|Bid||0.00 x 0|
|Ask||0.00 x 0|
|Day's Range||43.59 - 43.96|
|52 Week Range||33.14 - 46.00|
|Beta (5Y Monthly)||0.32|
|PE Ratio (TTM)||28.41|
|Forward Dividend & Yield||1.14 (2.59%)|
|Ex-Dividend Date||Mar 19, 2020|
|1y Target Est||49.10|
Pfizer (PFE) releases promising early results from its COVID-19 vaccine study. Several new drug/line extensions get approval in the United States, EU and Japan.
An appeals court ruling means biosimilar competition won't affect U.S. Enbrel sales for a long time.
Roche (RHHBY) receives FDA approval for a fixed-dose combination of Perjeta and Herceptin, Phesgo, plus chemotherapy as a treatment for HER2-positive breast cancer.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC, under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Genentech has combined two monoclonal antibodies that can be administered by a single SC injection.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.
The therapy, Phesgo, was approved for patients with HER2-positive breast cancer and comes with a boxed warning flagging risks of potential heart failure, fetal harm and lung toxicity. The injectable combination treatment includes Roche's breast cancer therapies Perjeta and Herceptin along with hyaluronidase, which is used to enhance the absorption of the drugs.
Spark Therapeutics will present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study, showing stable and durable factor VIII expression, substantial.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks.
(Bloomberg) -- Miami will close its popular beaches for the July 4 holiday weekend to stem the spread of Covid-19 as southern U.S. states wrestle with the coronavirus. Florida and Arizona said new cases climbed the most for one day, while U.S. cases rose the most since May 15.Vice President Mike Pence postponed Trump re-election rallies next week in two hard-hit states, though meetings with governors and health officials remain on his schedule.New York is investigating an outbreak tied to a traveler from Florida who went to a graduation ceremony then tested positive. Brazil is in a deal with the U.K. to locally make a vaccine developed by Oxford University.Key Developments:Global Tracker: Cases top 9.8 million; deaths pass 495,000Second-generation vaccines are built for impact over speedWhat a century of disease outbreaks teaches us about Covid-19Virus fatality picture obscured by ultimate lagging indicatorU.S.-EU discord imperils rebound in prime transatlantic flightsGermany’s billionaire ‘sausage king’ faces virus reckoningSubscribe to a daily update on the virus from Bloomberg’s Prognosis team here. Click VRUS on the terminal for news and data on the coronavirus.Pence Postpones Rallies in Arizona, Florida (4:40 p.m.)Vice President Mike Pence has postponed Trump re-election events in Arizona and Florida next week as coronavirus cases surge in those states. Pence, who heads the White House coronavirus task force, still plans to meet with governors and health-care teams in both states as well as Texas, a senior campaign official said.Texas Cases Increase in Line With Average (4:05 p.m.)Texas reported new cases rose in line with the 4.2% rate of the previous seven days, ending four days of above-average increases. The state, which on Friday closed bars and imposed limits on restaurants as cases spiked, recorded 5,747 new infections, raising the total to 143,731. Deaths climbed by 42, to 2,366.U.S. Cases Rise the Most Since May 15 (4 p.m. NY)Coronavirus cases in the U.S. increased by 45,450 from the same time Friday, to 2.49 million, according to data collected by Johns Hopkins University and Bloomberg News. It was the biggest percentage jump since May 15. The 1.9% increase was above the average daily rise of 1.5% over the past week.Fatalities rose 0.5% to 125,340.New York reported 703 new cases, a 0.2% increase, for a total of 391,923, with 13 new deaths, raising the toll to 24,830.New Jersey had 347 cases, a 0.2% rise, pushing the total to 170,873, with 36 deaths for a toll of 13,094.California cases rose 5,972, or 3% to 206,433, with 60 new deaths raising the total to 5,872.Michigan reported 314 new cases, a 0.5% rise, bringing the total to 63,009, with 19 deaths for a total of 5,907.Brazil in U.K. Vaccine Deal (3:30 p.m. NY)Brazil reached a deal with the U.K. to locally produce the Covid-19 vaccine that’s been developed by Oxford University and AstraZeneca Plc. Brazil will spend $287 million to buy doses and ingredients to make as many as 100 million shots, Health Ministry Executive Secretary Elcio Franco said at a press conference in Brasilia.The first order, regardless of the final results of the vaccine clinical trials, will cost Brazil $127 million, Franco said. That will include 30.4 million doses delivered in December and January, as well as the technology transfer. Brazil has second-highest number of coronavirus cases and deaths worldwide.Miami-Dade’s Covid-19 Patients Fall (2:20 p.m. NY)Miami-Dade County reported 917 patients with Covid-19 admitted to hospitals, a decline of 77 from a day earlier.The number of Covid-19 patients in intensive-care unit beds rose to 197 from 195, according to a report from the county, which is Florida’s most populous. The number of Covid-19 patients on ventilators fell to 84 from 85 a day earlier.The county noted the latest report didn’t include hospitalizations from two facilities that reported more than 100 admissions on Friday, suggesting the apparent drop could be due to a distortion.N.Y. Reports Cluster at Graduation Ceremony (2 p.m. NY)New York is investigating potential Covid-19 exposure in Westchester County after an individual recently in Florida attended a high school graduation ceremony then tested positive. Since then, four people at the event tested positive and are in self-isolation, the state said.The state Health Department urged anyone at the Horace Greeley High School drive-in graduation ceremony June 20 at Chappaqua Train Station to get tested. Florida has reported record new cases for two days in a row.“The pandemic is far from over and we need to stay vigilant,” Governor Andrew Cuomo said. “We’re prepared to do the aggressive testing and contact tracing required to slow and ultimately control any potential clusters of new cases like the one in Westchester County.”Greece Sets Entry Requirement (1:40 p.m. NY)Greece will require all arriving international travelers to fill in a passenger location form at least 48 hours before check-in, the Civil Aviation Authority said Saturday. The requirement is being introduced ahead of the resumption of inbound flights to all Greek airports starting Wednesday. The measure is in effect until Aug. 31 and is part of efforts to stop the spread of the coronavirus, the Authority said.Ireland’s Cases Most in 2 Weeks (1:30 p.m. NY)Ireland reported the most new cases since June 13, amid increasing worries about the virus spreading to younger people. 10 of the new cases are people under age 35, the health ministry said in a statement, while a further eight are between 35 and 54.“This is now a real concern and a worrying trend,” chief medical officer Tony Holohan said. Some recent cases have had “large numbers of close contacts,” he added. Overall, Ireland has 25,437 cases and 1,734 deaths.Texas Town Imposes Covid Curfew (1 p.m. NY)After a month of protest-related curfews, a town outside of Houston is imposing a curfew starting Saturday to stem the rapidly rising number of Covid-19 cases. The curfew in Galena Park will run from 10 p.m. to 5 a.m., Mayor Esmeralda Moya tweeted.“It is crucial to continue to practice good hygiene, stay home as much as possible, avoid unnecessary trips, gatherings, and wear a face-covering at all times when you leave your home,” Moya said in a statement reported by KHOU-TV. The town has 10,000 residents.Peru to Ease Quarantine Measures (12:50 p.m. NY)Peru will lift quarantine measures for most of the country starting Wednesday, easing one of the world’s strictest lockdowns as it faces a severe economic slide. The state of emergency will remain in effect until July 31, according to a government decree late Friday.Children and the elderly continue to face restrictions and borders will remain closed. Severe lockdown measures imposed in mid-March included soldiers on the streets to enforce stay-at-home measures.But the virus spread, leaving Peru with the almost 9,000 deaths and more than 272,000 cases as of Friday, highest caseload in Latin America after Brazil and the sixth-highest in the world. The International Monetary Fund forecasts the economy will contract 13.9% this year, the steepest drop among major economies in the region.Italy Cases Cross 240,000 (12:30 p.m. NY)Italy registered 175 new cases on Saturday, down from 259 on Friday, the health ministry said. The agency reported eight deaths in the past 24 hours, compared with 30 on Friday, leaving total fatalities at 34,716. Total infections reached 240,136.Lombardy, the hard-hit recgion that includes Milan, reported 77 cases, or 44% of the new national cases.Arizona Cases Rise by a Record (11:40 a.m. NY)Arizona’s new cases increased by a record 3,591 to 70,051, a 5.4% jump that matched the rate of change on Friday, the state reported Friday.The number of deaths rose by 44 to 1,579.Florida Cases Jump 7.8% (10:55 a.m. NY)Florida reported 132,545 cases on Saturday, up 7.8% from a day earlier, compared with an average increase of 4.6% in the previous seven days. Deaths reached 3,390, an increase of 0.7%, according to the report, which includes data through Friday.The state reported 9,585 new cases, a record for one day.New York Reports 13 Deaths (9:46 a.m. NY)Governor Andrew Cuomo said the state had just 13 deaths in the past 24 hours and 703, or less than 1%, of 73,262 tests conducted were positive.“Today’s numbers show a continued, steady decline in our hospitalization and death rates, and proves that a response based on science, not politics, is the only way to defeat this virus,” Cuomo said in a statement. “While this is good news, New Yorkers cannot become complacent.”Golfer Seeks Test During Tourney (9:45 a.m. NY)Jason Day asked to be tested for Covid-19 just before the third round of the Travelers Championship in Cromwell, Connecticut, where several players have already withdrawn, the Associated Press reported. Officials have decided to have him play as a single Saturday as a precautionary measure.Two more golfers withdrew because of the coronavirus Friday -- Denny McCarthy for a positive test, and Bud Cauley, who tested negative but decided to pull out after playing alongside McCarthy on Thursday.India Has More Than 500,000 Cases (9:30 a.m. NY)India became the fourth country with more than half a million cases after the U.S., Brazil and Russia. Infections increased 3.8%, in line with the past week, to 508,953 with 15,685 deaths.The country today extended the deadline for the submission of expressions of interest for investment in national carrier Air India Ltd. to Aug. 31 due to the Covid-19 situation. This is the seventh time the deadline has been extended since January.Portugal Reports Smaller Increase in New Virus Cases (9:06 a.m. NY)Portugal reported 323 new coronavirus cases on Saturday, down from 451 on Friday, taking the total to 41,189, the government said. Daily new cases have ranged between 192 and 451 in June. The additional cases are mostly in the greater Lisbon region, where authorities have tightened restrictions in 19 parishes and increased testing after new clusters were identified.Iran Infections Rise 1.13% (8:08 a.m. NY)The number of Covid-19 cases in Iran rose by 2,456 to more than 220,000 on Saturday. The increase of 1.13% is the smallest in percentage terms since May 3.Iran remains the Middle East’s worst-hit nation by the virus with at least 2,000 new cases every day over the past month. Fatalities reached 10,364 as 125 people died from the virus overnight.Elsewhere in the region, Iraq had a 5% daily increase to a total of 43,262. In Saudi Arabia, infections rose 2.2% to 178,504.Roche Ramping Up Antibody Test Production (6:56 a.m. NY)Roche Holding AG will increase production of antibody tests as it struggles to meet demand, its chairman said in an interview with a Swiss newspaper. “Demand exceeds our production,” Roche Chairman Christoph Franz told Tages Anzeiger.Virus Found in Spanish Wastewater in March 2019 (6 a.m. NY)A Spanish study found evidence of coronavirus in Barcelona wastewater 10 months before the Spanish government reported its first infection. The research, which hasn’t been scientifically reviewed by peers, is based on a finding from water collected March 12, 2019, and frozen for later testing. This indicates “that the infection was present in the population before the first imported case was reported,” according to the study, whose authors include Rosa Pinto, a microbiology professor at the University of Barcelona. Samples taken in the rest of 2019 resulted negative.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Swiss drugmaker Roche is unable to meet demand for molecular tests to identify active COVID-19 infections, its chairman told Swiss daily Tagesanzeiger. "The demand exceeds our production," Christoph Franz was quoted as saying in Saturday's paper. The decision on where tests were shipped to depended, among other things, on infection rates and the availability of diagnostic equipment.
uPath PD-L1 (SP263) image analysis uses automated pre-computing and one-click scoring to enable quicker and accurate detection and measurement of tumour cell staining.
Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™(tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK, a cancer drug that acts as a selective EZH2 gene inhibitor.
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 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 Therapeutics Inc (NASDAQ: NBSE) * Ocular Therapeutix Inc (NASDAQ: OCUL) * Ovid Therapeutics Inc (NASDAQ: OVID) * Passage Bio Inc (NASDAQ: PASG) * Pliant Therapeutics Inc (NASDAQ: PLRX) * Protagonist Therapeutics Inc (NASDAQ: PTGX) * Royalty Pharma plc (NASDAQ: RPRX) (IPOed Monday) * Sarepta Therapeutics Inc (NASDAQ: SRPT)(announced a licensing agreement with Selecta Biosciences Inc (NASDAQ: SELB) for licensing the latter's immune tolerance platform, ImmTOR for use in Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies) * Tandem Diabetes Care Inc (NASDAQ: TNDM) * TELA Bio Inc (NASDAQ: TELA) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) * Trevena Inc (NASDAQ: TRVN) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech Stocks Hitting 52-week Lows June 18) * CALLIDITAS THER/S ADR (NASDAQ: CALT)Stocks In Focus Mylan Wins Patent Lawsuit Against Biogen With Respect To Multiple Sclerosis Drug Mylan NV (NASDAQ: MYL) said the U.S. District Court for the Northern District of West Virginia ruled in its favor by invalidating Biogen Inc's (NASDAQ: BIIB) Tecfidera patent, U.S. Patent No. 8,399,514, for lack of written description. Mylan noted that the patent pertains to methods of treating multiple sclerosis using a dose of 480 mg/day of dimethyl fumarate delayed release capsules, and would have disallowed generic competition until 2028.With the patent win, Mylan is allowed to launch of its dimethyl fumarate product upon the receipt of FDA approval.In pre-market trading Friday, Mylan shares were rising 2.27% to $16.70.Assembly Biosciences Regains Rights To Gastrointestinal Programs After AbbVie Terminates Deal Assembly Biosciences Inc (NASDAQ: ASMB) said it will regain worldwide rights to all microbiome gastrointestinal programs, including ABI-M201 and ABI-M301, licensed under its collaboration agreement with AbbVie's Allergan. The development follows AbbVie deciding to terminate the R&D, collaboration and license agreement. This decision was not based on any efficacy, safety, or other data related to the collaboration programs, Assembly Biosciences said.ABI-M201 is currently being evaluated in a Phase 1b trial in patients with mild to moderate ulcerative colitis and ABI-M301 is a preclinical program for Crohn's disease, the company said. The transition is expected to be completed in the fourth quarter of 2020.In pre-market trading, Assembly Biosciences shares were rising 1.95% to $22.50.Tiziana to Get Patent For Platform Technology For Oral Administration Of Fully Human Monoclonal Antibodies Tiziana Life Sciences plc (NASDAQ: TLSA) announced the United States Patent and Trademark Office has granted a patent covering its proprietary platform technology for the oral administration of Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies. The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for regulation of immune system, the company added. The patent will be issued by the USPTO June 23.The stock rallied 16.09% to $7 in pre-market trading.Roche Reports Positive Results For Late-Stage Prostate Cancer Study Roche Holdings AG Basel ADR (OTC: RHHBY) said the phase 3 IPATential150 study that evaluated ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care plus placebo met its co-primary endpoint of radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer and whose tumours had PTEN loss.The company said overall survival benefit and additional secondary endpoints are not yet mature and the trial will continue until the next planned analysis.Endologix CFO Departs, Announces Interim CEO Endologix, Inc. (NASDAQ: ELGX) said its CFO Vaseem Mahboob,will leave the company, effective July 1, to take over as CFO of a private global healthcare company.View more earnings on IBBThe company announced the appointment of Cindy Pinto, VP, Financial Planning & Analysis, as interim CFO in addition to her current responsibilities, and it also said it has initiated a search process for a permanent successor.Miragen Appoints Pharma Industry Veteran As COO Miragen Therapeutics Inc (NASDAQ: MGEN) announced the appointment of Lee Rauch as Chief Operating Officer, effective immediately. Rauch, who has over 25 years of experience in the biotech and pharma industries, will report to the CEO and will be responsible for overseeing business development, licensing, partnerships, investor relations, corporate communications, intellectual property, and new product planning, the company said.In pre-market trading, the stock was up 4.20% t $1.24.Akebia Names David Spellman as CFO Akebia Therapeutics Inc (NASDAQ: AKBA) said David Spellman is joining Akebia as its new SVP, Chief Financial Officer and Treasurer, effective June 29, replacing Jason Amello, who has been serving in the position since 2013.Dynavax Says Human Trial of COVID-19 Vaccine Using Its Adjuvant Initiated Dynavax Technologies Corporation (NASDAQ: DVAX) announced the first participants have been dosed in the Phase 1 clinical trial to evaluate Clover Biopharma's vaccine candidate to prevent COVID-19 that contains the Company's CpG 1018 adjuvant.In pre-market trading, Dynavax shares were rising 9.30% to $6.70.Earnings Urovant Sciences Ltd (NASDAQ: UROV) reported a net loss of $1.68 per share for its fiscal-year 2019 fourth quarter compared to a loss of 96 cents per share a year ago. This was wider than the consensus loss estimate of $1.24 per share.The stock was down 3.48% to $11.10 in pre-market trading.BioNano Genomics Inc's (NASDAQ: BNGO) first-quarter revenues fell from $1.8 million in 2019 to $1.1 million in 2020. The net loss widened from $7.8 million to $10.5 million.The stock was sliding 5.80% to 49 cents in pre-market trading.On The Radar PDUFA Dates Nabriva Therapeutics PLC - ADR (NASDAQ: NBRV) is knocking at the FDA altar for the second time for its investigational antibiotic contepo for treating complicated urinary tract infection. The company hinted at the decision being delayed due to the FDA requiring inspection of the facilities of third-party manufacturers in Europe.Evoke Pharma Inc (NASDAQ: EVOK) has a PDUFA date in the unfolding for its Gimoti to treat women with acute and recurrent diabetic gastroparesis.IPOs Repare Therapeutics Inc., a precision oncology company enabled by its proprietary synthetic lethality approach, priced its upsized initial public offering of 11 million shares of its common shares at $20 per share. Repare's common shares are expected to begin trading on the Nasdaq under the ticker symbol RPTX.Forma Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, priced its IPO of 13.88 million shares at $20 per share. The shares are expected to begin trading on the Nasdaq under the ticker symbol FMTX.See more from Benzinga * The Daily Biotech Pulse: Eloxx Resumes Cystic Fibrosis Study, Rexahn's Reverse Merger, Ultragenyx, Epizyme Await FDA Decisions * The Daily Biotech Pulse: Patent Win For Amarin, FDA Nod For Novartis & Merck, Chembio's Coronavirus EUA Revoked * The Daily Biotech Pulse: GlaxoSmithKline, IDEAYA Strike Oncology Partnership, Decision Day For Merck, Adverum's New CEO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumors had PTEN loss. In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overall study population (intention-to-treat) was not met. The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks. The results of the IPATential150 study will be presented at an upcoming medical meeting.
·Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and.
A resurgence of coronavirus cases in key U.S. regions is nudging nationwide numbers higher, casting doubt on state efforts to relax lockdowns.
Roche's (RHHBY) phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy meets goal in early TNBC patients.
Despite the setback, the Swiss drugmaker said that it is pressing ahead with testing Actemra in another trial against COVID-19, the disease caused by the new coronavirus. Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments, the Italian Medicines Agency (Aifa), Italy's drugs regulator which authorized the study, said in a statement on Wednesday.