Nabriva Therapeutics plc - Ordinary Shares (NBRV) News
Nabriva Therapeutics plc - Ordinary Shares (NBRV)
Today's Latest Price: $0.69 USD
Updated Jul 10 4:00pm
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Ranked of 213 in Medical - Pharmaceuticals
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Latest NBRV News From Around the Web
Below are the latest news stories about Nabriva Therapeutics plc that investors may wish to consider to help them evaluate NBRV as an investment opportunity.
WEP Clinical Partners With Nabriva Therapeutics for the Named Patient Supply of XENLETA® (lefamulin)LONDON--(BUSINESS WIRE)--WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet availab |
Attention Biotech Investors: Mark Your Calendar For These July PDUFA DatesThe busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the total NME approvals for the year to 24. Among the NME approvals was Viela Bio Inc's (NASDAQ: VIE ) lead drug Uplinza, which is indicated for neuromyelitis optica spectrum disorder. Although Upliinza will be pitched against Alexion Pharmaceuticals, Inc.'s (NASDAQ: ALXN ) Soliris, the absence of black box warning gives the former an edge, H.C. Wainwright analyst Raghuram Selvaraju said in a note. There were disappointments too. Nabriva Therapeutics PLC's – ADR (NASDAQ: NBRV ) antibiotic Contepa, as expectedly, was handed down a second complete response letter, or CRL, and AbbVie Inc's (NYSE: ABBV ... |
CONTEPO CRL Is a Blow for Cash-Strapped Nabriva (NBRV), Says AnalystThe FDA’s equivalent of a red card – a CRL (complete response letter) – got handed out on June 19 to Nabriva Therapeutics (NBRV). Accordingly, the biotech’s share price has dropped nearly 15% since then.Nabriva might feel the market’s adverse reaction is a bit unfair. The company received the dreaded CRL for its complicated urinary tract infection (cUTI) treatment, CONTEPO, as a result of the FDA’s inability to inspect two of its manufacturing facilities due to coronavirus-induced travel restrictions.Nabriva already received a CRL for CONTEPO back in April of last year due to flaws at one of the company’s European CMOs (contract manufacturing organization).Before resubmitting CONTEPO’s NDA, Nabriva will request a meeting with the FDA to determine the next steps for the treatment’s road ... |
CymaBay Seladelpar Data, And Other News: The Good, Bad And Ugly Of BiopharmaCymaBay Posts Positive Seladelpar Data for Bile Duct Disorder CymaBay Therapeutics (CBAY) reported upbeat data for its open label Phase 2 study of seladelpar for treating patients suffering from primary biliary cholangitis. Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta. The drug candidate has shown anti-inflammatory and anti-cholestatic... |
Is Nabriva Therapeutics plc (NBRV) A Good Stock To Buy?We at Insider Monkey have gone over 821 13F filings that hedge funds and prominent investors are required to file by the SEC The 13F filings show the funds' and investors' portfolio positions as of March 31st, near the height of the coronavirus market crash. In this article, we look at what those funds think […] |
Nabriva strikes out again on FDA nod for fosfomycinNabriva Therapeutics (NBRV) has received a CRL from the FDA in response to its refiled marketing application seeking approval of Contepo (fosfomycin) for the treatment of complicated urinary tract infections, including pyelonephritis (urinary tract infection that has traveled to the kidney).The reason for the rejection was the agency's inability to... |
Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injectionNabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions. |
The Daily Biotech Pulse: Tiziana Snags A Patent Win, Decision Day For Nabriva And Evoke, IPOsHere's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs June 18) * ADC Therapeutics SA (NYSE: ADCT) * Adverum Biotechnologies Inc (NASDAQ: ADVM) * Alpine Immune Sciences Inc (NASDAQ: ALPN)( announced a licensing agreement with AbbVie Inc (NYSE: ABBV) * Amicus Therapeutics, Inc. (NASDAQ: FOLD) * Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * BioXcel Therapeutics Inc (NASDAQ: BTAI) * Burning Rock Biotech Ltd (NASDAQ: BNR) * Castle Biosciences Inc (NASDAQ: CSTL) * Cytokinetics, Inc. (NASDAQ: CYTK) * DiaMedica Therapeutics Inc (NASDAQ: DMAC) * Fennec Pharmaceuticals Inc (NASDAQ: FENC) * Neoleukin Therapeutics Inc (NASDAQ: NLTX) * Neubase Th... |
Nabriva Therapeutics (NBRV) Catches Eye: Stock Jumps 11.4%Nabriva Therapeutics (NBRV) saw a big move last session, as its shares jumped more than 11% on the day, amid huge volumes. |
Nabriva secures private $38M capital raiseNabriva Therapeutics (NBRV) inks an agreement with several institutional investors for the direct sale of 41,445,373 ordinary shares, each with an accompanying two-year warrant to purchase one ordinary share at $0.792, at a combined price of $0.91686.Gross proceeds should be ~$38M. Closing date is June 2.Friday's close was $1.14.... |
