|Bid||0.00 x 0|
|Ask||0.00 x 0|
|Day's Range||92.75 - 92.75|
|52 Week Range||74.46 - 96.50|
|Beta (3Y Monthly)||0.52|
|PE Ratio (TTM)||18.31|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
(Bloomberg) -- Zhang Haitao was a basketball-loving teenager who dreamed of going to a specialized sports high school when he got a pain in his right arm that just wouldn’t go away. It turned out to be acute lymphoblastic leukemia.The discovery set Zhang and his family, from a village deep in the mountains of southwestern China's Sichuan province, on a journey familiar to most cancer patients — a revolving door of hospital visits, blood tests and three rounds of chemotherapy. It was then that Zhang’s doctor suggested a last-ditch option: an experimental gene therapy being trialed by a Chinese startup called Gracell Biotechnology Ltd.After spending three weeks in the hospital in May — during which white blood cells were removed from his body, genetically engineered, and then infused back in — an analysis of Zhang’s bone marrow in June showed his body was clear of cancer.Seven months later, monthly medical tests conducted at a hospital in the nearby Chinese metropolis of Chongqing show he remains cancer free. “I don’t remember much about the treatment as I had a fever throughout,” said Zhang, who’s now almost 16 and spends his days playing video games and texting his friends. “It seems like a new solution that will give people hope.”Read more about how China is overhauling its healthcare systemThe therapy Zhang received was Chimeric Antigen Receptor-T cells, known as CAR-T, and it’s being hailed as one of the most exciting developments in the quest to cure cancer. First developed by Israeli scientist Zelig Eshhar in the 1980s, CAR-T re-works the genes of the body’s own immune cells so that they actively seek out and destroy cancer cells. While it’s been embraced by researchers and drugmakers around the world, perhaps nowhere is CAR-T having more impact — and being pushed dangerously close to its limits — than in China, home to the world’s biggest cancer population and some of the most ambitious experiments.CAR-T works by supercharging T-cells, the body’s main line of defense against disease, so that they latch onto and destroy cancer. In clinical trials, leukemia patients who failed to respond to other therapies have shown remission rates of over 90% within two months of treatment.Though drug giants Novartis AG and Gilead Sciences Inc. have been marketing CAR-T globally since 2017, it’s expensive. The process of engineering an individual’s cells in a laboratory and then replicating them has also meant that some patients with more aggressive cancers can die waiting for treatment.That’s where Gracell’s therapy was revolutionary. Instead of the two to three weeks taken by current treatments from American and European drug makers, the Shanghai-based company — set up by a group of veteran Chinese cell-therapy researchers — is churning out cancer-killing immune cells overnight.And they’re doing it much cheaper in some cases than global pharmaceutical giants. Gracell has developed a process using genetic engineering that speeds up the cell production stage, according to founder William Cao Wei. Gracell plans to price its CAR-T treatment for about 500,000 yuan ($71,000), well below the $475,000 price tag for Novartis’ Kymriah, the Swiss company’s CAR-T therapy used to treat the type of blood cancer that Zhang had. A similar treatment from Gilead, based in Foster City, California, costs $373,000.The aging population and a raft of lifestyle factors mean that more new cancer patients are emerging in China than anyplace else in the world, giving the country a significant stake in the global fight to find a cure. Emboldened by the government’s push to become a scientific superpower and to dominate the field of genetics, Gracell and other Chinese biotech startups are racing ahead, with China likely to approve CAR-T for widespread use as early as next year. Up for grabs is a market for cancer drugs and experimental treatments that has exploded to $133 billion a year worldwide, according to life sciences researcher Iqvia Institute.“There can be both cooperation and competition between us and CAR-T developers in developed markets,” said Cao, who is also Gracell’s chief executive officer. “But there will definitely be competition.” That drive to forge ahead — and in front — can be seen in the way China is approaching regulation of CAR-T. The country is weighing new rules that would loosen oversight of the revolutionary technology, allowing academic ethics committees within hospitals to approve new CAR-T treatments and then administer them to patients for a fee.That would markedly loosen China’s current framework, which is presently in line with the approach taken by regulatory bodies like the U.S Food and Drug Administration and the European Medicines Agency. These entities are the sole authorities in their jurisdictions that evaluate and approve all CAR-T therapies before they are cleared for public use.There is concern among researchers, regulatory experts and drugmakers themselves that allowing hospitals to market treatments for a fee could cause profit-making to trump ethical considerations. In a 2016 case widely reported in the Chinese media, a 22-year-old college student with a rare type of tissue cancer called synovial sarcoma died after going through an experimental cell therapy at a Beijing hospital.“Hospitals can become both players and referees at the same time”Before his death, the patient posted an essay online claiming the hospital had falsely advertised the treatment’s effectiveness, and that Chinese search engine Baidu Inc. had displayed the hospital’s advertising so that it appeared like a credible search result rather than a paid commercial. The essay went viral and sparked an outcry on Chinese social media over the ethics of private hospitals and the regulation of therapies for serious illnesses.Censured by the Cyberspace Administration of China, Baidu responded by restricting the number of sponsored posts to 30% of a results page, and established a 1 billion yuan fund to fight fraud. The hospital did not respond to requests for comment.It’s not the only death allegedly linked to genetic cell therapy in China. Last year, a hospital in the eastern city of Xuzhou was sued over the death of a lymphoma patient who died after receiving a CAR-T treatment. The patient developed severe side effects, including bleeding within the abdomen. The patient’s family argued that the treatment led to his death, but the hospital and doctor said it was the result of late-stage cancer. A court is yet to rule on the case.China’s proposed new framework is reminiscent of its wider approach to the regulation of science, an area President Xi Jinping has prioritized as part of his ambition to cement the country as a world power.The research of He Jiankui, an American-educated Chinese scientist whose revelation last year that he’d edited the genes of twin baby girls ignited a global firestorm, was signed off by the ethics committee of a Shenzhen hospital. The experiment, which He claimed made the twins immune to HIV, wasn’t backed by peer-reviewed data and still hasn’t been verified. Scientists around the world have condemned it as an irresponsible use of a technology that has the capacity to alter the very building blocks of life. The long-term effects of Crispr, the gene-snipping tool used by He and embraced by Chinese researchers, are also yet to be fully understood.China’s new draft rules on CAR-T could give rise to the same scenario, critics say.There’s no guarantee that the hospital committees have the qualifications to evaluate such a complicated therapy, said Tao Xin, a Washington, D.C.-based lawyer at Hogan Lovells LLP who specializes in the health-care regulatory law of both the U.S. and China.“The proposal indicates that hospitals can charge a fee for the therapy, in addition to approving its own therapy,” he said. “With these two combined, are we going to see a replay of the 2016 incident? If there’s money to be made and I get to decide whether to do it or not, that’s really controversial.”Read about how Crispr is being used in China’s quest to make a super pigGracell’s Cao is also critical of the new framework as it removes the role of an independent entity that evaluates the therapy’s safety and efficacy: “Hospitals can become both players and referees at the same time.”Novartis and Gilead declined to comment on China’s regulatory plans, while a spokesman for the National Health Commission, the body in charge of governing the country’s health sector, said that the proposed new rules are still under discussion.Read about how Chinese parents are using DNA tests to map out their children’s livesMeanwhile, Chinese companies are racing ahead on CAR-T and attracting hundreds of millions of dollars from investors like Singapore’s sovereign wealth fund Temasek Holdings Pte Ltd, as well as global pharmaceutical giants. Venture capital investment in Chinese biotech firms climbed to $17.6 billion last year, quadruple the amount from 2015, according to consultancy ChinaBio LLC. Gracell — which counts Temasek and Lilly Asia Ventures, the venture capital firm spun off from Eli Lilly & Co. as investors — says 32 of the 35 patients it’s enrolled in its China-based trials over the past year have gone into complete remission “with minimal residual disease tested negative” four weeks after the CAR-T infusion — a clinical term that basically means there was no evidence of disease remaining in their bodies, the highest possible efficacy level for a therapy.Other Chinese startups like Nanjing Legend, a unit of Hong Kong-listed Genscript Biotech Corp., and U.S.-listed Cellular Biomedicine Group Inc., have developed similar capabilities.In 2018, Novartis paid $40 million for a 9% stake in Shanghai-based Cellular Biomedicine, and will use their cell therapy facility to manufacture its Kymriah treatment, which is currently being assessed for approval by China’s drug regulator. The startup is also developing its own CAR-T therapies and testing their potential against solid tumors, not just blood cancers. Chief Executive Officer Tony Liu Bizuo said Cellular Biomedicine’s digitized and automated process cuts the cell engineering time from four weeks to less than 10 days.Cellular Biomedicine is now mulling building a bigger cell production facility with the Shanghai government, as demand for cell therapy grows and on expectations more commercial CAR-T treatments will be approved in China in the coming years. In a sign of the support startups are getting from the authorities, the city’s government has earmarked a 4 million square feet space for cell therapy research. Of the 21 cell therapies currently in clinical trials approved by China’s drug regulator, 11 are being conducted in the lab, which is fast becoming the nation’s CAR-T Ground Zero.The next frontier is to make CAR-T as accessible as any other drug, and Chinese startups are at the leading edge. Dubbed “universal CAR-T,” this involves finding a way to take T-cells from healthy people and engineering them so that they can be infused into any cancer patient. Gracell is studying the use of donor white blood cells, marking a step toward that goal. Other startups like French company Cellectis SA are also racing to make universal CAR-T a reality.“I’m very impressed with the pace of technological progress in China and the expansion of CAR-T research coming so rapidly,” said Bruce Levine, a professor specializing in cancer gene therapy at the Perelman School of Medicine at the University of Pennsylvania.“We all want these therapies to move fast and some are very good, but we need to be aware that some could be moving too fast for their expertise, even if they have very good intentions,“ he said.Read about how a Chinese genetics giant wants to tailor drugs to people’s DNAAfter a year in and out of hospital, Zhang, the teenage cancer patient in Chongqing, is starting to make plans for the future. If it wasn’t for the leukemia, he’d be in his first year of high school now.“I don’t think I can go to sports school anymore, but I hope to learn a professional skill,” said Zhang, who’s now a foot taller than his aunt, Chen Chunhua, his primary caregiver. “I want to grasp this chance I have.”While China’s approach to CAR-T may be criticized as moving too fast, Chen, who left her job at a ceramics factory to care for Zhang when he got sick, is thankful he had access to the treatment, which wouldn’t have been possible in China had the boy fallen ill just a year earlier.“I’m so happy we had this option within China,” she said. “It really helps to lessen our burden.” \--With assistance from Dong Lyu.To contact the editor responsible for this story: Rachel Chang at email@example.com, Anjali CordeiroFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
The full scope of Novartis' $500 million plan, revealed to Reuters in an interview with the company's gene therapy chief, has not been previously disclosed. It is second only to Pfizer , which has allocated $600 million to build its own gene therapy manufacturing plants, according to filings and interviews with industry executives.
Investing.com -- More happy talk from China on trade, while Fed Chairman Jerome Powell sees the economy's glass as "more than half full" (so no more rate cuts for now). Elsewhere, eBay keeps up the flurry of M&A; activity and the UN takes a swipe at countries for failing to live up to their Paris Accord pledges. Here's what you need to know in financial markets on Tuesday, 26th November.
Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Novartis AG (NYSE: NVS) resulting from allegations that Novartis may have issued materially misleading business information to the investing public.
(Bloomberg) -- Novartis AG agreed to buy Medicines Co. and its promising heart drug for $9.7 billion, the latest move in the Swiss drugmaker’s push to amass novel treatments for complex conditions.Medicines Co.’s experimental treatment inclisiran uses a new approach to lower bad cholesterol in especially hard-to-treat patients. Novartis Chief Executive Officer Vas Narasimhan was willing to foot the bill, which includes stock options and convertible debt, for a medicine that appears to be moving quickly to the U.S. market where it will compete against existing products from Amgen Inc., Regeneron Pharmaceuticals Inc. and Sanofi.Drugmakers are targeting conditions and technologies that can set them apart from rivals, leaving more room for sales growth and allowing them to charge higher prices in an increasingly cost-conscious market. Narasimhan is adding Medicines Co. to a list of purchases that includes AveXis, maker of the $2.1 million gene therapy Zolgensma, and Endocyte, developer of targeted cancer treatments.The 43-year-old CEO has moved to spin off contact-lens maker Alcon and to ditch a stake in the consumer-health venture with GlaxoSmithKline Plc that makes Panadol painkillers and Theraflu cold remedies.Medicines Co. gives Novartis entry into a realm where at least one drug, Repatha, is forecast to achieve blockbuster status by 2021. Another similar cholesterol treatment, Regeneron and Sanofi’s Praluent, hasn’t fared as well, and prices on both drugs were recently cut as studies questioned their cost-effectiveness.New TechnologyThe medicine at the heart of the Novartis transaction is based on a technology discovered in the last few decades, called RNA interference, which stops cells from making specific proteins. The therapy is injected just twice a year, unlike existing treatments that need to be administered once or twice a month. Should it be approved by regulators, annual sales might reach a peak of $4 billion, according to Peter Welford, an analyst at Jefferies in London.Medicines Co. shareholders will get $85 a share, Novartis said in a statement. That’s a 45% premium to the closing price on Nov. 18, before Bloomberg reported the two companies were in talks.Shares of Parsippany, New Jersey-based Medicines Co. surged as much as 23% in early New York trading. The stock had already tripled in 2019 with anticipation building over the blockbuster potential of inclisiran. Novartis rose 0.7% at 3:40 p.m. Monday in Zurich.Narasimhan is paying a high price for a deal that essentially delivers a single treatment, analysts said.The transaction doesn’t bring a research platform or other significant assets besides inclisiran, said Tim Anderson at Wolfe Research. “For an outlay of $9 billion, it would be nice to have the latter,” he wrote in a note.At Novartis, inclisiran will join a stable of products that includes the heart-failure treatment Entresto. High levels of bad cholesterol, also known as LDL, are a leading cause of heart attacks and millions of people take statin drugs to keep them under control. Novartis is targeting a patient population of around 50 million people, according to a presentation.The medicine could become one of Novartis’s biggest sellers and help boost profit margins in the company’s innovative drugs division to a percentage in the mid- to high-30s in the medium term, Narasimhan said. Medicines Co. plans to submit an application for the drug in the U.S. before year-end.‘Cause for Caution’Recent data on the cholesterol treatment, a partnership with Alnylam Pharmaceuticals Inc., suggest RNA interference will help inclisiran stand out from Repatha and Praluent.The only approved drugs that use the gene-silencing approach come from Alnylam, which licensed rights to inclisiran to Medicines Co. The success of the drug, which has shown few side effects in clinical trials, is good news for Alnylam, whose Onpattro treatment for a rare inherited protein abnormality was the first therapy approved in the field. Givlaari, another one of Alnylam’s RNA products that treats a rare liver disease, was approved last week and will carry an annual U.S. wholesale price of $575,000.“Novartis hopes to leverage its growing cardiovascular might and inclisiran’s differentiated profile,” Bloomberg Intelligence’s Sam Fazeli wrote in a note. “The lackluster performance of drugs targeting the same mechanism from Amgen and Sanofi is cause for caution.”At 11 times consensus 2023 sales, Novartis is paying a high price relative to recent deals, according to Fazeli.Medicines Co.’s drug cleared a key hurdle this summer as a late-stage study showed it cut bad cholesterol levels in half over 18 months. Two years ago, the company said it would lay off most of its workers as it restructured to focus on developing inclisiran.(Updates shares in eighth paragraph.)\--With assistance from Cristin Flanagan and John Lauerman.To contact the reporters on this story: James Paton in London at firstname.lastname@example.org;John Lauerman in London at email@example.comTo contact the editors responsible for this story: Eric Pfanner at firstname.lastname@example.org, Marthe Fourcade, Anne PollakFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Swiss drugmaker Novartis is betting on heart drug prospect inclisiran in a $9.7 billion (£7.56 billion) takeover of The Medicines Co as it challenges cardiovascular medicines from Amgen Inc , Sanofi and Regeneron Pharmaceuticals . Novartis is paying $85 per share in cash, a 24% premium over The Medicines Co's closing price of $68.55 on Friday, to acquire the U.S. biotechnology company's lone drug, the cholesterol-lowering injection inclisiran. The deal shows Novartis CEO Vas Narasimhan is ready to spend billions on not just rare disease treatments, as it did in 2018 when it paid $8.7 billion for gene therapy specialist AveXis, but also for cardiovascular medicines aimed at a market with potentially millions of patients.
(Bloomberg) -- Novartis AG is close to a deal to buy Medicines Co., the developer of a promising cholesterol drug, for $85 a share, according to news reports.An agreement could be announced today, according to the Wall Street Journal, which assigned a $7 billion price tag to the deal. Umer Raffat, an analyst at Evercore ISI, put the transaction value at $9.1 billion when taking the fully diluted shares into account.The Swiss drugmaker has been conducting due diligence on the Parsippany, New Jersey-based company, Bloomberg reported last week. At $85 a share, Novartis would be paying about a 45% premium over where the stock traded before the Bloomberg report.Snapping up Medicines Co. would complement Novartis’s stable of drugs to treat heart failure. Medicines Co.’s injectable drug inclisiran cleared a key hurdle this summer as a late-stage study showed it cut bad cholesterol levels in half over 18 months. High levels of the substance are a leading cause of heart attacks.“This will be a major execution story,” Raffat wrote in a note. “The asset itself is very elegant, but the market needs to be majorly developed.”Novartis Chief Executive Officer Vas Narasimhan has relied on deals to sharpen the company’s focus on innovative drugs for cancer and rare diseases. The Basel, Switzerland-based company has announced close to $16 billion of acquisitions since he took over in February 2018, according to data compiled by Bloomberg. He has also spun off the Alcon Inc. eye-care division and ditched a stake in a consumer-health venture.To contact the reporter on this story: James Ludden in New York at email@example.comTo contact the editors responsible for this story: Matthew G. Miller at firstname.lastname@example.org, Ian FisherFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
The deal, in which Novartis has agreed to pay $85 a share, could be announced this weekend, the Journal reported, citing people familiar with the matter. Novartis declined to comment. The Medicines Co did not respond to a request for comment on Saturday.
Swiss-listed eyecare company Alcon reported another quarterly loss, specified its profit outlook, boosted projections for the cost of its spinoff from Novartis and announced a $300 million restructuring program. The company now expects a core operating margin of 17-17.5% for 2019, compared with 17-18% previously and tweaked its sales goal to 4-5% growth, from 3-5%. Alcon increased its expected separation costs from Novartis to $500 million, from $300 million, due to work on IT systems, among other things.
(Bloomberg) -- Medicines Co., the developer of a promising cholesterol drug, has attracted takeover interest from suitors including Novartis AG, people familiar with the matter said.Novartis has been holding talks about a potential acquisition of Parsippany, New Jersey-based Medicines Co., according to the people. The Swiss drugmaker is conducting due diligence on the company, one of the people said, asking not to be identified because the information is private.Other potential acquirers have also expressed interest in a purchase of Medicines Co., and there’s no certainty an agreement will be reached, the people said. Shares of Medicines Co. have more than tripled in New York trading this year, giving it a market value of about $4.7 billion.The stock surged as much as 26% New York, the biggest intraday gain since 2010, and was up 19% to $69.96 at 10:51 a.m. Novartis showed little change in Zurich, down less than 1% to 89.15 Swiss francs, valuing the company at about 225 billion francs ($228 billion).Representatives for Medicines Co. and Novartis declined to comment.Novartis Chief Executive Officer Vas Narasimhan has relied on deals to sharpen the company’s focus on innovative drugs for cancer and rare diseases. The Basel, Switzerland-based company has announced close to $16 billion of acquisitions since he took over as CEO in February 2018, according to data compiled by Bloomberg. He has also spun off the Alcon Inc. eye-care division and ditched a stake in a consumer-health venture.Medicines Co.’s injectable drug inclisiran cleared a key hurdle this summer as a late-stage study showed it cut bad cholesterol levels in half over 18 months. High levels of the substance are a leading cause of heart attacks.“Novartis currently has a rapidly growing heart failure drug, so the addition of another cardiovascular medicine would fit,” said Bloomberg Intelligence analyst Sam Fazeli.The company said Monday that the treatment achieved all of its goals in the latest study, showing durable and potent results in lowering patients’ cholesterol. Medicines Co. plans to submit the drug to regulators in the U.S. in the fourth quarter and in Europe in the first quarter of 2020.The data bolstered the treatment’s prospects to compete with older therapies from Amgen Inc. and partners Regeneron Pharmaceuticals Inc. and Sanofi. Two years ago, Medicines Co. announced it would lay off most of its workers as it restructured to focus on developing inclisiran.At Novartis, the medicine would join a stable of therapies that includes Entresto, a treatment for heart failure.Novartis is betting on cutting-edge drugs, rolling out products like gene therapy Zolgensma aimed at a devastating muscle disease. The company gained Zolgensma by acquiring drugmaker AveXis Inc. for $8.7 billion in 2018. Last year, it also bought Endocyte Inc. for $2.1 billion.(Updates Medicines Co. shares in fourth paragraph)\--With assistance from Marthe Fourcade, Bailey Lipschultz, Aaron Kirchfeld, Manuel Baigorri and James Paton.To contact the reporters on this story: Ed Hammond in New York at email@example.com;Nabila Ahmed in New York at firstname.lastname@example.org;Dinesh Nair in London at email@example.comTo contact the editors responsible for this story: Ben Scent at firstname.lastname@example.org, ;Liana Baker at email@example.com, Jeff Sutherland, Eric PfannerFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Novartis is considering an offer for U.S. biotechnology firm The Medicines Co , Bloomberg reported on Tuesday, a deal that could broaden the Swiss drugmaker's cabinet of heart medicines and shore up growth threatened by patent expirations. Novartis, which declined to comment on the report, is hunting for a $5 billion (£4 billion) acquisition in the United States, two banking sources told Reuters separately without identifying a target. New Jersey-based The Medicines Co's top drug candidate is cholesterol-lowering drug inclisiran for heart patients.
Novartis is exiting drug discovery at its Shanghai site and shifting its focus to drug development, saying accelerating approvals in China are pushing the Swiss company to dedicate the operation's resources to getting its medicines to market. The move marks an about-face from just three years ago, when Novartis had christened the $1 billion campus as its Chinese hub for early-stage research. About 150 of the more than 1,000 Shanghai staffers will lose their research jobs, while Novartis plans to add 340 new positions to develop up-and-coming drug prospects over the next four years, a period in which it expects to file 50 new drug applications with China's regulator.
The drug will be priced between $84,852 and $113,136 per year for most patients, who will typically infuse themselves with between three and four vials each month, Novartis said. The biologic drug, also known as crizanlizumab, was shown in trials in its high-dose formula to cut sickle cell pain crises nearly by half to 1.63 incidents annually from 2.98 in those getting a placebo. Novartis has forecast that the drug's annual sales will top $1 billion, much of which will likely come from U.S. government payers such as Medicare and Medicaid.
Novartis is buying the Japanese generics unit of South Africa's Aspen Pharmacare in a deal worth up to 400 million euros (344.5 million pounds) to expand in the world's third-biggest drug market, the Swiss drugmaker said on Monday. Novartis's Sandoz generics business agreed to pay 300 million euros initially, plus a deferred amount not expected to exceed 100 million euros based on certain conditions being met, Novartis said.
U.S. regulators have halted a trial of Novartis's Zolgensma treatment after an animal study raised safety concerns, the company said on Wednesday, in a setback for the drugmaker's plan to expand its use to older patients. The U.S. Food and Drug Administration's partial hold on the so-called STRONG trial impacts patients aged up to five with spinal muscular atrophy (SMA) who were to receive a higher dose of the gene therapy via a spinal infusion. The hold was issued after Novartis told health authorities about the animal study's findings that showed dorsal root ganglia (DRG) mononuclear cell inflammation, a neurological condition sometimes accompanied by nerve damage or loss.
Novartis sales data on Tuesday suggested the Swiss drugmaker is reaping less than the $2.1 million U.S. list price for its gene therapy Zolgensma, as insurers may be getting breaks on the world's most-expensive one-time treatment. The spinal muscular atrophy (SMA) treatment, approved by the U.S. Food and Drug Administration in May, has reaped $175 million in revenue this year, including $160 million in the third quarter. On a call following third-quarter results, Chief Executive Vas Narasimhan said roughly 100 patients have been treated under the paid programme.
Swiss drugmaker Novartis boosted its 2019 forecasts on Tuesday after beating third-quarter expectations, a feat helped by the sales debut of gene therapy Zolgensma, the world's most expensive one-time treatment. CEO Vas Narasimhan's bet on the potential cure for spinal muscular atrophy (SMA) has drawn scrutiny, initially due to its $2.1 million (£1.6 million) price and since August over a data manipulation scandal that has prompted a U.S. Food and Drug Administration (FDA) investigation. "We're very pleased with the uptake," Narasimhan told reporters on a call.
Novartis AG blamed former executives Brian and Allan Kaspar for the manipulation of data behind its $2.1 million gene therapy Zolgensma, saying they either personally manipulated the data or pressured subordinates into doing so. The Kaspar brothers were executives at AveXis, the company that developed the drug and was acquired by Novartis for $8.7 billion last year. Last month, the U.S. Food and Drug Administration said Novartis could face civil or criminal penalties because of the data manipulation and the possibility the company had waited to notify regulators.
NEW YORK, Sept. 23, 2019 -- Levi & Korsinsky notifies investors that it has commenced an investigation of Novartis AG (“Novartis” or “the Company”) (NYSE: NVS) concerning.
The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Novartis AG (“Novartis” or “the Company”) (NYSE: NVS) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Novartis was the subject of an FDA statement issued on August 6, 2019. According to the FDA, the Company had submitted manipulated data for its biologics license application (“BLA”) for its gene therapy drug, Zolgensma.
Hoy Health launched less than two years ago, but sees strong growth potential in paving the way to the Latin American health care market.
Glancy Prongay & Murray LLP (“GPM”) continues its investigation on behalf of Novartis AG (“Novartis” or the “Company”) (NYSE: NVS) investors concerning the Company and its officers’ possible violations of federal securities laws. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, at 310-201-9150, Toll-Free at 888-773-9224, or by email to firstname.lastname@example.org, or visit our website at www.glancylaw.com. On August 6, 2019, the U.S. Food and Drug Administration (“FDA”) issued a statement revealing that data submitted in the Company’s biologics license application (“BLA”) for its gene therapy drug, Zolgensma, had been manipulated.