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
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
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
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
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
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
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
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
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-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
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
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
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
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
NEEDHAM, Mass., Dec. 12, 2023 (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 its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the...Read more
First-in-class and best-in-class potential in NRAS-mutated melanoma and other RAS/MAPK pathway-altered solid tumors Naporafenib has been dosed in more than 500 patients to date, establishing its safety, tolerability, and preliminary proof-of-concept in multiple indications Pivotal Phase 3 SEACRAFT-2 trial initiation in NRAS-mutated melanoma on track for H1 2024 SAN DIEGO, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq:...Read more
Next-generation gene transfer therapy to treat Duchenne receives FDA Fast Track Designation CHARLESTOWN, Mass., Dec. 07, 2023 (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 (FDA) for SGT-003, the company’s...Read more
Designation is for 2nd or 3rd line treatment of patients with disease progression following treatment with endocrine therapy and a CDK 4/6 inhibitor Data updates and further development plans to be presented at 2023 San Antonio Breast Cancer Symposium (SABCS) SOLANA BEACH, Calif. and REDWOOD CITY, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective...Read more
Pivotal Phase 3 Study of Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer Initiated in September 2022 Phase 2 Trial of Olvi-Vec- Demonstrated Clinical Reversal of Platinum Resistance and Refractoriness and Met Primary Endpoint of Objective Response Rate with Durable Responses WESTLAKE VILLAGE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology...Read more
CM-101's Unique Dual Anti-Fibrotic and Anti-Inflammatory Activity Has Disease Modifying Potential in this Poorly Treated Condition CM-101's Phase 2 SPRING Trial in PSC is Advancing Towards Completion of Enrollment with Top-line Readout Expected in 2H 2024 TEL AVIV, Israel, Nov. 15, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and...Read more
SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL Patients with Standard of Care is 25.8% Fast Track Designation Accelerates SLS009's Path to U.S. FDA Submission for Treatment of r/r PTCL NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage...Read more
GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH. NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally....Read more
SAN DIEGO, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting androgen receptor inhibitor (DAARI), as a Fast Track development program for the investigation of the treatment of patients with relapsed or...Read more
Designation Facilitates and Expedites Development of Drugs for Patients with Serious Unmet Medical Needs Enrollment Progressing in NVG-291 Phase 1b/2a Clinical Trial, with Initial Cohort Data Expected in Mid-2024 Vancouver, British Columbia--(Newsfile Corp. - October 23, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of...Read more
Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with HR+, Her2-, BRCA1/2 mutant advanced or metastatic breast cancer patients who have been pretreated with hormonal, CDK4/6 inhibitor and PARP inhibitor therapies Represents a second indication in the IDE161 development program to receive Fast Track designation, complementing the designation for BRCA1/2 mutant ovarian cancer patients Ongoing Phase 1...Read more
Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with BRCA1/2 mutant advanced or metastatic ovarian cancer who are platinum resistant and have received prior antiangiogenic and PARP inhibitor therapies Enables IDE161 development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review Ongoing Phase 1 expansion, with focus in...Read more
WATERTOWN, Mass., Sept. 20, 2023 (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 MWTX-003 for the treatment of patients with polycythemia...Read more
KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical antitumor activity in patients expected in the fourth quarter of 2023 Fast Track designation can potentially accelerate KT-333’s development path for the treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a...Read more
Tulmimetostat follows pelabresib (2018) and tafasitamab (2014) as the company's third clinical program to receive Fast Track designation PLANEGG and MUNICH, GERMANY / ACCESSWIRE / September 12, 2023 / MorphoSys AG (FSE:MOR) (NASDAQ:MOR) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, the company's investigational next-generation dual inhibitor of EZH2 and EZH1, for...Read more
AFM13 in combination with AlloNK® (also known as AB-101) will be investigated in the LuminICE-203 open-label, multi-center, multi-cohort, phase 2 study evaluating the efficacy and safety of the treatment in patients with relapsed/refractory Hodgkin lymphoma The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical...Read more
Fast Track Designation (FTD) is designed to accelerate the development and expedite the review of therapies with potential to address unmet medical needs for a serious or life-threatening condition TSHA-102 has also received Orphan Drug and Rare Pediatric Disease designations from the United States (U.S.) Food and Drug Administration (FDA) and has been granted Orphan Drug designation from the European Commission DALLAS, Aug. 24,...Read more
On Track for Proof-of-Concept Results in HAE Patients in Mid-2024 Results To-Date Support STAR-0215 Administration Once Every Three or Six Months for Robust Suppression of HAE Attacks BOSTON / Jul 20, 2023 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and...Read more
SAN DIEGO, July 19, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate (ADC) investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor...Read more
ANAHEIM, CA, July 18, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced the submission of a fast track application to the U.S. Food and Drug Administration (“FDA”) for BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD). Fast track...Read more
Regulatory Designation Includes Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis Pivotal Phase 3 Study of Selinexor and Ruxolitinib in Treatment-Naïve Myelofibrosis Initiated in June 2023 NEWTON, Mass., July 17, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today...Read more
CAMBRIDGE, Mass., July 11, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to labafenogene marselecobac (previously known as SYNB1934) for the treatment of phenylketonuria (PKU)....Read more
SYDNEY, July 6, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that its lead program, paxalisib, has been awarded Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. The FDA's decision to...Read more
Third FDA Fast Track Designation Further Validates the Potential of REQORSA AUSTIN, Texas, June 28, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's lead drug...Read more
Ongoing Phase 1b/2 ABATE study enrolling well and expanding to sites in USA with Investigational New Drug (IND) clearance for ACI-24.060 Dosed first individual with Down syndrome (DS) in the DS cohort of ABATE Interim safety and immunogenicity data in Alzheimer’s disease (AD) and DS cohorts expected in H2 2023 Initial PET data on amyloid plaque reduction in AD expected H1 2024 Lausanne, Switzerland, June 27, 2023 – AC Immune SA...Read more
SAN DIEGO, June 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CD388, Cidara’s novel drug-Fc conjugate (DFC) candidate. CD388 is being developed in collaboration...Read more
Company believes CAL02 is a new chemical entity (NCE), which would result in five years of marketing exclusivity upon approval or three years without NCE designation; total potential of eight or ten years of exclusivity Eagle has approved patents running until September 2035, with filed patent applications that would extend into 2037 or later Eagle may qualify for up to five additional years of patent term exclusivity, up...Read more
VICTORIA, BC, June 13, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the investigation of EP-104IAR in the treatment of adults with osteoarthritis ("OA") of the knee. The Fast Track...Read more
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...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...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...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...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...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...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...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,...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...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...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...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...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...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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