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Companies That Recently Received FDA Fast Track Designation

Company
Last Trade
Change
Volume
Shares Out
Market Cap
US$ 27.64
-0.10 -0.36
14.94M
5.67B
US$ 156.690B
US$ 41.16
0.12 0.29
5.86M
2.03B
US$ 83.550B
US$ 222.75
-2.83 -1.25
520,163
145.60M
US$ 32.430B
US$ 84.54
-1.34 -1.56
324,510
240.99M
US$ 20.370B
US$ 41.23
0.42 1.03
157,894
145.96M
US$ 6.020B
US$ 79.08
-2.40 -2.95
280,849
69.31M
US$ 5.480B
US$ 26.55
-0.50 -1.85
764,811
187.13M
US$ 4.970B
US$ 171.46
0.25 0.15
146,689
28.56M
US$ 4.900B
US$ 40.30
2.69 7.15
1.34M
95.64M
US$ 3.850B
US$ 25.06
1.27 5.34
836,540
124.20M
US$ 3.110B
US$ 36.71
0.44 1.21
352,618
75.69M
US$ 2.780B
US$ 18.20
0.00 0.00
5,488
150.65M
US$ 2.740B
US$ 22.17
1.32 6.33
531,650
90.78M
US$ 2.010B
US$ 31.48
0.21 0.67
164,905
61.36M
US$ 1.930B
US$ 25.37
0.07 0.28
543,866
68.43M
US$ 1.740B
US$ 45.55
0.14 0.31
94,785
36.08M
US$ 1.640B
US$ 17.46
0.65 3.87
401,086
93.41M
US$ 1.630B
US$ 20.25
0.03 0.15
94,985
68.73M
US$ 1.390B
US$ 5.12
0.26 5.25
1.24M
272.32M
US$ 1.390B
US$ 21.50
0.53 2.53
686,921
61.07M
US$ 1.310B
US$ 43.47
2.22 5.38
148,200
24.72M
US$ 1.070B
US$ 9.13
0.27 3.05
100,556
113.04M
US$ 1.030B
US$ 26.72
0.13 0.49
177,964
26.93M
US$ 719.570M
US$ 26.56
-0.75 -2.75
283
27.08M
US$ 719.240M
US$ 11.94
0.05 0.42
384,274
49.26M
US$ 587.920M
US$ 2.04
0.005 0.25
307,321
272.82M
US$ 555.190M
US$ 16.99
0.19 1.13
20,741
32.42M
US$ 550.820M
US$ 2.86
0.10 3.62
2.65M
187.02M
US$ 534.880M
US$ 15.92
0.24 1.53
143,409
32.95M
US$ 524.560M
US$ 6.42
0.47 7.91
1.10M
70.90M
US$ 454.820M
US$ 8.82
0.49 5.88
551,529
48.28M
US$ 425.830M
US$ 4.07
-0.02 -0.49
49,540
98.90M
US$ 402.520M
US$ 13.99
0.41 3.02
229,347
21.00M
US$ 293.680M
US$ 3.38
-0.04 -1.17
232,102
84.22M
US$ 284.660M
US$ 6.63
0.33 5.24
2.36M
38.38M
US$ 254.460M
US$ 3.20
0.01 0.31
138,392
78.52M
US$ 251.260M
US$ 11.31
-0.12 -1.05
54,425
21.18M
US$ 239.550M
US$ 15.12
0.63 4.35
110,366
14.48M
US$ 218.940M
US$ 6.43
-0.09 -1.38
46,619
30.88M
US$ 198.560M
US$ 3.18
0.00 0.00
0
58.24M
US$ 185.200M
US$ 5.82
-0.16 -2.68
200,467
29.76M
US$ 173.200M
US$ 2.14
-0.005 -0.23
5,103
80.84M
US$ 172.590M
US$ 1.75
0.03 1.75
685,635
90.32M
US$ 158.070M
US$ 3.45
-0.07 -1.99
91,979
42.45M
US$ 146.450M
US$ 5.43
0.12 2.26
31,192
26.73M
US$ 145.140M
C$ 2.22
-0.06 -2.63
3,108
59.36M
C$ 131.780M
US$ 6.83
0.00 0.00
37,808
18.36M
US$ 125.310M
US$ 2.65
0.00 0.00
0
47.17M
US$ 125.000M
US$ 0.96
0.01 1.05
291,045
124.62M
US$ 119.410M

Recent FDA Fast Track Designation News


FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis

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


Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis

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


Repare Therapeutics Announces Fast Track Designation Granted by the FDA for Lunresertib in Combination with Camonsertib for the Treatment of Platinum-Resistant Ovarian Cancer

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


Quince Therapeutics Receives U.S. FDA Fast Track Designation for EryDex System

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


Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer

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


Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

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


Precision BioSciences Announces Receipt of FDA Fast Track Designation for ECUR-506, iECURE’s Program for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

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


MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

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


Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency

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


Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy

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


PureTech Health Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

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


Syros Pharmaceuticals Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

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


Keros Therapeutics Announces U.S. FDA Fast Track Designation for KER-050 in Lower-Risk Myelodysplastic Syndromes

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


Disc Medicine Receives FDA Fast Track Designation for DISC-0974 for the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

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


Immuneering Receives FDA Fast Track Designation for IMM-1-104 in Pancreatic Cancer

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


PepGen Receives U.S. FDA Fast Track Designation for PGN-EDODM1 for the Treatment of Myotonic Dystrophy Type 1

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


Edgewise Therapeutics Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (Duchenne)

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


Candel Therapeutics: CAN-3110 Receives FDA Fast Track Designation for Treatment of Recurrent High-Grade Glioma

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


Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung

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


BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

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


Ionis Pharmaceuticals: Eplontersen granted U.S. FDA Fast Track designation for patients with transthyretin-mediated amyloid cardiomyopathy

CARLSBAD, Calif., Feb. 8, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults. The FDA grants development programs Fast Track designation to facilitate the development and expedite the review of drugs that... Read more


Arvinas and Pfizer’s Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer

Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC®) protein degrader designed to target and degrade the estrogen receptor (ER) protein  NEW HAVEN, Conn. and NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment... Read more


BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305

Designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer1 Fast Track designation can facilitate the development and expedite the regulatory review of BNT325/DB-1305  Ovarian cancer is the fourth most common gynecological tumor type2 with over 300,000 cases diagnosed globally each year3; over 90% of ovarian tumors arise... Read more


Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

Ongoing RAMP 203 Trial Assessing a More Complete Vertical Blockade with RAF/MEK and KRAS G12C Inhibition Along RAS Pathway to Improve Outcomes in KRAS G12C-Mutant NSCLC Confirmed Responses Observed in Both KRAS G12C Inhibitor Naïve and Pre-treated Patients in Initial RAMP 203 Trial Results; Enrollment Ongoing in Expansion Phase BOSTON / Jan 18, 2024 / Business Wire / Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for... Read more


Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory CLL and SLL

SAN FRANCISCO, Jan. 16, 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 adult patients with relapsed or... Read more


NRx Pharmaceuticals Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA review QIDP designation grants Priority Review and an additional 5 years of additional product exclusivity 3 million Americans develop complicated Urinary Tract Infection (cUTI) each year at a cost that ranges from $4497 to $17,431 with a high rate of antibiotic resistance and need for inpatient hospitalization1 Unlike many advanced-generation antibiotics, NRX-101 is not contra-indicated... Read more


SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory...

Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached; 89% of Patients Alive with Significant Antileukemic Effect Observed in 87.5% of Evaluable Patients  First Enrolled Patient in Phase 2a Study Achieved Complete Remission and Continues on Study With Full Recovery and in Seventh Month of Survival; Second Enrolled Patient Continues on Study in Sixth Month of Survival; Median OS in Relapsed/Refractory (r/r) Acute Myeloid Leukemia... Read more


Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155

VOWST preliminary net sales of approximately $10.4 million (unaudited) for the fourth quarter of 2023 Significant adoption of VOWST since commercial launch in June 2023 through year-end 2023 with 2,833 patient enrollment forms received and 2,015 new patient starts SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024 Seres to Present at 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024 CAMBRIDGE, Mass. / Jan... Read more


FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

PRINCETON, N.J., Jan. 8, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast... Read more


Cabaletta Bio Receives Additional FDA Fast Track Designations for CABA-201 in Dermatomyositis and Systemic Sclerosis

Second and third FDA Fast Track Designations for CABA-201, following the systemic lupus erythematosus (SLE) and lupus nephritis (LN) designation, providing the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases  PHILADELPHIA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies... Read more

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