Welcome to our dedicated page for EAGLE PHARMS news (Ticker: EGRX), a resource for investors and traders seeking the latest updates and insights on EAGLE PHARMS stock.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) is a leading specialty pharmaceutical company committed to the development and commercialization of innovative injectable products targeted at critical care, orphan diseases, and oncology. The company’s robust portfolio includes four FDA-approved products: Argatroban, Ryanodex, Belrapzo, and Bendeka. Eagle is also advancing multiple product candidates through late-stage development, with several under review by the Food and Drug Administration (FDA).
Recently, Eagle achieved a significant regulatory milestone with its product Barhemsys® (amisulpride) injection. On January 1, 2024, Barhemsys will receive a unique, product-specific billing code (J-0184) from the Centers for Medicare & Medicaid Services (CMS), facilitating better access and separate reimbursement for the drug outside of surgical bundled payments. Barhemsys is the only FDA-approved medication for treating postoperative nausea and vomiting (PONV) in patients who have failed PONV prophylaxis, addressing a critical unmet medical need.
In addition to its marketed products, Eagle Pharmaceuticals boasts an extensive pipeline focusing on oncology and CNS/metabolic critical care. Noteworthy among these is the ready-to-dilute formulation of Pemfexy, used in treating non-small cell lung cancer and malignant pleural mesothelioma. Pemfexy's unique J-Code from CMS has earned it a 24% share in the non-340B pemetrexed market, reflecting its commercial success and innovation.
Financially, Eagle remains strong, with steady revenues from its commercialized products and a commitment to reporting accurate financial results. While the company has revised its 2023 guidance downward, it remains confident in the outlook for 2024, backed by ongoing development and new initiatives.
This strategic focus is further reinforced by Eagle’s robust intellectual property protections and recent litigation successes. The company is actively defending its patents against generic competitors, ensuring the continued commercial viability of its flagship products, Bendeka and Belrapzo.
With a team of dedicated professionals in research, development, clinical, and commercial operations, Eagle Pharmaceuticals is poised to make significant strides in the pharmaceutical industry. For the latest news and updates, visit their official website at www.eagleus.com.
Eagle Pharmaceuticals (NASDAQ: EGRX) has achieved a significant legal victory as the U.S. District Court for the District of Delaware ruled that its proposed vasopressin product does not infringe any patents asserted by Par. The ruling allows Eagle to continue its plans to market a generic version of Vasostrict, which generated $786 million in U.S. sales in 2020. CEO Scott Tarriff expressed optimism about providing a generic alternative, emphasizing its importance for public access. The court's decision does not address Eagle's claims regarding the invalidity of Par's patents.
Eagle Pharmaceuticals (NASDAQ: EGRX) announced the grant of U.S. Patent No. 11,103,483 for formulations of Bendamustine. This patent will be listed in the FDA’s Orange Book for BENDEKA and BELRAPZO. The company had previously asserted patents against Slayback Pharma, Apotex, Mylan, and Fresenius regarding abbreviated new drug applications referencing BENDEKA, with court rulings affirming patent validity. Both the asserted patents and the new patent expire in 2031, strengthening Eagle's IP rights. CEO Scott Tarriff expressed satisfaction with these developments.
Eagle Pharmaceuticals (EGRX) has entered a licensing agreement with Combioxin for CAL02, a novel antitoxin agent targeting severe pneumonia. Results from a first-in-human clinical trial indicate CAL02 demonstrated a favorable safety profile and improved clinical outcomes when used with standard antibiotics. The company plans a robust Phase 2b/3 study in 2022 and anticipates regulatory exclusivity for 10 years. With pneumonia causing 2.4 million deaths annually, CAL02 addresses a significant unmet need and could transform treatment protocols, highlighting its potential impact on patient care.
Eagle Pharmaceuticals announced its financial results for Q2 2021, reporting total revenues of $48.1 million, up from $41.9 million in Q2 2020. The net income was $3.6 million or $0.28 per share, a turnaround from a net loss in the previous year. Significant developments include a licensing agreement for Landiolol and progress in the vasopressin program, anticipating a commercial launch before year-end. The company expects combined royalty and milestone revenue from TREAKISYM in Japan to reach $20-$25 million, marking strong growth potential.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced a licensing agreement with AOP Orphan Pharmaceuticals for the U.S. rights to Landiolol, an ultra-selective beta-1 blocker approved in Europe for tachycardia. Eagle will submit a new drug application (NDA) to the FDA for Landiolol's approval for short-term ventricular rate reduction in supraventricular tachycardia (SVT). The agreement includes a $5 million upfront payment and potential future payments upon regulatory approvals. Landiolol shows promise for critical care management and has the potential for pediatric applications.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced the release of its Q2 2021 financial results on August 9, 2021, prior to market opening. CEO Scott Tarriff and CFO Brian Cahill will lead a conference call at 8:30 a.m. ET to discuss the results. Participation details include toll-free numbers for U.S. and international callers and a webcast available for replay. The company focuses on innovative medicines with products like RYANODEX®, BENDEKA®, and BELRAPZO®. Additional information is available on their website.
Eagle Pharmaceuticals (Nasdaq: EGRX) announced the FDA has maintained Priority Review for its ANDA for vasopressin, with a GDUFA date set for December 15, 2021. The response to the CRL was submitted on June 15, 2021. CEO Scott Tarriff emphasized the importance of this program, highlighting its COVID priority status, and expressed confidence in a commercial launch before the year ends. Eagle is the first to file an ANDA for vasopressin, which had U.S. sales of $786 million in 2020.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced it has responded to the Complete Response Letter (CRL) concerning its Abbreviated New Drug Application (ANDA) for vasopressin. The company believes it has fully addressed the FDA's concerns and expects final approval soon, highlighting the product as a critical program with significant potential value for shareholders. Eagle is the first to file an ANDA referencing Vasostrict, which earned $786 million in U.S. sales in 2020. The company prioritizes this application as a COVID-related project, aiming for a launch within the year.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced that CEO Scott Tarriff and CFO Brian Cahill will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 1:30 p.m. Eastern Time. The presentation will be available for live webcast and archived for 30 days on Eagle's website. Eagle is a fully integrated pharmaceutical company focusing on innovative medicines that significantly improve patient outcomes, with products like RYANODEX®, BENDEKA®, and BELRAPZO®. More details can be found at www.eagleus.com.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) will present at the 2021 RBC Capital Markets Global Healthcare Conference on May 18, 2021, at 1:20 p.m. Eastern Time. CEO Scott Tarriff and CFO Brian Cahill will lead the presentation, which will be available via a live webcast and archived for 30 days on the company’s website under the Investors Section. Eagle is dedicated to developing innovative medicines, with commercialized products including RYANODEX®, BENDEKA®, and BELRAPZO®. For more information, visit www.eagleus.com.
FAQ
What is the current stock price of EAGLE PHARMS (EGRX)?
What is the market cap of EAGLE PHARMS (EGRX)?
What products does Eagle Pharmaceuticals offer?
What recent regulatory updates have impacted Eagle Pharmaceuticals?
What areas does Eagle Pharmaceuticals focus on?
How is Eagle Pharmaceuticals performing financially?
What is Pemfexy used for?
What distinguishes Barhemsys in the market?
What is Eagle Pharmaceuticals' approach to intellectual property?
What is the focus of Eagle Pharmaceuticals' pipeline?
How can I stay updated on Eagle Pharmaceuticals' latest news?
What is the impact of Eagle's litigation efforts?
