|Bid||87.86 x 900|
|Ask||88.26 x 800|
|Day's Range||86.32 - 88.44|
|52 Week Range||64.78 - 88.44|
|Beta (3Y Monthly)||0.67|
|PE Ratio (TTM)||16.59|
|Forward Dividend & Yield||2.83 (3.45%)|
|1y Target Est||99.00|
A $2.1 million price tag could make Zolgensma a blockbuster medicine for these companies.
ZURICH/NEW YORK, (Reuters) - Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million. The Food and Drug Administration approved Zolgensma for children under the age of two with SMA, including those not yet showing symptoms. "This is potentially a new standard of care for babies with the most serious form of SMA," said Dr. Emmanuelle Tiongson, a pediatric neurologist at Children's Hospital Los Angeles who has provided Zolgensma to patients under an expanded access programme.
When Malachi Anderson was diagnosed with a rare and often deadly disease called spinal muscular atrophy (SMA) as an infant nearly four years ago, his parents Tina and Torence had a decision to make. In years past, many of the babies born with the most severe form of SMA, like Malachi, died before their second birthday. By 2015, drugmakers were testing two experimental therapies in clinical trials: a one-time gene therapy treatment that is now owned by Novartis AG and Spinraza, a Biogen Inc drug which is given through spinal infusion every four months, indefinitely.
ZURICH/NEW YORK, May 24, (Reuters) - Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million. The Food and Drug Administration approved Zolgensma for children under the age of two with SMA, including those not yet showing symptoms. "This is potentially a new standard of care for babies with the most serious form of SMA," said Dr. Emmanuelle Tiongson, a pediatric neurologist at Children's Hospital Los Angeles who has provided Zolgensma to patients under an expanded access program.
U.S. regulators have approved the most expensive medicine ever, for a rare disorder that destroys a baby's muscle control and kills nearly all of those with the most common type of the disease within a couple of years.
Novartis stock popped Friday as the Food and Drug Administration approved its gene therapy, Zolgensma, for spinal muscular atrophy treatment, throwing a challenge to Biogen and Ionis.
Novartis AG said late Friday the U.S. Food and Drug Administration has approved one of its treatments for a type of advanced breast cancer afflicting patients carrying a gene mutation. The mutations are associated with tumor growth, resistance to endocrine treatment, and a poor overall prognosis, Novartis said. The treatment, Piqray, is the first ever for treatment specifically for the type of advanced breast cancer with the mutation, the company said. "We are proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," Novartis' oncology Chief Executive Susanne Schaffert said in a statement. "We are grateful to our researchers' bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone." American depositary shares of Novartis rose nearly 1% in the extended session Friday, after ending the regular trading day up 3.7%.
The U.S. Food and Drug Administration (FDA) said on Friday that it had approved Novartis AG's treatment in combination with a hormone therapy for postmenopausal women, as well as for men, with a form of advanced breast cancer. The drug, alpelisib, to be marketed under the brand name Piqray, belongs to a class of drugs known as PI3K inhibitors and is the first of its kind to be approved, the FDA said in a statement. "Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer," the FDA said.
It was a quiet trading session on Friday, with U.S. stocks rising modestly ahead of a three-day holiday weekend. Will we see more selling pressure next week or will positive trade talk give stocks a lift? When one tweet can move the market, it's impossible to say. So let's look at a few top stock trades out there. Top Stock Trades for Tomorrow No. 1: Roku Click to Enlarge The other day we opted to cover PepsiCo (NYSE:PEP) over Roku (NASDAQ:ROKU), but promised to look at the stock on Friday. Well, here we are and this beast has gotten even stronger. Shares are up more than 6% on the day and have risen above $95. The run has been nothing short of amazing.We've been pounding the table on Roku, calling it a buy in Q4 and Q1. Now it's almost up to $100 a share. Should you get long now?InvestorPlace - Stock Market News, Stock Advice & Trading TipsNo. Shares are up more than 70% in about five weeks. It has almost quadrupled from its December lows (not that it deserved to be that low in the first place). But the point is still the same: you've missed the boat.I love ROKU over the long term, but to think that we won't see sub-$95 prices again is absurd. With the stock overbought in the short-term and coming into possible resistance, hedging and/or taking some profits doesn't seem like a bad idea at this point … at least until lower prices come around. Top Stock Trades for Tomorrow No. 2: Splunk Click to Enlarge Splunk (NASDAQ:SPLK) is going splat, falling 7% on Friday after reporting earnings. The move forced a test of the 200-day moving average, which held as support.Aggressive bulls who feel compelled to go long SPLK stock can do so against Friday's low.I would love a lower open near the 200-day on Tuesday that quickly reclaims Friday's close and goes green. Preferably, SPLK would also reclaim the 50% retracement at $120.78 in the process. * 5 Safe Stocks to Buy This Summer If it falls under Friday's low, SPLK can go even lower. On a rally, we need to see if it can climb back to Friday's highs near $130, and/or the 20-day and 50-day moving averages. Top Stock Trades for Tomorrow No. 3: Autodesk Click to Enlarge Autodesk (NASDAQ:ADSK) is off by more than 5% on Friday after disappointing earnings results. Shares are bouncing off that $157.50 to $158 area, but are now meaningfully below the 50-day moving average for the first time since early January.Below $155.56 -- the 38.2% retracement -- aggressive bulls who are getting long on Friday's decline may want to consider stepping out. It would put ADSK below several key support levels and suggest that sellers have not yet exhausted themselves. In that case, look for a possible test of the 200-day.Reclaiming the 50-day would repair some of the damage, but beware that this level may act as resistance. That would give short-sellers an entry, with a retest of the $158 area in mind. Top Stock Trades for Tomorrow No. 4: Novartis Click to Enlarge Novartis (NYSE:NVS) stock is up almost 4% after getting approval for its $2 million-plus gene therapy treatment.The move has NVS hitting new highs in Friday's session. The stock has been largely limited by channel resistance and buoyed by channel support. As it hits channel resistance, we'll have to watch to see if NVS will break out to a new range, or be limited in upside as a result.As long as $84.50 to $85 holds as support, NVS looks good to buy on the dips.Bret Kenwell is the manager and author of Future Blue Chips and is on Twitter @BretKenwell. As of this writing, Bret Kenwell is long ROKU. More From InvestorPlace * 4 Top American Penny Pot Stocks (Buy Before June 21) * 5 Safe Stocks to Buy This Summer * The 5 Best Telecom Stocks to Buy Now * 6 Innovative Stocks With Big Long-Term Growth Potential Compare Brokers The post 4 Top Stock Trades for Tuesday: ROKU, ADSK, SPLK, NVS appeared first on InvestorPlace.
Novartis has announced it will charge $2.1 million for Zolgensma, a gene therapy for infants with lethal spinal muscular atrophy. The seeds of this extraordinary price were sewn in 1983, when Congress passed the Orphan Drug Act, a well-meaning law designed to encourage research into rare diseases. It offered drug makers tax breaks and other incentives for such work, rapid review by the Food and Drug Administration, a lower bar for market approval, and longer protection from competition.
An IPO that happened on Thursday, a filing for another one, and more than $600 million in funding tops the Bay Area's venture news heading into the holiday weekend.
Biogen has new competition: Swiss pharma giant Novartis received FDA approval Friday for a spinal muscular atrophy drug that can stave off and potentially cure the disease with a single treatment.
BASEL, Switzerland, May 24, 2019 /PRNewswire/ -- AveXis, a Novartis company, today announced the US Food and Drug Administration (FDA) has approved Zolgensma® (onasemnogene abeparvovac-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion.
The FDA approved Novartis' Zolgensma, a one-time treatment for spinal muscular atrophy. Zolgensma, a gene therapy, will cost $2.1 million. Novartis had previously said it could price the treatment between $1.5 million and $5 million.
CNBC's Healthy Returns Summit was held earlier this week in New York City, covering topics from controversial genetic-editing technique CRISPR to the way AI is changing the practice of drug discovery and medicine and reform of the U.S. health-care system. An audience of health-care leaders from the private and public sector shared their views. Here are some edited excerpts.
CNBC's Healthy Returns Summit was held earlier this week in New York City, featuring keynote presentations and panel discussions on the future of the health-care industry. Topics ranged from controversial genetic-editing technique CRISPR to the way AI is changing the practice of drug discovery and medicine and reform of the U.S. health-care system. A Chinese scientist last year made history by using CRISPR technology to genetically modify two newborns, pushing the ethics of human germline gene editing to the forefront of public debate.
Key highlights of the week include Merck's (MRK) offer to buy private cancer biotech and AbbVie (ABBV) and Lilly's (LLY) updates from clinical studies.
The US Food and Drug Administration on Friday approved what will be the most expensive drug in the world, a gene therapy from Novartis that treats spinal muscular atrophy at a cost of $2.1m. Vas Narasimhan, chief executive of Novartis, said the drug is a “historic advance” and a “landmark one-time gene therapy”, and it had been priced at what he said was half the cost of existing treatments for patients with spinal muscular atrophy.
Novartis (NVS) reports encouraging data on combination asthma drug. The company also highlights its growth plans at its annual meet.
Even among marijuana stocks. a volatile bunch, Tilray (NASDAQ:TLRY) has been the ultimate roller coaster. Tilray stock IPOed in the U.S. last August at $17 per share. \By the beginning of September, TLRY stock price was crossing $50 per share. Incredibly, over the next two weeks, it spiked to as much as $300 per share. Since then, it's been all downhill. TLRY stock fell back to $100 in October. It slid to around $75 by year-end. In April, Tilray stock crossed the $50 mark, and it's now fallen under $45.Can anything stop Tilray's slide? The main issue, at least at this point, has been that Tilray's business execution has been extremely lackluster. Sure, the $300 peak price for Tilray stock was crazy. But Tilray stock need not have crashed quite this far.InvestorPlace - Stock Market News, Stock Advice & Trading Tips * 6 Stocks to Buy for This Decade's Massive Megatrend Tilray's Earnings ReportSome TLRY stock bulls looked at its first-quarter earnings report as a positive. Tilray stock rose for a short time following the release.It's not hard to see why. Its revenues surged from $7.8 million in Q1 of 2018 to $23 million last quarter. That was well ahead of expectations; analysts, on average, were expecting closer to $20 million. On the income side, the company's losses widened, and they were not better than the consensus outlook. But like so many marijuana companies, TLRY's focus is on scaling up its revenues for the time being.But this report was underwhelming in other ways. The annualized revenue rate was around $100 million, which still leaves Tilray stock trading at an exorbitant price/sales ratio. And much of the revenue growth came from non-organic growth after Manitoba Harvest, which TLRY acquired in February, began contributing to Tilray's results. Further, it's worth looking at the company's whole business, as not everything is booming. Its medical marijuana sales, for example, were merely flat year over year. Losing Its Leadership PositionThe earnings report was hardly a home run. In fact, it shows just how far Tilray's star has fallen. The company now has low-to-mid-single-digit-percentage- market share in the Canadian recreational space. That puts it outside of Canada's top five players.Less than a year ago, TLRY was duking it out with Canopy Growth (NYSE:CGC) for the largest market cap among marijuana stocks. Now TLRY stock price has shriveled, and it has failed to turn last year's excitement into a leading position in the Canadian pot market.Importantly, Tilray failed to lock in a key partnership with a big backer from the alcohol or tobacco industries. This has given rivals like Canopy and Cronos (NASDAQ:CRON), which did make such deals, a big advantage compared with Tilray.TLRY did sign a deal with Novartis (NYSE:NVS) to collaborate globally on medical marijuana distribution. This partnership, signed late last year, is certainly better than nothing. But it's a far cry from the large equity cash infusions and distribution deals that other, bigger players have been able to obtain. Slower Progress by Design?Earlier this year, TLRY CEO Brendan Kennedy made some interesting comments. He said on the company's Q4 earnings conference call that: "We will not purchase or invest in what we believe to be overpriced supply assets in Canada, which we believe will erode in value in the medium to long term, as the market normalizes." That's a reasonable position. Supply has already exceeded demand in some legal markets in the United States. And in the long run, there's little to constrain the output of commodity marijuana producers.Still, however, the owners of Tilray stock are going to demand more progress. People need Tilray to grow rapidly before they can get excited about TLRY stock again. So far, the company hasn't done enough to stand out from the pack. The Verdict on Tilray StockTilray's major shareholder, Privateer Holdings, announced earlier this year that it wouldn't sell any TLRY stock in the first half of 2019. That was huge news, as Privateer holds 75 million shares of Tilray stock. Even with the bad performance of Tilray stock lately, that stake is still worth more than $3 billion. But it was worth more than $12 billion at one point.How long will Privateer, which owns the majority of Tilray, be willing to watch its stake keep shriveling away? It said it wouldn't sell any stock in the first half of 2019, but that limitation expires in less than two months. If Privateer starts selling shares, TLRY stock price could fall much lower.As it is, the company's last earnings report showed real progress. But it also showed just how far away Tilray is from being a leading marijuana company at the moment. The company has to do far more to justify even a $50 share price, let alone its former highs.At the time of this writing, Ian Bezek held no positions in any of the aforementioned securities. You can reach him on Twitter at @irbezek. More From InvestorPlace * 4 Top American Penny Pot Stocks (Buy Before June 21) * 6 Stocks to Buy for This Decade's Massive Megatrend * The 7 Best Stocks to Buy From the IPO ETF * 7 Athletic Apparel Stocks With Marathon Pace Compare Brokers The post Tilray Stock Still Hasn't Bottomed appeared first on InvestorPlace.
Novartis Chief Executive Vas Narasimhan said takeover targets in China for global pharmaceuticals groups are scarce due to few novel drugs, data quality fears and lagging regulatory standards in the most-populous country. Narasimhan added he anticipates impending structural reforms in China, including for drug tendering, will free up $30 billion as the local market shifts to international companies' generic products from established brands.
Novartis shares are on the rise after the FDA approved the company's gene therapy drug. It's priced at $2.1 million total over five years. CNBC's Meg Tirrell reports.
Dr. Vasant Narasimhan, CEO of the Swiss-based pharma giant Novartis, talks innovation, new pricing models and new product pipelines, all at scale. Watch his one-on-one interview with CNBC's Jim Cramer about refocusing big pharma.