FDA Grant

Jasper Therapeutics (NASDAQ: JSPR) announced that its lead asset JSP191 has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. JSP191 is...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kymera Therapeutics’ (NASDAQ: KYMR) product candidate KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL). KT-333 is being evaluated in an ongoing Phase 1 clinical trial to assess safety, tolerability...

Centessa Pharmaceuticals (NASDAQ: CNTA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SerpinPC for the treatment of hemophilia B. A Phase 2a proof-of-concept study evaluated SerpinPC in severe hemophilia A and B patients not on prophylaxis....

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s (NASDAQ: TCON) lead asset envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who...

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GENFIT’s (NASDAQ: GNFT) drug candidate GNS5611 (ezurpimtrostat) for the treatment of cholangiocarcinoma. The pre-clinical studies evaluating GNS561 has been completed and a Phase 1b trial confirming the...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ: SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer. The ongoing Phase 1 trial is evaluating SY-5609 in combination with chemotherapy in pancreatic cancer patients who...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD). The company is currently investigating...

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). XMT-1660 being evaluated in a Phase 1 trial,...

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). SLN124 is designed to address a range of hematological diseases by targeting TMPRSS6...

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...

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...

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). Lomecel-B is being evaluated in ELPIS II, Phase 2a clinical trial intended to evaluate the...

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). BCX9250 evaluated in a Phase 1 clinical trial in healthy subjects, the drug candidate was...

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...

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). MK-2060 is being investigated in a Phase 2 study to...