|Bid||0.00 x 1000|
|Ask||35.00 x 900|
|Day's Range||24.11 - 24.58|
|52 Week Range||13.12 - 37.08|
|Beta (5Y Monthly)||1.71|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 07, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||46.14|
The financial regulations require hedge funds and wealthy investors that exceeded the $100 million equity holdings threshold to file a report that shows their positions at the end of every quarter. Even though it isn't the intention, these filings to a certain extent level the playing field for ordinary investors. The latest round of 13F […]
UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced the grants of inducement restricted stock units ("RSUs") on June 3, 2020 to eight new employees in connection with their employment with UroGen. These new team members will support the Company’s commercial launch of JelmytoTM (mitomycin) for pyelocalyceal solution, its first approved product.
UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that Liz Barrett, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020, at 3:30 PM Eastern Time.
UroGen Pharma Ltd. (Nasdaq: URGN) today announced the presentation of positive interim data from the Phase 2b OPTIMA II trial evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here.
UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto™ (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here. More information can also be accessed via UroGen’s virtual AUA experience here.
Ladies and gentlemen, thank you for standing by and welcome to the UroGen Pharma First Quarter 2020 Earnings Conference Call. Please note that we are conducting our call today from different locations.
UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the first quarter ended March 31, 2020 and provided an overview of the Company’s recent developments.
UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced that it will report first quarter 2020 financial results on Thursday, May 7, 2020, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.
We can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...
UroGen Pharma Ltd. (Nasdaq: URGN) today announced The Lancet Oncology published results from the pivotal Phase 3 OLYMPUS trial, reporting that 59% of low-grade upper tract urothelial cancer (LG-UTUC) patients treated with UGN-101, now referred to as Jelmyto™ (mitomycin) for pyelocalyceal solution, achieved a Complete Response (CR). Additionally, in the publication, durability at 12 months (based on interim data) was estimated to be 84% by Kaplan-Meier analysis.1
And we have a winner. After a long and arduous development process, only a few biotech names will emerge having attained the ultimate prize, an FDA approval. To get to this point, a company will need to successfully progress through several clinical phases of testing to ensure the product is both effective and safe.Given that only a few key factors indicate its trajectory during the development stage, shares can be sent soaring rapidly in either direction on account of news regarding study results or regulatory approvals. This is because if a candidate ultimately receives approval, it often signals that sustainable revenues are on the horizon.However, that’s not to say healthcare companies tap out on gains once they reach the finish line. Even after the FDA gives the all-clear, there’s still plenty of work to be done.Taking all of this into consideration, we used TipRanks’ database to pinpoint two compelling biotech stocks whose products have just won FDA approval. Here's what the analyst community has to say about these Buy-rated tickers.Urogen Pharma (URGN)Urogen is developing chemoablative agents for urological cancers using its cutting edge RTGel platform, which enables drug delivery to hard-to-reach anatomy as well as increases medication dwell time. With its recently-approved Jelmyto (UGN-101) therapy standing to change the treatment of low-grade upper tract urothelial carcinoma for the better, it’s no wonder the Street is excited.Oppenheimer’s Leland Gershell points out that URGN “has infrastructure in place for a June 1 launch that will incorporate marketing strategies designed to accommodate COVID-19 restrictions.” This includes 48 sales reps which will cover curology practices that see 90% of the LG UTUC patient population. In addition, the company is deploying virtual-based detailing strategies, with a premixing service agreement already in place for point-of-care delivery of ready-to-use product.Even though the company still hasn’t published the final durability data as some patients haven’t hit the twelve-month mark, Gershell sees a large re-treatment opportunity. “Given Jelmyto's kidney-sparing profile, we view the prospect of re-treatment following tumor recurrence to be favorable to the alternative option of kidney removal. While retreatment data are currently lacking, URGN intends to begin a post-marketing study in this setting in the coming months,” he noted. To this end, the analyst estimates Jelmyto 2024E revenue in low-grade UTUC will hit $400 million.On top of this, early clinical data for its other candidate, UGN-102, is promising. “We remain enthusiastic for UGN-102's opportunity in low-grade non-muscle-invasive bladder cancer (NMIBC) following encouraging Phase 2b interim efficacy reveal, with Phase 3 on track to begin around year end,” Gershell commented.Bearing this in mind, Gershell decided to stay with the bulls. Along with his Outperform call, the five-star analyst gave the price target a lift, from $45 to $47. This conveys his confidence in URGN’s ability to soar 100% in the next year. (To watch Gershell’s track record, click here)Turning now to the rest of the Street, other analysts are on the same page. With 4 Buys and a single Hold, the word on the Street is that URGN is a Strong Buy. At $47.50, the average price target puts the upside potential at 107%. (See Urogen stock analysis on TipRanks)Seattle Genetics (SGEN)Using advanced antibody-drug conjugate technology, Seattle Genetics was able to develop a better way to deliver cancer-killing therapies to tumor cells. On the heels of its third commercial product approval from the FDA, one analyst tells investors not to miss out on this exciting biotech play.Way before its August 20 PDUFA date, the regulatory agency gave SGEN’s TUKYSA (tucatinib) drug a thumbs up only four months after filing through the Real-Time Oncology Review (RTOR) program, which was the company’s second approval of this kind. TUKYSA was designed for use in metastatic HER2 positive breast cancer patients, including patients with brain Mets. It will be used along with trastuzumab (Herceptin) and capecitabine in patients who have already gone through at least one HER2 targeting therapy.Writing for Needham, five-star analyst Chad Messer noted, “We find the rapid approval impressive, particularly with the challenges of the ongoing COVID pandemic, and is testament to the unmet need in this patient population.”Messer goes so far as to say TUKYSA could become the standard of care in metastatic HER2 positive breast cancer as it was given a strong label for metastatic breast cancer (mBC), HER2 positive patients following progression on at least one anti-HER2 therapy. The label specifically states the therapy should be considered for brain Mets treatment, which differentiates it from other treatment options.Expounding on the label’s implications, Messer said, “The approved label is broader than the patient population evaluated in HER2CLIMB, which included mostly 3rd-line patients.” He added, “The commercial organization to launch TUKYSA is already in place.” Additionally, the candidate could be approved for use in Europe, and is undergoing further testing that could potentially enable it to be used in earlier lines of therapy in mBC.Based on all of the above, Messer left a Buy rating on the stock and bumped up the price target from $144 to $157. Should this new target be met, a twelve-month gain of 10% could be in store. (To watch Messer’s track record, click here)Looking at the consensus breakdown, 10 Buys and 4 Holds add up to a Moderate Buy consensus rating. However, the $138.33 average price target implies a slight downside potential from current levels. (See Seattle Genetics stock analysis on TipRanks)To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Shares of UroGen Pharma Ltd. gained 10.7% in premarket trading on Thursday after the Food and Drug Administration approved the company's urothelial cancer treatment the night before. The therapy, Jelmyto, allows patients to undergo treatment for this type of rare cancer without surgery, the company said. "This novel, minimally invasive, kidney-sparing treatment has the potential to transform the way low-grade upper tract urothelial cancer is treated," Dr. Seth Lerner, principal investigator of the treatment's Phase 3 trial, said in a news release. "We believe a non-surgical option such as Jelmyto is meaningfully differentiated," Stifel analysts told investors on Thursday, though they noted that it's still unclear how the company will approach a commercial launch strategy during the COVID-19 pandemic. UroGen's stock has tumbled 36.9% year-to-date, while the SPDR S&P Biotech Exchange-Traded Fund is down 11.2%.
Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 15.) * Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO) * Calithera Biosciences Inc (NASDAQ: CALA) (provided an update on the impact of COVID-19 on its ongoing clinical trials) * Eli Lilly And Co (NYSE: LLY) * Keros Therapeutics Inc (NASDAQ: KROS) (went public April 8) * Masimo Corporation (NASDAQ: MASI) * Moderna Inc (NASDAQ: MRNA (analysts hiked price targets for the shares following the company's Virtual Vaccines Day) * Pluristem Therapeutics Inc. (NASDAQ: PSTI) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN)Down In The Dumps (Biotech stocks that hit 52-week lows April 15.) * Akorn, Inc. (NASDAQ: AKRX) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * TherapeuticsMD Inc (NASDAQ: TXMD) * Vaccinex Inc (NASDAQ: VCNX) * Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Stocks In Focus UroGen's Kidney Cancer Drug Gets FDA Approval Urogen Pharma Ltd (NASDAQ: URGN) said the FDA granted expedited approval for its Jelmyto for pyelocaliceal solution, indicated to treat adults with low-grade upper tract urothelial cancer. The company said the approval was granted based on positive results from a Phase 3 Olympus trial that demonstrated Jelmyto's effectiveness in this rare and difficult-to-treat cancer.Jelmyto consists of mitomycin, an established chemotherapy and sterile hydrogel, using Urogen's proprietary sustained release RTGel technology.The stock was trading more than 14% higher at $24 in Thursday's premarket session. Accelerate Diagnostics Pre-Announces In-Line Q1 Revenue Accelerate Diagnostics Inc (NASDAQ: AXDX) said it expects first-quarter net sales of $2.3 million, higher than $1.8 million in the year-ago period and in line with the consensus estimate.Citing the uncertainty surrounding the duration of the COVID-19 pandemic, the company withdrew its guidance.The stock rallied 7.89% to $9.02 in after-hours trading.Vanda To Study Impact Of Human Genetic Variations On Coronavirus Infection, Progression Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 infection and disease progression. The company said it will collaborate with the University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in COVID-19 patients."The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes," according to Vanda. Separately, Vanda said it has enrolled the first patient in its ODYSSEY trial at Lenox Hill Hospital in New York City with Northwell Health's research arm. The ODYSSEY trial is a Phase 3 study investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.The stock was trading 8.45% higher at $11.30 in Thursday's premarket session. See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates Vir Presents Positive Data For Hepatitis B Virus Drug Vir Biotechnology Inc (NASDAQ: VIR) announced additional interim data from the ongoing Phase 2 study and results from the Phase 1 trial in healthy volunteers of VIR-2218, an investigational small interfering ribonucleic acid that mediates RNA interference for the treatment of chronic hepatitis B virus infection.The company said interim results from the Phase 2 study showed VIR-2218 resulted in a significant dose-dependent and durable reduction in hepatitis B surface antigen through week 24 in patients who received two doses ranging from 20 mg to 200 mg.Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). Vir said it will initiate combination trials of VIR-2218 with a shortened course of pegylated interferon, with dosing likely to begin in the second half of 2020.Vir shares were trading 0.79% higher at $29.50 in the premarket session. Co-Diagnostics Says COVID-19 Tests Validated For Use With Saliva Samples Co-Diagnostics Inc (NASDAQ: CODX) said OralDNA Labs, a CLIA-certified laboratory, recently validated a COVID-19 PCR test based on the its patented CoPrimer technology for use with saline oral rinse samples, and has notified the FDA of their intent to use the validated test in their CAP accredited high-complexity laboratory.The stock was adding 7.16% to $10.18 in premarket trading. Soligenix Licenses COVID-19 Vaccine Adjuvant From Boston Scientific Unit Soligenix, Inc. Common Stock (NASDAQ: SNGX) announced an agreement for exclusive worldwide licensing of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), for SARS-CoV-2.View more earnings on IBBThe stock was ripping higher by 60% to $2.24 in premarket trading. Eagle Pharma Submits IND For Coronavirus Treatment Candidate Eagle Pharmaceuticals Inc (NASDAQ: EGRX) said its Ryanodex for injectable suspension inhibited the growth of SARS-CoV-2 in lab tests. The company said it submitted an IND to the FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with the virus.Inovio Nets $6.9M In Funding To Initiate South Korean Clinical Trial Of Coronavirus Vaccine Candidate Inovio Pharmaceuticals Inc (NASDAQ: INO) has been granted $6.9 million in funding by the Coalition for Epidemic Preparedness Innovations to work with the International Vaccine Institute and the Korea National Institute of Health for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate INO-4800 in South Korea, according to the IVI. The organization said it will conduct the trial in South Korea.In premarket trading Thursday, Inovio shares were advancing 7.84% to $7.70.Ascendis' Growth Hormone Deficiency Drug Granted Orphan Drug Designation Ascendis Pharma A/S (NASDAQ: ASND) said the FDA has granted Orphan Drug Designation to its TransCon hGH as a treatment for growth hormone deficiency.AEterna Warned On Nasdaq Listing Standards, Has 180-Day Grace Period To Regain Compliance AEterna Zentaris Inc. (NASDAQ: AEZS) said it has received notice from Nasdaq indicating the company is not in compliance with the minimum $1-per-share bid price requirement, having closed below $1 per share for the prior 30 consecutive business days. The company said it has been provided a grace period of 180 calendar days through Oct. 5 to regain compliance.Novavax Coronavirus Vaccine To Enter Clinics In Australia Novavax, Inc.'s (NASDAQ: NVAX) Australian development partner Nucleus Network said it is due to commence Phase 1 testing of the former's NVX-CoV2372, a SARS-CoV-2 recombinant spike protein nanoparticle vaccine, at its Melbourne and Brisbane clinics in the coming weeks.In premarket trading Thursday, Novavax shares were adding 2.51% to $17.97. Offerings Calithera said it has priced its underwritten public offering of 5 million shares at $6.25 per share. The company expects to raise gross proceeds of $31.25 million from the offering. The offering is expected to close April 20.The stock was down 1.18% to $7.51 in the premarket session. Arcturus Therapeutics Ltd (NASDAQ: ARCT), which recently issued an update on its COVID-19 vaccine development program, said it intends to sell shares of its common stock in an underwritten public offering. All the shares are to be offered by the company.The company said it intends to use the net proceeds for working capital and general corporate purposes, including capex and R&D expenses related to the advancement of its LUNAR-OTC, LUNAR-COV19 and its other product candidates and clinical trial expenditures.The stock was down 3.06% at $17.45 in the premarket session. Athersys Inc (NASDAQ: ATHX) said it intends to offer $50 million of its common stock for sale in an underwritten public offering. The company said it will use the net proceeds for working capital and general corporate purposes, including funding its acute respiratory distress syndrome clinical program, which includes initiation of a Phase 2/3 pivotal study for COVID-19-induced ARDS patients, and its process development and manufacturing projects.The stock was down 25.81% at $2.30 in the premarket session. On The Radar Clinical Readouts Moleculin Biotech Inc (NASDAQ: MBRX) is hosting a web-based investor conference call at 4:30 p.m. ET Thursday to explain the significance of the recent discovery that the active compound in its WP1122 drug candidate, which it has licensed to WPD Pharmaceuticals Inc (OTC: WCOTF), has been shown to reduce replication of SARS-CoV-2 by 100%.Earnings Thursday Abbott Laboratories (NYSE: ABT) (before the market open)Intuitive Surgical, Inc. (NASDAQ: ISRG) (after the close)Related Link:Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use See more from Benzinga * 3 Frontrunners In COVID-19 Vaccine Development: What You Need To Know * The Daily Biotech Pulse: Applied DNA Ships Vaccine Constructs For Animal Testing, Herceptin Biosimilar Now Available In US * The Daily Biotech Pulse: Amarin Reports Strong Q1 Vascepa Sales, BeiGene Aces Late-Stage Lung Cancer Study, Glaxo, Sanofi Strike COVID-19 Vaccine Partnership(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto™ (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.
UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). These data were featured in a late-breaking abstract published in the April Supplement to The Journal of Urology. The detailed results presentation will be available online via the American Urological Association (AUA) in mid-May 2020.
UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced promotions for key members of the Executive Leadership Team. These appointments will better position the Company for its next growth phase with the anticipated approval and launch of its first product candidate, UGN-101 (mitomycin gel) for instillation, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). In December 2019, the U.S. Food and Drug Administration accepted for filing and granted priority review for the Company’s UGN-101 application and assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020.
UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent developments.
Although the masses and most of the financial media blame hedge funds for their exorbitant fee structure and disappointing performance, these investors have proved to have great stock picking abilities over the years (that's why their assets under management continue to swell). We believe hedge fund sentiment should serve as a crucial tool of an […]
UroGen Pharma Ltd. (NASDAQ:URGN) shareholders should be happy to see the share price up 22% in the last month. But...
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Nov. 11) ACADIA Pharmaceuticals Inc (NASDAQ: ACAD ) Agenus Inc ...
Just because a business does not make any money, does not mean that the stock will go down. For example, although...