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News Breaks
February 14, 2014
15:21 EDTBMRNBioMarin's Vimizim gets FDA approval to treat enzyme disorder
The U.S. Food and Drug Administration approved Vimizim, the first FDA-approved treatment for Mucopolysaccharidosis Type IVA. Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Vimizim was granted priority review. An FDA priority review provides for an expedited review of drugs for serious diseases or conditions that may offer major advances in treatment. Vimizim is also the first drug to receive the Rare Pediatric Disease Priority Review Voucher, a provision that aims to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. Vimizim is marketed by BioMarin Pharmaceutical. Reference Link
News For BMRN From The Last 14 Days
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April 1, 2015
09:13 EDTBMRNSarepta surges as analysts see CEO change helping FDA interactions
Shares of biopharmaceutical company Sarepta Therapeutics (SRPT) are surging in pre-market trading after the company announced the resignation of its president and Chief Executive Officer. WHAT'S NEW: Sarepta, which has drugs in development for Duchenne muscular dystrophy and infectious diseases like Ebola, said late last night that Christopher Garabedian has resigned as president, CEO and as a member of the board, effective immediately. Chief Medical Officer Edward Kaye has been appointed as the company's interim CEO, also effective immediately. Kaye will continue to serve as CMO in addition to his interim CEO role as the company seeks a new full-time CEO, and will focus his efforts on heading the regulatory process for eteplirsen, the company's lead product candidate, as well as follow on "exon" drug candidates for DMD. Kaye commented that the company is on track in collecting and analyzing data that has been requested by the Food and Drug Administration that is necessary for the company to submit the new drug application for eteplirsen in mid-2015 as planned. WHAT'S NOTABLE: On the company's conference call discussing Kaye's appointment, Kaye commented that decision to replace Garabedian as CEO had "nothing to do" with the data for eteplirsen and that it was "between the board and Chris." Kaye said that the company will meet in the second quarter with the FDA and if there are any changes in the company's planned mid-year submission, Sarepta "certainly" will let people be aware of that. Kaye said the company is still collecting the safety information and that it will be submitted to the FDA, but noted that the company has not had any changes to date in its safety profile for eteplirsen. ANALYST REACTION: RBC Capital thinks that a change at the CEO position could enhance the company's interactions with the FDA and increase its credibility with investors, noting that Garabedian's interactions had previously drawn investor criticism. The firm, which has a Market Perform rating on Sarepta, ultimately thinks the determining factor for the stock will be the eteplirsen data and how the FDA views it. SunTrust, which has a Neutral rating on the stock, says it is "very pleased" by Kaye's promotion, as he has always been "a stabilizing force" at Sarepta. The firm also noted that Kaye's experience in developing orphan drugs has always been "well-appreciated" by the Street. Roth Capital this morning noted the "strained" relationship between the FDA and Sarepta under Garabedian's leadership, including the "mutual animosity and distrust" between the two. The firm believes the management transition is aimed at normalizing relations with the FDA. ANOTHER TO WATCH: Prosensa, which has been acquired by Biomarin (BMRN), is also at work on Duchenne muscular dystrophy treatments. PRICE ACTION: Sarepta shares jumped 8% to $14.35 in pre-market trading after the announcement of the leadership change.
March 31, 2015
13:57 EDTBMRNBioMarin a takeover target but valuation challenging, says dealReporter
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11:14 EDTBMRNOptions with increasing implied volatility
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March 30, 2015
14:47 EDTBMRNDMD drug panelist confirms conflict of interest, Boston Business Journal says
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07:48 EDTBMRNAcquisition of BioMarin would make sense for several companies, says SunTrust
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March 27, 2015
16:23 EDTBMRNOn The Fly: Closing Wrap
Stocks opened slightly higher but were unable to gather any upside momentum. They quickly crossed into negative territory but never really picked up speed to the downside. After the slightly better than expected consumer confidence reading, the averages moved back into positive ground where they spent most of the session hovering near the flat line. Near the close, comments by Fed Chair Janet Yellen that an interest rate hike "may be warranted later this year," lifted the averages into positive territory. ECONOMIC EVENTS: In the U.S., real GDP growth was steady at 2.2% in Q4, falling below consensus forecasts for 2.4% growth. GDP price index grew 0.1% on a linked quarter basis, matching expectations. U.S. consumer sentiment fell to 93.0 against consensus of 92.1. The current conditions index dipped to 105.0 from February's 106.9, while the consumer expectations index dropped to 85.3 from 88.0. COMPANY NEWS: Dow Chemical (DOW) and Olin (OLN) were up 3% and 14%, respectively, after announcing that Dow will separate much of its chlorine value chain and merge the entity with Olin in a $5B deal. Additionally, the companies announced a 20-year arrangement in which Dow will supply Olin with ethylene. Late in the session, the Wall Street Journal reported that Intel (INTC) was in talks to acquire Altera (ALTR), sending both stocks higher by 6% and 28%, respectively. MAJOR MOVERS: Among the notable gainers was Carnival (CCL), which rose over 6% after beating earnings expectations and raising FY15 revenue yield guidance. Also higher was BioMarin (BMRN), jumping 11% after speculation of a Shire (SHPG) takeover deal. Among the noteworthy losers was Southern Cooper (SCCO), which fell nearly 4% after the company cancelled its Tia Maria mining project. Also lower was OvaScience (OVAS), down 10% after Oppenheimer reported pushback from academics during the company's presentation of early Augment data. Opco cautioned, however, that criticism of non-trial data is "inevitable" and JMP Securities called the results encouraging. INDEXES: The Dow rose 34.43, or 0.19%, to 17,712.66, the Nasdaq gained 27.86, or 0.57%, to 4,891.22, and the S&P 500 added 4.87, or 0.24%, to 2,061.02.
12:36 EDTBMRNOn The Fly: Midday Wrap
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10:31 EDTBMRNOptions with increasing implied volatility
Options with increasing implied volatility: ZU ARWR HLSS CREE BMRN SWKS IOC CMG INFN HOT
10:29 EDTBMRNBioMarin rises amid takeover speculation, price target raises
The shares of BioMarin (BMRN) are climbing after a blog reported last night that Shire (SHPG) is considering offering to acquire the company. Meanwhile, analysts at UBS and Deutsche raised their price targets for the orphan drug maker, in part due to the possibility of a takeover. WHAT'S NEW: "Well-informed" sources are saying that Shire recently approached BioMarin about a merger deal, Ben Harrington of the blog Betaville reported last night. It's not clear how far the talks have progressed, but Morgan Stanley and Lazard are advising Shire on a deal that could be worth $65B, the blog added. ANALYSTS' TAKE: The recent acquisition of Pharmacyclics (PCYC) by AbbVie (ABBV) shows that drug companies need to acquire products and pipelines, UBS analyst Andrew Peters wrote in a note to investors earlier today. Given its diversified pipeline of orphan products and multi-billion revenue potential, BioMarin is among the most attractive targets in the sector, according to Peters. As a result, the analyst finds it appropriate to assign premiums to drug companies for their strategic value. Additionally, the analyst has become more upbeat on several of BioMarin's pipeline drugs and on its R&D capabilities. He raised his price target on the stock to $136 from $112 and kept a Buy rating on the shares. Also upbeat on the stock was Deutsche Bank analyst Robyn Karnauskas. BioMarin's top four pipeline drugs have 25%-50% chances of succeeding, but not everything in the company's pipeline needs to work for it to obtain an M&A premium, the analyst stated in a note to investors today. She believes that BioMarin can be acquired for $194-$271 per share in the next year, depending on the data from several of its drug candidates. The analyst raised her price target on the name to $140 from $90 and kept a Buy rating on the stock. PRICE ACTION: In early trading, BioMarin jumped 13.5% to $130. PRICE ACTION: In early trading, BioMarin climbed 13.5% to $130.
10:01 EDTBMRNHigh option volume stocks
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09:26 EDTBMRNOn The Fly: Pre-market Movers
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08:17 EDTBMRNDeutsche Bank biotech analyst holds an analyst/industry conference call
Biotech Analyst Karnauskas provides a deep dive look into BioMarin on an Analyst/Industry conference call to be held on March 27 at 10 am.
07:38 EDTBMRNBioMarin price target raised to $140 from $90 at Deutsche Bank
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05:58 EDTBMRNBioMarin price target raised to $136 from $112 at UBS
UBS analysts Andrew Peters and Matthew Roden raised their price target for BioMarin (BMRN) shares to $136 saying investors "are still well served" to buy the stock despite the recent outperformance and talk of a bubble in the Biotech space. The analysts view BioMarin as among the most attractive takeover targets in biotech. They add the company's 2015 is filled with pipeline catalyst and keep a Buy rating on the name. The target raise at UBS comes after Ben Harrington last night, former M&A and Markets Editor at the Daily Telegraph and current editor of the blog Betaville, said that Shire (SHPG) is weighing a takeover of BioMarin. Shares of the orphan drug maker closed yesterday down 7c to $115.55 and are trading up $8.95 to $124.50 in pre-market trading.
March 26, 2015
19:30 EDTBMRNBioMarin up 4% after blog says Shire weighing takeover
BioMarin (BMRN) is trading up over 4% in the after-hours after Ben Harrington, former M&A and Markets Editor at the Daily Telegraph and current editor of the blog Betaville, said that Shire (SHPG) is weighing a takeover of BioMarin. Reference Link
10:10 EDTBMRNAnalyst calls sharp pullback in biotech stocks 'misguided'
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06:45 EDTBMRNBiotech valuation concerns 'misguided,' says Piper Jaffray
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