|Bid||N/A x N/A|
|Ask||N/A x N/A|
|Day's Range||43.54 - 43.90|
|52 Week Range||33.57 - 46.63|
|Beta (5Y Monthly)||0.32|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||1.14 (2.57%)|
|Ex-Dividend Date||Mar 19, 2020|
|1y Target Est||50.10|
With the first half of 2020 in the books and the second-quarter earnings season in full swing, it looks as if global markets are starting to return to some semblance of normalcy.The CBOE Volatility Index is nearing its lowest point since February 24, when Covid-19 fears first swept through Wall Street. And on OTC Markets, trading volume has started to recede back to pre-March levels. With the exception of the OTCQB Venture Market, which just experienced its highest volume month of the year in June, trading volume on the OTCQX Best Market and Pink Current Information Market have reverted back to levels in-line with typical activity.Here are four other takeaways from first-half trading activity on OTC Markets.Elevated Volume Was A Theme Through 2020's halfway mark, total dollar volume on OTC Markets was about $224.6 billion, up 32% on a year-over-year basis.Unsurprisingly, March was the highest volume month as investors digested the implications of a pandemic and economic crisis. Nearly 25% of the total year-to-date dollar volume on OTC Markets occurred in March.As A Whole, Venture Companies Outperformed Of the nine indexes that track the broad-based performance of securities on OTC Markets, the benchmark with the best performance in the first half was the OTCQB Index, which fell 5.36% from the end of 2019. In addition to early stage venture companies, the OTCQB market is home to many metals and miners, which are typically seen as safe-haven assets during times of market turmoil.This was followed by the OTCQX Dividend Index, a benchmark of all the OTCQX members that pay a regular dividend, which fell 8.19%.There Were 115 New Companies On OTCQX And OTCQB This includes companies from across the economic landscape, specifically community banks, miners, and venture stage biotechs. The 115 new QX and QB securities figure is on par with prior year totals, a sign that businesses still see the U.S. capital markets as a viable option for raising capital in 2020.The average year-to-date gain of these new securities in the first half of 2020 was 20.84%.Roche And GBTC Were The Most Actively Traded Names Through June, Roche Holding Ltd (OTCQX: RHHBY) was the only security on the OTCQX Best Market, the top tier of OTC Markets, to exceed $10 billion in dollar volume. In keeping with the trend from 2019, Roche and GBTC were far and away the two most actively traded securities on the market through the first six months.Below is a list of the top 10 most actively traded securities on the OTCQX tier of OTC Markets in the first half:Company Ticker First Half Volume Market Cap* Roche Holding Ltd (OTCQX: RHHBY, RHHBF, RHHVF) $12,594,906,931 $297.4 billion Grayscale Bitcoin Trust (OTCQX: GBTC) $6,389,893,871 $5.2 billion Danone (OTCQX: DANOY, GPDNF) $1,854,398,826 $45.7 billion adidas AG (OTCQX: ADDYY, ADDDF) $1,283,167,427 $54.7 billion BNP Paribas (OTCQX: BNPQY, BNPQF) $1,040,232,206 $50 billion BASF SE (OTCQX: BASFY, BFFAF) $778,893,311 $50.3 billion Imperial Brands PLC (OTCQX: IMBBY,IMBBF) $765,614,985 $15.8 billion AXA (OTCQX: AXAHY, AXAHF) $762,624,422 $48.3 billion Infineon Technologies AG (OTCQX: IFNNY, IFNNF) $694,588,314 $30.8 billion Koninklijke Ahold Delhaize N.V. (OTCQX: ADRNY, AHODF) $612,063,744 $1.06 billion *As of July 31, 2020Image: RocheSee more from Benzinga * With Gold And Silver On Fire, 23 Metals & Mining Executives Set To Give Investor Update This Week * Trading Activity In Emerging Names Increased On OTC Markets In June * Fintech Trends To Watch Out For In The Second Half Of 2020(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
* FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation * Accurate monitoring of Epstein-Barr virus DNA levels is critical, as they are associated with a range of life threatening-diseases including cancer in transplant patients * Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S., allowing for results to be easily comparable across hospitals and labs Basel, 5 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time. “Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients,” said Thomas Schinecker, CEO Roche Diagnostics. “The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients.” The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA. The test was previously granted FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions. About the cobas EBV test The cobas EBV test is a real-time PCR (polymerase chain reaction) viral load test with dual target technology, which provides quantitative accuracy and guards against the risk of sequence variations that may be present in the Epstein-Barr virus. The cobas EBV test has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma. The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making. The fully automated cobas EBV test can be run on the cobas 6800/8800 Systems providing absolute automation with proven performance and flexibility. Simultaneous testing with CMV or other virology tests leads to time savings and increased efficiency. About Epstein-Barr virus (EBV) Epstein-Barr virus is a member of the herpes virus family and has been associated with a range of cancers in transplant patients, such as post-transplant lymphoproliferative disorder (PTLD). Once infection with EBV occurs, the virus establishes as a latent form and can remain in the body. Most people harbor EBV with no long-term clinical ramifications. EBV spreads most commonly through bodily fluids, primarily saliva. This does not always cause symptoms, but people with weakened immune systems, including transplant patients, are more likely to develop symptoms if EBV reactivates.1 About the cobas 6800/8800 Systems When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.* Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.* These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship. Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy and traceability to World Health Organization standards. Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever. Learn more now: www.cobas68008800.com or http://diagnostics.roche.com. *May vary based on workflow demands About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References  Kanakry JA, et al. The clinical significance of EBV DNA in the plasma and peripheral blood mononuclear cells of patients with or without EBV diseases. Blood. 2016; Apr 21;127(16):2007-17 Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: email@example.comDr. Nicolas Dunant Phone: +41 61 687 05 17 Patrick Barth Phone: +41 61 688 44 86 Daniel Grotzky Phone: +41 61 688 31 10 Karsten Kleine Phone: +41 61 682 28 31 Nina Mählitz Phone: +41 79 327 54 74 Nathalie Meetz Phone: +41 61 687 43 05 Barbara von Schnurbein Phone: +41 61 687 89 67 Roche Investor Relations Dr. Karl Mahler Phone: +41 61 68-78503 e-mail: firstname.lastname@example.org Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail: email@example.com Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: firstname.lastname@example.org Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: email@example.com Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: firstname.lastname@example.org Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: email@example.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: firstname.lastname@example.org Dr. Lisa Tuomi Phone: +1 650 467 8737 e-mail: email@example.com Attachment * 05082020_MR_EBV
July turned out to be a mixed month for FDA approvals. Endo International PLC's (NASDAQ: ENDP) cellulite treatment, Osmotica Pharmaceuticals PLC's (NASDAQ: OSMT) eye disorder drug and Jazz Pharmaceuticals PLC's (NASDAQ: JAZZ) drug to treat excessive daytime sleepiness were among those which successfully cleared the FDA hurdle.A few others, including Verrica Pharmaceuticals Inc (NASDAQ: VRCA) and Eagle Pharmaceuticals Inc (NASDAQ: EGRX), are forced to wait. The regulatory agency handed down a complete response letter for Verrica's viral skin infection treatment, while Eagle Pharma's PDUFA date for its exertional heat stroke drug was postponed until Aug. 8 due to FDA's reallocation of resources due to COVID-19.Four new molecular entities, or NMEs, were approved in July, taking the total number of NME approvals for the year to 29.Here are the key PDUFA dates scheduled for August.GSK Seeks To Expand Use Of Triple Combo Drug To Asthma * Company: GlaxoSmithKline plc (NYSE: GSK) * Type of Application: sNDA * Candidate: Trelegy Elypta * Indication: asthma * Date: Aug. 2 (estimated based on the 10-review period from the regulatory application filing date of Oct. 2)Trelegy Elypta is a single inhaled triple therapy consisting of fluticasone furoate/umeclidinium/vilanterol) and has already been approved for chronic obstructive pulmonary disease. The company is now seeking label expansion to include asthma as an indication.The investigational asset is jointly developed by GlaxoSmithKline and Innoviva Inc (NASDAQ: INVA). Theravance Biopharma Inc (NASDAQ: TBPH) has an economic interest in potential future payments from GlaxoSmithKline.Adcom Cancellation Reduces Likelihood Of DBV's Peanut Allergy Patch Approval * Company: DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT) * Type of Application: BLA * Candidate: Viaskin Peanut * Indication: Peanut allergy in children, ages 4-11 years * Date: Aug. 5Viaskin Peanut is DBV's lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts. A non-invasive, once-daily, epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to activate the immune system.The investigational immunotherapy, which has Breakthrough and Fast Track designations, was accepted for review in October 2019\. The FDA communicated its intention to hold an Adcom meeting on May 15. With the agency canceling the meeting due to questions over patch's efficacy, including the impact of patch-site adhesion, the probability of approval has reduced.Can Second Time Prove Charm For Trevena? * Company: Trevena Inc (NASDAQ: TRVN) * Type of Application: NDA * Candidate: Oleceridine * Indication: moderate-to-severe acute pain * Date: Aug. 7Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted.Trevena's original NDA was handed down a complete response letter in November 2018, with the FDA requesting additional clinical data on QT prolongation and indicating the submitted safety database is not of adequate size for the proposed dosing.The company resubmitted the regulatory application in February, and the FDA deemed it as a complete response and assigned a PDUFA date of Aug. 7."Positive physician feedback builds a strong use case of IV oliceridine," HC Wainwright analyst Douglas Tsao said in a March note.Eagle Pharma Awaits Decision On Heat Stroke Drug * Company: Eagle Pharma * Type of Application: NDA * Candidate: Ryanodex * Indication: exertional heat stroke, or EHS. * Date: Aug. 8Ryanodex, or dantrolene sodium for injectable suspension, is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures. The original NDA for treating EHS was handed down a CRL in July 2017. Eagle resubmitted the application in Jan. 2020.EHS, a severe form of heat-related illness, is characterized by core body temperature of 104° F or greater and significant neurological dysfunction, such as sudden changes in behavior, seizures or coma."We believe expectations for approval are low; thus, if EGRX is successful in gaining approval on or by the PDUFA date, we would expect this to be positively received given that it would provide upside not fully reflected in current estimates," Cantor Fitzgerald said in a recent note.Second Try For Eton's Eye Inflammation Drug * Company: Bausch Health Companies Inc (NYSE: BHC) and Eton Pharmaceuticals Inc (NASDAQ: ETON) * Type of Application: NDA * Candidate: EM-100 * Indication: allergic conjunctivitis. * Date: Aug. 10EM-100 is Eton's preservative-free ophthalmic solution for the treatment of allergic conjunctivitis. The company has executed a commercialization deal with Bausch Health to market the ophthalmic solution. Bausch Health, which had filed a regulatory application for EM-100, received a complete response letter for the application in July 2019.Following a resubmission, the FDA assigned a PDUFA date of Aug. 10.Fennec Waits to Hear On Drug To Treat Chemotherapy-induced Hearing Loss * Company: Fennec Pharmaceuticals Inc (NASDAQ: FENC) * Type of Application: NDA * Candidate: Pedmark * Indication: chemotherapy-induced ototoxicity * Date: Aug. 10Pedmark is a unique formulation of sodium thiosulfate, and is being evaluated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.The company announced in April FDA accepted the regulatory application with priority review.If approved, Pedmark could be the first product for the prevention of Cisplatin-induced hearing loss in children, Fennec said.Roche Seeks Label Expansion For Asthma Biologic * Company: Roche Holdings AG (OTC: RHHBY) * Type of Application: sBLA * Candidate: Xolair * Indication: Nasal polypsDate: Q3 (estimated to be Aug. 11 based on 10 months from the filing of regulatory application)Xolair, an antibody, has been approved in the U.S. for the treatment of moderate-to-severe persistent asthma in patients 6 years and older and chronic idiopathic urticaria in patients 12 years and older.Roche's Genetech unit is seeking to get approval for the additional indication of treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E, the company said.Gilead Awaits Nod For Rheumatoid Arthritis Drug * Company: Gilead Sciences, Inc. (NASDAQ: GILD) and GALAPAGOS NV/S ADR (NASDAQ: GLPG) * Type of Application: NDA * Candidate: filgotinib * Indication: Rheumatoid arthritis * Date: Aug. 19 (estimated assuming a priority review)Filgotinib, an oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis, is widely believed by analysts to possess blockbuster potential. Gilead had licensed the investigational asset from Galapagos.Gilead submitted the NDA in December, along with a Priority Review voucher.Go Or No-Go For BioMarin's Hemophilia Gene Therapy? * Company: BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Type of Application: BLA * Candidate: Valoctocogene roxaparvove * Indication: hemophilia A * Date: Aug. 21Valoctocogene roxaparvovec is BioMarin's investigational AAV5 gene therapy for treating adults with hemophilia A. If approved, it will become the first gene therapy for any type of hemophilia.Tricida Staring Down the Barrel Ahead Of Vevermier PDUFA Date * Company: Tricida Inc (NASDAQ: TCDA) * Type of Application: NDA * Candidate: TRC 101 * Indication: metabolic acidosis in patients with chronic kidney disease * Date: Aug. 22Veverimer, codenamed TRC101, is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease.Casting doubts on decision coming by the scheduled date, the company said on July 15 it received a notification from the FDA, stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.There is little time left from now until the PDUFA date for the FDA to inform Tricida of the nature of the deficiency and for Tricida to subsequently respond, Needham analyst Alan Carr said, commenting on the FDA communication. A Complete Response Letter appears increasingly probable, he said.However, if the company is requested to submit additional information prior to the PDUFA date, a major amendment, triggering a three-month extension of the PDUFA date may also be a possibility.Roche Eyes SMA Drug Approval After 3-Month Delay * Company: Roche and PTC Therapeutics, Inc. (NASDAQ: PTCT) * Type of Application: NDA * Candidate: Risdiplam * Indication: spinal muscular atrophy * Date: Aug. 24 (expected)Roche is leading the clinical development of risdiplam, as part of a collaboration with the SMA Foundation and PTC. Risdiplam is an investigational, orally-administered survival motor neuron-2 splicing modifier for spinal muscular atrophy.Roche's NDA was accepted for Priority Review in Decemeber, with a PDUFA date of May 24. The FDA extended the review period by three months, reasoning that it needs time to review additional data submitted by Roche in February based on its discussion with the FDA.Will Lipocine Succeed With Its Fourth Try? * Company: Lipocine Inc (NASDAQ: LPCN) * Type of Application: NDA * Candidate: Tlando * Indication: Hypogonadism * Date: Aug. 28Tlando, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.The investigational asset stumbled at the FDA altar three times in the past. Following Lipocine's third resubmission, the FDA has established a PDUFA action date of Aug. 28Roche Hopes To Be Better Late Than Never * Company: Roche * Type of Application: BLA * Candidate: Satralizumab * Indication: neuromyelitis optica spectrum disorder, or NMOSD * Date: Aug. 29Satralizumab is an investigational humanized monoclonal antibody that targets the IL-6 receptor. The cytokine IL-6 is thought to be a key driver of NMOSD, triggering the inflammation cascade and leading to damage and disability.Roche announced FDA acceptance of the BLA Oct. 30, and assuming a standard ten-month review period, the decision is expected Aug. 29.Earlier this year, the Japanese drug regulatory agency approved satralizumab for treating NMOSD.If the approval comes through, Roche may have to face competition from two drugs already in the market, namely Alexion Pharmaceuticals, Inc.'s (NASDAQ: ALXN) Soliris and Viela Bio Inc's (NASDAQ: VIE) Uplizna.Morphosys-Incyte Await FDA Word On Lymphoma Drug * Company: Incyte Corporation(NASDAQ: INCY) and Morphosys Ag (NASDAQ: MOR) * Type of Application: BLA * Candidate: Tafasitamab * Indication: diffuse large B cell lymphoma, or DLBCL * Date: Aug. 30Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Morphosys had licensed the investigational asset from Xencor Inc (NASDAQ: XNCR) in 2010. In January, Morphosys and Incyte entered into a a collaboration and licensing agreement to commercialize tafasitamab globally.The FDA accepted March 2, Morphosys' BLA, seeking approval for tafasitamab, in combination with Revlimid, as a treatment option for relapsed or refractory DLBCL. The agency set a PDUFA action date of Aug. 30.Adcom CalendarFDA Oncology Drug Advisory Committee will discuss Mesoblast limited's (NASDAQ: MESO) BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.See more from Benzinga * Gilead Analysts Downplay Q2 Miss Amid Remdesivir's COVID-19 Opportunity * Apple's Path To Trillion Is Set As Wall Street Lauds Resilience, Ecosystem Engagement * Moderna Targeted By Chinese Hackers For Data Theft: Report(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.