FDA Grant

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis, a major form of interstitial lung disease. A Clinical proof-of-concept was recently...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ: RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). REL-1017 is being investigated in an on-going monotherapy Phase 3 clinical trial under...

ALX Oncology Holdings (NASDAQ: ALXO) receives Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead asset Evorpacept in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Omeros Corporation’s (NASDAQ: OMER) lead asset OMS906 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). OMS906 is evaluated in the Phase 1 clinical in healthy subjects. The company expects to...

Pliant Therapeutics (NASDAQ: PLRX) received Fast Track designation for its lead asset PLN-74809 from the U.S. Food and Drug Administration (FDA) for the potential treatment of primary sclerosing cholangitis (PSC). PLN-74809 is being investigated as part of the INTEGRIS-PSC Phase 2a clinical trial...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Olema Oncology’s (NASDAQ: OLMA) lead asset OP-1250 for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. OP-1250 is currently being evaluated...

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Karyopharm Therapeutics’ (NASDAQ: KPTI) lead asset Eltanexor as monotherapy for the treatment of patients with relapsed or refractory Myelodysplastic Syndromes (MDS). Eltanexor is being evaluated in an ongoing...

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Amryt’s (NASDAQ: AMYT) lead drug Mycapssa for the treatment of carcinoid syndrome. Carcinoid syndrome (CS) is the most common functional syndrome associated with neuroendocrine tumours (NETs). Mycapssa (oral...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for AVROBIO’s (NASDAQ: AVRO) lead drug AVR-RD-05 for the treatment of mucopolysaccharidosis type II (MPSII), or Hunter syndrome. Hunter syndrome is a rare and seriously debilitating lysosomal disorder that...

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to investigate the use of Abbott’s (NYSE: ABT) deep brain stimulation (DBS) system in treatment-resistant depression (TRD) to manage major depressive disorder (MDD). The regulatory grant paves way for the...

The US Food and Drug Administration (FDA) granted a Fast Track designation to InflaRx’s (NASDAQ: IFRX) lead candidate Vilobelimab for the treatment of ulcerative Pyoderma Gangrenosum (PG). The FDA grant was supported by the positive data readout in pyoderma gangrenosum (PG) from its Phase 2a...

The United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia Therapeutics’ (NASDAQ: KZIA) lead drug Paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT). AT/RT is a rare and highly-aggressive childhood brain cancer,...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ (NASDAQ: AURA) belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The company has planned Phase 1 clinical trial with belzupacap sarotalocan in...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALX Oncology Holdings’ (NASDAQ: ALXO) Evorpacept for the treatment of patients with acute myeloid leukemia (AML). Evorpacept in combination with venetoclax and azacitidine is being evaluated in the Phase 1/2...

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Mustang Bio’s (NASDAQ: MBIO) lead drug MB-106 for the treatment of Waldenstrom macroglobulinemia (WM), a rare type of B-cell non-Hodgkin lymphoma (B-NHL). MB-106 is being developed in a collaboration between...