00 a.m. Eastern Time.

Paratek Pharmaceuticals Hosting Investor Webinar with Corporate Updates and Key Opinion Leader and Patient Advocate Presentations on Non-Tuberculous Mycobacteria, M. abscessus

The company gets off to a roaring start in June with an important FDA nod.

Why Paratek Pharmaceuticals Crushed the Market Today

The FDA has approved Paratek Pharmaceuticals Inc's (NASDAQ: PRTK) supplemental marketing application for the oral-only dosing regimen of Nuzyra for Community-Acquired Bacterial Pneumonia (CABP). The approval of an oral-only dose regimen for NUZYRA represents a significant opportunity to treat patients in either the outpatient or primary care setting to potentially reduces/eliminates hospitalizations and the associated risk and costs from a hospital stay, the company said.

Paratek's Stock Gains After Nuzyra's Oral Regime Wins FDA Approval For Pneumonia

- Oral-only dosing for the Treatment of CABP Expands the Commercial Opportunity for Primary Care Promotion

Paratek Pharmaceuticals Announces FDA Approval of NUZYRA® (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)

BOSTON, May 26, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the Jefferies Virtual Healthcare Conference which will be broadcast on Wednesday, June 2, 2021 at 9:00 a.m. ET.

Paratek Pharmaceuticals to Present at Jefferies Virtual Healthcare Conference

Paratek Pharmaceuticals, Inc. (PRTK) CEO Evan Loh on Q1 2021 Results - Earnings Call Transcript

Shares of Paratek Pharmaceuticals (NASDAQ:PRTK) remained unaffected after the company reported Q1 results. Quarterly Results Earnings per share rose 40.91% year over year to ($0.39), which missed the estimate of ($0.38).

News for Paratek Pharma Stock (PRTK)