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FDA Grant Recent News

Mersana Shares Climb As FDA Grants Fast Track Status To Triple-Negative Breast Cancer Candidate
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ (NASDAQ: MRSN) lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC).
Silence Therapeutics Gets FDA Fast Track Status For Blood Cancer Candidate
Silence Therapeutics  (NASDAQ: SLN) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead candidate SLN124 for the treatment of polycythemia vera (PV).
Pfizer Gets FDA Breakthrough Therapy Designation For GBS Vaccine Candidate
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE: PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.
Intellia Gets FDA Orphan Drug Status For Hereditary Angioedema Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ: NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). NTLA-2002 is currently being evaluated in a Phase 1/2 study in adults with Type I or Type II HAE.
Longeveron Shares Ascend As FDA Grants Fast Track Status To Congenital Heart Disease Candidate
Longeveron (NASDAQ: LGVN) received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead drug Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS).
BioCryst Secures FDA Orphan Drug Status For Rare Connective Tissue Disease Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BioCryst’s (NASDAQ: BCRX) lead asset BCX9250 for the treatment of fibrodysplasia ossificans progressiva (FOP).
FDA Grants Fast Track Status To Synlogic's Rare Genetic Disorder Drug
Synlogic, Inc. (NASDAQ: SYBX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate SYNB1353 for the potential treatment of homocystinuria (HCU). SYNB1353 is currently being evaluated in a Phase 1 clinical study in healthy volunteers.
Merck Gets FDA Fast Track Status For Chronic Kidney Disease Candidate
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE: MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
aTyr Pharma Shares Ascend As FDA Grants Fast Track Status To Lung Disease Candidate
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.
Relmada Secures FDA Fast Track Status For Depressive Disorder Candidate
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).
ALX Oncology Shares Gain As FDA Grants Fast Track Status To Head And Neck Cancer Candidate
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 carcinoma (HNSCC).
Omeros Shares Climb As FDA Grants Orphan Drug Status To Blood Disorder Candidate
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).
Pliant Therapeutics Secures FDA Fast Track Status For Liver Disease Drug
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).
Olema Oncology Shares Ascend As FDA Grants Fast Track Status To Breast Cancer Candidate
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.
Karyopharm Shares Soar On FDA Fast Track Status, EU Orphan Medicinal Product Status To Preleukemia Candidate
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).
Amryt Shares Shoot Higher As FDA Grants Orphan Drug Status To Carcinoid Tumor Candidate
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).
AVROBIO Shares Climb As FDA Grants Orphan Drug Status To Genetic Disorder Candidate
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.
Abbott Gets FDA Breakthrough Device Status For Depression Therapy System
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).
InflaRx's Stock Gains Following FDA Fast Track Status To Skin Disease Drug
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).
Kazia Shares Shoot Higher As FDA Grants Rare Pediatric Disease Designation To Brain Cancer Candidate
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).
Aura Biosciences' Stock Gains As FDA Grants Fast Track Status To Bladder Cancer Drug
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).
ALX Oncology Shares Soar As FDA Grants Orphan Drug Status To Blood Cancer Candidate
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).
Mustang Bio Shares Gain As FDA Grants Orphan Drug Status To Waldenstrom Drug
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).

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