$ABMD (ABIOMED, Inc.)

$ABMD {{ '2016-04-07T20:39:29+0000' | timeago}} • Announcement

$ABMD, a leading provider of breakthrough heart support technologies, said that it has received FDA Pre-Market Approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock.

$ABMD {{ '2017-09-20T21:54:10+0000' | timeago}} • Announcement

$ABMD received US FDA pre-market approval for the Impella RP heart pump. The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, heart transplant, or open-heart surgery.

$MDXG {{ '2017-09-19T15:22:20+0000' | timeago}} • Announcement

$MDXG has filed with the FDA to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee. The objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.

$ABT {{ '2017-09-18T12:47:46+0000' | timeago}} • Announcement

$ABT is extending its previously announced tender offer to purchase all outstanding shares of Series B Convertible Perpetual Preferred Stock of Alere Inc. for $402 per share of Preferred Stock. The offer is being extended to allow additional time for the consummation of the merger, which is a condition to the completion of the offer.

$AMGN {{ '2017-09-14T19:26:48+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi for the treatment of five types of cancer. Amgen and Allergan's bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a Marketing Authorization Application submitted in December 2016.

$AMGN {{ '2017-09-14T19:26:21+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi (bevacizumab-awwb) for the treatment of five types of cancer. The approval was based on totality of evidence from global development program showing Mvasi is highly similar to Avastin. Mvasi is the first anti-cancer biosimilar, as well as first bevacizumab biosimilar, approved by the FDA.

$ABT {{ '2017-09-14T16:50:10+0000' | timeago}} • Announcement

$ABT BoD declared a quarterly common dividend of $0.265 per share. The dividend is payable Nov. 15, 2017, to shareholders of record at the close of business on Oct. 13, 2017.

$MDXG {{ '2017-09-13T13:59:54+0000' | timeago}} • Announcement

$MDXG said its production operations in Georgia and placenta recovery functions are operating normally, and its previously published expectation for 3Q17 revenue to exceed the $80MM mark is unaffected by Hurricane Irma. $MDXG remains confident in its ability to meet or exceed revenue projections for 2017, which are at $309-311MM range.

$LMNX {{ '2017-09-12T12:54:37+0000' | timeago}} • Announcement

The BoD of $LMNX has declared a cash dividend of $0.06 per share of common stock for 3Q17, payable on Oct 13, 2017 to stockholders of record as on Sept 22, 2017.

$AGN {{ '2017-09-08T19:54:30+0000' | timeago}} • Announcement

$AGN transferred all patents for its dry eye treatment drug Restasis to the St. Regis Mohawk tribe to protect the drug patents. The tribe has granted Allergan back an exclusive license for the drug. As per the agreement, the tribe will get $13.75MM as one-time payment, and potentially $15MM annually in royalties.

$ABBV {{ '2017-09-08T16:14:15+0000' | timeago}} • Announcement

$ABBV's BoD declared a quarterly cash dividend of $0.64 per share. The dividend is payable on Nov. 15, 2017 to stockholders of record on Oct. 13, 2017. Since the company's inception in 2013, $ABBV has increased its dividend by 60%.

$AMGN {{ '2017-09-07T20:44:44+0000' | timeago}} • Announcement

$AMGN's new data demonstrates Aimovig reducing monthly migraine days for patients with chronic migraine and prior treatment failure, a population with significant unmet meed. Aimovig is the only investigational biologic product specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation.

$MDXG {{ '2017-09-07T14:14:35+0000' | timeago}} • Announcement

$MDXG said it received green signal from the FDA to proceed with a new drug phase-3 clinical study of its AmnioFix injection, for the treatment of Achilles Tendonitis. MiMedx expects to commence patient enrollment in the next quarter. The objective of the study is to determine the safety and effectiveness of the formulation, compared to placebo.

$AMGN {{ '2017-09-07T12:11:23+0000' | timeago}} • Announcement

$AMGN announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a novel anti-thymic stromal lymphopoietin monoclonal antibody being developed by $AZN in collaboration with $AMGN.

$ABBV {{ '2017-09-06T15:45:07+0000' | timeago}} • Announcement

$ABBV, in cooperation with $NBIX, has submitted a New Drug Application to the FDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, being evaluated for the management of endometriosis with associated pain. The pain includes daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

$MDXG {{ '2017-09-05T17:12:01+0000' | timeago}} • Announcement

Biopharmaceutical company $MDXG said that its expectation for 3Q17 revenue is expected to exceed $80MM, the high end of its 3Q17 revenue guidance range. The company previously guided to a 3Q17 revenue range of $79-80MM. The updated guidance is based on the strength of its July and August revenue performance.

$TFX {{ '2017-09-05T13:19:54+0000' | timeago}} • Announcement

$TFX agreed to acquire NeoTract. The acquisition is expected to be slightly dilutive to adjusted EPS in 2017, however, $TFX does not expect to adjust its prior adjusted EPS range. During 2018, the acquisition is expected to be breakeven to adjusted EPS, with significant accretion thereafter, including $0.35-0.40 of adjusted EPS accretion in 2019.

$TFX {{ '2017-09-05T13:17:43+0000' | timeago}} • Announcement

$TFX agreed to acquire NeoTract in a transaction valued up to $1.1Bil. The BoDs of both Teleflex and NeoTract have unanimously approved the transaction. During 2017, NeoTract's revenues are expected to be $115-120MM, and anticipates revenues to grow at least 40% in 2018.

$TFX {{ '2017-09-05T13:13:57+0000' | timeago}} • Announcement

$TFX agreed to buy NeoTract Inc. in a transaction valued up to $1.1Bil. $TFX will buy NeoTract for an upfront cash payment of $725MM at closing, and up to an additional $375MM upon the achievement of certain commercial milestones related to sales through the end of 2020. This transaction is expected to close within the next 30 days.

$ABT {{ '2017-09-01T12:22:31+0000' | timeago}} • Announcement

$ABT said it is extending its tender offer to buy for cash all outstanding shares of Series B Convertible Perpetual Preferred Stock of Alere at $402 per share. The offer will now expire on Sept. 15, 2017.

$ABT {{ '2017-08-31T13:43:11+0000' | timeago}} • Announcement

$ABT said the Ministry of Health Labour and Welfare in Japan has granted national reimbursement for the FreeStyle Libre glucose monitoring system effective Sept. 1, 2017. The revolutionary system will be widely available to the more than 1MM Japanese people ages six and above with diabetes, both Type 1 and Type 2, on insulin therapy.

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