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Stock Market & Financial Investment News

News Breaks
May 19, 2014
07:33 EDTFMS, MNKMallinckrodt raised Ofirmev price by 140%, says Piper Jaffray
Piper Jaffray says that according to Price Rx, Mallinckrodt (MNK) implemented a 140% price increase for Ofirmev on May 15. Piper views the increase as larger than expected and says it significantly reduces the risk to shares should Fresenius (FMS) launch its Ofirmev generic over the next two years. Piper thinks the risk/reward on shares of Mallinckrodt is compelling and it reiterates an Overweight rating on the stock.
News For MNK;FMS From The Last 14 Days
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November 25, 2014
06:29 EDTMNKMallinckrodt says Questcor received subpoena from FTC in June
Mallinckrodt (MNK) disclosed in its quarterly regulatory filing that on June 11, Questcor received a subpoena and Civil Investigative Demand from the Federal Trade Commission seeking documentary materials and information regarding the FTC’s investigation into whether Questcor’s acquisition of certain rights to develop, market, manufacture, distribute, sell and commercialize Synacthen Depot from Novartis (NVS) violates the antitrust laws.
November 19, 2014
14:11 EDTFMSFresenius, Permira made joint bid for Danone nutrition unit, WSJ reports
Fresenius SE, the German parent company of Fresenius Medical (FMS), and buyout firm Permira made a joint bid for Danone’s (DANOY) medical nutrition business, according to The Wall Street Journal, citing people familiar with the matter. Danone has set early next week as the deadline for others to bid, though one of the people said the joint bid is currently the only one on the table, the report noted. Reference Link
13:47 EDTFMSFresenius, Permira made joint bid for Danone nutrition unit, DJ reports
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09:16 EDTMNKOn The Fly: Pre-market Movers
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07:01 EDTMNKMallinckrodt reports Q4 adjusted EPS $1.68, consensus $1.41
Reports Q4 revenue $789.3M, consensus $757.86M.
November 18, 2014
15:21 EDTMNKNotable companies reporting before tomorrow's open
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November 17, 2014
07:21 EDTFMSDanone mulls IPO for nutrition unit as sale talks disappoint, Reuters says
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November 14, 2014
17:27 EDTMNKPaulson & Co. gives quarterly update on stakes
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09:51 EDTMNKMallinckrodt management to meet with Oppenheimer
Meeting to be held in Europe on November 20 hosted by Oppenheimer.
November 13, 2014
10:44 EDTMNKMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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08:20 EDTMNKMallinckrodt could be down $6-$8 on FDA reclassification, says UBS
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06:43 EDTFMSFresenius Medical to acquire Cogent Healthcare, financial terms not disclosed
Fresenius Medical Care AG & Co. KGaA announced that Sound Physicians has entered into an agreement to acquire Cogent Healthcare with more than 650 providers, who offer hospitalist and intensivist services to more than 80 hospitals throughout the United States. Combined, the expanded Sound Physicians organization will now serve over 180 hospitals in 35 states with more than 2,250 providers including physicians and advanced care practitioners. Fresenius Medical Care is the majority shareholder in Sound. The company expects Cogent to generate approximately $250M in revenue in 2015 and expects the investment to be accretive to earnings within 18-24 months after closing including the transaction/integration cost and potential synergies. The investment will be financed through available cash. The parties involved agreed not to disclose the financial terms of the acquisition. The parties expect the transaction, which remains subject to regulatory clearance, to close this quarter.
06:11 EDTMNKMallinckrodt responds to FDA expected reclassification of methylphenidate ER
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release, or ER, tablets, USP may not be therapeutically equivalent to the category reference drug Concerta. As a result, the agency indicated that it has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB to BX. The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014. Although the Draft Guidance has an open comment period through January 5, 2015, the agency nevertheless confirmed that this change would be reflected on November 13, 2014 in the on-line Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Mallinckrodt strongly believes its methylphenidate ER products are safe and effective when used in accordance with the approved labels. Mark Trudeau, president and CEO of Mallinckrodt stated, “We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients." Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug to the company’s methylphenidate ER products.

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