|August 21, 2014|
|07:57 EDT||GILD, ABBV||Gilead HCV risks overblown, says Bernstein |
Bernstein believes that investors are concerned about upcoming competition to Gilead's (GILD) HCV drug from AbbVie's (ABBV) HCV treatment. But Bernstein says that insurers can only prevent 16% of the U.S. population from receiving Gilead's drug, and the firm does not expect the HCV market share dynamics to change in the near-term. It keeps an Outperform rating on Gilead.
News For GILD;ABBV From The Last 14 Days
|September 1, 2015|
|07:31 EDT||ABBV||Bristol-Myers, AbbVie say FDA accepts BLA for Empliciti for priority review|
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|August 31, 2015|
|14:00 EDT||ABBV||AbbVie September calls active|
AbbVie September 65 and 67.5 calls are active on total call volume of 37K contracts (9K puts). September weekly call option implied volatility is at 37, September is at 36, October is at 31; compared to its 52-week range of 18 to 36. Active call volume suggests traders taking positions for price movement.
|August 26, 2015|
|17:06 EDT||GILD||Gilead 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.
|August 25, 2015|
|19:34 EDT||ABBV, GILD||Experts tell White House to expand use of Hepatitis C drugs, NYT says|
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
|09:03 EDT||ABBV||Acorda has major overhang removed by IPR denials, says Leerink|
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|August 24, 2015|
|13:36 EDT||GILD||Biotech 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.
|August 20, 2015|
|16:34 EDT||GILD||Gilead MAA for HIV regimen has been fully validated by EMA|
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
|August 19, 2015|
|06:09 EDT||ABBV||United Therapeutics agrees to sell PPRV to AbbVie for $350M|
United Therapeutics (UTHR) announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher, or PPRV, to a subsidiary of AbbVie (ABBV). United Therapeutics received the PPRV when Unituxin was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease. Upon closing of the transaction, United Therapeutics will receive $350M in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
|05:57 EDT||ABBV||AbbVie implied volatility of 20 at lower end of index mean range|