Generation of additional clinical data allows for a more comprehensive assessment of the full potential of EVX-01, while strengthening the already strong clinical data package Will provide insights into the durability of immune and clinical responses up to three years Extension phase enables exploration of EVX-01 as monotherapy, following initial combination with standard of care Minimal costs are associated with the extension as...Read more
Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense Topline results from the trial are expected in the second half of 2026 CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals...Read more
BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5...Read more
SOUTH SAN FRANCISCO, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that the first patient has been dosed with CX-801 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / May 19, 2025 / Business Wire / The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing...Read more
First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the...Read more
REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. RASolve 301 will evaluate the safety and efficacy of daraxonrasib (RMC-6236), a RAS(ON) multi-selective...Read more
Absci becomes clinical stage company with ABS-101, first AI-designed biologic for IBD, beginning Phase 1 trial Preclinical data for ABS-101 demonstrates high potency and potential for quarterly dosing, an improvement in efficacy and convenience over first-generation anti-TL1As Interim data anticipated in the second half of 2025 VANCOUVER, Wash., May 13, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ: ABSI) a clinical-stage...Read more
ATTRibute-CM, BridgeBio’s Phase 3 clinical trial of acoramidis in patients with ATTR-CM, achieved statistical significance in reducing the risk of ACM or first CVH versus placebo in ATTRv-CM patients (59.1% risk reduction), establishing the mechanistic hypothesis that stabilizing TTR may delay or prevent ATTRv-CM ACT-EARLY is a registrational, randomized, double blind, placebo controlled, event driven prevention study that will enroll...Read more
In a Phase 1 study, EMP-01 (oral R-MDMA) demonstrated a unique, dose-dependent subjective effect profile that was generally found to be more similar to classical psychedelics than to racemic MDMA The exploratory, randomized, double-blind, placebo-controlled Phase 2 study will assess the safety, tolerability and efficacy of EMP-01 in adults with social anxiety disorder Topline data anticipated in the first quarter of 2026 NEW YORK...Read more
Amylyx expects completion of recruitment for the LUCIDITY trial in 2025, with topline data in first half of 2026 Pivotal Phase 3 LUCIDITY trial evaluating avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and Orphan Drug Designation; FDA-agreed-upon primary outcome of reduction in hypoglycemic events Avexitide has been previously evaluated in five post-bariatric hypoglycemia (PBH) clinical trials of...Read more
SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced today that the first patient was treated with [212Pb]PSV359 in a Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients...Read more
Phase 2 registration-intent trial enrolling Part 2a dose confirmation arms Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for...Read more
Phase 1 dose-escalation study to evaluate ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure Combination of ziftomenib and imatinib shows robust and durable antitumor activity in imatinib-sensitive and imatinib-resistant GIST preclinical models SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed...Read more
NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1...Read more
NEW YORK, April 23, 2025 (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 that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients...Read more
Data from the BroADen Phase 1b atopic dermatitis (AD) patient trial expected to be reported in 4Q25 Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025 Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively WATERTOWN, Mass., April 22, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical...Read more
BOSTON, April 21, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, announced the first patient has been dosed in an Investigator Sponsored Trial (IST) to evaluate tovecimig (CTX-009, a DLL4 x VEGF-A bispecific antibody) for the first time in the front-line setting for patients with biliary tract cancer (BTC)....Read more
SIGNAL-AA Part B topline data readout on-track for 1H'26 WALTHAM, Mass., April 16, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio" or the "Company"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases, today announced that the Company has dosed the first patients in both the Part A open-label extension (OLE) and...Read more
Emerge is the first Phase 3 study of lysergide D-tartrate (LSD) in MDD; primary endpoint will measure change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between MM120 Orally Disintegrating Tablet (ODT) 100 µg and placebo Emerge builds on positive Phase 2b study results in generalized anxiety disorder (GAD), which showed MM120’s potential antidepressant effects Topline data from the...Read more
SEATTLE, April 11, 2025 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), as monotherapy in patients with histologically...Read more
CT-95 is a mesothelin x CD3 T cell engaging bispecific antibody CT-95 is Context’s second T cell engaging bispecific antibody to enter the clinic in 2025 PHILADELPHIA, April 09, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95,...Read more
Amylyx expects early cohort data from LUMINA this year AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS CAMBRIDGE, Mass. / Apr 09, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in LUMINA, the Company’s Phase 1, multinational,...Read more
Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US New Next-Generation HCV Therapies are Needed to Improve Patient Outcomes BOSTON, April 09, 2025 (GLOBE NEWSWIRE) -- Atea...Read more
Salt Lake City, UT, April 08, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced that the first patient has been dosed in the Phase 1 EXCELERIZE clinical study evaluating REC-3565 for the treatment of relapsed or refractory B-cell lymphomas. "REC-3565 showed durable tumor regressions in preclinical studies, both as a monotherapy and in...Read more
Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to 12% of the population globally TMJ causes pain and stiffness in the jaw, making it difficult to chew TMJ osteoarthritis currently has no long-term effective treatments Ness-Ziona, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV,...Read more
CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient has been dosed in MAGNITUDE-2, a global, pivotal Phase 3 trial of nexiguran ziclumeran (nex-z) for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). “We are pleased to have...Read more
NEW YORK, April 02, 2025 (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 dosing has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2...Read more
MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia. ZOLAR is a first-in-human, proof-of-concept and...Read more
Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine (also known as...Read more
DOYLESTOWN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in the ongoing ACESOT-1051 clinical trial...Read more
CB1 inverse agonism is a clinically validated mechanism to induce weight loss CRB-913 is markedly more peripherally restricted compared to monlunabant and rimonabant SAD/MAD Phase 1 trial scheduled for completion Q3 2025 and Phase 1b dose-range finding scheduled for completion H2 2026 NORWOOD, Mass., March 28, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and...Read more
Preclinical data demonstrates that SPY003 is highly potent and has potential for quarterly or biannual dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-IL-23 monoclonal antibodies Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated in the second half of 2025 Subject to interim results, Spyre expects to incorporate SPY003 into its...Read more
NEW YORK, March 25, 2025 (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 dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal...Read more
First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for Immutep Global Phase III with efti will enrol approximately 756 patients at more than 150 clinical sites Trial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology SYDNEY, AUSTRALIA, March 25, 2025 (GLOBE NEWSWIRE) -- Immutep...Read more
SEATTLE, March 17, 2025 (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, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with...Read more
Positive preliminary data from all five single ascending dose (SAD) cohorts and first three completed multiple ascending dose (MAD) cohorts support safety and tolerability of PALI-2108 No serious adverse events (SAEs) and no treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs seen to date On track to report topline data in first half of 2025 Carlsbad, CA, March 14, 2025 (GLOBE NEWSWIRE) -- Palisade Bio,...Read more
BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development...Read more
Elumina is a Phase 2, multicenter, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of VLS-01 (buccal film DMT) in people suffering from treatment-resistant depression VLS-01 is being developed as a rapid-acting, robust and durable antidepressant for people suffering from treatment-resistant depression, which affects approximately 100 million people globally VLS-01 is...Read more
BOTHELL, Wash. / Mar 10, 2025 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC. “Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients,” said Bob Lechleider, M.D., Chief...Read more
Phase 1a study will evaluate single and multiple ascending doses of ABI-6250 in healthy participants with data expected in Q3 2025 Biomarker of ABI-6250 target engagement, serum bile acids, will be assessed in addition to safety and pharmacokinetic measures SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics...Read more
Topline data expected Mid-Year SAN DIEGO / Feb 26, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in...Read more
OCALA, Fla., Feb. 25, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”). Several subjects from Phase 1 who...Read more
Rapid Enrollment and Dosing of First Patients Encouraging and Underscores Unmet Need for Better Treatment Options for Alzheimer’s Disease Six-month Interim Results Expected in 1H 2026 with Topline Results Anticipated in 2H 2026 CAMBRIDGE, Massachusetts, Feb. 25, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody...Read more
Key Data Readouts from Sentinel Participant Expected in 2Q 2025 and 3Q 2025 NEW HAVEN, Conn. / Feb 11, 2025 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that the first participant has been dosed in the Phase 2 trial investigating RLYB212 in pregnant women at...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular, and metabolic diseases, today announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients...Read more
Enrollment of Part A completed ahead of schedule and exceeded enrollment target with 123 patients enrolled Part A 16-week proof-of-concept data anticipated in mid-2025 SAN FRANCISCO and BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology...Read more
Trial taking place at Sheikh Khalifa Medical City, a flagship United Arab Emirates hospital and largest teaching medical center in Abu Dhabi Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID Proof-of-concept (POC) data generated from this study could potentially lead to reimbursed early patient access in certain...Read more
Panorama is the second Phase 3 trial of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo Panorama builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 and will be conducted at sites in the US and...Read more
First Patient enrolled and treated at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital Aethlon Advances Hemopurifier® Study in Solid Tumors Not Responding to Anti-PD-1 Antibodies SAN DIEGO, Jan. 29, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced a significant...Read more
Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO)...Read more
Initial data from the Phase 1 trial expected in 2025 SAN FRANCISCO, CALIFORNIA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its...Read more
IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4 MARSEILLE, France / Jan 27, 2025 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1 study (NCT06781983), investigating the safety and tolerability of IPH4502, an innovative Antibody-Drug Conjugate (ADC),...Read more
Expects to Complete Enrollment of First 25 Patients in Phase 2 Expansion Study During Second Half of 2025 for Interim Analysis Acclaim-3 Study Has FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, Jan. 23, 2025 /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...Read more
Trial taking place at Sheikh Khalifa Medical City, a flagship tertiary hospital in the United Arab Emirates POC data generated from this study could potentially lead to reimbursed early patient access in certain European countries for crofelemer for MVID Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and short bowel syndrome...Read more
SAN DIEGO, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases, today announced that it has begun dosing in human subjects to evaluate its potential first-in-class, oral, pan-TRK protein degrader for the treatment of...Read more
CAMBRIDGE, Mass., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient has been dosed in the global Phase 3 study of NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is a wholly owned investigational in vivo CRISPR-based therapy in development as a...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...Read more
ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025 Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with...Read more
KRRO-110 is the first product candidate from Korro’s proprietary RNA editing OPERATM platform Interim readout from REWRITE expected in the second half of 2025 Korro to advance additional pipeline programs towards clinical development CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on...Read more
The Company's natural psilocybin extract powers a culturally transformative study to address methamphetamine addiction through indigenous frameworks. Vancouver, British Columbia--(Newsfile Corp. - January 13, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is proud to...Read more
CB-010 GALLOP Phase 1 trial initiated in lupus CB-012 AMpLify Phase 1 trial in r/r AML completes dose level 3 with no DLTs; enrolling patients at dose level 4 CB-010 ANTLER 2L LBCL and CB-011 CaMMouflage r/r MM Phase 1 clinical data expected in H1 2025 Sri Ryali appointed chief financial officer Caribou to present at 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, at 10:30 am PST BERKELEY, Calif., Jan. 12,...Read more
LAVA-1266 is a potent and selective bispecific anti-CD123 Gammabody® First-in-human study enrolling adult patients with CD123-expressing AML or MDS Initial Phase 1 data read-out expected by year-end 2025 UTRECHT, The Netherlands and PHILADELPHIA, Jan. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody®...Read more
BELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers. “Dosing the first patient in...Read more
SAN DIEGO and TORONTO, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company, today announced dosing the first set of patients in the TUSCANY Phase 1/2 study with tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) as a frontline triple drug combination (triplet) therapy for patients newly diagnosed with acute...Read more
AUSTIN, Texas, January 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors. “The initiation of the PULS Trial represents a major milestone in efforts to...Read more
Epstein-Barr virus (EBV) causes infectious mononucleosis and is associated with several types of cancer and multiple sclerosis There are no current treatments or vaccines for EBV First participant dosed with novel investigational EBV vaccine targeting multiple viral proteins in Phase I study WESTON, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), announces dosing of the first...Read more
EDINBURGH, Scotland, Dec. 20, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the...Read more
JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904. Camilla Chong, MD, Chief...Read more
NOVATO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the first patient has been dosed in the pivotal Phase 3 Aspire study (NCT06617429) evaluating the efficacy and safety of GTX-102, its investigational antisense oligonucleotide (ASO) for Angelman syndrome. "Initiation of patient dosing in our Phase 3 Aspire study represents an important step forward in the development of...Read more
Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's...Read more
Enrollment underway for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) Company expects to share preliminary Phase 1 clinical data in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Dec 19, 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...Read more
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal...Read more
The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in patients with advanced cancers expressing PIWIL1 First immunotherapy program to target PIWIL1, a cancer-testis antigen overexpressed in a range of cancers, including colorectal cancer (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 17 December 2024) Immunocore...Read more
Phase 1b trial will evaluate receptor occupancy of PIPE-791 in the brain and lungs of patients in multiple cohorts using a PET tracer of the LPA1 receptor Topline data readout planned for the second quarter of 2025 SAN DIEGO / Dec 16, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) metastatic colorectal cancer (mCRC). Petosemtamab...Read more
Dose-finding clinical trial in China designed to evaluate safety and preliminary anti-tumor activity of SN301A (SENTI-301A manufactured in China) in hepatocellular carcinoma (“HCC”) SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit...Read more
Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 Topline data from the 12-week double-blind...Read more
Twice daily (BID) dosing regimen expected to maximize clinical benefit for patients by optimizing the activity of Aprea’s experimental drug, ATRN-119, over a 24-hour daily cycle New regimen potentially optimizes clinical outcomes and strengthens the clinical path forward ATRN-119 is the first macrocyclic ATR inhibitor to enter clinical trials DOYLESTOWN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq:...Read more
Marks successful completion of full enrollment of SAD cohorts and the first two MAD cohorts in the healthy volunteer study Up to 10 adult participants with genetically confirmed Duchenne Muscular Dystrophy (“DMD”) to be enrolled in the now ongoing Phase 1b trial in DMD patients Phase 1 data to be presented at major medical conference in Q1 2025 TORONTO / Dec 11, 2024 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB:...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc.,...Read more
First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer Selected initial...Read more
NORWOOD, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody targeting latent TGFβ...Read more
WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR),...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson’s...Read more
Topline data for Phase 3 pivotal program anticipated in 2026 WATERTOWN, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the LUCIA trial, the Company’s second global Phase 3 clinical trial of...Read more
First program to result from end-to-end use of OS to identify a novel target and new chemical matter, which moved from target ID to IND enabling studies in under 18 months with ~200 compounds synthesized REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile in Solid tumors and Lymphoma >100,000 patients in the US and EU5 initially addressable SALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) --...Read more
REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that the first patient has been dosed in Jasper’s Phase 1b/2a...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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