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News Breaks
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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September 1, 2015
10:05 EDTBMRNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 8point3 Energy (CAFD) initiated with an Equal Weight at Barclays... AMAG Pharmaceuticals (AMAG) initiated with an Outperform at Raymond James... Acadia (ACHC) initiated with an Outperform at Leerink... Acorda Therapeutics (ACOR) initiated with a Market Perform at Raymond James... Alexion (ALXN) initiated with a Strong Buy at Raymond James... Amedisys (AMED) initiated with an Outperform at Wells Fargo... Amgen (AMGN) initiated with a Market Perform at Raymond James... Amplify Snack Brands (BETR) initiated with a Neutral at Credit Suisse... BioMarin (BMRN) initiated with an Outperform at Raymond James... Biogen (BIIB) initiated with a Strong Buy at Raymond James... Celgene (CELG) initiated with a Strong Buy at Raymond James... CoreLogic (CLGX) initiated with a Neutral at SunTrust... Digi International (DGII) initiated with an Overweight at Stephens... First Solar (FSLR) initiated with an Overweight at Barclays... LHC Group (LHCG) initiated with an Outperform at Wells Fargo... Lancaster Colony (LANC) initiated with a Buy at BB&T... McCormick (MKC) initiated with a Buy at BB&T... NephroGenex (NRX) initiated with a Buy at H.C. Wainwright... Omega Protein (OME) initiated with a Hold at BB&T... Preferred Apartment (APTS) initiated with an Outperform at FBR Capital... Qorvo (QRVO) initiated with an Outperform at CLSA... Regeneron (REGN) initiated with an Outperform at Raymond James... Skyworks (SWKS) initiated with an Outperform at CLSA... SunPower (SPWR) initiated with an Equal Weight at Barclays... TESARO (TSRO) initiated with a Strong Buy at Raymond James... Ultragenyx (RARE) initiated with an Outperform at Raymond James... VEREIT (VER) initiated with a Buy at Goldman... Westmoreland (WLB) initiated with an Outperform at BMO Capital.
August 31, 2015
19:25 EDTBMRNBioMarin initiated with an Outperform at Raymond James
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08:36 EDTBMRNBioMarin announces two oral presentation at Study of Inborn Errors of Metabolism
BioMarin Pharmaceutical announced that the company will present data in two oral and 19 poster presentations at the Society for the Study of Inborn Errors of Metabolism 2015 Annual Meeting which will be held on September 1-4 in Lyon, France. In an oral platform session, long-term efficacy and safety data from a Phase 2 extension study of pegvaliase, or PEG-PAL, rAvPAL-PEG, BMN 165, in adults with phenylketonuria, or PKU, will be presented. PKU is a rare genetic condition in which the body cannot metabolize the essential amino acid phenylalanine. Designated Orphan Drug status in the United States and European Union, pegvaliase is an enzyme substitution therapy that is designed to substitute phenylalanine ammonia lyase for phenylalanine hydroxylase, the enzyme deficient in people with PKU. A separate oral platform presentation will provide an overview of the reveglucosidase alfa, or BMN 701, clinical program in late onset Pompe disease. In addition, the overview will summarize the three ongoing trials; the ongoing Phase 3 INSPIRE trial, a switchover study designed to assess safety and efficacy of reveglucosidase alfa in patients previously treated with enzyme replacement therapy; an observational study in patients with late onset Pompe disease; and a transdiaphragmatic stimulation study in late onset Pompe patients treated with reveglucosidase alfa. The overview also includes a review of nonclinical activity as well as interim safety and efficacy results in treatment naive, late-onset Pompe patients treated with reveglucosidase alfa. Pompe disease is an inherited condition caused by the deficiency in the enzyme acid alpha-glucosidase, which leads to progressive weakening of muscles in the body, including diaphragm muscles essential for breathing. Reveglucosidase alfa is a novel fusion protein of insulin-like growth factor 2 and acid alpha-glucosidase, designed to target delivery to cell structures called lysosomes where the enzyme is most needed.
August 27, 2015
12:57 EDTBMRNFDA will approve Sarepta and BioMarin DMD drugs, Feuerstein says
TheStreet's biotech reporter Adam Feuerstein predicts that the FDA will approve both Biomarin's (BMRN) drisapersen and Sarepta's (SRPT) eteplirsen, which are both drugs to treat Duchenne muscular dystrophy, adding that the agency has been "essentially approving every drug that comes before it" and that it "can't and won't" say no to two drugs meant to improve the lives of kids with a fatal disease. Feuerstein noted he doesn't think the drugs are equivalent and he's still in the "eteplirsen is better than drisapersen" camp. Reference Link
08:35 EDTBMRNMedivation price target raised to $166 at William Blair after talazoparib deal
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August 26, 2015
13:38 EDTBMRNSarepta rises after FDA accepts muscular dystrophy drug application
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August 24, 2015
13:54 EDTBMRNFly Watch: Sarepta upgraded ahead of FDA deadline on DMD drug
The 60-day FDA review period for Sarepta's (SRPT) rolling NDA submission for its Duchenne muscular dystrophy drug eteplirsen ends tomorrow, Tuesday, August 25. Piper Jaffray is among research firms taking a bullish stance on the stock ahead of tomorrow's deadline. BACKGROUND: Eteplirsen is an "exon skipping" treatment that attempts to bypass genetic mutations to allow improved functioning of the affected gene. On August 21, Sarepta announced that the FDA granted a rare pediatric disease designation for eteplirsen, in addition to its previous orphan designation and fast track status. Piper Jaffray's Edward Tenthoff noted today that the drug could see a February 2016 PDUFA date, potentially yielding "blockbuster sales" for the company. Importantly, BioMarin's (BMRN) drisapersen is slightly ahead of eteplirsen's approval process with a December 27 PDUFA date, posing a potential competitive risk for Sarepta. PDUFA dates are FDA deadlines for approving new drugs, normally coming within 6 or 10 months of an NDA acceptance depending on the drug's priority status. ANALYST TAKE: Tenthoff stated in note to investors this morning that he expects the Food and Drug Administration to accept the New Drug Application for Sarepta's eteplirsen at the end of its 60-day review period tomorrow. Additionally, Tenthoff sees a joint advisory committee for eteplirsen and the similar drisapersen from BioMarin on November 23-24. On May 19, Sarepta said it held pre-NDA meetings with the FDA, and Piper Jaffray said it believes the company has now met all of the agency's information requests. The analyst upgraded Sarepta to Overweight from Neutral and hiked his price target to $48 from $28 and now values eteplirsen at $1.3B, up from $919M previously. PRICE ACTION: Shares of Sarepta Therapeutics are up roughly 1% in intraday trading to $34.21. The stock jumped about 60% on May 20 after the company announced its mid-year NDA plans for eteplirsen. BioMarin shares, meanwhile, are down 2% to $123.59 this afternoon.
07:02 EDTBMRNMedivation to acquire worldwide rights to Talazoparib from BioMarin
Medivation (MDVN) and BioMarin Pharmaceutical (BMRN) have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib, a highly-potent, orally-available poly ADP ribose polymerase inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis. Under the terms of the agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib. At the closing of the transaction, Medivation will assume all financial obligations associated with the development and commercialization of talazoparib. The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close in 2015.
August 21, 2015
09:38 EDTBMRNUBS global healthcare analysts hold an analyst/industry conference call
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06:23 EDTBMRNUBS sees 'meaningful' upside to BioMarin on positive Hemophilia data
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August 19, 2015
16:06 EDTBMRNBioMarin receives rare pediatric disease designation from FDA for drisapersen
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09:17 EDTBMRN'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTBMRNFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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