|Bid||1.5000 x 1100|
|Ask||1.5600 x 2900|
|Day's Range||1.5500 - 1.6500|
|52 Week Range||1.1600 - 3.2700|
|Beta (5Y Monthly)||2.55|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 11, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||7.00|
The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 8.) Allergan plc (NYSE: AGN ): AbbVie Inc ...
Nabriva Therapeutics plc (NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs). In the acknowledgement letter for the resubmitted NDA, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter the FDA issued on April 30, 2019.
The company, which has its U.S. headquarters in King of Prussia, is also planning to raise $20 million in a private stock sale.
Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale in a registered direct offering of (i) an aggregate of 13,793,106 ordinary shares and (ii) warrants to purchase up to an aggregate of 13,793,106 ordinary shares. Each ordinary share and accompanying warrant are being sold together at a combined purchase price of $1.45. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
Shares of Nabriva Therapeutics PLC soared 10.5% in premarket trading Friday, after the biotechnology company said it resubmitted its new drug application (NDA) for Contepo, its treatment for complicated urinary tract infections. The NDA was submitted after the Food and Drug Administration said in a complete response letter (CRL) in April that it couldn't approve the previous NDA, citing issues related to facility inspections and manufacturing deficiencies. The NDA was resubmitted based on the outcome of a Type A meeting with the FDA. "We are pleased to have received input from the FDA on the required information to include in the CONTEPO NDA resubmission to address the CRL," said Nabriva Chief Executive Ted Schroeder. The stock has lost 21.8% over the past three months through Thursday, while the iShares Nasdaq Biotechnology ETF has rallied 14.8% and the S&P 500 has gained 7.1%.
Nabriva Therapeutics plc (NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva anticipates a six-month review period by the FDA.
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Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has granted non-statutory stock options to purchase an aggregate of 18,000 ordinary shares of Nabriva Therapeutics as inducements to 4 newly-hired employees. The awards were made pursuant to the Nasdaq inducement grant exception as a component of the new hires’ employment compensation. The stock options were granted effective November 29, 2019 with an exercise price of $2.02 per share, which is equal to the closing price of Nabriva Therapeutics’s ordinary shares on the date of grant.
Benzinga has examined prospects for many investor favorite stocks over the past week. Bearish calls included two leaders in computing and a well-known shoe retailer. Much of the market and economic news was overshadowed this week by drama in Washington, D.C. as the impeachment hearings continued on Capitol Hill, though it was hard to see much of an effect on the markets.
Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Gary Sender Chief Financial Officer and Francesco Lavino Chief Commercial Officer, will provide a company overview and business update at the 31st Annual Piper Jaffray Healthcare Conference on Wednesday, December 4, 2019 at 4:30 p.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
ADR (NASDAQ: NBRV) shares have gained about 46% year-to-date. Nabriva has a commercial product in lefamulin IV/oral, which was approved by the FDA in August for treating community-acquired bacterial pneumonia, or CABP. The mode of action is through binding to the peptidyl transferase center present in the ribosome of the bacteria, interfering with the interaction of protein production at two key sites — the A site and P site — that inhibit protein production and in turn the growth of bacteria.
S. pneumoniae continues to be designated by the CDC as “Serious Threat” underscoring need for rapid detection and prevention strategies, particularly in community.
-More than 200 hospital formulary reviews of XENLETA™ scheduled before the end of the year- -Approximately 50% of all covered lives have outpatient formulary access to XENLETA-.
Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its third-quarter 2019 financial results after the close of the U.S. financial markets on Tuesday, November 12, 2019. Nabriva’s management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com.
Nabriva 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 will present data on the pooled results from completed Phase 3 trials of XENLETA™ (lefamulin) at the CHEST Annual Meeting 2019, to be held October 19-23 in New Orleans. XENLETA is a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of community-acquired bacterial pneumonia (CABP) in adults and is now commercially available in the United States. “The clinical community desperately needs new classes of antibiotics with different mechanisms of action that have targeted, potent antimicrobial activity and improved safety and tolerability over existing therapies,” said Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics.
In any industry, there are always deals that are too good to be true and unfortunately, they usually are. The best thing to do before any kind of investment is to educate yourself before you make any hasty decisions. Being extra cautious could be an excellent idea.When it comes to the stock market though, “playing it safe” doesn’t always pay off and putting your money on a seemingly ‘sure bet’ that most big players are investing in, might not get you the results you are actually looking for.When you take a deeper look, you’ll notice that there are actually incredible opportunities in “smaller” and less heard of biotech stocks that can bring you closer to the sweet payday.Using TipRanks’ Stock Screener, we’ve highlighted 3 ultra-promising biotechs that are showing upside of nearly 300% and above.Gamida Cell (GMDA) Gamida Cell is a clinical-stage biopharmaceutical company that is creating and developing cell therapies for different types of cancers. The company has its own proprietary nicotinamide-based (or NAM based) cell expansion technology which is pretty much its “trade secret." NAM-based cell expansion takes the natural state of cancer cells and modifies them so that they are no longer harmful to the body.Gamida is hoping to bank on the success of its frontrunner drug ‘omidubicel’ which is expected to be a life-saving stem cell transplant solution for patients with high-risk blood cancers and bone marrow failure disorders. Omidubicel is currently in Phase 3 of its clinical trials.4-star JMP analyst Jason N. Bulter sees the Phase 3 results for omidubicel in 1H20 “as the primary value driver for the stock” and identifies “potential for success based on positive Phase 2 results.” And that’s good enough reason for Bulter to rate the stock an Outperform along with $16 price target. If the price target is reached within 12 months, that would provide a 12-month return of nearly 261%."Our..price target is derived through an NPV analysis of omidubicel sales, for which we project U.S. sales of ~$580MM by 2027 and assign a 75% probability of approval.” the analyst explained.Overall, we can see from TipRanks that Gamida has a “Strong Buy” consensus rating. In the last three months, the stock has received 22 buy ratings and seven hold ratings. Based on these ratings, the average $175 price target on X stock translates into upside of over 10% from the current share price.Gamida stock has a resounding “yes” on Wall Street. TipRanks analytics show that out of three analysts polled in the past 3 months, all three are bullish. The price target of $17.67 shows a potential upside of about nearly 300% from where the stock is currently trading. (See Gamida stock analysis on TipRanks)Nabriva Therapeutics (NBRV) Similarly to GMDA, Nabriva Therapeutics is a company that also has 2 premiere projects in the works and has a lot of promising developments going on. Nabriva's lead drug XENLETA, which treats patients with community-acquired bacterial pneumonia (CABP), recently won FDA approval and is being distributed in the U.S. since August. Nabriva also recently acquired Zvante Therapeutics and added CONTEPO to its portfolio; an injection for the treatment of complicated urinary tract infections. In contrast to XENLETA, however, CONTEPO has yet to gain FDA approval.Northland analyst Carl Brynes is forecasting "peak global sales of XENLETA at $1B, supported by XENLETA's clinical differentiation and oral/IV dosing forms." With a market cap of only $130.58 million, the analyst sees huge upside for NBRV stock, as he reiterates an Outperform rating and $12.50 price target. (To watch Brynes' track record, click here)Wedbush analyst Robert Driscoll added, "We see XENLETA’s profile as well suited for the treatment of CABP, given its favorable safety and efficacy profile, a narrow but CABP-targeted spectrum, and flexible IV to oral/oral dosing. Importantly, two Ph 3 studies have demonstrated efficacy with a short treatment course of 5-7 days, which we note aligns with antibiotic stewardship principles. With recent favorable changes to the reimbursement landscape and a clear plan in place for lefamulin commercialization, plus clarification around second asset CONTEPO NDA resubmission timelines, we believe NBRV shares are currently undervalued."All in all, the drug maker is without question a Wall Street favorite, considering TipRanks analytics indicate NBRV as a Strong Buy. Out of 5 analysts polled in the last 3 months, all 5 are bullish on the stock. With a return potential of nearly 390%, the stock's consensus target price stands at $8.70. (See Nabriva stock analysis on TipRanks)PhaseBio Pharmacuticals (PHAS)Rounding out our list is PhaseBio Pharmacuticals, a clinical-stage biopharmaceutical, developing treatments for orphan diseases with cardiopulmonary indications. PhaseBio's stake in the race is PB2452; medication that the company hopes will undo the negative effects of the antiplatelet drug ticagrelor. The company also has a really good second offering in PB1046; its treatment of PAH (pulmonary arterial hypertension), which creates high blood pressure in the arteries of the lungs.The company recently announced that it completed the Phase 2a clinical trial of PB2452 on healthy elderly patients and that the results have been consistent to its former Phase 1 study with younger, healthy patients. This is good news for PHAS and shows that the company is right on track with its clinical trial advances.William Blair analyst Matt Phipps believes “the completion of the Phase 2a study continues a pattern of excellent execution from company management, and we look forward to the full data presentation at an upcoming medical conference and initiation of pivotal trials in the coming months." The analyst added that “the base case...for PB2452, which assumes a peak penetration for ticagrelor of 40% of the addressable market, results in a risk-adjusted net present value of roughly $16 per share.”With that in mind, it's not surprising why Phipps reiterated an Outperform rating on PHAS stock, while boosting his price target to $7.00 (from $5.00).How does Phipps' bullish forecast echo against the word of the Street? Quite positively, it seems, as TipRanks analytics exhibit PHAS as a Strong Buy. Based on 5 analysts polled in the last 3 months, all 5 rate the stock a "buy." Meanwhile, the 12-month average price target stands at $18.33, marking nearly 340% upside from where the stock is currently trading. (See PhaseBio stock analysis on TipRanks)
52 Presentations by Coalition Members During the Annual Meeting WASHINGTON , Oct. 1, 2019 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug-resistant ...
DUBLIN, Ireland, Sept. 27, 2019 -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative.
DUBLIN, Ireland, Sept. 26, 2019 -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative.
Nabriva Therapeutics plc (NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Chief Executive Officer Ted Schroeder will provide a company overview and business update at the 2019 Cantor Global Healthcare Conference on Wednesday, October 2, 2019 at 1:50 p.m. ET. Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).