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July 30, 2014
16:24 EDTREGN, BMRNBioMarin sells priority review voucher for $67.5M to Regeneron
BioMarin Pharmaceutical (BMRN) announced that it has sold the Rare Pediatric Disease Priority Review Voucher it obtained in February of this year. The company received the voucher under an FDA program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of VIMIZIM, a new biological product for patients with Mucopolysaccharidosis type IVA, also known as Morquio A syndrome. BioMarin received $67.5M from Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals (REGN), in exchange for the voucher. "Leveraging the sale of the Priority Review Voucher to reinvest in products to treat rare and ultra-rare diseases makes the most sense for BioMarin given our stage of growth," said Jean-Jacques Bienaimé, CEO of BioMarin.
News For BMRN;REGN From The Last 14 Days
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August 28, 2015
08:01 EDTREGNAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
August 27, 2015
19:14 EDTREGNExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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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 25, 2015
08:21 EDTREGNRegeneron has multiple catalysts, says Leerink
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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.
07:23 EDTREGNRegeneron should be bought on pullbacks, says RBC Capital
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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 23, 2015
12:35 EDTREGNBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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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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August 17, 2015
06:22 EDTREGNPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).

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