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Latest FDA Fast Track Designations

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia

December 19
Last Trade: 19.83 -0.21 -1.05

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


FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

December 17
Last Trade: 4.84 0.16 3.42

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


Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma

December 12
Last Trade: 2.01 0.17 9.24

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


Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)

December 3
Last Trade: 3.13 -0.08 -2.49

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


Corbus Pharmaceuticals: FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer

December 3
Last Trade: 13.00 -0.33 -2.48

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


Sana Biotechnology Announces Fast Track Designation for SC291 in Relapsed/Refractory Systemic Lupus Erythematosus

December 2
Last Trade: 1.65 0.05 3.12

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


Rigel Pharmaceuticals Announces R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS

December 2
Last Trade: 17.09 -0.12 -0.70

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


Belite Bio: Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007

November 27
Last Trade: 64.12 0.68 1.07

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


Protara Therapeutics Granted FDA Fast Track Designation for Intravenous Choline Chloride for Patients Receiving Parenteral Support

October 21
Last Trade: 5.37 0.19 3.67

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


Lantern Pharma’s Investigational Drug-Candidate, LP-184, Receives Fast-Track Designation in Glioblastoma from the FDA

October 15
Last Trade: 3.13 -0.08 -2.49

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


Ionis Pharmaceuticals: Zilganersen granted U.S. FDA Fast Track designation for people living with Alexander disease

October 1
Last Trade: 35.63 0.04 0.11

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


PTC Therapeutics: FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program

September 26
Last Trade: 46.24 0.99 2.19

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


Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

September 23
Last Trade: 0.58 -0.05 -7.30

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


Azitra Receives Fast Track Designation for ATR-04 for Skin Rash from EGFR Inhibitors

September 18
Last Trade: 0.42 0.02 5.01

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


Perspective Therapeutics Granted Fast Track Designation for VMT01 for the Diagnosis and Treatment of MC1R-Positive Melanoma

September 5
Last Trade: 2.85 0.01 0.35

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


Caribou Biosciences Announces the FDA has Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in Relapsed or Refractory AML

September 3
Last Trade: 1.80 -0.01 -0.55

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


AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions

August 28
Last Trade: 2.68 -0.02 -0.74

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


BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL

August 26
Last Trade: 176.50 1.78 1.02

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


Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation

August 14
Last Trade: 0.92 0.00 0.00

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


Amylyx Pharmaceuticals Receives Orphan Drug Designation From the European Commission for AMX0035 for the Treatment of Wolfram Syndrome

August 2
Last Trade: 4.05 0.09 2.27

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


Corvus Pharmaceuticals Granted FDA Fast Track Designation for Soquelitinib for Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

August 1
Last Trade: 4.99 -0.10 -1.96

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


Immuneering Granted FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer

July 31
Last Trade: 2.01 0.17 9.24

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


Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia

July 25
Last Trade: 0.61 0.04 7.54

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


AC Immune’s ACI-35.030 (now “JNJ-2056”) Granted FDA Fast Track Designation for Alzheimer’s Disease

July 25
Last Trade: 2.68 -0.02 -0.74

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


Tiziana Life Sciences Granted FDA Fast Track Designation

July 24
Last Trade: 0.78 -0.06 -6.85

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


BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

July 23
Last Trade: 0.69 -0.50 -41.76

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


Longeveron Announces U.S. FDA Grants Fast Track Designation for Lomecel-B™ for the Treatment of Mild Alzheimer’s Disease

July 17
Last Trade: 1.65 0.05 3.12

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


Adicet Bio Receives FDA Fast Track Designation for ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma

July 8
Last Trade: 0.91 0.05 5.78

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


Inozyme Pharma Announces FDA Fast Track Designation for INZ-701 in ABCC6 Deficiency

July 2
Last Trade: 2.99 0.18 6.41

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


Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection

June 26
Last Trade: 7.34 -0.03 -0.41

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


Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors

June 25
Last Trade: 0.41 -0.03 -7.13

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


BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer

June 24
Last Trade: 113.08 1.74 1.56

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


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

June 11
Last Trade: 0.78 -0.06 -6.85

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


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

June 5
Last Trade: 0.91 0.05 5.78

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


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

June 4
Last Trade: 1.30 -0.02 -1.52

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


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

June 3
Last Trade: 1.78 0.02 1.14

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


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

May 29
Last Trade: 1.19 0.01 0.85

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


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...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...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...Read more


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

April 23
Last Trade: 0.90 0.00 0.00

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


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

April 16
Last Trade: 6.28 0.24 3.97

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


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

April 11
Last Trade: 20.29 -0.79 -3.75

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


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

April 9
Last Trade: 0.20 0.0002 0.10

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


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

March 14
Last Trade: 17.03 0.11 0.65

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


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

February 20
Last Trade: 64.50 1.55 2.46

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


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

February 20
Last Trade: 2.01 0.17 9.24

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


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

February 20
Last Trade: 3.63 -0.46 -11.25

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


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

February 13
Last Trade: 30.78 -0.02 -0.06

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


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

February 13
Last Trade: 8.70 -1.26 -12.65

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...Read more


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

February 13
Last Trade: 164.83 4.00 2.49

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...Read more


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

February 12
Last Trade: 0.34 0.03 9.07

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...Read more


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

February 8
Last Trade: 35.63 0.04 0.11

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...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

February 6
Last Trade: 18.48 0.65 3.65

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)...Read more


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

January 31
Last Trade: 113.08 1.74 1.56

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;...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)

January 18
Last Trade: 4.19 -0.25 -5.63

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...Read more


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

January 16
Last Trade: 19.83 -0.21 -1.05

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...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

January 16
Last Trade: 1.50 -0.02 -1.32

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...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 Acute Myeloid Leukemia Patients

January 9
Last Trade: 0.89 -0.01 -1.11

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...Read more


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

January 9
Last Trade: 0.94 0.02 2.29

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...Read more


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

January 8
Last Trade: 2.95 -0.13 -4.22

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...Read more


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

January 8
Last Trade: 2.38 0.07 3.03

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...Read more


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