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January 29, 2024
Achieved primary and secondary endpoints in Phase 1 portion of LEGEND study in non-muscle invasive bladder cancer (NIMBC); pivotal portion underway with...
November 13, 2023
Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO trial of tebipenem HBr; Trial expected to begin with First Patient, First Visit in 4Q 2023 Conference call and webcast at 4:30pm ET...
November 9, 2023
– Initial clinical data from CABA-201 treated patients in Phase 1/2 trials for lupus and/or myositis expected in the first half of 2024, with the ...
August 14, 2023
14.08.2023 - Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J., Aug. 14, 2023 (GLOBE ...
August 10, 2023
- Strengthened balance sheet by closing $100M public offering extending cash runway into the fourth quarter of 2025 - PHILADELPHIA, Aug. 10,... -Today at 07:19 am- MarketScreener
August 10, 2023
– Received second IND application clearance for CABA-201 in myositis as well as Fast Track Designation in SLE and LN – – Strengthened balance sheet by closing $100M public offering extending... -Today at 07:02 am- MarketScreener
August 10, 2023
SPA Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr Phase 3 PIVOT-PO trial is expected to begin with First Patient, First Visit in 4Q 2023 Sath Shukla Became President and...
May 15, 2023
15.05.2023 - Upcoming Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD)Pre-launch commercial activities ...
May 11, 2023
Phase 2 trial of SPR720 in nontuberculous mycobacterial pulmonary disease on track for top line data readout in 1H 2024 Update on status of Special Protocol Assessment agreement for tebipenem HBr... | May 11, 2023