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PRTK

Paratek Pharmaceuticals

$25.40

0.2 (0.79%)

08:06
10/06/17
10/06
08:06
10/06/17
08:06

Paratek Pharmaceuticals says Omadacycline met FDA-specified primary endpoint

New microbiology data from Paratek Pharmaceuticals show that its well-tolerated, once-daily, oral and IV, broad-spectrum investigational antibiotic, omadacycline, is active against the clinically important typical and atypical community-acquired bacterial pneumonia, or CABP, pathogens. The microbiological data from the Phase 3 OPTIC, or Omadacycline for Pneumonia Treatment in the Community, study, which will be presented tomorrow at IDWeek 2017, demonstrate the in vitro antibacterial activity and clinical efficacy against gram-positive and gram-negative bacterial isolates. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. In the analyses, pathogens were identified at screening through blood culture, lower respiratory tract culture, urinary antigen for Legionella pneumophila or Streptococcus pneumoniae, or positive serology titers for L. pneumophila, Mycoplasma pneumoniae or Chlamydophila pneumoniae. The most frequent pathogen isolates were: S. pneumoniae, H. influenzae, H. parainfluenzae, Klebsiella pneumoniae and S. aureus. Omadacycline showed potent in vitro activity across all isolates. Overall, in the OPTIC study, monotherapy with IV to once-daily oral omadacycline was effective in adult CABP patients with the most frequently isolated pathogens, including multi-drug resistant S. pneumoniae. The global, pivotal Phase 3 OPTIC study compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP. In the study, 774 patients were randomized. Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority, or NI, in the intent-to-treat, or ITT, population compared to moxifloxacin at the early clinical response, or ECR, 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively. Additionally, the FDA-specified secondary endpoint was the investigator assessment of response at the post treatment evaluation, or PTE, visit in both the ITT population and in the clinically evaluable, or CE, population. Rates of treatment emergent adverse events, or TEAEs, were 41.1% for omadacycline vs. 48.5% for moxifloxacin.

  • 17

    Oct

PRTK Paratek Pharmaceuticals
$25.40

0.2 (0.79%)

07/18/17
HCWC
07/18/17
NO CHANGE
Target $43
HCWC
Buy
Paratek Pharmaceuticals price target raised to $43 from $36 at H.C. Wainwright
H.C. Wainwright analyst Ed Arce raised his price target for Paratek Pharmaceuticals to $43 after the company announced positive top-line results of its alloral Phase 3 trial of omadacycline for the treatment of acute bacterial skin and skin structure infections. The analyst sees higher rates of nausea and vomiting as having a negligible impact to omadacycline's commercial opportunity. He keeps a Buy rating on Paratek shares.
07/18/17
LEER
07/18/17
NO CHANGE
Target $37
LEER
Outperform
Oral only skin study represents third positive Phase 3 for Paratek, says Leerink
Leerink analyst Paul Matteis notes that Paratek Pharmaceuticals announced positive Phase 3 results from its oral only omadacycline acute bacterial skin and skin structure infection Phase 3 trial, with the study showing statistical non-inferiority on all key clinical endpoints. With three positive Phase 3s, the analyst models a 90% probability of omadacycline approval, likely by late 2018 or early 2019. Matteis reiterates an Outperform rating and $37 price target on the shares.
07/20/17
CANT
07/20/17
NO CHANGE
Target $50
CANT
Overweight
Paratek Pharmaceuticals recent selloff overdone, says Cantor
Cantor Fitzgerald analyst Louise Chen says the two day selloff in shares of Paratek Pharmaceuticals (PRTK) after "positive and competitive" data from the company's OASIS-2 trials is overdone. The issues experienced by Cempra's (CEMP) community antibiotic product are entirely product-specific and not a read-through to Paratek, Chen told investors last night in a research note. She believes Paratek will be able to market Omadacycline effectively if it is approved and keeps an Overweight rating on the shares with a $50 price target.
08/23/17
RAJA
08/23/17
NO CHANGE
Target $36
RAJA
Strong Buy
Paratek takeover speculation 'seems plausible,' says Raymond James
After Bloomberg reported that Paratek Pharmaceuticals (PRTK) is exploring its strategic options, including a possible sale, after receiving takeover interest, Raymond James analyst Laura Chico said she sees omadacycline as a promising asset and sees a takeout as "certainly one plausible outcome." While its "probably premature to think about a takeout price," Chico said that a possible price could arguably fall in the high-$40 to low-$50 range, adding that Merck (MRK), Pfizer (PFE) and Allergan (AGN) would all be potential buyers. She keeps a Strong Buy rating and $36 price target on Paratek shares.

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