Achaogen (NASDAQ:AKAO) is a clinical-stage biotechnology company specializing in creating antibiotics to treat MDR (multidrug resistant) bacteria. Its lead candidate, plazomicin, recently was recommended for approval for cUTI (complicated urinary tract infections) on May 2 by an FDA advisory committee. This almost guarantees the FDA will approve the drug for marketing, but the stock price dropped rather dramatically (Achaogen down 26% premarket after Ad Com vote).
The fall was because the committee did not recommend plazomicin for treating bloodstream infections. This brought into question how broadly applicable plazomicin might become. Typically, after receiving the first FDA approval in an indication, companies seek label expansion (approval in other indications) by submitting further trial data. The long-term value of a company may vary greatly by how broadly applicable a commercial drug is.
The situation is similar to the situation for another company, Tetraphase (NASDAQ:TTPH), which has been developing a rival drug, with a very different mechanism of action, to treat MDR infections. In the Tetraphase case Phase 3 data for cUTI failed to reach the expected endpoint, but the drug appears on track for a likely approval for treating cIAI (complicated intra-abdominal infections), with a decision due towards the end of August.
Best Biotech Stocks To Own Right Now: Biogen Idec Inc(BIIB)
Advisors' Opinion:- [By Brian Orelli]
Data source: Ionis Pharmaceuticals.
What happened with Ionis Pharmaceuticals this quarter? Revenue increased thanks to $41 million in royalties from Biogen's (NASDAQ:BIIB) sales of Spinraza, up from just $5 million in the year-ago quarter. Because the tiered royalty rates reset each year, the royalties as a percentage of sales will end up being higher in the quarters to come this year. Despite the higher revenue, earnings turned negative on a GAAP (generally accepted accounting principles) basis: Ionis and Akcea Therapeutics (NASDAQ:AKCA) increased spending in preparation for the launch of Tegsedi for hereditary transthyretin amyloidosis (hATTR), and Waylivra for familial chylomicronemia syndrome, a rare disease that causes the buildup of lipids. Ionis is still the majority owner of Akcea, so its financials are incorporated into Ionis' financials. The Food and Drug Administration pushed back its goal for making a decision on the marketing application for Tegsedi (the new brand name for inotersen) to Oct. 6, 2018. Ionis provided additional data analysis that the FDA needs additional time to review. In April, Ionis signed another deal with Biogen to develop antisense drugs for neurological disorders. In the deal, Ionis gets $1 billion up front, including an equity investment, in exchange for Biogen having first choice of neurology targets on which to exclusively collaborate with Ionis. Biogen is paying for everything beyond the initial discovery stage, with Ionis eligible for royalties and milestone payments as the drugs advance.Image source: Getty Images.
- [By Brian Orelli]
Drug-developer Biogen (NASDAQ:BIIB) reported a pretty strong earnings�increase in the first quarter. While revenue growth wasn't as solid, investors appear to be giving management a pass, thanks to its explanations on why slowing first-quarter sales aren't a sign of future trouble.
- [By Garrett Baldwin] Markets are keeping a close eye on the 10-year bond, which is hovering near 3% – an important psychological level that is likely to influence future price movements. On Monday, Fox Business Network's "Varney & Co." asked Money Morning Chief Investment Strategist Keith Fitz-Gerald if investors should be worried. Here's what Keith had to say about the 10-year Treasury yield… and how it will affect your stocks and bonds in the future. The price of Brent crude oil topped $75.00 and hit its highest level since November 2014. Oil traders were eyeing the ongoing efforts of OPEC and Russia to reduce excessive production around the globe, rising demand ahead of peak driving season, and the possibility that the Trump administration will slap Iran with a new round of sanctions. Three Stocks to Watch Today: KO, GOOGL, SLM Shares of The Coca-Cola Co.�(NYSE: KO) added 1.2% after the firm easily beat earnings and revenue expectations. The firm cited strong demand for its new flavors of Diet Coke and its Coke Zero Sugar. Demand was so strong for the quarter that the firm reported organic sales growth of 5%. The company reported earnings per share of $0.47, topping estimates by a penny. Revenue of $7.6 billion easily beat Wall Street estimates. Shares of Alphabet Inc. (Nasdaq: GOOGL) seesawed in pre-market hours. The online search giant topped Wall Street earnings and revenue expectations after the bell Monday. However, shares were off 0.5% after executives announced that its business costs were on the rise. The firm's real estate and computer purchases tripled in one year, to $7.3 billion. About one-third of that total came from its $2.4 billion purchase of the Chelsea Market building in New York City. Good news for SLM Corp.�(NYSE: SLM) investors, but bad news for indebted college students and graduates. The firm – also known as Sallie Mae – topped Wall Street earnings expectations on Monday. The firm said that it increased its loan o
- [By Chris Lange]
Short interest in Biogen Inc. (NASDAQ: BIIB) increased to 3.86 million shares from the previous 3.45 million. The stock recently traded at $287.00, within a 52-week range of $244.28 to $370.57.
- [By Shannon Jones]
In this week's episode of Industry Focus: Healthcare, host Michael Douglass and Motley Fool contributor Shannon Jones look at what went wrong with Incyte's Epacadostat, where the company can go from here, and what this unfortunately means for the immuno-oncology sector on the whole. Then, in more pleasant news, the hosts dive into Novartis' (NYSE:NVS) newest acquisition of gene therapy company AveXis. Find out what this means for Novartis, why Biogen (NASDAQ:BIIB)�might be getting the stink eye from their investors right about now, whether or not Novartis overpaid to tuck this company under their belt, and more.
- [By Sean Williams, Chuck Saletta, and Brian Feroldi]
As noted, the ability to take numerous swings for the fence makes Ionis special. It's often a marvel when a mid-cap drugmaker has a half-dozen experimental drugs, let alone one working with 25. Spinal muscular atrophy drug Spinraza, which was licensed to Biogen (NASDAQ:BIIB), is one such drug that's put Ionis and its antisense technology on the map. Last year, Spinraza netted "just" $882 million in total sales, but delivered $364 million globally in the first quarter of 2018. That extrapolates out to more than $1.4 billion, which means added royalty revenue for Ionis.
Best Biotech Stocks To Own Right Now: Alnylam Pharmaceuticals Inc.(ALNY)
Advisors' Opinion:- [By Joseph Griffin]
BidaskClub lowered shares of Alnylam Pharmaceuticals (NASDAQ:ALNY) from a strong-buy rating to a buy rating in a research report released on Monday.
- [By Keith Speights]
I wrote three months ago that I viewed Alnylam Pharmaceuticals (NASDAQ:ALNY) stock as a pretty good pick -- but with a couple of qualifications. First, I didn't think that the biotech would generate returns in 2018 nearly as great as it did last year. Second, I thought that there were even better stocks to buy than Alnylam.
- [By Brian Orelli]
The delay in an FDA decision for Tegsedi puts it behind competitor Alnylam Pharmaceuticals (NASDAQ:ALNY), which expects to hear from the FDA by Aug. 11 for its hATTR drug patisiran. But Sarah Boyce, the president at Akcea Therapeutics, doesn't think a few months will really matter: "We don't really feel that's going to have any impact and the drugs will be close enough together from a launch perspective. So not really [going] to make any adjustments, and we're very well prepared to be ready to launch following approval."
Best Biotech Stocks To Own Right Now: Amgen Inc.(AMGN)
Advisors' Opinion:- [By Cory Renauer]
Patient Amgen Inc.�(NASDAQ:AMGN) shareholders have seen the stock quadruple in price over the past decade, plus they've enjoyed one of the fastest-growing dividends in biopharma. Now that the company's launched a new migraine headache drug, investors are wondering if the former highflier can put on another memorable performance.
- [By ]
This week we get our first look at quarterly numbers from major drug and biotech giants such as AbbVie (ABBV) , Amgen (AMGN) , Biogen (BIIB) , Biomarin Pharmaceuticals (BMRN) and Action Alerts PLUS holding Eli Lilly (LLY) , which all provide the market a glimpse of how the first quarter was for the industry over the next few days," according to Real Money Pro columnist Bret Jensen.
- [By Logan Wallace]
Shares of Amgen (NASDAQ:AMGN) have earned an average recommendation of “Hold” from the twenty-seven research firms that are presently covering the company, Marketbeat reports. Two investment analysts have rated the stock with a sell rating, fourteen have assigned a hold rating and ten have given a buy rating to the company. The average 1 year target price among brokers that have issued a report on the stock in the last year is $193.19.
Best Biotech Stocks To Own Right Now: ArQule Inc.(ARQL)
Advisors' Opinion:- [By Stephan Byrd]
ArQule, Inc. (NASDAQ:ARQL) Director Ronald M. Lindsay acquired 23,900 shares of the company’s stock in a transaction on Thursday, May 10th. The stock was acquired at an average price of $2.67 per share, for a total transaction of $63,813.00. Following the purchase, the director now directly owns 43,900 shares of the company’s stock, valued at $117,213. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.
- [By Ethan Ryder]
ArQule, Inc. (NASDAQ:ARQL) insider Value Fund L. P. Biotechnology sold 1,035,939 shares of the business’s stock in a transaction dated Wednesday, May 30th. The shares were sold at an average price of $5.00, for a total value of $5,179,695.00. The transaction was disclosed in a filing with the SEC, which is available through this hyperlink.
- [By Joseph Griffin]
ArQule (NASDAQ:ARQL)‘s stock had its “buy” rating restated by equities researchers at Needham & Company LLC in a research report issued to clients and investors on Tuesday, Marketbeat Ratings reports. They currently have a $6.00 price target on the biotechnology company’s stock, up from their prior price target of $5.00. Needham & Company LLC’s price target suggests a potential upside of 134.38% from the company’s previous close.
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