Clinical Trials
9
2 active
Approvals
8
Total approvals
Agencies
1
Regulatory bodies
Founded
2007
Active, not recruiting
1
11.1%
Completed
4
44.4%
Not yet recruiting
1
11.1%
Recruiting
1
11.1%
Suspended
1
11.1%
Terminated
1
11.1%
- The community-acquired bacterial pneumonia (CABP) treatment market is expected to grow positively by 2036 across the United States, EU4, the United Kingdom, and Japan, with the U.S. holding the largest share in 2025. - Around 80% of the nearly 4 million community-acquired pneumonia cases in the U.S. are classified as CABP, underscoring the substantial burden of bacterial pathogens. - Emerging Phase II candidates CAL02, AON-D21, and Trimodulin (BT588) target bacterial virulence factors and host inflammatory responses to complement conventional antibiotics. - Rising antimicrobial resistance and an aging population with comorbidities are driving demand for next-generation antibacterial therapies.
- Eagle Pharmaceuticals has entered into a $69 million royalty purchase agreement with Blue Owl Capital to sell its royalty interest in BENDEKA, a treatment for chronic lymphocytic leukemia and non-Hodgkin lymphoma. - The non-dilutive capital will be used to repay $52.5 million in existing debt, with remaining proceeds allocated to general corporate purposes and ongoing R&D programs. - Eagle continues to invest in its pipeline, including CAL02 for severe community-acquired bacterial pneumonia and EA 114, a novel formulation of Fulvestrant for hormone-receptor-positive metastatic breast cancer.
- Eagle Pharmaceuticals' PEMFEXY® gains FDA approval for use with pembrolizumab and platinum chemotherapy in metastatic non-squamous NSCLC patients without EGFR or ALK aberrations. - PEMFEXY®, a ready-to-dilute liquid formulation, now holds the same indications as ALIMTA®, offering advantages like eliminating reconstitution steps. - This marks the fifth indication for PEMFEXY®, expanding its role in treating non-squamous NSCLC and mesothelioma, enhancing Eagle's oncology portfolio. - The approval strengthens Eagle Pharmaceuticals' position in the market, providing a valuable treatment option for patients undergoing chemotherapy.
- Eagle Pharmaceuticals announced that AOP Orphan Pharmaceuticals submitted a new drug application to the FDA for landiolol, seeking approval for short-term reduction of ventricular rate in patients with supraventricular tachycardia. - Landiolol is an ultra-short-acting, cardio-selective beta-1 adrenergic blocker with a β1:β2 ratio of 255:1, making it the most cardioselective beta blocker available. - The drug is already commercially available in Japan and several European markets, with multiple clinical studies demonstrating its safety and efficacy for rapid short-term control of tachyarrhythmias. - If approved, Eagle expects five years of new chemical entity exclusivity and anticipates approval by mid-year 2023 based on FDA feedback from a Type C meeting.
