|Over a week ago|
Fly Intel: Pre-market Movers » 09:0306/2206/22/20
SPCE, EVOK, PCG, MYO, EVLO, AAL, TSN, LK, NBRV
Check out this morning's…
Nabriva Therapeutics price target lowered to $1.50 from $2.50 at Northland » 07:4506/2206/22/20
Northland analyst Carl…
Northland analyst Carl Byrnes lowered the firm's price target on Nabriva Therapeutics to $1.50 from $2.50 and keeps an Outperform rating on the shares after the company received a Complete Response Letter, or CRL, for CONTEPO as the FDA was unable to complete observations at the company's manufacturing partners due to travel restrictions. While calling this news a setback, Byrnes said he anticipates visibility into the timing of an NDA resubmission late in the third quarter.
Nabriva Therapeutics receives CRL from FDA on NDA for CONTEPO for injection » 15:2106/2106/21/20
Nabriva Therapeutics announced that it received a Complete Response Letter from the U.S. Food and Drug Administration for the New Drug Application resubmission seeking marketing approval of CONTEPO for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis. The company said that although Nabriva's European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at the company's manufacturing partners that could not be resolved due to FDA's inability to conduct onsite inspections because of travel restrictions. In general, previously identified product quality and facility inspection related observations at its contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL. Nabriva plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA's plans for completing foreign facility inspections. CONTEPO has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA for the treatment of serious infections, including cUTI.
FDA PDUFA Date for Nabriva Therapeutics CONTEPO (Fosfomycin) is June 19, 2020 08:0306/1906/19/20
Largest borrow rate increases among liquid names » 08:4506/1706/17/20
MARK, DNR, EURN, SSYS, MAC, SRNE, BGS, SAND, NBRV, EOLS
Latest data shows the…
Latest data shows the largest indicative borrow rate increases among liquid option names include: Remark Media (MARK) 125.48% +8.28, Denbury Resources (DNR) 36.99% +2.03, Euronav NV (EURN) 22.48% +1.38, Stratasys (SSYS) 6.53% +1.16, Macerich (MAC) 7.26% +0.80, Sorrento Therapeutics (SRNE) 34.21% +0.66, B&G Foods (BGS) 1.95% +0.65, Sandstorm Gold (SAND) 1.56% +0.49, Nabriva Therapeutics (NBRV) 7.22% +0.40, and Evolus (EOLS) 21.76% +0.38.
|Over a month ago|
Nabriva Therapeutics announces $38M at-the-market registered direct offering » 06:3606/0106/01/20
Nabriva Therapeutics announced that it has entered into a definitive agreement with several healthcare-focused institutional investors, including Fidelity Management & Research Company, LLC, for the purchase and sale of an aggregate of 41,445,373 ordinary shares and warrants to purchase up to an aggregate of 41,445,373 ordinary shares in a registered direct offering priced at-the-market under Nasdaq rules. Each ordinary share and accompanying warrant are being sold together at a combined purchase price of $0.91686. The warrants have an exercise price of $0.792 per share, are exercisable on the issuance date and will expire on the two-year anniversary of the issuance date. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
Nabriva gets 'positive' EU CHMP opinion for Xenleta for CAP treatment » 08:3105/2905/29/20
Nabriva Therapeutics announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion recommending approval of XENLETA, lefamulin, for the treatment of community-acquired pneumonia, CAP, in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. The CHMP opinion will be reviewed by the European Commission (EC), which has the authority to approve medicines for all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A regulatory decision is anticipated during the second half of 2020. "Today's announcement brings us one step closer to the first approval of a new class of antibiotics for patients with community-acquired pneumonia in Europe in almost 20 years," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "XENLETA has a novel mechanism of action and provides an urgently needed short course, empiric monotherapy treatment alternative for adult patients with CAP. We look forward to the European Commission's decision and the opportunity to bring this important medicine to patients." The CHMP recommendation for marketing authorization is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants.
Nabriva Therapeutics announces publication of study on S. pneumoniae » 08:1605/1805/18/20
Nabriva Therapeutics announced the publication of a study entitled, A Multicenter Evaluation of the U.S. Prevalence and Regional Variation in Macrolide Resistant S. pneumoniae from Blood or Respiratory Cultures among Adult Patients, online in the proceedings of 30th European Congress on Clinical Microbiology and Infectious Diseases. This study assessed 3,510 patients with a positive S. pneumoniae blood or respiratory culture in the ambulatory and inpatient setting at 329 hospitals across nine U.S. Census geographic regions over 12 months ending 3Q2019 to determine the prevalence and rates of macrolide resistance in S. pneumoniae. Macrolide resistance was observed in 47.3 percent of S. pneumoniae obtained from respiratory cultures, and 29.6 percent from blood cultures. Higher rates of macrolide resistance were seen among ambulatory patients (45.3 percent) as compared with inpatients. While the overall rate of macrolide resistance was 39.5 percent, regional variation occurred, ranging from 13.9 percent in the Mountain region to 54.2 percent in the West North Central region, demonstrating the importance of local epidemiology data to inform selection of empiric therapy for patients with community-acquired bacterial pneumonia. S. pneumoniae is the leading cause of community-acquired bacterial pneumonia, a lung infection and the most common type of pneumonia that occurs outside of hospitals or other health care facilities. In its 2019 Antibiotic Threats Report, the Centers for Disease Control and Prevention designated macrolide-resistant S. pneumoniae as a "Serious Threat" to patients. According to the CDC, S. pneumoniae causes 900,000 infections and 3,600 deaths annually. Joint guidelines issued by the Infectious Disease Society of America and the American Thoracic Society for the treatment of CABP recommend macrolide antibiotics only be used in geographical regions where outpatient macrolide resistance is less than 25 percent. XENLETA is a systemic pleuromutilin antibiotic for the intravenous and oral treatment of CABP in adults. XENLETA offers an effective and well tolerated empiric monotherapy for CABP with a treatment duration as short as five days and the potential to address the limitations of existing agents. XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics. It has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. XENLETA is also convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community.
Nabriva Therapeutics reports Q1 EPS (25c), consensus (26c) » 16:1505/1105/11/20
Reports Q1 revenue $789K,…
Reports Q1 revenue $789K, consensus $460K
Nabriva announces publication of results from analysis of lefamulin data » 07:4305/0505/05/20
Nabriva Therapeutics announced that Open Forum Infectious Diseases, an official journal of the Infectious Diseases Society of America, has published results from a post-hoc analysis of clinical data from patients who initiated treatment in the hospital from the pivotal Lefamulin Evaluation Against Pneumonia 1 and LEAP 2 Phase 3 clinical trials. The analyses indicate that lefamulin results in a rapid and similar time to clinical response, a proxy for hospital "discharge readiness," compared to moxifloxacin. In the post-hoc analysis, investigators examined pooled data of 926 inpatients from the LEAP trials; 468 patients were treated with lefamulin and 458 were treated with moxifloxacin. The analysis evaluated three outcomes among the study population: time to clinical response, time to clinical stability, and time to clinical improvement. Of the 926 patients included, investigators were able to assess time to clinical response in 918, clinical stability in 925, and clinical improvement in 923. Analyses demonstrated that time to clinical response was nearly identical in both treatment groups, with a median time from treatment initiation to clinical response of 4 days for lefamulin and 4 days for moxifloxacin. The median time from treatment initiation to clinical stability or clinical improvement was 3 days in both the lefamulin and moxifloxacin groups. Given the association between time to clinical response and readiness for hospital discharge in patients with CABP, the findings support the potential of lefamulin as an effective IV and oral short-course, monotherapy for CABP that may enable early discharge. XENLETA is a pleuromutilin antibiotic approved by the U.S. Food and Drug Administration for the treatment of community-acquired bacterial pneumonia. It is available in IV and oral formulations enabling initiation of treatment in the hospital, transitioning to outpatient setting or initiating treatment in the community. XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics which has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. Full results of the post-hoc analysis of LEAP trials data is included in the paper titled: Post Hoc Assessment of Time to Clinical Response Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxacin in Two Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials, published in Open Forum Infectious Diseases, April 24, 2020.