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News about "IND Application "
FibroBiologics Files IND Application with US FDA for CYPS317 in Psoriasis
FibroBiologics has filed an Investigational New Drug (IND) application with the US FDA for CYPS317, marking a key step towards initiating clinical development of the therapy for psoriasis, supported by encouraging preclinical data showing reduced disease severity and relapse.
IND Application | 03/01/2026 | By News Bureau
Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis
Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.
IND Application | 04/10/2025 | By Dineshwori | 155
Hemispherian Secures FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Hemispherian AS has received FDA clearance for its IND application to begin a Phase 1 trial of GLIX1, a first-in-class small molecule targeting DNA repair vulnerabilities in glioblastoma and other solid tumours.
IND Application | 05/08/2025 | By Mrinmoy Dey | 200
EuMentis Therapeutics Secures US FDA Clearance of IND Application for EM-221
EuMentis Therapeutics has received FDA clearance to initiate a Phase 2 clinical trial of EM-221, its novel PDE10A inhibitor, for the treatment of schizophrenia.
IND Application | 31/07/2025 | By Mrinmoy Dey | 174
Adcendo Receives FDA Clearance of IND Application for Phase I Tiffany-01 Trial of ADCE-T02
Tiffany-01 is an ongoing first-in-human Phase I multicenter, open-label, dose escalation study of ADCE-T02 as a monotherapy in patients with advanced solid tumors.
IND Application | 27/02/2025 | By Aishwarya | 482
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