SAN FRANCISCO, July 29, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex... Read more
SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic... Read more
Potential first-to-market small molecule telomere targeting agent targets a $34 billion NSCLC treatment market
Latest data in pivotal Phase 2 THIO-101 clinical trial shows median overall survival of 17.8 months CHICAGO / Jul 28, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and... Read more
Enrollment is ongoing in U.S. Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, in KRAS G12D advanced solid tumors
KRAS G12D mutation is the most prevalent KRAS mutation in human cancers and 37% of pancreatic cancers harbor a KRAS G12D mutation BOSTON / Jul 24, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the... Read more
SGT-501 has now received FDA Fast Track, Orphan Drug and Rare Pediatric Disease designations
Potential first-in-class therapy with FDA IND clearance and Health Canada CTA approval designed to address underlying causes of CPVT, a life-threatening, arrhythmogenic cardiac condition
Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 CHARLESTOWN, Mass., July 23, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a clinical... Read more
FDA designation highlights the potential of PMN310 to deliver a more targeted approach to treating Alzheimer’s Disease CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s... Read more
Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need NEW YORK / Jun 27, 2025 / Business Wire / Schrödinger, Inc. (Nasdaq: SDGR) today announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s... Read more
BOSTON, June 10, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to mavorixafor, an oral CXCR4 antagonist, for the treatment of chronic neutropenia (CN). The company is currently conducting a global, pivotal Phase 3 clinical trial (4WARD) evaluating mavorixafor in certain... Read more
AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS
Phase 1 LUMINA trial of AMX0114 underway; early cohort data expected in 2025 CAMBRIDGE, Mass. / Jun 03, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an... Read more
Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibody
Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac disease
Candidate demonstrates Teva’s commitment to bringing important new treatment options to underserved patient populations TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the... Read more
The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung cancer (SCLC) in 2025 SHANGHAI & CAMBRIDGE, Mass. / May 19, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer... Read more
Fast Track Designation highlights potential of ATH434 to address high unmet need for individuals with MSA MELBOURNE, Australia and SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast... Read more
LONDON and NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and often severe pain but without an FDA-approved therapy, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP).
Fast... Read more
WALTHAM, Mass., April 30, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and other autoimmune and inflammatory diseases, today announced that the United States Food and Drug Administration ("FDA") has granted Fast Track designation (FTD) to Q32 Bio's bempikibart (ADX-914) for the treatment of AA. Bempikibart is a fully human anti-IL-7Rα antibody that... Read more
DURHAM, N.C. / Apr 15, 2025 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PBGENE-HBV, the Company’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating... Read more
BOSTON, April 11, 2025 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VERVE-102 for the treatment of patient groups with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol (LDL-C). VERVE-102 is the company’s novel, in vivo, investigational... Read more
SAN DIEGO / Apr 10, 2025 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicine company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for... Read more
Designations Follow Recent Investigational New Drug (IND) Application Clearance for the RESOLUTION Basket Study of ALLO-329 in Rheumatology
Dual CD19/CD70 CAR T Specifically Designed to Enhance Therapeutic Benefit, Expanding Treatment Potential Across a Range of Autoimmune Indications
Leverages Proprietary Dagger® Technology to Reduce or Eliminate Lymphodepletion, Potentially Expanding Access to a Broader Patient Population
Phase 1 RESOLUTION Trial Initiation Planned... Read more
CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and address unmet medical... Read more
Sjögren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments
The Company is actively enrolling patients in the Phase 3 DAFFODIL study
This marks the fourth nipocalimab FDA Fast Track designation SPRING HOUSE, Pa., March 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab... Read more
LONDON and NEW YORK, March 10, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease, a multi-billion-dollar market, is pleased to announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for... Read more
REDWOOD CITY, Calif. & BOSTON / Feb 27, 2025 / 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 adult patients with systemic sclerosis (SSc).
Fast Track Designation is a process designed to facilitate... Read more
BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy... Read more
Underscores high unmet need for a therapeutic alternative to opioids and surgical interventions
Reflects positive preliminary Phase 2 Safety and Efficacy data reported to date
May also lead to Priority Review and Accelerated Biologics License Application (“BLA”) Approval for BRTX-100 MELVILLE, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical... Read more
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s disease.
NKGen will benefit from increased FDA interactions, enhanced visibility and potential eligibility for Accelerated Approval, Priority Review, and Rolling Review of the regulatory dossier, with a faster path to market for troculeucel. SANTA ANA, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq:... Read more
The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions where there is an unmet medical need. FAP, an inherited condition that puts people at a much greater risk of developing colon cancer, falls into that category. The condition is typically diagnosed in the early teenage years and results in a nearly 100% lifetime risk of colorectal cancer. To be considered a "serious" disease by the FDA,... Read more
Underscores unmet need for a therapeutic alternative with the potential to delay or prevent surgical removal of the colon and/or rectum February 10, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced today that the US Food and Drug Administration (“FDA”) has granted Fast Track... Read more
Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC
Amezalpat builds momentum with both Fast Track and Orphan Drug Designations BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted... Read more
SAN FRANCISCO, Feb. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Rezpegaldesleukin is an investigational... Read more
REDWOOD CITY, Calif. & BOSTON / Feb 05, 2025 / 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 adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement.
Fast... Read more
