CRANBURY, N.J. / Jun 08, 2023 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to RP-A601, the Company’s gene therapy candidate for the treatment of plakophilin-2 related arrhythmogenic ca... Read more
SAR’579, ANKET® platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi. MARSEILLE, France / Jun 08, 2023 / Business Wire / Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) is pleased to share Sanofi’s news that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for... Read more
SAN DIEGO / Jun 01, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines 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 to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine... Read more
SAN DIEGO, May 30, 2023 /PRNewswire/ -- Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). Fast Track designation... Read more
The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway PRINCETON, N.J. / May 25, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen), today announced that all three... Read more
BOSTON and LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibito... Read more
BRISBANE, Calif. / May 22, 2023 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. Fast Track designation aims to facilitate the development and expedite the review of new therapeutics that are intended to treat serious... Read more
VE303 receives Fast Track designation for prevention of recurrent C. difficile infection ahead of global pivotal Phase 3 study Exploratory analyses from the VE303 Phase 2 CONSORTIUM study identify statistically significant relationships between VE303 bacterial species and multiple parameters that provide further mechanistic support for VE303’s observed efficacy BOSTON / May 09, 2023 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or... Read more
In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy responses, including complete responses, in a proportion of patients with solid tumors, including platinum-resistant ovarian cancer Previous blinded, prospectively-designed studies have demonstrated that the ACR-368 OncoSignature test is able to enrich for responders in two separate pretreatment tumor biopsy studies in patients with ovarian cancer previously... Read more
TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the U.S. Food and Drug Administration... Read more
TORONTO, May 02, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced the submission of a Fast Track Application to the U.S. Food and Drug Administration (“FDA”) for KETARX™ (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”). Fast Track designation aims to expedite the development and review of new... Read more
PHILADELPHIA, May 01, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed to deplete CD19-positive B cells and improve... Read more
ERAS-801 has demonstrated broad preclinical activity against oncogenic EGFR variants and wildtype alterations Initial THUNDERBBOLT-1 Phase 1 data in patients with recurrent GBM expected in H2 2023 SAN DIEGO, May 01, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the United... Read more
BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to bemnifosbuvir for the treatment of COVID-19. Bemnifosbuvir is an oral, direct-acting antiviral drug candidate being... Read more
First-ever orphan drug designation for genetically modified gamma-delta T cell therapies This orphan drug designation offers potential 7-year market exclusivity for both autologous (INB-400) and allogeneic (INB-410) candidates INB-400 is an autologous, genetically engineered gamma-delta T cell therapy that was recently cleared by the FDA for a Phase 2 trial targeting newly diagnosed glioblastoma multiforme (GBM) NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) --... Read more
BEDFORD, Mass. and INDIANAPOLIS, April 24, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, and POINT Biopharma Global, Inc. (“POINT”) (NASDAQ: PNT), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals,... Read more
SAN DIEGO, April 24, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1044 for the treatment of Duchenne muscular dystrophy (DMD) in people with mutations amenable to exon 44 skipping (DMD44). DMD is a rare genetic condition... Read more
LEXINGTON, Mass. / Apr 17, 2023 / Business Wire / Agenus Inc. (Nasdaq: AGEN), a leading immuno-oncology company specializing in immunological agents for cancer and infectious diseases, has been granted Fast Track Designation from the US Food and Drug Administration (FDA) for the investigation of the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR)... Read more
NEEDHAM, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted fast track designation for its lead asset CAN-2409, an investigational viral immunotherapy, plus valacyclovir in combination with pembrolizumab in... Read more
ARLINGTON, Mass., April 12, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kala’s human mesenchymal stem cell secretome (MSC-S) therapy (KPI-012) for the treatment of persistent corneal... Read more
RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023 ROCKVILLE,... Read more
WATERTOWN, Mass. / Apr 06, 2023 / Business Wire / Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). "Receiving Fast Track designation from the FDA underscores EDP-323’s... Read more
CaMMouflage Phase 1 trial for CB-011 enrolling patients with r/r MM at dose level 1 BERKELEY, Calif., April 04, 2023 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-011, which is being developed for relapsed or refractory multiple myeloma (r/r MM). CB-011 is being evaluated... Read more
PASADENA, Calif. / Mar 20, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome (FCS). ARO-APOC3 was previously granted Orphan Drug designation by the FDA and the European Union. ARO-APOC3 is Arrowhead’s investigational RNAi therapeutic targeting apolipoprotein C-III... Read more
BOSTON, March 06, 2023 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IK-175, the Company’s novel aryl hydrocarbon receptor (AHR) antagonist, in combination with immune checkpoint inhibitors in patients with advanced urothelial carcinoma who have progressed... Read more
SEATTLE, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent... Read more
SAN FRANCISCO and SAN DIEGO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor... Read more
Designation Aims to Accelerate Time to Market Toronto, Ontario--(Newsfile Corp. - February 7, 2023) - Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted Awakn an Innovation Passport as part of the Innovative Licensing and Access... Read more
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD) Depression is a public health issue with significant unmet medical need CAMBRIDGE, Mass., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application... Read more
TORONTO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss advancing KETARX™ (racemic ketamine) into Phase 3 development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”). This Type C meeting allows... Read more
FCS is a rare and debilitating genetic disease often leading to significant risk of acute, potentially fatal pancreatitis If approved, olezarsen would be the first approved treatment for FCS in the U.S. CARLSBAD, Calif., Jan. 31, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted olezarsen Fast Track designation for the treatment of familial chylomicronemia syndrome (FCS). FCS... Read more
IRVINE, Calif., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted mavodelpar (REN001) Fast Track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the predominant genotypes in... Read more
Currently evaluating tamibarotene in combination with azacitidine pivotal SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed HR-MDS patients with RARA gene overexpression CAMBRIDGE, Mass. / Jan 26, 2023 / Business Wire / -- Syros Pharmaceuticals, Inc. (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... Read more
COPENHAGEN, Denmark, Jan. 19, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, today announced that the U.S. Food and Drug Administration (“FDA”) has granted fast track designation for the Company’s personalized cancer therapy, EVX-01, in combination with KEYTRUDA®. In December 2023, Evaxion received FDA approval to... Read more
SAN DIEGO, Jan. 18, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked... Read more
Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle’s BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer. BT8009 is a potential first in... Read more
Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients. TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company's... Read more
NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Fast Track is a process designed to facilitate the development and expedite... Read more
If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years of age or older NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, as submitted for the prevention of lower respiratory tract disease caused by RSV in... Read more
HOUSTON, Dec. 7, 2022 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM"). The FDA's Fast Track designation is intended to potentially facilitate... Read more
Designation Represents Potential to Bring Important New Therapy to Patients Earlier Stable Disease Observed in Two Out of Four Evaluable Patients in eAPC Phase 1/2 Trial Including a Pronounced Pharmacodynamic Response in a Patient with Prolonged Stable Disease Interim Results from Ongoing SQZ® eAPC Phase 1/2 Trial Showed Favorable Safety Data and Investigational Therapy was Generally Well Tolerated Median Drug Viability of Greater than 90 Percent for Both SQZ® eAPC... Read more
The Fast Track designation may expedite development of PH10 for treatment of major depressive disorder in adults SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (NASDAQ: VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation... Read more
Fast Track designation granted by U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM) Enables darovasertib / crizotinib development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review SOUTH SAN FRANCISCO, Calif., Dec. 5, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality... Read more
Fort Lee, NJ, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian... Read more
FDA Fast Track designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective response rate SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine... Read more
SAN DIEGO, Nov. 28, 2022 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara's REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC). REM-001 was studied in four Phase 2/3 clinical... Read more
BBP-398, an investigational SHP2 inhibitor, is a potentially optimal agent for use in combination therapies given its continuous, once-daily dosing in addition to synergistic activity with other agents to treat cancers driven by KRAS G12C mutations The combination of investigational therapy BBP-398 and LUMAKRAS, if successful, has the potential to address the serious unmet need for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). This combination... Read more
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lomecel-B™ for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year. Lomecel-B™,... Read more
Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IK-930, the Company’s novel TEAD inhibitor targeting the Hippo signaling pathway, in patients with unresectable NF2-deficient malignant pleural mesothelioma (MPM). Fast Track designation granted by FDA facilitates the development... Read more
Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara's VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM). Fast Track is a process designed to facilitate the development, and expedite the review of... Read more
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