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News Breaks
June 17, 2014
12:25 EDTBLUE, BLUE, BMRN, BMRN, CELG, CELG, CLDN, CLDN, MDGN, MDGN, QURE, QURE, SGMO, SGMO, AGTC, AGTC, ALGN, ALGNPiper Jaffray biopharm analyst holds an analyst/industry conference call
Biopharmaceuticals Analyst Schimmer discusses gene therapy and highlights public and private companies involved in the field, as well as the large-cap pharma partnerships on an Analyst/Industry conference call. Relevant companies AGTC, ALGN, BLUE, BMRN, CELG, CLDN, MDGN, QURE and SGMO may be included on the Analyst/Industry conference call to be held on June 18 at 2 pm.
News For AGTC;ALGN;BLUE;BMRN;CELG;CLDN;MDGN;QURE;SGMO From The Last 14 Days
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August 27, 2015
07:16 EDTAGTCApplied Genetic announces achievement of XLRS patient enrollement milestone
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05:36 EDTQUREuniQure reports Q2 EPS (EUR 87c) vs. (EUR 51c) last year
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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
07:31 EDTCELGCelgene announces expiration of tender offer for Receptos shares
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August 24, 2015
18:55 EDTCELGOn The Fly: After Hours Movers
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18:52 EDTCELGJazz, Celgene, Shire up after USPTO rejects Acorda patent challenge
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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.
13:36 EDTCELGBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
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 EDTCELGBiotech 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 20, 2015
16:24 EDTAGTCBiogen reports 8.1% passive stake in Applied Genetic
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08:34 EDTBLUEJPMorgan views bluebird bio selloff as 'highly compelling opportunity'
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August 19, 2015
18:34 EDTAGTCOn The Fly: After Hours Movers
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17:46 EDTAGTCApplied Genetic says Biogen collaboration effective, equity investment closed
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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
09:13 EDTQUREuniQure data positive, says Roth Capital
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