|Bid||0.8601 x 1100|
|Ask||0.9000 x 1800|
|Day's Range||0.8650 - 0.8800|
|52 Week Range||0.4300 - 0.8800|
|Beta (5Y Monthly)||N/A|
|PE Ratio (TTM)||0.22|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
J&J (JNJ) to begin human clinical studies on coronavirus vaccine candidate in September. Sanofi (SNY) begins outside U.S. study on Kevzara for severe COVID-19 infection.
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 April 2)BELLUS Health Inc (NASDAQ: BLU)Down In The Dumps (Biotech Stocks Hitting 52-week Lows April 2) * BIOLASE Inc (NASDAQ: BIOL) * BioNano Genomics Inc (NASDAQ: BNGO) (priced $18 million common stock and warrant offering) * Celcuity Inc (NASDAQ: CELC) * China SXT Pharmaceuticals Inc (NASDAQ: SXTC) * Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) * ENDRA Life Sciences Inc (NASDAQ: NDRA) * Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) * Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) * Mediwound Ltd (NASDAQ: MDWD) * Merus NV (NASDAQ: MRUS) * Myokardia Inc (NASDAQ: MYOK) * Neovasc Inc (NASDAQ: NVCN) * Opko Health Inc. (NASDAQ: OPK) * PDS Biotechnology Corp (NASDAQ: PDSB) * Phio Pharmaceuticals Corp (NASDAQ: PHIO) * Precipio Inc (NASDAQ: PRPO) * Seelos Therapeutics Inc (NASDAQ: SEEL) * Sellas Life Sciences Group Inc (NASDAQ: SLS) * Chanticleer Holdings Common Stock (NASDAQ: SONN) * Vaccinex Inc (NASDAQ: VCNX)Stocks In Focus Fate Announces CAR T-cell Therapy Licensing Deal With J&J's Janssen Unit Fate Therapeutics Inc (NASDAQ: FATE) said it has entered into a global collaboration and option agreement with Johnson & Johnson (NYSE: JNJ)'s Janssen unit, under which it will apply its iPSC product platform to research and preclinically develop new iPSC-derived chimeric antigen receptor, or CAR, NK and CAR T-cell product candidates.Janssen will contribute proprietary antigen-binding domains for up to four tumor-associated antigen targets, and pay Fate $50 million in cash and also subscribe to $50 million in the latter's common shares at $31 per share.Fate will be responsible for developing candidate until IND filing after which Janssen has the right to exercise options to license these.Fate is eligible to receive payments of up to $1.8 billion upon the achievement of development and regulatory milestones and up to $1.2 billion upon the achievement of commercial milestones, plus double-digit royalties on worldwide commercial sales of products targeting the antigens.Fate shares jumped 23.40% to $26 in after-hours trading.Sanofi, Regeneron Announces Positive Latestage Data For Dupixent-SoC Combo In Eczema In Kids Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) announced data from pivotal Phase 3 study of Dupixent combined with standard-of-care topical corticosteroidsin children aged 6-11 years with uncontrolled severe atopic dermatitis, which showed significantly improved disease signs, symptoms and health-related quality of life.The company said detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis Virtual Conference on Sunday.See Also: Attention Biotech Investors: Mark Your Calendar For These April PDUFA DatesNovartis, Incyte to Study Ruxolitinib For COVID-19 Related Cytokine Storm Novartis AG (NYSE: NVS) said it a plans to initiate a Phase 3 clinical trial in collaboration with Incyte Corporation (NASDAQ: INCY) to evaluate the use of ruxolitinib for the treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.Novartis said it is taking steps to manage the anticipated increase in COVID-19 related requests for Jakavi - trade name of ruxolitinib in territories outside of the U.S. - without interrupting access for patients taking the drug for its licensed indications.Novartis has licensed Jakavi from Incyte to commercialize in regions outside of the U.S., while Incyte markets it in the U.S. under the name Jakafi.Novartis shares gained 1.18% to $84.59 in after-hours trading, while Incyte stock rose 1% to 1.86% to $78.50 in after-hours trading.Immucell Pre-announces Q1 Net Product Sales Growth of 11.3% ImmuCell Corporation (NASDAQ: ICCC) announced preliminary first-quarter results, expecting product sales of $4.9 million, up 11.3% year-over-year.Savara Licenses Latestage Inhaled Antibiotic Asset From Grifols Savara Inc (NASDAQ: SVRA) said it has entered into an exclusive license and collaboration agreement with Grifols SA - ADR ADR Class B (NASDAQ: GRFS) for Apulmiq - inhaled liposomal ciprofloxacin. Apulmiq is a late-stage investigational inhaled antibiotic in Phase 3 development for the treatment of non-cystic fibrosis bronchiectasis.The agreement provides for Savara obtaining worldwide rights to develop and commercialize Apulmiq for an upfront payment. if regulatory approval is obtained, Grifols will be eligible for regulatory milestone payments as well as royalties and potential tiered sales milestones upon commercialization.Savara said it expects to work with regulatory agencies to plan a confirmatory Phase 3 study.The stock rallied 11.83% to $2.08 in after-hours trading.Emergent Biosolutions Gets $14.5M Grant For COVID-19 Therapy Development Emergent Biosolutions Inc (NYSE: EBS) said it has entered into a formal partnership with the U.S. government to expedite development of plasma-derived therapy for patients with COVID-19. The company said it has received $14.5 million from the BARDA for its COVID-HIG program - one of the hyperimmune development programs announced by the company in March.Announcements On COVID-related Impacts Updating on COVID-19 impact, Denali Therapeutics Inc (NASDAQ: DNLI), a neurodegenerative diseases-focused biopharma, said it does not expect delays to its clinical trials due to manufacturing or supply-chain issues. The company, however, said it has paused enrollment of new patients into some of its trials.The company also said it has sufficient cash to fund business operations through 2022.The stock slipped 2.41% to $17.02 in after-hours trading.Dynavax Technologies Corporation (NASDAQ: DVAX) announced withdrawal of its 2020 guidance, citing uncertainties about the duration and effect of the COVID-19 pandemic and the potential impact on hepatitis B vaccine - Heplisav-B - product sales.The company also said it has already exceeded the Heplisav-B minimum product revenue covenant in its term loan agreement of $30 million for the annual measurement period ending June 30.On The Radar Clinical Readout Prothena Corporation PLC (NASDAQ: PRTA) said its development partner Roche Holdings AG Basel ADR (OTC: RHHBY) will present baseline data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease in an oral presentation at the Advances in Alzheimer's and Parkinson's Therapies AAT-AD/PD Focus Meeting being held virtually.IPO Zentalis Pharma, a biopharma focused on developing small molecule therapeutics targeting fundamental pathways of cancer, said it has priced its initial public offering of 9.18 million shares at $18 per share for raising gross proceeds of $165.2 million. The company expects the offering to close April 7. The shares are to be listed on the Nasdaq under the ticker symbol ZNTL.See more from Benzinga * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test * The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection * The Daily Biotech Pulse: NY State Endorses Mallinckrodt's Opioid Settlement, Kamada To Work On COVID-19 Treatment(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
The FDA requests drugmakers to withdraw all ranitidine medications, which includes Sanofi's (SNY) popular heartburn drug Zantac, due to possible increase in risk of cancer.
The FDA asked producers of the heartburn medication ranitidine, known widely as the Zantac brand, to pull the products from the market. The agency had earlier said the product has an impurity that could cause cancer.
The U.S. Food and Drug Administration said on Wednesday it was requesting makers of all versions of heartburn drug Zantac to remove the drugs from the market immediately due to the presence of a probable carcinogen. Zantac, sold in the United States by French drugmaker Sanofi SA, and some generic versions of the treatment have been recalled over the last year due to possible contamination with N-nitrosodimethylamine (NDMA). The FDA said it had determined that NDMA in some ranitidine products increases over time and when stored at higher than room temperatures, resulting in consumer exposure to unacceptable levels of the impurity.
The US drugs regulator has requested the heartburn drug Zantac be pulled from the market amid an investigation into whether the medicine made by Sanofi could be contaminated with a carcinogen. The Food and Drug Administration said on Wednesday that it had discovered that a cancer-causing impurity in some products based on ranitidine, known by the brand name Zantac, increases over time and when stored at higher temperatures. The agency said this may “result in consumer exposure to unacceptable levels of this impurity”.
(Bloomberg Opinion) -- If we want a vaccine or drug treatment to stop coronavirus, the government should ignore those complaining about drug-company profits and commit to a huge reward that encourages more businesses to develop one. It wouldn’t just save lives; it could save the global economy. The coronavirus could cost the U.S. $1.5 trillion in annual economic output, or $125 billion every month — and that’s a conservative estimate. The losses for the entire world economy will be four to five times larger. And these economic costs will be dwarfed by the human costs of illness and death. Absent a vaccine or treatment, this pandemic will likely be with us for more than a year. Speeding the development of vaccines and effective drug therapies by vastly increasing the rewards for businesses would decisively limit the economic damage. Based on the economic losses in the U.S. alone, the government should be willing to spend at least an additional $62.5 billion to spur Covid-19 research and development. Even if that shortened the crisis by just two weeks, it would be a bargain. Research teams at large pharma companies such as Roche, Eli Lilly, Sanofi Pasteur and Takeda, and smaller biotech firms such as BioNTech, are racing to develop a vaccine. But these firms stand to capture only a small fraction of the large economic benefit that will accrue to society when they successfully produce a vaccine or therapy. Developers will likely be pressured to offer a future vaccine at a low price. Even now, there have been calls to sharply limit future profits from such a vaccine. The result is significant underinvestment in the development of vaccines that will likely have large social benefits. Here is a simple way to see this. U.S. spending on all pharmaceutical R&D in 2020 was projected to be $80 billion — equivalent to three weeks of the annual U.S. economic output loss — with only a small fraction of this directed toward infectious diseases. In 1967, 26 pharmaceutical companies produced vaccines; by 1980, 17 did; only four — GlaxoSmithKline, Merck, Pfizer and Sanofi Pasteur — undertake significant production today. This is not surprising. Developing a vaccine requires $500 million to $1 billion in investment, recent estimates suggest, while only 7% of projects result in a vaccine. As a result, even today, with the pandemic raging, many small biotech firms are watching from the sidelines. Those working on vaccines rely on money from foundations and government initiatives. Two of the most promising developers of a Covid-19 vaccine, Inovio and Moderna, are funded by the Coalition for Epidemic Preparedness Innovations (Cepi), an alliance of charities and governments. The U.S. government, perhaps working with others, should guarantee a significant financial payment to whoever first develops a vaccine. One way to do this would be to commit to a high price for each administered dose of an effective vaccine or treatment therapy. As an example, if the U.S. government were to promise a price of $190 per administered dose to the developers, spending a maximum of $62.5 billion to vaccinate or treat all Americans, then society would have earned back its investment even if this only sped up the development by two weeks. The vaccine should also be made available at marginal cost to developing countries.The government could further stimulate collaboration by committing to large awards for successful clinical trials, provided that the research is fully disclosed. If the European Union were to make a similar commitment to this price per administered dose, the total incentives could be strengthened by another $100 billion. While creating vaccines always takes time, experts in the field have learned from previous episodes that there can be major bottlenecks in vaccine development and manufacturing. Once developed, the supply is likely to fall short of demand for a long period. Additional financial resources can relieve these production bottlenecks. We are not asking the U.S. government, or any other government, to pick winners. We are asking the government to make an ironclad commitment right now, backed by legislation, to reward those companies that successfully lead the fight against Covid-19 and future outbreaks.This column does not necessarily reflect the opinion of Bloomberg LP and its owners.Hanno Lustig is a professor of finance at Stanford University. Jeffrey Zwiebel is a professor of finance at Stanford University. For more articles like this, please visit us at bloomberg.com/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
A flurry of news about potential coronavirus treatments and vaccines helped shares of biopharmas Gilead Sciences, Regeneron Pharmaceuticals and Johnson & Johnson to pop Monday.
Sanofi (SNY) begins treatment in a second phase II/III study evaluating its rheumatoid arthritis drug Kevzara to treat patients with severe COVID-19 outside the United States.
Regeneron and Sanofi said they'd treated the first patient outside the U.S. in a trial, within a global clinical program, of a drug designed to treat patients hospitalized with severe Covid-19.
For his first Executive Decision segment of "Mad Money" last Friday, Jim Cramer spoke with Paul Hudson, CEO of Sanofi , a leading vaccine maker based in France. In the meantime, Sanofi is partnering with Regeneron Pharmaceuticals to put Kevzara, a rheumatoid arthritis drug, into clinical trials as a possible treatment for Covid-19. Hudson said there are reports that some patients saw benefits from the drug.
The companies said enrolments for the mid-to-late stage trial of Kevzara, an immune-system modifying drug known as a monoclonal antibody, have now started in Italy, Spain, Germany, France, Canada, and Russia. The U.S. trials began last week. The trial, expected to enroll about 300 patients, will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19 infection, a disease caused by the highly contagious coronavirus.
Translate Bio stock rose Friday after the biotech company inked a deal with Sanofi to develop a coronavirus vaccine using messenger RNA. The two companies began partnering in 2018.
Here's a roundup of top developments in the biotech space over the last 24 hours.None of the NYSE- or Nasdaq-listed biotech stocks hit 52 week highs Thursday.Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 26) * Aptevo Therapeutics Inc (NASDAQ: APVO) (reacted to its fourth-quarter results) * TFF Pharmaceuticals Inc (NASDAQ: TFFP)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 Sanofi's Multiple Myeloma Drug Gets Positive European Regulatory Agency Committee Opinion Sanofi SA (NASDAQ: SNY) said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.In premarket trading Friday, the stock was up 1.28% to $43.50.Translate Bio, Sanofi to Partner for COVID-19 Vaccine Research Translate Bio Inc (NASDAQ: TBIO) Bio said it will collaborate with Sanofi to develop a mRNA vaccine for COVID-19, joining a host of companies working on a vaccine for the SARS-CoV-2. Translate Bio has begun to produce multiple mRNA constructs, and it expects to use its mRNA platform for developing SARS-CoV-2 vaccine candidate.Separately, Translate Bio said the FDA has granted Rare Pediatric Disease designation for MRT5005 for the treatment of cystic fibrosis, its first inhaled mRNA therapeutic. The company also said it expects interruptions in enrolment, dosing and follow-up in the ongoing Phase 1/2 trial in patients with cystic fibrosis.It said it will provide an updated timing on the interim data readout of the additional single-ascending dose group and the multiple ascending dose portion of the trial at a later date.Translate Bio shares were jumping 21.95% to $12.50 in premarket trading Friday.TherapeuticsMD Suspends FY20 Guidance, Announces Cost Cuts TherapeuticsMD Inc (NASDAQ: TXMD) pre-announced first-quarter total net revenues of more than $11 million, while analysts expect revenues of $11.64 million. The company said it is suspending its 2020 guidance, citing the unknown impact of COVID-19 on its business.The company also announced measures to cut or defer more than $30 million in annual spending.The stock was slipping 7.75% to $1.19 in premarket trading Friday.Zealand Announces Private Placement of Common Stock Danish biotech ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) announced a private placement and directed share issue of 741,816 new ordinary shares to a U.S.-based investor at 185 Danish Krone per new ordinary share. The company said it expects to receive gross proceeds from the placement of about 137,236,000 Danish Krone.The company said it will use the net proceeds for supporting its peptide platform, accelerating development of late stage assets, and prepare for the launch of its first fully-owned asset.Arbutus Announces Positive Early-stage Results For Hepatitis B Drug Arbutus Biopharma Corp (NASDAQ: ABUS) announced positive preliminary results from a Phase 1a/1b clinical study of its RNAi therapy AB-729 in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy. The study was meant to determine the most effective dose and dosing interval for use in future Phase 2 combination clinical trials.View more earnings on IBB"These encouraging preliminary results demonstrate that AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels and support its further development as a treatment for people living with chronic hepatitis B," the company said.The stock was advancing 3.98% to $2.35 in premarket trading Friday.Earnings Neubase Therapeutics Inc's (NASDAQ: NBSE) fourth quarter net loss widened from 25 cents in 2018 to 26 cents in 2019, but was narrower than the consensus loss estimate of 32 cents per share. The company said its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.In premarket trading Friday, Neubase shares were rallying 19.28% to $6.99.NovaBay Pharmaceuticals, Inc.'s (NYSE: NBY) fourth-quarter revenues fell from $3.6 million in 2018 to $1.7 million in 2019. The net loss per share widened from 7 cents to 13 cents. Analysts had estimated a loss of 7 cents per share.The stock was plunging 10.92% to 78 cents in premarket trading Friday.aTyr Pharma Inc (NASDAQ: LIFE) reported total revenues of $0.1 million and a loss of $1.54 per share for the fourth quarter of 2019. In the year-ago quarter, the company reported no revenues and a loss of $2.92 per share. The consensus estimate had called for a loss of $1.59 per share for the recent fourth quarter.As of Dec. 31, the company had cash, cash equivalents and investments of about $31.1 million.In premarket trading, the shares were adding 5.84% to $3.26.Vir Biotechnology Inc (NASDAQ: VIR), which is working on a cure for the new coronavirus, reported a decline in its fourth-quarter revenues from $3.1 million in 2018 to $1 million in 2019. The net loss per share widened from $3.05 to 71 cents, while analysts estimated a loss of 67 cents per share for the quarter.The stock was advancing 5% to $33.60 in premarket trading.On The Radar Earnings TELA Bio Inc (NASDAQ: TELA) (before the market open) Zyla Life Sciences (OTC: ZCOR) (before the market open) Ocugen Inc (NASDAQ: OCGN) (before the market open) Altimmune Inc (NASDAQ: ALT) (before the market open)See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Bristol-Myers Squibb, Xencor Licenses Tech To Vir For COVID-19 Treatment, Delay In Pfizer's Upjohn-Mylan Merger * The Daily Biotech Pulse: T2 Biosystems Licenses COVID-19 Test, Immuron CEO Steps Down * Novavax Shares Rally On Flu Vaccine Study Results: What You Need To Know(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
French healthcare company Sanofi Pasteur and U.S. company Translate Bio announced on Friday plans to collaborate on developing a vaccine to treat the coronavirus, which has killed thousands around the world. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks.
The Zacks Analyst Blog Highlights: Gilead Sciences, Regeneron, Sanofi, Moderna and Inovio Pharmaceuticals
(Bloomberg Opinion) -- Nothing says funding is not a problem during this crisis than a 10 billion-euro ($11 billion) debt issue. Spain, in a state of emergency because of the coronavirus, achieved this on Tuesday with a seven-year bond sale that attracted more than 36 billion euros of orders.The country was one of 11 high-grade borrowers testing the waters in what was the busiest day of the month for bond sales and the fourth-busiest of the year. This week’s volumes have already surpassed the total of the first three weeks of March, when the outbreak really suppressed supply. Wednesday is set to be even bigger.Raising such a jumbo deal did mean Spain had to offer a yield that was 18 basis points higher than an existing, slightly shorter seven-year bond. Its last syndicated issue, earlier this year, came with a lower yield than its existing debt. However, the world has changed profoundly and issuers have to be prepared to dangle a carrot to entice investor demand. In the circumstances, this wasn’t much of a premium for investors.A similar phenomenon was also evident for the European Investment Bank, whose three-year bond deal came at an 11 basis-point premium to its existing equivalent. Likewise, premiums were in evidence Monday for new deals from the German States of Bavaria and Saxony-Anhalt. Though, again, they weren’t huge, which shows how desperate investors are to find somewhere to put their money.Corporate deals are making a comeback too: Unilever NV and Engie SA last week followed the trend for higher yields. Company issuance has seen the biggest decline in the bond market this year, unsurprisingly give the business shutdowns, running nearly 20% behind last year's pace. Coca Cola European Partners, Sanofi and Nestle SA all came to the market with multi-tranche issues on Tuesday, illustrating the improvement in conditions. Heineken NV, Danaher Corp. and Carrefour SA were doing benchmark euro deals on Wednesday.The European Central Bank can breathe a bit easier as its 1 trillion euros of quantitative easing planned for the rest of this year is starting to take effect. As there will be considerable emphasis on its corporate sector purchasing program, many of the new investment grade deals should benefit from being scooped up by the ECB, if they’re from Europe-based issuing entities.Wednesday has also seen the return of major banks with Lloyds Banking Group Plc, HSBC Holdings Plc, and Goldman Sachs Group Inc. all bringing euro deals. Credit spreads (the yield on corporate debt relative to sovereign benchmarks) have ballooned since late February, offering better returns for investors than government bonds if they have cash to put to work. Those spreads will start to narrow, but the virus has created a new paradigm, whereby a decent new-issue premium is essential to a successful deal. Normality is returning to European debt capital markets, but the heady days of super-tight credit spreads and incredibly low non-core government bond yields look to be over.This column does not necessarily reflect the opinion of Bloomberg LP and its owners.Marcus Ashworth is a Bloomberg Opinion columnist covering European markets. He spent three decades in the banking industry, most recently as chief markets strategist at Haitong Securities in London.For more articles like this, please visit us at bloomberg.com/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Investors across a broad range of asset markets breathed a sigh of relief Tuesday, a day after the Federal Reserve rolled out unprecedented measures aimed at boosting liquidity and bolstering investor confidence in the face of a spreading coronavirus pandemic. As equities ripped higher around the world, a string of investment-grade companies tapped a better-functioning debt market for much-needed cash after the Fed's measures helped ease a logjam that had frozen credit markets. The rate at which companies could borrow high-grade, short-term loans mostly decreased, while rates for lower-grade paper continued to increase at some maturities and decreased modestly at others, according to Fed data.
Pfizer (PFE) is set to jointly develop BioNTech's potential coronavirus vaccine. Regeneron/Sanofi (SNY) and Roche will study their RA drugs, Kevzara & Actemra, respectively to treat severe COVID-19 infection.
The Zacks Analyst Blog Highlights: UnitedHealth, Sanofi, United Parcel Service, Caterpillar and Activision Blizzard