Akcea Therapeutics appoints Tracy Palmer Berns as CCO » 07:0606/2906/29/20
Akcea Therapeutics (AKCA)…
Akcea Therapeutics (AKCA) announced that Tracy Palmer Berns has joined the company as chief compliance officer, or CCO. In this role, Berns will be responsible for the company's ongoing compliance program focusing on policy development and training. She will also collaborate with other members of the executive team to provide counsel related to development of business goals and compliance matters related to Akcea's commercial products and investigational therapies. Before Akcea, Berns served as vice president, CCO and legal affairs at Amag Pharmaceuticals (AMAG) where she was responsible for the company's compliance program and therapeutic product legal team and provided legal advice on regulatory, development, pharmacovigilance and quality matters.
|Over a week ago|
Amag Pharmaceuticals CFO, COO Edward Myles to depart » 07:0906/1106/11/20
AMAG Pharmaceuticals announced that Edward Myles, CFO and COO, is leaving the Company. Brian Piekos, SVP of Finance, has been appointed interim CFO and will become a member of the company's Executive Leadership Team. Anthony (Casciano has been appointed COO and will add significant operational responsibilities to his role in addition to leading commercial operations. Both appointments are effective immediately.
|Over a month ago|
Amag Pharmaceuticals price target raised to $10 from $9 at H.C. Wainwright » 07:0505/1205/12/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Douglas Tsao raised the firm's price target on Amag Pharmaceuticals to $10 from $9 and keeps a Buy rating on the shares following the company's Q1 results.
Amag shares to continue to see pressure from headwinds, says Piper Sandler » 12:0205/1105/11/20
Piper Sandler analyst…
Piper Sandler analyst Christoper Raymond keeps an Underweight rating on Amag Pharmaceuticals after the company's Q1 earnings report when the company signaled a deepening deterioration of the business and yet another strategic retrenchment. Raymond thinks macro headwinds -- both temporary and more permanent -- make this turnaround an especially long putt and thinks shares are likely to continue to see pressure due to headwinds, a burdensome debt obligation and accompanying "going concern" worries. Raymond remains a seller of the stock.
Amag Pharmaceuticals pauses patient enrollment in AMAG-432 Phase 2b/3a trial » 07:2005/1105/11/20
The COVID-19 pandemic is…
The COVID-19 pandemic is an evolving situation and is having a serious impact on clinical trials globally. The AMAG-423 Phase 2b/3a clinical trial is a hospital-based trial and all sites have paused new patient enrollment. The company has had to pause initiation of new sites due to the pandemic, significantly impacting recruitment and enrollment. AMAG continues to work with the FDA to initiate the ciraparantag Phase 2b trial in healthy volunteers in the U.S. However, the COVID-19 pandemic has forced the clinical trial sites where the company expected to conduct the trial to close.
Amag Pharmaceuticals says FDA still reviewing matter of Makena » 07:1905/1105/11/20
In response to the…
In response to the company's request to the FDA for a meeting to discuss the future of Makena, the FDA indicated that it was premature to meet at this time as it was still reviewing the matter. AMAG remains committed to working collaboratively with the FDA to maintain access to Makena for eligible pregnant women.
Amag Pharmaceuticals says supply chain has not been 'materially affected' » 07:1905/1105/11/20
At this time, all of the…
At this time, all of the company's products remain available and the supply chain has not been materially affected by COVID-19. AMAG continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place to minimize potential supply interruptions, including redundant drug substance manufacturing and inventory safety stock, and will continue to work diligently with its suppliers to maintain continuous supply as the COVID-19 situation continues to evolve.
Amag Pharmaceuticals withdraws FY20 guidance » 07:1805/1105/11/20
"Based upon the…
"Based upon the extraordinary dynamics across the industry due to the COVID-19 pandemic, we have decided to withdraw our 2020 financial guidance," said Ted Myles, AMAG's chief financial officer and chief operating officer. "We remain committed to our previously stated goal of reducing total operating expenses by more than $100 million in 2020, as compared to 2019, and we are on track to achieve this objective. Furthermore, we continue to strive towards returning to profitability this year. The work force reduction that we announced today is an important step towards achieving these corporate objectives. While it was a difficult decision, we believe the organization is now the right size to support our long-term goals. We'd like to thank our colleagues who are leaving AMAG for their many contributions to our organization."
Amag Pharmaceuticals to reduce workforce by approx. 30% » 07:1805/1105/11/20
The company said,…
The company said, "Despite strong first quarter results, AMAG's products are being impacted by the COVID-19 pandemic as patient visits have declined during this period. Given the planned divestiture of Intrarosaand Vyleesi and the impact of COVID-19, AMAG has implemented a company-wide restructuring, which will reduce the workforce by approximately 30 percent. AMAG is withdrawing its 2020 financial guidance due to the uncertainty surrounding the duration of the COVID-19 pandemic. "
Amag Pharmaceuticals reports Q1 EPS (72c), consensus (3c) » 07:1705/1105/11/20
Reports Q1 revenue…
Reports Q1 revenue $68.7M, consensus $64.82M. "We are sharpening our focus on our priorities of maximizing Feraheme's value, retaining patient access to Makena and continuing to efficiently develop innovative therapies, namely ciraparantag," said Scott Myers, AMAG's president and chief executive officer. "As we look to the future, it is difficult to estimate the severity and duration of the COVID-19 pandemic. We've seen signs of stabilization and remain confident in the underlying demand for our products; however, we cannot speculate on the subsequent speed of recovery and the overall impact on our business."