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June 12, 2014
07:25 EDTBMRNBioMarin coverage transitioned with a Buy at UBS
Target $74.
News For BMRN From The Last 14 Days
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October 2, 2015
06:23 EDTBMRNBioMarin initiated with an Outperform at Raymond James
Target $148.
October 1, 2015
13:29 EDTBMRNBioMarin reiterated as a top mid-cap pick at Cowen
Cowen reiterated BioMarin as a top mid-cap pick following the announcement is reacquired the rights to Kuvan, ex-Japan, and pegvaliase from Merck Serono. Analyst Phil Nadeau views it as an attractive financial transaction for BioMarin and would use recent weakness to build a position. Nadeau rates BioMarin an Outperform with a $175 price target.
11:22 EDTBMRNSarepta jumps as trial data seen supporting DMD drug efficacy
Shares of Sarepta Therapeutics (SRPT) surged in morning trading after the company said that data from a recent trial of its Duchenne muscular dystrophy, or DMD, treatment had shown "positive" outcomes. WHAT'S NEW: Sarepta said that additional data from its Phase IIb program of eteplirsen in patients with DMD showed "positive outcomes." The company said the drug gave a statistically significant advantage of 151 meters in the study participants' ability to walk at three years, compared with external controls. The company added that the fourth biopsy data confirmed the "mechanism of action" of eteplirsen, showing exon skipping in all patients and dystrophin production in nearly every patient. The results from the trial have been included in the New Drug Application that the company sent to the U.S. Food and Drug Administration, the company said. Sarepta noted that the FDA granted eteplirsen Priority Review status and gave a Prescription Drug User Fee Act action date of February 26, 2016. WHAT'S NOTABLE: Today's trial data follows competitor BioMarin Pharmaceuticals' (BMRN) announcement after the market close Tuesday that the Patent Trial and Appeal Board, or PTAB, of the USPTO ruled in favor of its claims to the use of exon 51 antisense oligonucleotides for the treatment of DMD over Sarepta. The PTAB decision included the cancellation of Sarepta's patent, which included the skipping of exon 51 in the dystrophin gene. Sarepta plans to appeal the decision to the U.S. Court of Appeals for the Federal Circuit, the company has stated. STREET RESEARCH: Piper Jaffray analyst Edward Tenthoff said that Sarepta's additional data from its Phase IIB studies boosts confidence in eteplirsen's mechanistic and clinical efficacy as well as the chances of a positive regulatory decision. Tenthoff said that, following PTAB's decision to rule in favor of BioMarin on claims to use the exon 51 antisense oligonucleotides, he is waiting for decisions on two additional composition of matter interferences for Exon 51 and 53 skipping drugs. The analyst maintained an Overweight rating on Sarepta's stock with a $48 price target. In addition, William Blair analyst Tim Lugo said that the "strong" data presented by Sarepta leads him to continue to believe that eteplirsen will qualify for an accelerated approval when discussed at the FDA AdCom in November. The analyst maintained an Outperform rating on the company's stock. Yesterday, Lugo said he viewed BioMarin's favorable PTAB decision over Sarepta as "more noise than impact." He added that Sarepta will appeal the decision and the Patent Office will not issue the allowed claims until the appeal is completed. The analyst noted, however, that if BioMarin wins the appeal and its patents in the U.S. can block eteplirsen from the U.S. market, such actions will come later than an eventual FDA approval decision. In such an event, BioMarin trying to pull eteplirsen from the U.S. market would be a "nonstarter," Lugo said. The William Blair analyst, at the time of yesterday's note, maintained an Outperform rating on Sarepta's shares with a $52 price target. PRICE ACTION: In morning trading, Sarepta shares rallied 21% to $38.95, while BioMarin rose 1.5% to $106.90.
05:41 EDTBMRNBioMarin to acquire rights to Phenylketonuria franchise from Merck Serono
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05:18 EDTBMRNBioMarin to host a conference call
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September 30, 2015
09:13 EDTBMRNLeerink reiterates Outperform on BioMarin after time with management
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07:11 EDTBMRNLeerink to hold a roundtable
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07:09 EDTBMRNSarepta negative ruling 'more noise than impact, says William Blair
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07:03 EDTBMRNSarepta announces USPTO decision on patent interference proceeding with BioMarin
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September 29, 2015
18:16 EDTBMRNBioMarin receives favorable ruling in use of exon 51 antisense oligonucleotides
BioMarin Pharmaceutical (BMRN) announced that the Patent Trial and Appeal Board issued a decision in favor of BioMarin's claims to the use of exon 51 antisense oligonucleotides to treat Duchenne muscular dystrophy. The BioMarin patent application involved is U.S. Patent Application No. 14/198,992, which is licensed to BioMarin from the Academisch Ziekenhuis Leiden, The Netherlands. The decision by the PTAB is based on motions filed in the patent interference proceeding between BioMarin, due to the acquisition of Prosensa Therapeutics N.V. and Sarepta (SRPT) of Cambridge, Mass as licensee under patents filed by the University of Western Australia. The allowed claims cover the use of the antisense oligonucleotide drisapersen, as well as other antisense oligonucleotides that induce skipping exon 51 for the treatment of Duchenne muscular dystrophy. BioMarin also protects drisapersen under U.S. Patents 7,534,879 and 8,759,507, two patents which were not involved in the interference. The other interference between AZL and UAW related to composition of matter claims for antisense oligonucleotides for Exon 51 skipping, Interference 106,008, remains pending. In Europe, BioMarin's method patent EP 1 619 249 B1 was previously upheld in an amended form after an Opposition procedure initiated by AVI Biopharma (now Sarepta) before the European Patent Office Opposition Division. The upheld claims include the use of 14- to 40-mer antisense oligonucleotides directed to exon 51 in the DMD gene as a potential therapy to treat DMD. Although an appeal procedure is pending, BioMarin currently has an issued and enforceable patent, which encompasses antisense oligonucleotide product/product candidates directed to exons 51 and 46 in Europe.
September 28, 2015
16:13 EDTBMRNBioMarin enrolls first patient in Phase 1/2 trial of BMN 270 for hemophilia
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September 25, 2015
07:22 EDTBMRNEuropean Society for Medical Oncology to hold a conference
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September 23, 2015
08:26 EDTBMRNBioMarin October volatility increases on wide-price movement
BioMarin October call option implied volatility is at 56, November is at 50; compared to its 52-week range of 33 to 64, suggesting large near term price movement.
06:29 EDTBMRNOrphan drug pricing concerns overdone, says Leerink
Leerink analyst Joseph Schwartz says his firm's Orphan Drug Payor survey contrasts with the recent bearish investor sentiment over the orphan drug business model. The survey of 30 payors indicates that the reimbursement landscape "remains highly favorable" for commercially insured patients and is able to withstand potential weakness caused by proposed changes to Medicare pricing, Schwartz tells investors in a research note. His analysis suggests a "surprisingly limited" impact to valuations of orphan drug companies should Medicare patients receive drug discounts. Schwartz views the pricing concerns stemming from Hillary Clinton's plan to combat high drug prices as overdone. He reiterates Outperform ratings on AMAG Pharmaceuticals (AMAG), BioMarin (BMRN), Raptor Pharmaceuticals (RPTP) and Retrophin (RTRX).
September 22, 2015
20:02 EDTBMRNClinton vows $250 cap on monthly drug costs in blast against biotechs, insurers
Democratic presidential candidate Hillary Clinton railed against biotech companies as well as health insurers at a community health care forum in Iowa on Tuesday. Clinton began her speech by praising the Affordable Care Act, but quickly noted that she wants to strengthen it due to what she called the rising cost of prescription drugs. She explained, "Our pharmaceutical and biotechnology industries deserve credit... [But] too often, these drugs cost a fortune. Now, sometimes there is a good reason for that. Scientific breakthroughs are often the result of major investment... so it may makes sense, for a short period of time, to have to charge a lot of money for a drug. But when a drug has no competition, when there aren't any other treatments that can do what it does, pharmaceutical companies can charge astronomical fees far beyond anything that it would take to recoup their investment, and far beyond what they charge consumers anywhere else in the world outside of America." Referencing the recent criticism against Turing Pharmaceuticals, Clinton went on to say that "pharmaceutical companies that acquire an existing affordable drug that people rely on, and then turn around and charge a fortune for it, [are just betting] on the fact that desperate people will find some way to pay for it." Preemptively responding to questions of whether greater regulation will dampen investment, Clinton commented that "some people worry that my proposals will threaten innovation, but I have designed a plan that will do exactly the opposite... Under my plan, drug companies that want to keep getting federal support will have to redirect more of their profits into meaningful investments in research and development." Clinton also criticized incremental drug improvements, saying that "too often, so-called new drugs are really old drugs that have just been tweaked a little bit, but then they're marketed as breakthrough drugs and they're sold for high prices." The Democratic candidate went on to condemn advertising in the drug industry, remarking that "I also want to tackle direct to consumer advertising... Other countries ban these ads because they are so often misleading. But at the very least, we shouldn't be encouraging them with corporate write-offs... Under my plan, we will instead use that taxpayer money to fund innovation... I would also like to make sure any ads the drug industry does run are approved by the FDA." Moving more broadly onto Medicaid and health insurers, Clinton stated, "I believe Medicare should be able to negotiate for lower prices for its members... I will require drug companies to provide higher rebates for prescription drugs to low income Medicare patients, just like they have to do for Medicaid patients... I think the insurance companies need to be put on notice." Providing more concrete details of her plan, Clinton concluded, "I will cap out of pocket drug costs for working families. You won't have to pay more than $250 a month for covered medications... Particularly for people who have a chronic illness. Also under my plan, you will be able to import cheaper drugs from other countries legally. If the medicine you need costs less in Canada, you should be able to buy it from Canada or any other country that meets our safety standards... I will also make sure we have more generics on the market [by boosting funding for] the FDA's office of generic drugs."
17:35 EDTBMRNHillary Clinton vows to cap out-of-pocket drug costs at $250 per month
Presidential candidate Hillary Clinton said in a tweet that, "Under my plan, I'll cap out-of-pocket drug costs for families. You won't have to pay more than $250/month for covered medications." Reference Link
08:23 EDTBMRNAnalysts say buy select biotech stocks ahead of Clinton drug plan
Ahead of Presidential candidate Hillary Clinton laying out her plan to tackle "price gouging" in the specialty drug market at an event in Iowa later today, analysts at research firms Jefferies and Piper Jaffray are recommending select biotech stocks that they view as buys amid the weakness in the space. DEBATE: Biotech stocks broadly declined yesterday, with the NASDAQ Biotechnology index (IBB) sliding roughly 4.4%, after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on a 62-year-old drug that fights complication of AIDS and cancer. Furor around the sudden price hike for Turing's Daraprim reignited a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. The news also follows Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Pfizer's (PFE) Hospira, in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. Presidential candidate Hillary Clinton sent the debate to center stage yesterday by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan today to tackle "price gouging" in the specialty drug market. Clinton's proposal, which she'll outline in a speech in Iowa later today, would force pharmaceutical companies to reinvest their profits into research, allow for more generic and imported drugs and allow Medicare to negotiate lower drug costs and cap out-of-pocket expenses, according to details of the plan shared with USA Today. Zeke Emanuel, chair of medical ethics and health policy at the University of Pennsylvania, appeared on Nightly Business Report to discuss the problem of high drug prices and his suggested solutions. During his interview, Emanuel contended that giving Medicare the ability to negotiate drug prices may drive up prices for everyone else. DEFENSES: The Jefferies Biotechnology research team, led by Brian Abrahams, Eun Yang and Biren Amin, say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). Meanwhile, Piper Jaffray analyst Edward Tenthoff recommends buying shares of Vertex Pharmaceuticals (VRTX) following yesterday's selloff. Tenthoff believes that drugs like Vertex's Orkambi will maintain premium pricing because of the disease modifying value to patients and payors. Orkambi is approved to treat cystic fibrosis in patients 12 years and older. The analyst reiterates an Overweight rating on Vertex with a $163 price target. DOWNGRADE: Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, said Yang, who views the stock as more risky than in the past. PRICE ACTION: Horizon closed yesterday down $2.93, or 9.2%, at $28.99, while Vertex dropped $5.97, or 4.8%, to $118.19. A number of the biggest stocks in biotechnology were also weak yesterday, with Gilead sliding about 2.5%, Amgen (AMGN) dropping 2.3%, Celgene declining 2.8% and Biogen (BIIB) falling more than 5.5%.
08:00 EDTBMRNJefferies sees buying opportunities in select biotech names
Analysts at Jefferies say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). The Jefferies Biotechnology research team is led by Brian Abrahams, Eun Yang and Biren Amin.
September 21, 2015
13:17 EDTBMRNRBC reminds biotech investors that Republicans still control Congress
RBC Capital analyst Michael Yee notes that biotech indices are under pressure after Hillary Clinton tweeted about an upcoming plan to fight specialty drug pricing. The news follows a Wall Street Journal story about a private company dramatically increasing the price of their drug and another confirmed progressive multifocal leukoencephalopathy case for Biogen (BIIB), Yee tells investors in an intraday research note. Next year's election is likely to turn up the noise around drug pricing, creating headline risk for the biotech space, the analyst cautions. However, he reminds investors that Republicans control Congress, making it unlikely that "anything material" will get signed into law. Biotech names moving lower in today's trading include Biogen, AbbVie (ABBV), Gilead (GILD), Alkermes (ALKS), BioMarin (BMRN), Amicus (FOLD) and PTC Therapeutics (PTCT).
07:36 EDTBMRNBioMarin, Dr. Reddy's Labs reach settlement over Kuvan generic
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