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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.
As U.S. tech firms heed Trum's order effectively banning U.S. equipment sales to Chinese telecom giant Huawei, Akhan Semiconductor CEO Adam Khan sees anticipated short-term pain as long-term gain.
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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.
Blackstone Group (BX) closed at $40.65 in the latest trading session, marking a -1.22% move from the prior day.
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%.
Why There's Still Uncertainty around Sprint and T-Mobile Merger(Continued from Prior Part)T-Mobile and Sprint mergerThe merger of telecom rivals T-Mobile (TMUS) and Sprint (S) was announced on April 29, 2018, but it’s facing difficulty due to
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.
The building was recognized as one of the top influential new developments in 2016 by the Downtown Denver Partnership.
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.
Why There's Still Uncertainty around Sprint and T-Mobile Merger(Continued from Prior Part)MergerT-Mobile (TMUS) and Sprint (S) have decided to merge to expand their 5G network and grow their customer base amid declining postpaid phone subscribers
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.
Why There's Still Uncertainty around Sprint and T-Mobile MergerShare price movementThe stock price of Sprint (S), the fourth-largest US wireless carrier, jumped 4.2% to $6.95 on Thursday after its merger with rival T-Mobile US (TMUS) moved closer to
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.