TARPON SPRINGS, Fla., August 26, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian...Read more
Pemvidutide is the only drug currently granted Fast Track Designation in AUD RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently enrolling GAITHERSBURG, Md., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted...Read more
LEXINGTON, Mass. / Aug 19, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa. There is currently no approved treatment for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases...Read more
PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain...Read more
This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of the addressable population compared to the Designation granted in 2017 for bipolar depression alone The Designation includes an FDA determination that NRX-100 has the potential to address an unmet need, based on FDA's assessment of the data submitted Determination of "unmet need"...Read more
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...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...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...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...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...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...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...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)...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...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:...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...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...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...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...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...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...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,...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...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...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...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...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...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...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”)...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) --...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...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...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...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....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)...Read more
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation CHARLESTOWN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has received Fast Track designation from the U.S. Food and Drug Administration...Read more
Company Anticipates Submitting for U.S. Accelerated Approval in H1 2026 WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DYNE-101 for...Read more
CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the U.S. Food and Drug Administration (FDA) recently granted an additional Fast Track designation to XMT-1660. The company also announced that the...Read more
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200 is currently being evaluated in two Phase 1/2 trials for the potential treatment of AML/MDS and head and neck cancers BOSTON / Jan 09, 2025 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage...Read more
Azenosertib Fast Track Designation granted for Cyclin E1 positive patients by U.S. Food and Drug Administration (FDA) Manuscript focused on role of Cyclin E1/CDK2 activation predicting sensitivity to azenosertib published in npj Precision Oncology Corporate event to be held on January 29, 2025 to provide updates on azenosertib clinical data, development and regulatory path SAN DIEGO, Jan. 09, 2025 (GLOBE NEWSWIRE)...Read more
Building on decades of the Company's Alzheimer's research, two differentiated investigational therapies aim to slow pathological tau in distinct populations Fast Track designations reinforce J&J's commitment to Alzheimer's disease development and the potential of its precision approach TITUSVILLE, N.J., Jan. 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA)...Read more
SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK), for the treatment of...Read more
SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical...Read more
IMM-1-104 has the potential to benefit melanoma patients who have progressed on or are intolerant to immune checkpoint inhibitors IMM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative to MEK inhibitors currently used to treat melanoma Melanoma patients actively enrolling in one of five arms in the company’s ongoing Phase 2a clinical study of IMM-1-104 CAMBRIDGE, Mass.,...Read more
This is the second Fast Track Designation granted to LP-184 in 2024, following the designation for Glioblastoma (GBM) announced in October 2024. Fast Track Designation for LP-184 recognizes TNBC as a serious condition impacting approximately 29,000 patients annually in the US, with over 50% of patients relapsing within 3-5 years. LP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP...Read more
NORWOOD, Mass., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer. CRB-701 (SYS6002) is a next-generation antibody drug conjugate...Read more
Fast Track designation is designed to expedite clinical development and regulatory review timelines Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025 SEATTLE, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 2, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to R289 for the treatment of patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS). R2891, Rigel's...Read more
Fast Track designation indicates LBS-007’s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company’s investigational medicinal product for the treatment of acute leukemia A Phase 1/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company’s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S....Read more
Remain on track to initiate registrational THRIVE-3 trial in 1Q’ 2025 NEW YORK, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Intravenous (IV) Choline Chloride, the Company’s investigational IV...Read more
Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. Fast Track Designation for LP-184 (STAR-001) recognizes Glioblastoma (GBM) as a serious condition impacting more than 13,000 U.S. adults each year and approximately 300,000 globally. A phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025. LP-184, which will be...Read more
Zilganersen is the first investigational medicine in clinical development for adults and children living with Alexander disease, an ultra-rare neurological condition CARLSBAD, Calif., Oct. 1, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has granted zilganersen Fast Track designation for the treatment of children and adults with an...Read more
WARREN, N.J., Sept. 26, 2024 /PRNewswire/ -- PTC Therapeutics (NASDAQ: PTCT) announced today that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need. "The granting of Fast Track designation to the PTC518 program further supports the potential of PTC518 to provide a disease modifying therapy to...Read more
BOSTON, Sept. 23, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the...Read more
BRANFORD, Conn. / Sep 18, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for topically applied ATR-04 to treat moderate to severe Epidermal Growth Factor Receptor inhibitor (EGFRi) associated dermal toxicity. Francisco...Read more
SEATTLE, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced that the U.S. Food and Drug Administration (the “FDA”) granted Fast Track Designation for the development of 212Pb VMT01 for the diagnosis and treatment of patients with...Read more
Fast Track designation is designed to expedite clinical development and regulatory review timelines Additional FDA designation for CB-010 following earlier RMAT and Fast Track designations in B-NHL CB-010 GALLOP Phase 1 trial in patients with LN and ERL is on track to initiate by YE 2024 CB-012 AMpLify Phase 1 trial advancing in dose escalation BERKELEY, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration Follows two previous Fast Track designations for ACI-35.030 and ACI-24.060 active immunotherapies Affirms AC Immune’s leadership and commitment to bringing precision medicine to the management of neurodegenerative...Read more
Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) SAN MATEO, Calif. / Aug 26, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track...Read more
HOUSTON / Aug 14, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic...Read more
New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for AMX0035 in Wolfram syndrome granted in 2020 Topline data for all 12 participants from Phase 2 HELIOS trial studying impact of AMX0035 on endocrine, metabolic, and neurodegenerative aspects of Wolfram syndrome anticipated fall 2024 CAMBRIDGE, Mass. / Aug 02, 2024 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the...Read more
Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3 2024 Fast track designation underscores unmet need for patients with relapsed or refractory PTCL, an indication with poor overall outcomes and no approved drugs based on randomized trials BURLINGAME, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a...Read more
IMM-1-104 Fast Track designation now granted for the treatment of both first and second-line pancreatic ductal adenocarcinoma (PDAC); provides potential to accelerate IMM-1-104’s path to U.S. FDA submission for PDAC Phase 2a trial of IMM-1-104 includes multiple arms open to first-line pancreatic cancer patients, as well as arms open to patients with second-line pancreatic cancer, RAS-mutant melanoma, and RAS-mutant lung...Read more
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...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...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...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,...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...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...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...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...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...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...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...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...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...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,...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...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...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...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...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,...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...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...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...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...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...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...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...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...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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