Eagle Pharmaceuticals reports Q1 non-GAAP EPS 24c, consensus 65c » 06:5405/1005/10/21
Reports Q1 revenue $4M,…
Reports Q1 revenue $4M, consensus $45.41M. "Vasopressin is tracking as expected. The trial is now less than two months away and we have now completed the last study required to submit our response to the CRL to the FDA. Our expectation remains that we will receive final approval in time to bring the product to market this year. We believe we also have an outstanding and large opportunity with Treakisym in Japan representing another extension of our bendamustine franchise. Equally important and exciting is the Pemfexy launch early next year, which gives us four months of initial exclusivity," stated CEO Scott Tarriff. "We are now in late-stage diligence for several in-licensing opportunities that would leverage our capabilities, meet our criteria and broaden our portfolio and pipeline. We will aim to finalize a few such transactions that have the potential to bolster our earnings both in the short and longer term," concluded Tarriff.
Eagle Pharmaceuticals files for approval of Treakysm formulation in Japan » 06:5205/1005/10/21
Eagle Pharmaceuticals announced that Treakisym RI liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency in Japan. The application is based on the results of clinical studies investigating the safety and pharmacokinetics of Treakisym RTD administered by 10-minute intravenous infusion. In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name Treakisym in Japan utilizing Eagle's proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the Treakisym RTD and RI products using the licensed technology in Japan.
|Over a week ago|
Eagle announces approval of Treakisym RTD and rituximab combination in Japan » 06:5404/3004/30/21
Eagle Pharmaceuticals announced that TREAKISYM ready-to-dilute, or RTD, liquid formulation has been approved for a new indication in combination with rituximab as treatment for relapsed or refractory diffuse large B-cell lymphoma by the Pharmaceuticals and Medical Devices Agency in Japan. "This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25M at peak," stated Scott Tarriff, CEO.
|Over a month ago|
Eagle Pharmaceuticals transferred with an Outperform at RBC Capital » 16:4904/0604/06/21
RBC Capital transferred…
RBC Capital transferred coverage of Eagle Pharmaceuticals to analyst Daniel Busby and kept an Outperform rating and $52 price target on the stock.
Eagle Pharmaceuticals sees FY21 adjusted R&D spend $26M-$30M » 06:5203/0203/02/21
As compared to $27.8M in…
As compared to $27.8M in 2020. SG&A spend in 2021, on a non-GAAP basis, is expected to be $56M-$60M, as compared to $50.9M in 2020.
Eagle Pharmaceuticals reports Q4 adjusted EPS 96c, consensus (17c) » 06:5103/0203/02/21
Reports Q4 revenue…
Reports Q4 revenue $49.9M, consensus $53.16M.
|Over a quarter ago|
Eagle announces FDA responded to ANDA for vasopressin » 06:5702/0202/02/21
Eagle Pharmaceuticals announced that the FDA has issued a complete response letter, or CRL, for its Abbreviated New Drug Application, or ANDA, for vasopressin. Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days. Importantly, Eagle has completed an extensive amount of developmental work and continues to do so for its first-to-file polypeptide, where brand sales of the product are over $700M annually. In its communication with the Company, FDA restated that it has prioritized Eagle's ANDA, and it is also flagged as a COVID priority. Eagle believes it can fully respond to the questions raised. There is one additional short duration study that will need to be completed and analyzed. The study will be run either in mid-February or mid-March. Based on similar studies previously run on the Company's vasopressin product, Eagle expects the results will be satisfactory. In addition, the Company expects it will have 180 days of exclusivity.
Eagle Pharmaceuticals says vasopressin trial date postponed » 06:5102/0102/01/21
Eagle Pharmaceuticals announced that, on January 29, the United States District Court for the District of Delaware postponed the February 1 vasopressin trial between Eagle and Endo Par Innovation Company, et al. The Court expects to hold a call with the parties today to discuss a new trial date. Scott Tarriff, CEO of Eagle Pharmaceuticals, stated, "Par's asserted patent claims require a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that claimed in Par's patents. We are therefore looking forward to having the trial as soon as possible, especially considering that we expect to have 180 days of exclusivity."
Eagle Pharmaceuticals: Vasopressin trial postponed until February 1 » 06:5201/1101/11/21
Eagle Pharmaceuticals announced that, on January 8, the United States District Court for the District of Delaware postponed the January 11 vasopressin trial between Eagle and Endo Par Innovation Company in part, to ensure the health and safety of the trial teams in light of a COVID-19 concern. The trial is now scheduled to begin remotely starting February 1 and is expected to be concluded by February 5.
Eagle Pharmaceuticals CFO Pete Meyers departs, Brian Cahill to succeed » 06:5211/0211/02/20
On October 29, Brian…
On October 29, Brian Cahill, Eagle's VP, Finance, was promoted to the role of CFO, and Pete Meyers, Eagle's former CFO, left the Company to pursue other opportunities. Prior to joining Eagle, Cahill held Corporate Controller positions at Aralez Pharmaceuticals and Par Pharmaceuticals.