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Mesoblast (Nasdaq: MESO; ASX: MSB)announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on key components required to file a Biologics License Application (BLA) for its cell therapy candidate Revascor® (rexlemestrocel-L) for the treatment of ischemic heart failure with …
BofA Securities issued a notable downgrade forProKidney Corp. (NASDAQ: PROK)on Monday, shifting its rating fromNeutraltoUnderperformand sharply reducing its price target from USD3.00 to USD1.00 per share. The reassessment follows a combination of revised expectations for ProKidney’s lone therapeutic candidate, REACT, and growing caution regarding …
Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company focused on programmed T cell therapies, has announced updated results from its ongoing FELIX trial evaluating obe-cel, an autologous CD19 CAR T-cell therapy, in adults with relapsed or refractory (r/r) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) announced updates related to its Founded Entity, Vor Bio (Nasdaq: VOR), following two major financial transactions. Vor Bio has entered an exclusive global license agreement with RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331), excluding China, Hong Kong, …
Evotec SE (Frankfurt Stock Exchange: EVT; Nasdaq: EVO) has announced its participation in the NURTuRE-AKI consortium, a longitudinal research initiative focused on acute kidney injury (AKI) and its progression to chronic kidney disease (CKD). The study targets both adult and pediatric cardiac surgery patients …
InspireMD, Inc. (Nasdaq: NSPR), a medical technology company focused on stroke prevention, has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its CGuard Prime Carotid Stent System. The approval allows the commercial launch of the device in the U.S. …
argenx SE (Euronext & Nasdaq: ARGX)is a biopharmaceutical company focused on the development of antibody-based treatments for severe autoimmune diseases. Through collaborations with academic researchers, argenx aims to build a portfolio of immune-mediated therapies. The company is advancing its FcRn blocker, efgartigimod, across multiple …
GH Research PLC (Nasdaq: GHRS),a clinical-stage biopharmaceutical company focused on depression treatments, announced that it has submitted its full response to the U.S. Food and Drug Administration (FDA) concerning the clinical hold placed on its Investigational New Drug (IND) application for GH001. The company …
Roth Capital has reaffirmed its "Buy" rating on shares ofVerona Pharma PLC American Depositary Share(NASDAQ: VRNA) while raising its price target to USD116 from the previously assigned USD92. The revised target was noted in a research report issued Wednesday morning, as reported by Benzinga.
AbbVie, Inc. (NYSE: ABBV)is a U.S.-based biopharmaceutical company headquartered in North Chicago, Illinois. The firm was spun off from Abbott Laboratories in 2013 and focuses on research and development across several therapeutic areas, including immunology, oncology, neuroscience, and eye care. AbbVie markets several major …
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