|Bid||0.00 x 3200|
|Ask||0.00 x 43500|
|Day's Range||84.88 - 84.98|
|52 Week Range||19.13 - 84.98|
|Beta (5Y Monthly)||1.09|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Novartis and Britain's National Health Service (NHS) on Monday announced a pact that will clear the way for accelerated review by the country's health watchdog NICE for heart drug inclisiran, which could make it broadly available as soon as 2021. Novartis hopes the NHS deal will boost sales of cholesterol-lowering inclisiran, which the Swiss drugmaker bought in a deal announced last year for nearly $10 billion (£7.70 billion) and predicts will be a top seller. Inclisiran was submitted to U.S. regulators last year, and Novartis expects a European submission in coming weeks.
Hedge funds and other investment firms that we track manage billions of dollars of their wealthy clients' money, and needless to say, they are painstakingly thorough when analyzing where to invest this money, as their own wealth also depends on it. Regardless of the various methods used by elite investors like David Tepper and David […]
(Bloomberg Opinion) -- For all the flak the pharmaceutical industry has taken for its exorbitant pricing practices, there's no getting around the fact that it's been a pretty stunning decade for medical progress.Multiple new categories of medicines have moved from dreams and lab benches into the market and people’s lives, and investors who came along for the ride often reaped extraordinary profits. The Nasdaq Biotech Index is up 360% over the last 10 years to the S&P 500's 190%. And that’s without mentioning the hundreds of billions of dollars in takeovers that rewarded shareholders with windfalls. As 2020 approaches, it's worth highlighting how far we've come in the past 10 years in developing new therapies and approaches to treating disease, even as politicians grapple with how to rein in health-care costs without breaking an ecosystem that incentivizes the search for new discoveries. Here are some of the decade’s biggest medical breakthroughs:Cell therapies: First approved in the U.S. two years ago, these treatments still sound like science fiction. Drugmakers harvest immune cells from patients, engineer them to hunt tumors, grow them by the millions into a living drug, and reinfuse them. Yescarta from Gilead Siences Inc. and Novartis AG’s Kymriah — the two treatments approved so far — can put patients with deadly blood cancers into remission in some cases. At the beginning of the decade, academics were just beginning early patient tests. It’s still early days for the technology, and some issues are holding these drugs back. There are significant side effects, and the bespoke manufacturing process is expensive and time-consuming. That has contributed to a bruising price tag: Both of the approved medicines cost over $350,000 for a single treatment. And for now, cell therapy is mostly limited to very sick patients who have exhausted all other alternatives. Luckily, more options are on their way. Some drugmakers are focused on different types of blood cancers. Others hope to mitigate side effects or create treatments that can be grown from donor cells to reduce expenses and speed up treatment. In the longer run, companies are targeting trickier solid tumors. Scientists wouldn't be looking so far into the future without this decade’s extraordinary progress. Gene therapies: Researchers have spent years trying to figure out how to replace faulty DNA to cure genetic diseases, potentially with as little as one treatment. Scientific slip-ups and safety issues derailed a wave of initial excitement about these therapies starting in the 1990s; the first two such treatments to be approved in Europe turned out to be commercial flops. This decade, the technology has come of age. Luxturna, a treatment developed by Spark Therapeutics Inc. for a rare eye disease, became the first gene therapy to get U.S. approval in late 2017. Then in May came the approval of Novartis AG’s Zolgensma for a deadly muscle-wasting disease. The drugs have the potential to stave off blindness and death or significant disability with a single dose, and, unsurprisingly, Big Pharma has given them a substantial financial endorsement. Roche Holding AG paid $4.7 billion to acquire Spark this year, while Novartis spent $8.7 billion in 2018 to buy Zolgensma developer Avexis Inc. Dozens of additional therapies are in development for a variety of other conditions and should hit the market in the next few years. They offer the tantalizing potential not just to cure diseases, but to replace years of wildly expensive alternative treatment. If drugmakers can resist the temptation to squeeze out every ounce of value by doing things like charging $2.1 million for Zolgensma, there’s potential for these treatments to save both lives and money. RNA revolution: The above treatments modify DNA; this group uses the body’s messaging system to turn a patient’s cells into a drug factory or interrupt a harmful process. Two scientists won a Nobel Prize in 2006 for discoveries related to RNA interference (RNAi), one approach to making this type of drug, showing its potential to treat difficult diseases. That prompted an enormous amount of hype and investment, but a series of clinical failures and safety issues led large drugmakers to give up on the approach. Sticking with it into this decade paid off.Alnylam Inc. has been working since 2002 to figure out the thorny problems plaguing this class of treatments. It brought two RNAi drugs for rare diseases to the market in the past two years and has more on the way. The technology is also moving from small markets to larger ones: Novartis just paid $9.7 billion to acquire Medicines Co. for its Alnylam-developed drug that can substantially lower cholesterol with two annual treatments.Ionis Pharmaceuticals Inc. and Biogen Inc. collaborated on Spinraza, a so-called antisense drug that became the first effective treatment for a deadly rare disease. It was approved in late 2016 and had one of the most impressive drug launches of the decade. And Moderna Therapeutics rode a wave of promising messenger RNA-based medicines to the most lucrative biotechnology IPO of all time in 2018. From pharma abandonment to multiple approvals and blockbuster sales potential in under 10 years. Not bad! Cancer immunotherapy: Scientists had been working on ways to unleash the human immune system on cancers well before the 2010s without much luck. Checkpoint inhibitors — drugs that release the brakes on the body's defense mechanisms — have since produced outstanding results in a variety of cancers and are the decade’s most lucrative turnaround story. Merck got a hold of Keytruda via its 2009 acquisition of Schering-Plough, but it was far from the focus of that deal. Once Bristol-Myers Squibb & Co. produced promising results for its similar drug, Opdivo, Merck started a smart development plan that has turned Keytruda into the world’s most valuable cancer medicine. It’s now available to treat more than 10 types of the disease, and has five direct competitors in the U.S. alone. Analysts expect the category to exceed $25 billion in sales next year.If anything, the drugs may have been too successful. Copycat efforts are pulling money that could fund more innovative research. There are thousands of trials underway attempting to extend the reach of these medicines by combining them with other drugs. Some are based more on wishful thinking than firm scientific footing. Still, the ability to shrink some previously intractable tumors is a considerable advance. If drugmakers finally figure out the right combinations and competition creates pricing pressure that boosts access, these medicines will do even more in the years to come. Conquering hepatitis C: From a combined economic and public-health standpoint, a new group of highly effective hepatitis C medicines may outstrip just about anything else on this list so far. Cure rates for earlier treatments weren’t especially high; they took some time to work and had nasty side effects. The approval of Gilead’s Sovaldi in 2013, followed in time by successor drugs such as AbbVie Inc.’s Mavyret, have made hepatitis C pretty easily curable in a matter of weeks. For Gilead, getting to market rapidly with its drug proved enormously profitable; it raked in over $40 billion in revenue in just three years. Hepatitis C causes liver damage over time that can lead to transplants or cancer. The existence of a rapid cure is a significant long-term boon even if the initial pricing on the drugs made them, in some cases, prohibitively expensive. Sovaldi notoriously cost $1,000 per pill at launch and over $80,000 for a course of treatment. The good new is, treatments have become a lot more affordable, which should allow this class of drugs to have a broad and lasting positive health impact.Hepatitis C is one of the relatively few markets where the drug-pricing system has worked well. As competing medicines hit the market, the effective cost of these treatments plummeted. That, in turn, made the drugs more accessible to state Medicaid programs and prison systems, which operate on tight budgets and care for populations with higher rates of hepatitis C infection. Louisiana has pioneered the use of a “Netflix model,” under which the state paid an upfront fee for unlimited access to the drug. It’s an arrangement that will help cure thousands of patients, and other states are likely to follow its lead.Many of the medicines highlighted in this column have list prices in the six figures, a trend that’s helped drive up America’s drug spending by more than $100 billion since 2009. Building on this decade’s medical advances is going to lead to even more effective medicines that will likely come with steeper prices. I’d like to hope that policymakers will come up with a solution that better balances the need to reward innovation with the need to keep medicines accessible. That would really be a breakthrough.To contact the author of this story: Max Nisen at email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
Alnylam (ALNY) reports positive top-line results from the phase III study on lumasiran for the treatment of primary hyperoxaluria type 1.
Two of the industry’s leading gene-editing experts have unveiled their next venture: a gene-silencing startup called Triplet Therapeutics.
(Bloomberg Opinion) -- After a years-long trial that shocked the pharmaceutical industry, a surprise delay, and regulatory scrutiny, Amarin Corp. finally got the go-ahead late Friday to market its fish-oil-derived heart pill Vascepa to millions of additional Americans.The expanded approval for prevention of events including heart attacks and strokes isn’t quite as broad as Amarin hoped, but keeps blockbuster sales very much in play. Investors had a muted reaction to the long-awaited news, sending the company’s shares down 2% by midday Monday. The stock’s response looks less worrisome in the context of a 740% increase since September 2018, but it does suggest that much of Amarin’s good news is priced in. Getting in now is a potentially risky bet on a pricey takeover or surprising sales upside. With approval in the bag, Amarin’s next job is selling more Vascepa. The company projects as much as $700 million in sales next year, a big step up from the $400 million seen in a far narrower indication this year. Sales will need to accelerate from there to meet analysts’ high expectations and justify an $8.3 billion valuation. Vascepa certainly has the potential, but it won’t be easy. The FDA restricted Vascepa to people with high triglycerides who either have established cardiovascular disease or diabetes and other cardiac risk factors, reflecting some experts’ concerns about the drug’s utility in lower-risk patients. That said, it’s still very much a win; Amarin now has access to a huge market. The existence of restrictions will give insurers and pharmacy benefit managers opportunities to slow Vascepa’s growth, however. Payers may embrace the drug for its relatively low cost and ability to prevent costly cardiac events. Still, the fact that it could reach tens of millions of patients and cause a near-term jump in spending may lead them to throw up barriers to access. Launches of primary-care drugs such as Vascepa are often comparatively slow, marketing-intensive, and expensive. “Sell the launch” is a common refrain from biotech investors. Concern about a shaky start may be behind the negative response to the as-expected details of Amarin’s approval. A few sales beats and guidance boosts may go a long way.Cash from a deep-pocketed acquirer with commercial expertise would go a long way toward speeding Vascepa’s growth. More investors are likely hoping for a deal than to endure the vicissitudes of a solo heart drug launch. They may have to wait. Vascepa is a unique and potentially highly lucrative opportunity, there are some risks for a potential acquirer in buying Amarin. It’s hard to imagine the company selling without a solid premium, which could well take the purchase price well past $10 billion. Drugmakers typically don’t cross that threshold for a biotech target lightly. Big Pharma has been increasingly gravitating toward higher-priced and easier-to-launch rare-disease and cancer drugs, and away from medicines like Vascepa. While Novartis AG at least has gone the other way with its recent $9.7 billion acquisition of Medicines Co. for long-acting cholesterol medicine, other potential acquirers may be leaning closer to Sanofi, which just gave up entirely on researching cardiovascular and diabetes drugs. Possible patent and competitive risks may be creating some hesitation as well. Amarin’s approval is still historic and highly promising. The market just needs a bit more proof that it will actually translate into revenue and returns. To contact the author of this story: Max Nisen at email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
Biotech has been a great performer since I suggested it as a contrarian play on Oct. 11. In that time, the SPDR S&P Biotech exchange-traded fund (XBI) climbed 22.8% through Thursday, and the iShares Nasdaq Biotechnology Index (IBB) advanced 19.8%, compared with a 6.4% gain for the S&P 500 (SPX) The seven stocks I singled out in that column have done well: They jumped 26.6%. “Washington is very focused on impeachment and trade talks,” says Jefferies biotech analyst Michael Yee.
Mergers and acquisitions have lit up biotech stocks, and the hot pace shows no sign of slowing in 2020. Gene therapy and oncology companies are targets.
The volume of global M&A has already reached $3.6 trillion this year, according to data from Dealogic. As history has shown, it takes just one big signature Merger Monday to symbolize hubris and excess—and it may already have happened.
Juan Monteverde, founder and managing partner at Monteverde & Associates PC, a national securities firm headquartered at the Empire State Building in New York City, is investigating The Medicines Company (the "Company") (Nasdaq: MDCO) relating to the sale of the Company to Novartis AG. Under the terms of the transaction, shareholders of the Company will receive $85.00 in cash for each share of the Company common stock owned.
After several tireless days we have finished crunching the numbers from nearly 750 13F filings issued by the elite hedge funds and other investment firms that we track at Insider Monkey, which disclosed those firms' equity portfolios as of September 30th. The results of that effort will be put on display in this article, as […]
(Bloomberg Opinion) -- Drugmakers have spent years de-emphasizing heart medications in favor of higher-priced treatments for cancer and rare diseases. As America enters its most caloric season, it looks like that is starting to change, for now. Novartis AG made a particularly large commitment Sunday with its $9.7 billion purchase of Medicines Co. and its promising new cholesterol drug. Meanwhile, biotechnology company Amarin Corp.’s bet on its fish-oil-derived capsule Vascepa is starting to pay off: Its shares soared earlier this month after a Food and Drug Administration panel recently suggested the pill — which was shown to cut cardiac risk in a huge trial last year — be made available to millions of additional patients. Heart medicines are also key pipeline components or sales drivers at a number of big pharmaceutical companies as well, from Merck & Co. and Bayer AG to Pfizer Inc.Investment in cardiac medicines is positive for patients and public health; after all, heart disease remains the most significant cause of death in the U.S. There’s a reason that drugmakers had backed away, however. These companies will have to navigate a harsh market environment to keep this mini-renaissance alive. Effective heart disease medicines, including statins for cholesterol and drugs for high blood pressure, have become much cheaper as generic options have hit the market. That’s excellent for patients and health budgets, as expanded use of these drugs has been impactful enough to slow Medicare spending growth. But it makes things difficult for newer, higher-priced medicines to make inroads. Next-generation drugs need to prove they can add something on top of or substantially outperform cheaper options to have a chance at anything but niche success. They sometimes still struggle even if they do. Cardiovascular drugs take time to have an impact, and the American health-care system isn’t patient. People change health insurance all the time as they swap or lose jobs, pick a new plan, or have one selected for them. Health plans often focus on annual costs and don’t always want to pay extra for an uncertain benefit that might eventually save someone else money. That tendency is most pronounced in large markets, where rapid uptake of a new drug translates into substantial spending increases.Two relatively new cholesterol drugs — Praluent, from Sanofi and Regeneron Pharmaceutical Co., and Amgen Inc.’s Repatha — are the most significant recent cautionary tales. They were both approved in 2015 with high expectations and are effective medications, but the market balked at their high price and threw up barriers to access. The result was a glacial launch. Sales remain sluggish even after major price cuts. Medicine Co.’s inclisiran lowers cholesterol at a similar rate by using the same drug target as those medicines but requires far less frequent dosing. Novartis will have to find out whether convenience is enough to command a premium price and avoid the same commercial fate. As for Amarin, a drug-price watchdog called Vascepa a rare cost-effective option for heart disease earlier this year. That doesn’t guarantee a rapid ascent to blockbuster sales. The drug’s future is partially in the FDA’s hands. The exact language of the agency’s expanded approval will help determine how many new patients will get access. The bigger part is arguably once again up to health plans. They will decide how strictly to interpret the FDA’s guidelines, and whether patients will have to jump through hoops to get the medicine. The size of the potential patient population may inspire them to clamp down, cost-effectiveness be damned. The barriers to heart drugs are navigable. Novartis was likely inspired to pay up for Medicines because it managed the feat with its heart-failure treatment Entresto. Sales of the drug started extremely slowly, but are now growing at a respectable clip. There is a clear opportunity in this somewhat neglected space. Profiting from it might require a high risk tolerance and an extra measure of patience. To contact the author of this story: Max Nisen at email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
Biotech stocks advanced in the holiday-shortened week, with upside driven mainly by the broader market strength. Reflecting the extreme volatility in the space, a few stocks gyrated wildly in reaction ...
The home of the Fighting Irish had a large position in the drug company at the end of the third quarter, and it’s nearly doubled in value since. It also sold Netflix stock, and bought Morgan Stanley and Alibaba stock.
Arrowhead Pharmaceuticals grabbed an upgrade Friday as ARWR stock has rocketed 159% since October on enthusiasm for the biotech company's RNAi platform. ARWR stock is 98% above a buy point.
Alnylam (ALNY) gets FDA approval for givosiran injection for subcutaneous use to treat adults with acute hepatic porphyria. Givosiran injection will be marketed by the trade name of Givlaari.
WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the Board of Directors of The Medicines Co. ("MDCO" or the "Company") (NASDAQ: MDCO) in connection with the proposed acquisition of the Company by Swiss pharmaceutical company Novartis International A.G. Under the terms of the acquisition agreement, MDCO shareholders will receive $85.00 for each share they own.
Major benchmarks closed at record highs on Monday, thanks to newfound investor optimism around developments in the U.S.-China trade talks and possible completion of the phase one trade agreement before the year runs out.