Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need
Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults
NDA submission on track for second half 2024
Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals... Read more
Treatment of first randomized person with preclinical AD expected this quarter
Phase 2b ReTain trial is fully funded and conducted by development partner Lausanne, Switzerland, July 25, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the pathologic form of the Tau protein,... Read more
NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal... Read more
Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising clinical activity with a manageable safety profile in treatment-refractory patients with squamous cell carcinoma of the head and neck (SCCHN) in its Phase 2 clinical trial
The Company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024 SAN DIEGO, July 23, 2024 (GLOBE NEWSWIRE) -- BioAtla,... Read more
FDA designation enables expedited clinical development and regulatory review timelines for Lomecel-B™
Second designation received for Lomecel-B™ for the treatment of mild Alzheimer’s Disease after Regenerative Medicine Advanced Therapeutics (RMAT) Designation announced on July 9, 2024
Phase 2a Lomecel-B™ data in mild Alzheimer’s Disease selected for Featured Research Session oral presentation and poster presentation at upcoming... Read more
REDWOOD CITY, Calif. & BOSTON / Jul 08, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with... Read more
BOSTON, July 02, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency.
“Through Fast Track designation, the FDA recognizes... Read more
Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024 and underscores the unmet need for people living with chronic hepatitis delta SAN FRANCISCO / Jun 26, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation... Read more
Fast Track designation highlights potential for CT-0525 to address unmet need for patients with solid tumors
Initial Phase 1 data expected by year-end 2024 PHILADELPHIA, June 25, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast... Read more
Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2
With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support development and expedite regulatory... Read more
NEW YORK, June 11, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug... Read more
REDWOOD CITY, Calif. & BOSTON / Jun 05, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.
“The FDA’s decision to grant ADI-001... Read more
CAMBRIDGE, Mass. & MONTREAL / Jun 04, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.
Lunresertib in combination... Read more
Fast Track designation underscores the high unmet medical need, with currently no approved therapeutic treatments for the rare pediatric disease Ataxia-Telangiectasia SOUTH SAN FRANCISCO, Calif. / Jun 03, 2024 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the U.S. Food... Read more
Efficacy and safety of AFM24 in combination with atezolizumab, a checkpoint inhibitor, is being evaluated in non-small cell lung cancer patients with EGFR wild-type and EGFR mutant advanced/metastatic cancers in the ongoing AFM24-102 phase 1/2a study
The FDA’s Fast Track designation was granted after its review of the initial efficacy data of the EGFR wild-type cohort from the AFM24-102 study
Fast Track is a process designed to facilitate the development and expedite... Read more
ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival... Read more
DURHAM, N.C. / May 07, 2024 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, elimination, and excision, today announced that its partner iECURE has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ECUR-506. ECUR-506 is iECURE’s in vivo gene insertion... Read more
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial... Read more
WINNIPEG, MB / ACCESSWIRE / April 23, 2024 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the... Read more
NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA) cardiomyopathy.... Read more
LYT-200 is being evaluated in locally advanced/metastatic solid tumors, including head and neck cancers, as well as in hematological malignancies, such as acute myeloid leukemia and high-risk myelodysplastic syndrome
Phase 1b and Phase 1/2 clinical trials of LYT-200 ongoing BOSTON / Apr 11, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients... Read more
CAMBRIDGE, Mass. / Apr 09, 2024 / Business Wire / Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) with RARA overexpression... Read more
LEXINGTON, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation... Read more
WATERTOWN, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to DISC-0974 for the treatment of patients with non-dialysis dependent chronic kidney disease (NDD-CKD)... Read more
Fast Track designation has the potential to accelerate lead asset IMM-1-104’s path to U.S. FDA submission for pancreatic ductal adenocarcinoma
Company expects multiple readouts from its Phase 1/2a clinical trial in 2024 CAMBRIDGE, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today... Read more
BOSTON, Feb. 20, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PGN-EDODM1, an investigational candidate for the treatment of myotonic dystrophy type 1 (DM1). “Receiving... Read more
BOULDER, Colo. / Feb 13, 2024 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy... Read more
NEEDHAM, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for CAN-3110 -- a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate –... Read more
FDA clears IND and Phase 1 (KYANITE-1) clinical trial expected to be initiated in 1H 2024 PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard... Read more
Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence of microsatellite instability
BXCL701 is an investigational, oral innate immune activator designed to inflame the tumor microenvironment and augment CPI activity
Company to discuss registration path at upcoming meeting with FDA NEW HAVEN, Conn., Feb. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics,... Read more
