New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 27, 2013
13:53 EDTGSK, SRPTSarepta higher after report of hospitalizations related to GSK drug
Shares of Sarepta Therapeutics (SRPT) are up $2.86, or 9.85%, to $31.89 and the strength is being attributed to a report by TheStreet.com that said patients were hospitalized after being treated with GlaxoSmithKline's (GSK) experimental drug for Duchenne muscular dystrophy. The report adds that Sarepta is scheduled to meet with the FDA this quarter to discuss a possible accelerated approval filing of its own Duchenne muscular dystrophy treatment, eteplirsen.
News For SRPT;GSK From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
August 27, 2015
12:57 EDTSRPTFDA 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
August 26, 2015
17:06 EDTGSKGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
13:38 EDTSRPTSarepta rises after FDA accepts muscular dystrophy drug application
Subscribe for More Information
10:00 EDTSRPTOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
09:19 EDTSRPTSarepta upgraded at RBC Capital on expectations for eteplirsen approval
Subscribe for More Information
09:09 EDTSRPTSarepta upgraded to Outperform from Sector Perform at RBC Capital
Subscribe for More Information
09:02 EDTSRPTSarepta should be bought on any weakness, says Roth Capital
Subscribe for More Information
August 25, 2015
18:47 EDTSRPTOn The Fly: After Hours Movers
Subscribe for More Information
17:19 EDTSRPTFDA files NDA for Sarepta's eteplirsen
Sarepta Therapeutics announced that the FDA has filed the New Drug Application, or NDA, for eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD, amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation addressable by Eteplirsen/exon 51 skipping. The FDA has completed its filing review and has determined that our application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act action date for a decision on the application is February 26. The FDA has granted eteplirsen Priority Review status, which is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.
August 24, 2015
13:54 EDTSRPTFly 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.
13:15 EDTGSKFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
09:45 EDTSRPTOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
06:50 EDTSRPTSarepta upgraded to Overweight from Neutral at Piper Jaffray
Subscribe for More Information
August 21, 2015
10:36 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
Subscribe for More Information
05:25 EDTGSKNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 20, 2015
11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
August 19, 2015
09:17 EDTSRPT'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 EDTSRPTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
Subscribe for More Information
August 17, 2015
06:22 EDTSRPTPiper'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).

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use