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Stock Market & Financial Investment News

News Breaks
March 18, 2013
10:03 EDTTEVA, MYL, ACTGeneric drug makers fall after Wells analyst downgrades sector
A number of generic drug makers are losing ground after Wells Fargo analyst Michael Tong downgraded the sector to Market Weight from Overweight in a note to investors earlier today. After four years of outperformance, companies in the sector may have to exploit new catalysts in order to advance further, Tong believes. These new catalysts, however, carry more risks than previous drivers of the stock, the analyst contended. Upcoming catalysts for the sector include profitable international expansion, diversified brand portfolio, and biosimilars, Tong wrote. Investors should move out of generic drug stocks and buy the stocks of large drug companies, the analyst recommended. In the same note, Tong downgraded two specific generic drug makers. He dropped Teva (TEVA) to Market Perform from Outperform and lowered Actavis (ACT) to Market Perform from Outperform. Teva is taking longer than expected to implement its turnaround plan and may face increased competition to its Copaxone MS treatment, while Actavis' stock price has risen to the point where the shares accurately reflect the company's long-term outlook, Tong believes. In early trading, Teva fell 1% to $40.35, Actavis gave back 2% to $90, and Mylan (MYL) lost 1% to $30.15.
News For TEVA;ACT;MYL From The Last 14 Days
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January 20, 2015
10:40 EDTMYL, TEVAMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link
05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.
January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
January 14, 2015
18:18 EDTACTOn The Fly: After Hours Movers
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16:59 EDTACTGalena, Orexo AB receive "Paragraph IV" patent certification notice from Actavis
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January 13, 2015
14:00 EDTACTActavis says Allergan deal could close as early as Q1, as late as Q2
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13:49 EDTACTActavis says sees about $8B in free cash flow in 2016
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13:42 EDTACTActavis targeting 2017 EPS of $25
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13:38 EDTACTActavis sees Q4 adjusted EPS beating consensus by 10%-15%
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08:05 EDTACTActavis launches US generic specialty injectable portfolio
Actavis announced the launch of a portfolio of generic specialty injectable medications to be marketed to hospitals across the United States. Actavis will immediately begin marketing approximately 20 injectable products across a number of therapeutic categories in the U.S. The company hopes to be a leader in Oncology, with nearly a dozen marketed products including generic versions of Gemzar, Taxotere, Campostar and Zometa. Actavis also has an industry leading specialty injectable pipeline, with approximately 20 new filings under review at the U.S. Food and Drug Administration, as well as more than 50 additional projects currently in development.
January 12, 2015
12:45 EDTACTActavis CEO says 'can't speculate on what Pfizer is going to do'
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12:10 EDTACTRBC Capital says Celgene's shares could rise to $200 'over time'
The long-term profit guidance that Celgene (CELG) released today suggests that the stock, currently trading around $115, could reach $200 "over time," RBC Capital wrote in a note to investors today. WHAT'S NEW: After Celgene estimated that its EPS would exceed $12.50, excluding certain items, by 2020, RBC Capital says that the guidance exceeded the firm's previous outlook. RBC added that Celgene's projection increases its confidence in the predictability of the drug maker's performance over the longer term. The firm recommended that investors own Celgene in 2015, noting that the company has the potential to settle its patent case with Actavis (ACT). A settlement would enable investors to focus on Celgene's visible long-term growth and the robust opportunity provided by its drugs in development, RBC stated. Historically, investors have not given Celgene credit for these strengths, the firm stated. PRICE ACTION: In early afternoon trading, Celgene rose 1.5% to $115.35.
09:37 EDTACTSupreme Court rejects Allergan appeal on generic Latisse, Bloomberg reports
09:35 EDTTEVATeva may need to jump back into M&A after quiet 2014, Bloomberg says
Teva (TEVA), one of few leading pharmaceutical makers that did not make a sizable acquisition in 2014, may need to catch up with peers in that regard, with Perrigo (PRGO) and Sweden’s Meda AB mentioned by analysts as potentially suitable targets, said Bloomberg's "Real M&A" column. Reference Link
08:34 EDTACTActavis expects Q4 non-GAAP EPS to exceed consensus by 10%-15%
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08:31 EDTTEVAAMRI announces the departure of CFO Michael Nolan
AMRI announced that Michael Nolan, senior vice president and CFO, will be departing AMRI. Nolan will remain with AMRI through February 2015 to support an orderly transition. The company also announced that Felicia Ladin will join the company in the same role, effective February 4, 2015. Ladin most recently served as Senior Vice President, CFO, Global Specialty Medicines at Teva (TEVA).
08:09 EDTACTActavis and Allergan announce early termination of HSR waiting period
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08:07 EDTACTActavis, Allergan announce early termination of Hart Scott Rodino waiting period
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07:17 EDTMYLJPMorgan to hold a conference
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