Dabogratinib is the only oral FGFR3-selective inhibitor in clinical development for achondroplasia Initial results from safety sentinel cohort expected in 2H 2026 CARLSBAD, Calif., Aug. 21, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology,...Read more
Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-631 in Healthy Volunteers SOUTH SAN FRANCISCO, Calif., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective...Read more
QUEENSBURY, N.Y. / Aug 19, 2025 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer...Read more
- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN...Read more
First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGen Trial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a...Read more
First-in-human study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102, an orally available small molecule with potential best-in-class profile Initial development planned in obesity; BGE-102 demonstrated robust weight loss in preclinical models, both as monotherapy and in combination with GLP-1 receptor agonists Initial Phase 1 SAD data anticipated by end of 2025, with top-line readout of obesity...Read more
BOSTON, Aug. 14, 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 the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients...Read more
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV)...Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease BEDFORD, Mass., & CAMBRIDGE, Mass. / Aug 11, 2025 / Business Wire / Stoke Therapeutics, Inc....Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq:...Read more
First patient successfully completes dosing at Toronto General Hospital St. Michael’s Hospital is expected to be the next Canadian clinical site activated Arch is looking for additional clinical sites in North America to join the trial TORONTO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the first patient has successfully completed...Read more
Successful First-In-Human Use of New Parenchymal Spinal Delivery System First-ever Administration of OPC1 to a Chronic Injury Patient CARLSBAD, Calif. / Aug 04, 2025 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions, announced today that the first-ever...Read more
Initiation of additional trial sites and patient enrollment activities ongoing with multiple patients in screening LAWRENCEVILLE, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the...Read more
MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy...Read more
Phase 1 clinical trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab in a variety of EGFR-expressing solid tumors such as NSCLC, CRC, HNSCC and cSCC VIR-5525, the Company’s third dual-masked T-cell engager leveraging the PRO-XTEN™ technology, is designed to expand the therapeutic index by selectively activating in the tumor microenvironment Dose escalation...Read more
Phase 1 clinical trial of ADI-001 in autoimmune diseases actively enrolling patients with lupus nephritis (LN), systemic lupus erythematosus (SLE) and SSc Preliminary clinical data from Phase 1 trial of ADI-001 in autoimmune diseases expected in 2H/2025 REDWOOD CITY, Calif. & BOSTON / Jul 24, 2025 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma...Read more
MRT-8102 Phase 1 study includes single and multiple ascending dose cohorts in healthy volunteers and is designed to evaluate safety, pharmacokinetics, NEK7 protein degradation, and other key downstream pharmacodynamic markers; initial results anticipated in H1 2026 Additional Phase 1 cohort designed to evaluate potential early proof of concept in subjects with increased cardiovascular disease (CVD) risk and elevated CRP BOSTON,...Read more
MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). “Dosing the first patient is...Read more
Milestone payment of $10 million triggered under the global license agreement with Takeda LEXINGTON, Mass., July 17, 2025 (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”)...Read more
BUOY-1 builds on successful Phase 1 and Phase 2a data with GlyphAllo – a novel oral prodrug of allopregnanolone and a potential first-in-class treatment for MDD Allopregnanolone has demonstrated rapid antidepressant and anxiolytic activity in clinical settings, but its clinical scope was previously constrained by limitations that Glyph™ is specifically designed to solve BOSTON / Jul 17, 2025 / Business Wire / PureTech Health plc...Read more
CHICAGO / Jul 09, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly...Read more
Eye drop administration of KB801 designed to enable sustained expression of NGF in the front of the eye Investor call and webcast to be held July 9 at 8:30 am ET to discuss program and trial design PITTSBURGH, July 09, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the first patient has been dosed in its Phase 1/2 clinical trial (“EMERALD-1”), a 2:1 randomized, double-masked,...Read more
Investigator initiated exploratory clinical study being conducted in Israel pursuant to agreement with collaboration partner, PeriNess Company evaluating systemic recombinant human DNase I (DNase I) in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors FRAMINGHAM, MA / ACCESS Newswire / July 8, 2025 / Xenetic...Read more
Substantial clinical need expected to facilitate rapid overall trial enrollment HOUSTON, July 08, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization...Read more
Dosing of the first patient in Phase 2b marks an important transition of the RESOLVE trial from a Phase 2a open-label study to a Phase 2b placebo-controlled study. This is a critical step required prior to proceeding to pivotal clinical trials necessary for regulatory approval Eupraxia plans to enroll a minimum of 60 patients in the Phase 2b portion of the RESOLVE study in up to 25 sites globally, assessing tissue health measured by...Read more
Global Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug administered every 12 or 24 weeks in moderate-to-severe COPD Broadens global development program for verekitug into third indication, strengthening pipeline across severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and COPD Program updates also include completion of enrollment in...Read more
Trial is expected to provide key insights on safety, tolerability and immune system response for its THT treatment of late-stage melanoma patients Halifax, Nova Scotia--(Newsfile Corp. - July 7, 2025) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, announces that a first...Read more
Vancouver, Canada, June 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its...Read more
Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy THE WOODLANDS, TX, June 30, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device...Read more
TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC Initial 3-month complete response (CR) data expected to be reported in 1H 2026 CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor...Read more
Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes ABI-1179 IND cleared to support study expansion to sites in United States Phase 1b studies for ABI-1179 and ABI-5366 running concurrently with interim data for both candidates on track for fall 2025 SOUTH SAN FRANCISCO, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a...Read more
BOSTON, June 27, 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 Phase 1/2 trial of TNG462 and Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) or zoldonrasib (RAS(ON) G12D-selective inhibitor) in patients with MTAP-deleted...Read more
Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY, June 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum...Read more
Combination cohort initiated following successful review of monotherapy cohort Over 100 participants dosed to-date in monotherapy cohort Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer Data update on schedule for later this year NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company...Read more
Phase 1 dose-escalation study to evaluate VS-7375 in the U.S., with plans to expand as monotherapy into pancreatic cancer and non-small cell lung cancer cohorts, along with colorectal cancer in combination with cetuximab BOSTON / Jun 24, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the...Read more
C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada 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...Read more
Intra-patient, double-blind, multicenter, placebo-controlled study with crossover design Repeat administration under compassionate use was previously shown to be well tolerated and associated with full corneal healing by 3 months as well as significant visual acuity improvement from hand motion to 20/25 at 8 months PITTSBURGH, June 24, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced...Read more
Fourth cohort dose is three million CAR positive cells; thirty times higher than the first cohort dose SAN JOSE, Calif., June 23, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel...Read more
NEW YORK, June 13, 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 announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing...Read more
Potential to Address a Broad Range of Complement-Mediated Diseases with Initial Focus on Immune Platelet Transfusion Refractoriness and Refractory Antiphospholipid Syndrome Data Readouts Expected from Cohort 1 in 3Q 2025 and Cohort 2 in 4Q 2025 NEW HAVEN, Conn. / Jun 12, 2025 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative...Read more
Completion of enrollment anticipated in 2026 CARLSBAD, Calif. / Jun 11, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the first participant has been dosed in the global Phase 3 REVEAL study, which is designed to evaluate the efficacy and safety of ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS), a serious and rare neurodevelopmental...Read more
WASHINGTON, June 10, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S). VCA-894A is being developed for a patient...Read more
SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary...Read more
Trial is expected to provide key insights on how paxalisib therapy can be combined with established immunotherapies and standard of care chemotherapy to improve patient outcomes in advanced breast cancer SYDNEY, June 5, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing innovative therapies for difficult-to-treat cancers, today...Read more
Initial Data from the Ongoing, Blinded Phase 1 Single-Ascending Dose Trial Has Demonstrated Favorable Safety and Pharmacokinetics IND Application Submitted to Expand RESTORE-FA Trial to U.S. Sites; Notice Received from FDA Placing Clinical Hold on IND Application to Open U.S. Sites CARLSBAD, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company...Read more
New trial arm to evaluate safety, dosing and preliminary anti-tumor activity of the combination therapy in advanced solid tumors NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial...Read more
EMERYVILLE, Calif. / May 29, 2025 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS®...Read more
Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, May 29, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease...Read more
Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine...Read more
Bria-OTS has cleared its safety evaluation in the Phase 1/2 study monotherapy dosage setting Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic breast cancer First Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis PHILADELPHIA and VANCOUVER, British Columbia, May 27, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq:...Read more
Trial is evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) with topline interim data expected in the first half of 2026 AUSTIN, Texas, May 27, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced...Read more
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
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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