AMAG Pharmaceuticals, Inc.NASDAQ
Short AMAG Pharmaceuticals After Poor Acquisition
Tue, Aug. 9, 9:19 AM
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Tue, May 3, 7:06 AM
- AMAG Pharmaceuticals (NASDAQ:AMAG): Q1 EPS of $0.94 misses by $0.17.
- Revenue of $109.3M (+22.1% Y/Y) misses by $15.53M.
Mon, May 2, 5:30 PM
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Mon, Apr. 11, 11:28 AM
- AMAG Pharmaceuticals (AMAG -2.6%) appoints Ted Myles as SVP, Chief Financial Officer and Treasurer. He joins the firm from Ocata Therapeutics where he was CFO and COO.
- Read now Time To Buy Biotech Starting With AMAG Pharmaceuticals
Tue, Feb. 23, 6:33 PM
- Snyder's-Lance (NASDAQ:LNCE) will replace California Resources (NYSE:CRC) in the S&P MidCap 400 after Wednesday's close. TREX will take Snyder's-Lance's spot in the S&P SmallCap 600.
- AMAG Pharma will replace Diamond Foods (about to be acquired by Snyder's-Lance) in the S&P 600.
- LNCE +1.8% after hours. TREX +3.7%. AMAG +4.6%.
Tue, Feb. 23, 1:17 PM
- The FDA approves AMAG Pharmaceuticals' (AMAG +1.1%) single-dose preservative-free formulation of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in pregnant women who have a history of preterm birth. The clearance is a good turnaround from the CRL the company received in November.
- Commercialization will commence in Q2.
- Makena was originally cleared in a multi-dose vial format in February 2011.
- Previously: AMAG Pharma receives CRL for single-dose Makena; shares off 11% premarket (Nov. 19, 2015)
Wed, Feb. 17, 8:43 AM
- AMAG Pharmaceuticals (AMAG) Q4 results: Revenues: $108.7M (+103.9%); R&D Expense: $7.9M (+1.3%); SG&A: $50.3M (+82.9%); Operating Income: $22.7M (+767.6%); Net Income: $7.2M (-95.0%); EPS: $0.20 (-95.7%); Non-GAAP EPS: $1.12 (+239.4%).
- FY2015 results: Revenues: $418.3M (+236.3%); R&D Expense: $42.9M (+77.3%); SG&A: $160M (+121.3%); Operating Income: $111.2M (+999%); Net Income: $32.8M (-75.8%); EPS: $0.93 (-82.9%); Non-GAAP EPS: $4.43 (+999%); Quick Assets: $228.7M (+91.7%).
- 2016 Guidance: Total Revenue: $520M - 570M from $395M - 430M; Adjusted EBITDA: $255M - 285M; Non-GAAP net income: $195M - 225M.
Wed, Feb. 17, 7:03 AM
- AMAG Pharmaceuticals (NASDAQ:AMAG): Q4 EPS of $1.12 misses by $0.04.
- Revenue of $120.55M (+136.6% Y/Y) beats by $0.42M.
Tue, Feb. 16, 5:30 PM
Dec. 16, 2015, 8:24 AM
- Soligenix (OTCQB:SNGX) announces positive results from a Phase 2 clinical trial assessing SGX942 for the treatment of severe oral mucositis (OM) in patients undergoing chemoradiation therapy (CRT) for head and neck cancer.
- Patients receiving 1.5 mg/kg of SGX942, a synthetic peptide called an innate defense regulator that modulates the body's reaction to injury and infection, experienced a median reduction in the duration severe OM of 50% (18 days to nine days; p=0.099) while those undergoing the most aggressive CRT showed a median duration reduction of 67% (30 days to 10 days; p=0.040).
- The data will be submitted for publication and presentation at a future scientific conference.
- OM usually occurs in the mouth of patients undergoing anticancer therapies. It affects ~500K Americans or 40% of those receiving chemo and almost all head and neck cancer patients receiving chemoradiation.
- The FDA has designated SGX942 for Fast Track review for the indication.
- The company will host a conference call this morning at 9:00 am ET to discuss its recent clinical trial results and development milestones.
- OM-related tickers: (OTCPK:CTIX)(NASDAQ:AMAG)(NYSE:XON)(NYSEMKT:OGEN)(NASDAQ:SCMP)
Nov. 25, 2015, 9:10 AM
- The FDA designates Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse Brilacidin-OM for Fast Track review for the prevention of oral mucositis, a common and debilitating inflammation and ulceration in the mouth that occurs as a side effect of certain cancer treatments. There is only one approved therapy for the condition, AMAG Pharma's (NASDAQ:AMAG) MuGard oral rinse.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint (WHO OM Score) in the 60-subject Phase 2 trial is June 2016. The estimated study completion date is December 2016.
- Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Nov. 23, 2015, 11:16 AM
- AMAG Pharmaceuticals (AMAG +0.7%) submits its formal response to the FDA's Complete Response Letter (CRL) that it received on November 19 for its approval application for a single-dose vial of Makena (hydroxyprogesterone caproate). Based on feedback from the agency, the company believes the agency may review the data in less than the standard four months.
- Previously: AMAG Pharma receives CRL for single-dose Makena; shares off 11% premarket (Nov. 19)
Nov. 19, 2015, 8:05 AM
- AMAG Pharmaceuticals (NASDAQ:AMAG) slumps 11% premarket on light volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA in response to its application for a single-dose vial of Makena (hydroxyprogesterone caproate), currently cleared in a 5 mL multidose vial for reducing the risk of preterm birth in women who have a history of preterm birth.
- The company is working with its manufacturer to submit the requested information as soon as possible.
Nov. 3, 2015, 12:48 PM