$AMAG (AMAG Pharmaceuticals, Inc.)

$AMAG {{ '2016-07-12T17:57:53+0000' | timeago}} • Announcement

Biopharmaceutical company $AMAG said it has appointed Mark Stanton as VP, Market Access & Corporate Accounts. He will report to Nik Grund, Chief Commercial Officer of $AMAG. Mr. Stanton comes to $AMAG from AstraZeneca.

$AMAG {{ '2017-09-07T13:58:27+0000' | timeago}} • Announcement

$AMAG appointed Laura Williams as SVP of clinical development, effective immediately. She will report to Julie Krop, M.D., chief medical officer and SVP of clinical development and regulatory affairs at $AMAG. Prior to joining $AMAG, she served as VP of clinical development at Myovant Sciences.

$AMAG {{ '2017-08-08T16:06:08+0000' | timeago}} • Announcement

$AMAG appointed Oscar Sanchez as VP of quality effective immediately. He will report to Joseph Vittiglio, general counsel and SVP of legal affairs and quality.

$AMAG {{ '2017-08-03T16:39:43+0000' | timeago}} • Announcement

$AMAG completed submission to FDA to broaden existing label for Feraheme (ferumoxytol) to include treatment of all adults with iron deficiency anemia (IDA) who have intolerance or unsatisfactory response to oral iron. $AMAG anticipates FDA decision on filing in 1H18. The current indication is limited to treatment of IDA with chronic kidney disease.

$AMAG {{ '2017-07-24T16:26:48+0000' | timeago}} • Announcement

$AMAG announced the commercial availability of Intrarosa (prasterone) in the US. Intrarosa is the first and only FDA-approved, local non-estrogen product for the treatment of moderate to severe dyspareunia (pain during intercourse) due to menopause.

$AMAG {{ '2017-06-26T12:43:06+0000' | timeago}} • Announcement

$AMAG said that the U.S. FDA has accepted the supplemental new drug application (sNDA) for the Makena subcutaneous auto-injector. The agency established a Prescription Drug User Fee Act target action date of Feb. 14, 2018. The FDA acknowledged the filing of sNDA is subject to a standard 10-month review against a 6-month review communicated earlier.

$AMAG {{ '2017-05-16T12:17:47+0000' | timeago}} • Announcement

$AMAG appointed Helen Milton to the role of VP of regulatory affairs. Dr. Milton will have responsibility for $AMAG’s regulatory activities, including leading the strategic direction and regulatory approach for all products.

$AMAG {{ '2017-05-15T12:24:13+0000' | timeago}} • Announcement

$AMAG announced that it has paid in full the remaining balance of $321MM of its term loan, which was due in 2021. “With the completion of these transactions and expected EBITDA generation from our business operations, including anticipated future milestone payments, we expect to end 2017 with more than $300 million of cash,” said CFO Ted Myles.

$AMAG {{ '2017-05-05T14:14:15+0000' | timeago}} • Announcement

$AMAG priced $300MM of 3.25% Convertible Senior Notes due 2022 in an underwritten public offering. $AMAG lifted the size of the offering from the originally announced $250MM. The offering is expected to close on May 10, 2017

$AMAG {{ '2017-05-04T19:03:57+0000' | timeago}} • Announcement

$AMAG plans to offer $250MM of Convertible Senior Notes due 2022 in an underwritten public offering. $AMAG expects to grant the underwriters an option to purchase, exercisable within a 30-day period, up to an additional $37.5MM of notes, solely to cover over-allotments, if any.

$AMAG {{ '2017-04-25T22:00:07+0000' | timeago}} • Announcement

$AMAG has appointed Arpad Simon, to the role of VP of pharmacovigilance. Prior to joining AMAG, he served in executive-level pharmacovigilance roles at numerous companies including $PFE.

$AMAG {{ '2017-04-17T17:21:36+0000' | timeago}} • Announcement

$AMAG has submitted a supplemental new drug application (sNDA) to the US FDA for the Makena subcutaneous auto-injector, a drug-device combination product. $AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in 4Q17.

$AMAG {{ '2017-03-06T17:28:49+0000' | timeago}} • Announcement

$AMAG announced that Frank Thomas, president and COO, intends to transition out of the organization on April 30, 2017. Ted Myles, CFO, and Joseph Vittiglio, general counsel, along with $AMAG's business development function, will report directly to CEO William Heiden. Paul Williams has been appointed to lead newly created women's health business.

$AMAG {{ '2017-02-14T16:00:11+0000' | timeago}} • Announcement

$AMAG and Endoceutics entered into an exclusive license agreement that provides $AMAG with U.S. commercial rights to Intrarosa (prasterone). It will treat moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA), due to menopause.

$AMAG {{ '2017-02-14T14:51:38+0000' | timeago}} • Webcast

With respect to Intrarosa steroid launch, $AMAG commented that it had retained a recruiting firm to get sales reps in place prior to launch. The company has also got an agency to market Intrarosa. "We've been already engaging in a significant amount of pre-launch work," $AMAG said.

$AMAG {{ '2017-02-14T14:37:19+0000' | timeago}} • Webcast

$AMAG said that it had revised non-GAAP disclosure package to comply with the new SEC guidance. Non-GAAP cash taxes were $5.3MM and cash interest was little less than $17MM for FY16. The company plans to provide updated FY17 guidance for the entire company when it reports 1Q17 results.

$AMAG {{ '2017-02-14T14:26:45+0000' | timeago}} • Webcast

With respect to Intrarosa transaction, $AMAG agreed to pay Endoceutics $50MM at closing of the deal and issue 600,000 shares of the company stock. $AMAG will also pay $10MM upon delivery of first commercial supply of Intrarosa and another $10MM upon the first anniversary of the effective date. The transaction is expected to close in 1H17.

$AMAG {{ '2017-02-14T14:26:01+0000' | timeago}} • Webcast

$AMAG expanded its women's health franchise with the exclusive US license agreement for Intrarosa steroid with Endoceutics. This deal adds some large near-term commercial opportunities to the company's portfolio with an anticipated launch in May 2017, $AMAG said.

$AMAG {{ '2017-02-14T14:07:33+0000' | timeago}} • Webcast

$AMAG stated that it remains on track to submit SNDA for Makena auto-injector program to the FDA in the next quarter with an anticipated decision in 4Q17. $AMAG structured Rekynda and Intrarosa drug deals to maximize future flexibility. The company said that it will invest the capital into additional portfolio expanding the opportunities.

$AMAG {{ '2017-02-14T13:38:44+0000' | timeago}} • Webcast

$AMAG said that Makena drug sales increased 44% in 4Q16. In Feraheme IDA trial, the company is targeting a mid-year SNDA filing to broaden authorities label, which is six months ahead of original schedule. $AMAG expects strong revenue growth in 2017.

$AMAG {{ '2017-02-14T13:01:17+0000' | timeago}} • Announcement

$AMAG's total costs and expenses rose nearly 60% to $137MM in 4Q16 compared to the prior year quarter. The increase was related to higher cost of products sold, an impairment charge of a $3.7MM related to the CBR trade name intangible asset, higher R&D expenses, and higher SG&A expenses.

Recent Transcripts

LCI (Lannett Company, Inc.)
Wednesday, August 23 2017 - 8:30pm
MDT (Medtronic plc)
Tuesday, August 22 2017 - 12:00pm
NVO (Novo Nordisk A/S)
Thursday, August 10 2017 - 12:15pm
NVO (Novo Nordisk A/S)
Wednesday, August 9 2017 - 11:00am
OPK (Opko Health, Inc.)
Tuesday, August 8 2017 - 8:30pm
MNK (Mallinckrodt Public Limited Company)
Tuesday, August 8 2017 - 12:30pm
MSA (MSA Safety Incorporated)
Friday, August 4 2017 - 12:30pm
PKI (PerkinElmer Inc.)
Thursday, August 3 2017 - 9:00pm
EBS (Emergent BioSolutions, Inc.)
Thursday, August 3 2017 - 9:00pm
AGN (Allergan plc)
Thursday, August 3 2017 - 12:30pm
AMAG (AMAG Pharmaceuticals, Inc.)
Thursday, August 3 2017 - 12:00pm
NUS (Nu Skin Enterprises Inc.)
Wednesday, August 2 2017 - 9:00pm
MOH (Molina Healthcare, Inc.)
Wednesday, August 2 2017 - 9:00pm
OMI (Owens & Minor Inc.)
Wednesday, August 2 2017 - 12:00pm
FMS (Fresenius Medical Care AG & Co. KGAA)
Tuesday, August 1 2017 - 1:30pm
MRK (Merck & Co. Inc.)
Friday, July 28 2017 - 12:00pm
GSK (GlaxoSmithKline plc)
Wednesday, July 26 2017 - 1:00pm
JNJ (Johnson & Johnson)
Tuesday, July 18 2017 - 12:30pm
NVS (Novartis AG)
Tuesday, July 18 2017 - 12:00pm
MDT (Medtronic plc)
Thursday, May 25 2017 - 12:00pm

AlphaGraphics you may like