Here's Why Insmed Incorporated Is Skyrocketing

What happened

Investors in Insmed (NASDAQ: INSM) are having an incredible start to the short trading week. Shares of the rare disease focused biotech are up 110% as of 11:15 a.m. EDT, after the company announced upbeat top-line results from its phase 3 Convert trial.

So what

The Convert trial was designed to measure the effect of adding Insmed's drug Amikacin Liposome Inhalation Suspension (ALIS) to guideline-based therapy (GBT) in patients who have treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex.

Data from the 336-patient trial showed that ALIS was able to meet its primary endpoint. Specifically, the study showed that adding ALIS to guideline-based therapy eliminated evidence of NTM lung disease by month 6 in 29% of patients. That was a statistically significant increase when compared to the 9% of patients who received GBT alone.

This data was so encouraging that Insmed plans on pursuing accelerated approval for ALIS. The therapy has also already been granted both "breakthrough therapy" designation and fast-track status by the U.S. Food and Drug Administration.

Insmed's CEO Will Lewis stated:

We consider these compelling top-line data to be a remarkable accomplishment in a rare disease state with no currently approved therapies. We are particularly encouraged by the consistency of these data when compared with our Phase 2 study results and look forward to additional data as the CONVERT study continues over the next two years.

Given the upbeat clinical news, it is easy to understand why investors are cheering today.

Image source: Getty Images.

Now what

Pause

Current Time0:00

/

Duration Time0:00

Stream TypeLIVE

Loaded: 0%

Progress: 0%

0:00

Fullscreen

00:00

Unmute

The only potential wrinkle in the data related to the drug's safety. The dropout rate for patients who used ALIS and GBT was 19.6%, which was a fair bit higher than the 9% dropout rate observed in the GBT group alone. Management stated that safety issues "were predominately mild or moderate in nature and generally declined after the second month of treatment."

To give investors more context on this issue, Dr. Paul Streck, Insmed's chief medical officer, offered this commentary:

The current guideline-based therapy to which we were compared in this study is not approved for the treatment of this disease, but is generally regarded as the best available option for these patients. Our drug candidate, ALIS, delivers high levels of an aminoglycoside directly to the lung macrophages and pulmonary tissue where the infection resides, and we believe this accounts for the significant impact on conversion that the drug demonstrated in these trial results.

All in all, today's clinical update clearly provides investors with reasons to be bullish on the future of Insmed. Risk-loving investors might want to consider putting this small-cap biotech on their watchlist.

10 stocks we like better than Insmed

When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*

David and Tom just revealed what they believe are the 10 best stocks for investors to buy right now... and Insmed wasn't one of them! That's right -- they think these 10 stocks are even better buys.

Click here to learn about these picks!

By Brian Feroldi

Source: https://goo.gl/yPY1Co

Goldman has a new favorite biotech because of potential Alzheimer's 'blockbuster'

• Research analyst Terence Flynn added Biogen to Goldman Sachs' Americas Conviction List on optimism its Alzheimer's drug may be the first to successfully slow the progression of the disease.
• By 2050, one new case of Alzheimer's is expected to develop every 33 seconds, according to the report.
• Goldman projects that one of the two drugs, known as Aducanumab, could reach peak sales of $12 billion.

Suzanne Kreiter | The Boston Globe | Getty Images

Goldman Sachs added Biogen to its Americas Conviction List, highlighting the biotech's lead pipeline Alzheimer's drug as possibly one of the first to successfully prevent or slow the progression of the disease.

"Biogen has a broad Alzheimer's disease portfolio, which, if successful, would allow it to access a greenfield, blockbuster market opportunity," wrote Goldman analyst Terence Flynn, Ph.D. "It is difficult to overstate the growing societal burden of Alzheimer's disease … By 2050, one new case of Alzheimer's disease is expected to develop every 33 seconds in the United States."

Cambridge-based Biogen focuses on discovering and developing therapies for neurological and hematologic disorders including multiple sclerosis and hemophilia. Through a partnership with Eisai, the two companies have two Alzheimer's drugs in late-stage development, both of which could be huge money generators.

Goldman projects that one of the two drugs, known as Aducanumab, could reach peak sales of $12 billion.

The analyst has a $338 price target on Biogen, representing 17 percent upside from Tuesday's close. The shares rose 1.4 percent in premarket trading Wednesday after Goldman's call.

Biogen is also a key player in treatment of multiple sclerosis, handling 38 percent of all MS patients globally. With more and more competitors entering the MS market, Biogen has started to feel pressure on some of its established drugs.

"MS is a mature market and competition has been increasing. But while generics and other new entrants could capture share, we don't expect wholesale 're-pricing' of the category," continued Flynn.

In all, Goldman Sachs not only sees room for drug catalysts, but additional business development could provide Biogen with free cash.

"Our firepower analysis suggests $14 billion in capacity, which is above what management discussed on the 2Q call regarding the maximum size deal it could pursue," wrote Flynn.

"Hence, in addition to potential business development deals, we believe the company could more aggressively repurchase shares."

By Thomas Frank

Source: https://goo.gl/X84QWG

Opinion: Three biotech companies to watch ahead of earnings

Harry Boxer focuses on Exelixis, ImmunoGen and Impax Laboratories

Here are three biotechnology companies and one services company that are displaying strong technical charts ahead of their earnings reports.

Exelixis Inc. EXEL, -2.49% extended out of its bull wedge consolidation pattern, gaining 88 cents to close at $28.11 on 3.8 million shares traded Monday. That’s the highest price the stock has reached since October 2000. The biopharma stock has gained over 90% this year and has progressed up a clear rising channel in the run-up to the company’s earnings announcement next Wednesday. Short-term target is $29.50-$30.

ImmunoGen Inc. IMGN, -3.47% snapped back Monday to $6.34, up 68 cents, or 12%, on 4.3 million shares traded. The stock bounced off the bottom of its rising channel as well as its 50-day moving average after having pulled back from its channel top in the last three weeks. The move came on no apparent news, although the company announces second-quarter earnings Friday. With continued momentum, price could move up to $8-$10 in the next few weeks.

Impax Laboratories Inc. IPXL, +3.47% is on the move, having recently broken out of a head-and-shoulders bottoming pattern. The stock closed at $18.75, up 60 cents, or 3.3%, on 1.5 million shares traded and no news, and is now up more than 40% off its mid-June low of $13.25. The stock saw large gains last week with news of FDA approval of a generic version of its ADHD drug, Concerta, and expected product launch by the end of 2017. The company is expected to report earnings Aug. 8 before the market opens. The next target range is $20-$23.

Outside of biotech, CAI International Inc. CAI, -2.38% is seeing excellent follow-through from last Friday, when price popped all the way up to a high of $26.12. On Monday the stock gained $1, or 3.8%, to close at a three-year high of $26.93 on 427,600 shares traded. Analysts have dramatically increased earnings expectations for the transportation finance and logistics company in recent weeks, and earnings will be announced this Wednesday after the close. The stock is being traded at some of the heaviest volume this year. Having already blown through significant resistance in the $25-$26 zone, price could easily reach $30 in the near term. The price channel shows that this could be a $40 stock or more in the longer term.

By Harry Boxer

Source: https://goo.gl/hxnn7e

Bluebird Bio shares pop on what CEO calls ‘very exciting’ cancer news

• Bluebird Bio and its partner, Celgene, released positive results from an ongoing study of patients with relapsed/refractory multiple myeloma.
• The patients have had an "incredible response rate," Bluebird CEO Nick Leschly told CNBC.
• "We're really trying to harness the immune system to attack your cancer," he said.

Shares of Bluebird Bio popped on Monday after the announcement of what CEO Nick Leschly called "very exciting data."

The biotech company and its partner, Celgene, released updated clinical results from an ongoing study of patients with relapsed/refractory multiple myeloma, a blood cancer.

In the trial active dose cohorts, 73 percent of evaluable patients received a very good partial response.

Leschly told CNBC's "Closing Bell" the people taking part in the study are "terribly sick."

"They've tried everything in the book and are sort of at the end of the line. And those patients have had an incredible response rate."

The idea is to take cells outside of the patient's body, use technology to "harness and direct it" and then put the cells back into the patient, he explained.

"We're really trying to harness the immune system to attack your cancer," Leschly said.

And while there are multiple drugs that have made a "big difference" for multiple myeloma patients, unfortunately the cancer comes back in a lot of patients, Leschly said.

"Then you have a very shortened lifespan on the order of 6 to 8 months. That's the need that we're talking about."

Bluebird Bio closed 8.5 percent higher at $91.30 on Monday.

By Michelle Fox

Source:https://goo.gl/pZjd54

Biotech stock Neurocrine surges more than 22% after FDA approves first drug for movement disorder

Getty Images

• Biotech gets FDA approval for first drug to treat movement disorder tardive dyskinesia, or TD.
• Neurocrine shares were up 7 percent on the year before the announcement.
• Disorder causes uncontrollable, abnormal and repetitive movements in certain upper body muscles.

View:https://goo.gl/AOX9o1 mother's day gifts

Shares of Neurocrine Biosciences leaped more than 22 percent Wednesday after the biotech firm announced federal approval of its drug for a movement disorder. The stock closed up over 24 percent.

Neurocrine announced late Tuesday that the Food and Drug Administration has approved Ingrezza, the only product for treatment of adults with tardive dyskinesia, or TD.

The condition is characterized by uncontrollable, abnormal and repetitive movements in certain upper body muscles caused by treatments often prescribed for mental illness, the drugmaker said in a release.

It said an estimated 500,000 Americans have the condition.

Neurocrine Biosciences extended-hours trade

Source: FactSet

Christoph U. Correll, professor of psychiatry and molecular medicine at the Hofstra Northwell School of Medicine, said in the release that Ingrezza "significantly and rapidly improved" symptoms compared to a placebo.

"These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD," he said.

Neurocrine shares were up 33 percent year-to-date through Wednesday's close.

View : https://goo.gl/4glEbR

By Evelyn Cheng

Source:https://goo.gl/W0jE3H

5 FDA Decisions to Watch Out for in Mar 2017

RHHBY SNY MRK REGN AMGN RDUS VRX

FDA, which gave its nod to 22 treatments last year, has given its approval to 5 drugs so far in 2017. This includes Synergy’s Trulance (treatment of chronic idiopathic constipation (CIC) in adults), Amgen’s (AMGN - Free Report) Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis), Marathon’s Emflaza (Duchenne muscular dystrophy), Valeant’s (VRX - Free Report) Siliq (moderate-to-severe plaque psoriasis) and Lexicon’s Xermelo (treatment of carcinoid syndrome diarrhea).

Roche Holding AG (RHHBY - Free Report) will also be getting a response from the FDA for Ocrevus (ocrelizumab) -- the FDA action date for this candidate was extended by three months to Mar 28, 2017 in Dec 2016. The extension resulted from additional data submitted by Roche related to the commercial manufacturing process for the drug. Roche is looking to get the drug approved for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche, a Zacks Rank #5 (Strong Sell) stock, has underperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 3.1% compared to the industry gain of 6.6%.
Here is a look at a few important regulatory events scheduled for the month of March.

First up is drugmaker Merck & Co., Inc. (MRK - Free Report) which is awaiting two FDA decisions this month for its anti-PD-1 therapy, Keytruda. While a decision regarding the approval status of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Mar 8, a decision regarding the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy should be out by mid-March. Keytruda, one of Merck’s new products, is already approved for different types of cancer and brought in sales of $1.4 billion in 2016. Merck is working on expanding the label of the product. Merck, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 26.5% compared to the industry gain of 6.6%.

Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017. Dupixent, which has blockbuster potential, is being investigated for other indications as well including asthma and nasal polyps. A confirmatory phase III study for the asthma indication is ongoing and positive results would allow the company to file for FDA approval in the fourth quarter of 2017. While both Sanofi and Regeneron are Zacks Rank #3 stocks, you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sanofi has performed better than the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 10.8% during this period. Regeneron, on the other hand, has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 7.2% over the last one year compared to the industry decline of 2.5%.

Science-driven biopharmaceutical company Radius Health, Inc. (RDUS - Free Report) is also awaiting a response from the FDA for its regulatory application for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. A response from the agency should be out by Mar 30. Radius is currently working on putting a commercial structure in place so that the product can be launched immediately after gaining approval. The Zacks Rank #3 stock has outperformed the Zacks-categorized Medical-Drugs industry over the past one year with shares gaining 24.8% compared to the industry gain of 4.9%.

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.

by Arpita Dutt 

Source:https://www.zacks.com/stock/news/251688/5-fda-decisions-to-watch-out-for-in-mar-2017

Opinion: Harry Boxer: Watch these two biotechnology stocks

Gene-therapy company bluebird bio and cannabis-based biotech firm Cara Therapeutics break out with big moves

President Trump pressed Big Pharma executives to increase U.S. production and lower drug prices.

As biotechnology stocks have been showing momentum following a meeting between President Trump and pharmaceutical executives Tuesday, our two “long” investments to watch are in that sector. There are also several “shorts” among our charts to watch to play the potential downside in this near-term, toppy-looking stock market.

Gene-therapy company bluebird bio Inc. BLUE, +2.54% has a strong-looking chart. The stock recently broke out of a wedge pattern, in which its price range had narrowed for two months in essentially a sideways direction. The stock continued the upmove on Tuesday when it popped $5.90, or over 8%, to $74.50, and followed through for another $1.10 on Wednesday to $75.60. The stock is now positioned to challenge its recent high at $79.70 from early December. A break through there could lead to a move into the mid-$80s, followed by a next target in the mid-$90s. With short interest of 9.2 its average volume, the price advance could be further fueled by short covering.

Cara Therapeutics Inc. CARA, +5.11% a cannabis-based biotech, has been steadily climbing since the start of the year. On Wednesday, the stock popped $1.17, or 7.6%, to $16.49 on 4.7 million shares, which is huge volume for this stock, the biggest since mid-November. The stock got as high as $17.20 intraday before pulling back into the close. It is a bit extended near the top of its channel and could pull back and consolidate before its next move, but momentum could carry it a bit further toward $18.

–– ADVERTISEMENT ––

On the short side, Carter’s Inc. CRI, -3.21% continues lower since its July 2016 top above $112. On Wednesday, shares in the children's wear retailer were down another $1.05, or 1.3%, to $82.70, on 690,100 shares traded. The stock appears headed toward the bottom of its declining channel in the $73-$74 range.

Signet Jewelers Ltd. SIG, +0.24% is also continuing lower. The stock rallied from the bottom of its declining price channel to the top in the last quarter of 2016, but has since broken down. Shares fell another 66 cents to $77.01 on 1.5 million shares traded on Wednesday. Watch for a test of the late-September low in the $72-$73 range. A takeout of that could drop the stock near its channel bottom in the low- to mid-$60s.

See Harry’s video chart analysis on these and other stocks.

By Harry Boxer

Source:http://www.marketwatch.com/story/harry-boxer-watch-these-two-biotechnology-stocks-2017-02-02?siteid=yhoof2&yptr=yahoo

7 Biotech And Healthcare Picks For 2017 From Cantor Fitzgerald

After a forgettable year for biotech and healthcare stocks, 2017 has dawned with new hopes. Although the Democratic threat on a clamp down on price gouging hit the space for much of 2016 amid the presidential election campaign, the election of Republican Donald Trump initially generated some optimism. However, Trump has since sent out a veiled threat of being uncomfortable with higher drug prices.

7 In Focus

Against this backdrop, Cantor Fitzgerald initiated coverage of the following biotech and healthcare stocks at Overweight, making these its top picks in the space for 2017:

• athenahealth, Inc ATHN 1.67%: price target of $135 (18 percent upside from current levels).
• Cerner Corporation CERN 0.21%: price target of $66 (34 percent upside from current levels).
• eHealth, Inc. EHTH 5.01%: price target of $15 (48 percent upside from current levels).
• Evolent Health Inc EVH 5.3%: price target of $26 (74 percent upside from current levels).
• NantHealth Inc NH 2.82%: price target of $17 (73 percent upside from current levels).
• Omnicell, Inc. OMCL 1.36%: price target of $40 (21 percent upside from current levels).
• Teladoc Inc TDOC 0.91%: price target of $25 (over 50 percent upside from current levels).

Athenahealth's Traditional Market Disrupting Cloud-based Offering

Cantor analyst Steven Harper noted that athenahealth has demonstrated its ability to disrupt the traditional market for physician practice management and clinical information systems with its cloud-based offering. The analyst also highlighted the company's 2017 guidance for 18.5 percent top line growth, with indications that it could hit operating income growth of 34 percent, as it realizes operating leverage. The firm feels the shares are attractive.

Cerner: Bellwether Among Publicly Traded Healthcare IT Companies

Cantor said Cerner remains the bellwether among publicly traded healthcare IT companies. Notwithstanding the recent disappointing performance, the firm said it does not share investor concerns about the company's future growth prospects. Harper feels the shares of Cerner are considerably undervalued at this juncture. The $66 price target represents 36 percent upside from current levels.

EHealth: Well Suited To Weather The Storm

Cantor feels eHealth may benefit if the incoming Trump administration dismantles the Affordable Healthcare Act, beginning in 2018. The ACA negatively impacted eHealth, as many individuals now buy insurance on an exchange, bringing down the company's individual and family plan membership by 25 percent year-over-year. Analysts Harper said it remains to be seen if the company's new strategy outlined in its third quarter results will pay dividends. Accordingly, the firm believes the company is well suited to weather the storm.

Evolent Health: Well Positioned To Grow Rapidly

Harper believes Evolent Health, a technology-enabled cloud-based service provider, is well positioned to grow rapidly from the ongoing shift to value-based reimbursement, due to the large addressable market. The company's population health management tools allow healthcare organizations to transition to value-based reimbursement, with captive health insurance plans of large integrated delivery networks being its primary customers. The analyst believes market forces will continue to drive the shift to value-based reimbursement in many large population markets.

NantHealth's Unique Cancer Screening Test A Game changer

Cantor believes NantHealth's unique cancer screening test, called GPS Cancer, is poised to change cancer care. The slower than expected ramp of the strategy does not diminish the firm's enthusiasm.

Omnicell To Continue To Gain Share

Cantor is of the view that Omnicell will continue to gain market share from industry leader Pyris, a subsidiary of Becton Dickinson and Co BDX 1.87%, given its product differentiation and lower cost of ownership. The firm noted that over the years, the company has broadened its product set to improve hospital pharmacy efficiencies beyond dispensing. Cantor views the acquisition of Aesynt, a provider of robotic technology hospitals and a growing IV automation solution, to be transformative.

Teladoc: Poised To See Strong Industry Growth

Harper believes Teladoc, a provider if telehealth services to health plans and employers, is poised to see strong industry growth over the next several years. Explaining the prospects, the analyst highlighted the CDC data that showed 1.25 billion ambulatory visits occur each year. The company believes about at least one-third of these visits could be treated with telehealth, the analyst noted.

By Shanthi Rexaline

Source: http://www.benzinga.com/analyst-ratings/analyst-color/17/01/8878069/7-biotech-and-healthcare-picks-for-2017-from-cantor-fitz