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Paratek Pharmaceuticals, Inc. (PRTK)

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Previous Close4.8600
Open4.9200
Bid0.0000 x 1000
Ask0.0000 x 1300
Day's Range4.8000 - 5.0600
52 Week Range2.5000 - 6.7200
Volume344,652
Avg. Volume616,166
Market Cap233.963M
Beta (5Y Monthly)1.32
PE Ratio (TTM)N/A
EPS (TTM)-2.9190
Earnings DateAug 10, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateOct 31, 2014
1y Target Est15.00
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  • Paratek Pharmaceuticals Presenting New Data on NUZYRA® (Omadacycline) at IDWeek 2020
    GlobeNewswire

    Paratek Pharmaceuticals Presenting New Data on NUZYRA® (Omadacycline) at IDWeek 2020

    Key Highlights Include Data on NUZYRA as an Alternative to Standard of Care to Reduce Clostridioides Difficile Infections and Real-World Experience with NUZYRA for Nontuberculous Mycobacterial and MDR/XDR Gram Negative InfectionsBOSTON, Oct. 21, 2020 (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, announced today that data from its NUZYRA (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2020 virtual meeting. NUZYRA 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. Poster presentations are available beginning on Wednesday, October 21 in the IDWeek ePoster Gallery.Presentation Title: Subinhibitory Concentrations of Omadacycline Inhibit Staphylococcus aureus Hemolytic Activity In Vitro Poster : 1202 Presenter: A. SerioPresentation Title: In Vitro Activity of Omadacycline Against 7000 Bacterial Pathogens from the United States Stratified by Infection Type (2019) Poster : 1253 Presenter: M. HubandPresentation Title: Comparative Activity of Omadacycline Against Extended-spectrum Beta-lactamase Positive and Negative Escherichia coli and Klebsiella pneumoniae Strains Recovered from Urine Specimens Poster : 1267 Presenter: T. StonePresentation Title: Real-World Experience with Omadacycline for Nontuberculous Mycobacterial and Gram-Negative Infections: A Multicenter Evaluation Poster : 1290 Presenter: T. MorrisettePresentation Title: Targeted Substitution of Omadacycline in Place of Standard of Care for CABP Treatment is Associated with a Risk Reduction of Clostridioides difficile Infection and Financial Cost Savings in the Acute Care Setting Poster : 1492 Presenter: M. RodriguezPresentation Title: Omadacycline in Female Adults with Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study Poster : 1687 Presenter: K. WrightPresentation Title: Omadacycline in Female Adults with Cystitis: Results from a Randomized, Double-Blinded, Adaptive Phase 2 Study Poster : 1688 Presenter: K. Wright"These poster presentations continue our commitment to share new data about the clinical safety and efficacy of NUZYRA and ensure clinicians have comprehensive information available to them as they make treatment decisions for their patients with community-acquired infections," said Randy Brenner, Chief Development & Regulatory Officer of Paratek. "To that end, Paratek supports analysis of real-world use of NUZYRA, including the potential utility of NUZYRA in nontuberculous mycobacterium abscessus lung infections, a rare, chronic and difficult-to-treat lung infection for which there are currently no FDA approved therapies."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. 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 to support the development 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 antibiotic with both once-daily 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 InformationContraindications 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 including statements related to our overall strategy, products, prospects and potential.  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, 2019 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.CONTACTS:Investor and Media Relations: Ben Strain 617-807-6688 ir@ParatekPharma.com

  • GlobeNewswire

    Paratek Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference

    BOSTON, Sept. 09, 2020 (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 H.C. Wainwright 22nd Annual Global Investment Conference, Monday, September 14, 2020 at 5:00 p.m. ET.To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/hcw7/prtk/1629433.Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.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. 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 to support the development of NUZYRA for the treatment of pulmonary anthrax.For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.Forward Looking Statements  This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  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, 2019 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.CONTACT:    Investor and Media Relations:    Ben Strain    617-807-6688    ir@ParatekPharma.com

  • Billionaire David Shaw Pours Money Into 3 “Strong Buy” Stocks
    TipRanks

    Billionaire David Shaw Pours Money Into 3 “Strong Buy” Stocks

    Are the tides turning on Wall Street? Stocks fell in the past three trading sessions, as investors abandoned the tech heavyweights that have been at the forefront of the market’s remarkable charge forward. What’s behind the sell-off? Sky-high valuations reminiscent of the dot-com era have sparked fears of a tech bubble. To this end, investors are wondering if this pullback is just a correction, or if it is the start of a larger drawdown.In times like these, the legends can offer some guidance. We are referring to the people that transformed the way we play the investing game, namely David Shaw.A former Columbia University computer-science professor, Shaw founded the D. E. Shaw group at a small bookstore in New York City in 1988. Starting out with six employees and $28 million in capital, he pioneered a new investing approach, one that computerized the industry and fundamentally changed the culture of hedge funds, making way for math and science fanatics as well as musicians and English majors.Among these misfits was Jeff Bezos, who was a senior vice president at D.E. Shaw in charge of the hedge fund’s online retail project. He was intrigued by the potential, and thus, the seeds of Amazon were planted.As D.E. Shaw has become a $50 billion hedge fund, and Shaw’s net worth lands at $7.5 billion, we wanted to take a closer look at three stocks the fund picked up recently. Running the tickers through TipRanks’ database, we learned that each one boasts a “Strong Buy” consensus rating from the analyst community and massive upside potential.Paratek Pharmaceuticals (PRTK)Providing physicians with the tools they need, Paratek Pharmaceuticals hopes its solutions will generate positive outcomes and patient stories. Based on the success of its product launch, it’s no wonder Wall Street focus has locked in on this healthcare name. Shaw is among those cheering the company. Increasing its stake by 82%, D.E. Shaw bought up 457,341 shares in the second quarter. Following the purchase, the fund’s total PRTK position lands at 1,018,465 shares and is worth $4,267,368.Writing for H.C. Wainwright, 5-star analyst Ed Arce cites NUZYRA’s performance as a key component of his bullish thesis, noting that the company's therapy is “already on track to be one of the most successful antibiotic launches of the last decade.” The asset is a tetracycline-class antibacterial designed as a treatment for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).During Q2 2020, sales growth for NUZYRA continued to ramp up, with net sales coming in at $8.1 million, up 11.4% sequentially from Q1 2020, which was already up 34.9% from Q4 2019.Weighing in on the result, Arce stated, “We find this quarter's growth particularly encouraging because not only is it all in the hospital setting—which is notoriously slow with trial and adoption of new medicines—but it was achieved during a time in which most of the U.S. was under full or partial lockdown and restricted hospital access due to the ongoing COVID-19 pandemic." The analyst added, "Management depicted the growth curve of IV and oral NUZYRA sales versus other recent antibiotic launches, based on data from IQVIA, which we believe offers a clear graphical representation of this differentiated launch, even under trying circumstances.” On top of this, PRTK filed a supplemental NDA with the FDA to obtain an oral-only dosing label for community-acquired bacterial pneumonia (CABP). An updated label for NUZYRA could come around the end of January 2021. “We view this as an important update that is likely to significantly boost sales momentum further, as not only will it allow Paratek to capture some of the 2020-2021 flu season demand, but critically enables the company to execute its broader strategy to expand into the community setting early next year,” Arce commented.Summing it all up, Arce said, “Overall, we believe Paratek is on course to establishing itself as a leading, commercially successful, independent antibiotic biotech company, with a pathway to cash flow breakeven.”To this end, Arce rates PRTK a Buy along with a $19 price target. Should his thesis play out, a potential twelve-month gain of 353% could be in the cards. (To watch Arce’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings, 4, in fact, have been issued in the last three months. Therefore, the message is clear: PRTK is a Strong Buy. Given the $14.67 average price target, shares could skyrocket 250% in the next year. (See PRTK stock analysis on TipRanks)Eiger Biopharmaceuticals (EIGR)Focused on the development of therapies for rare and ultra-rare diseases for which no approved drugs exist, Eiger Biopharmaceuticals wants to address the high unmet medical need. With a strong development pipeline, some believe big things are in store for EIGR.Shaw is standing squarely with the bulls on this one. During Q2, D.E. Shaw snapped up 142,385 shares, bringing the size of the holding to 217,813 shares. After this 189% boost, the value of the position comes in at $2,250,000.Ahead of an upcoming regulatory ruling, Ladenburg analyst Michael Higgins is also on board. The analyst tells clients that the PDUFA for Zokinvy (lonafarnib), the company's potential treatment for Progeria and Progeroid Laminopathies, is still set for November 20. Back in May, the company revealed that the FDA had accepted the application with Priority Review.“We agree with management that an advisory committee meeting is not expected. We remind investors lonafarnib was granted Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation which allows for an expedited approval process. The Rare Pediatric Disease Designation also makes lonafarnib eligible for a priority review voucher (PRV) upon approval, which we value at ~$100 million (to be split 50/50 with the Progeria Research Foundation) based on the four most recent transactions ($80 million-$130 million). We continue to have a high level of confidence that Zokinvy will be approved, given the impressive clinical evidence (including mortality endpoint), lack of adequate treatments and safety profile,” Higgins commented. It should be noted that the EU application for lonafarnib in progeria and progeroid laminopathies has been delayed due to COVID-related travel restrictions that prevented the EMA from completing the standard manufacturing inspections. That said, Higgins points out that the asset was already on an accelerated review, so the delay basically means the application is subject to a standard review timeline.The analyst added, “We expect this only adds ~60 days to the review, for an early Q1 2021 decision, which should still allow synchronized worldwide launch. While its possible this review is delayed again, supporting the approval is the filings’ relatively limited size and impressive clinical evidence.”To this end, Higgins stated, “With cash of $90.8 million, a ~$15 million quarterly burn and cash expected following Zokinvy’s PDUFA (via PRV monetization and revenues in Progeria), Eiger is well-positioned to continue to execute in developing its pipeline.”Everything EIGR has going for it keeps Higgins with the bulls. Along with a Buy rating, the analyst leaves a $28 price target on the stock. This target suggests shares could climb 171% higher in the next year. (To watch Higgins’ track record, click here)All in all, other analysts echo Higgins’ sentiment. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $27.67, the upside potential comes in at a whopping 168%. (See EIGR stock analysis on TipRanks)Atara Biotherapeutics (ATRA)Developing off‑the‑shelf, allogeneic T‑cell immunotherapies, Atara Biotherapeutics believes its products could potentially transform the lives of patients with serious medical conditions. Given its promising pipeline, ATRA has received significant attention from Wall Street.During Q2, Shaw’s fund made a major purchase. Scooping up 297,003 shares, the hedge fund’s new ATRA position is valued at $3,997,660. Turning to the analyst community, 5-star analyst Tony Butler, of Roth Capital, tells clients that ATRA has big plans to drive value in 2020. First and foremost, the company remains on track to file the BLA for tab-cel, its off-the-shelf, allogeneic T-cell immunotherapy, in post-transplant lymphoproliferative disorder (PTLD) following solid organ transplant (SOT) or hematopoietic stem cell transplant (SCT) with the FDA in 2H20.ATRA plans to conduct an interim analysis of the Phase 3 trial in Q3 2020, and after this analysis, there will be a preBLA meeting with the FDA, where it will discuss the data generated to date from the tab-cel program in PTLD.Reflecting another positive, Butler pointed out, “Atara is targeting additional EBV+ ultra-rare indications to increase the market opportunity of tab-cel. For this purpose, Atara will initiate a Phase 2 trial to evaluate tab-cel in up to six EBV+ indications during 2H20.” These indications include leiomyosarcoma, lymphoproliferative disorders (LPDs) related to primary and acquired immunodeficiency, front-line PTLD and first- or second-line CNS PTLD.On top of this, the company is set to kick off the randomized placebo-controlled portion of the allogeneic T-cell program to treat multiple sclerosis (MS). The program is in a Phase 1 trial that is being conducted in two parts. Looking at the early data, there were distinct improvements in patient outcomes based on the sustained disability improvement (SDI) score.Expounding on this, Butler stated, “Improvement in patients' disability were particularly pronounced at doses of 20 and 40 million cell doses and Atara chose the 20 million cells dose as the go-forward dose for the randomized phase II portion of the trial. The company stated that if the data show signals indicating an improvement in disability, which can potentially mean a transformational product in the treatment paradigm of MS, then the company may choose to opt for an accelerated developmental pathway.”It should come as no surprise, then, that Butler stayed with the bulls. To this end, he puts a Buy rating and $30 price target on the stock, suggesting 123% upside potential. (To watch Butler’s track record, click here)In general, other analysts are on the same page. With 6 Buy ratings and 1 Hold, the word on the Street is that ATRA is a Strong Buy. The $33.60 average price target brings the upside potential to 143%. (See ATRA stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.