One dose of nex-z led to rapid, deep and durable TTR reductions, with mean reductions of at least 90% from baseline sustained through three years Stabilization or improvement in disease-related clinical measures observed at 24 months Continue to observe generally favorable safety data with no new drug-related events within the follow-up period Data presented today at the 5th International ATTR Amyloidosis Annual Meeting for Patients...Read more
Interim Data Support Advancing RLYB116 as a Differentiated Therapeutic and Enable Progression to Cohort 2 Data Readouts for Completed Study Expected in 4Q 2025 NEW HAVEN, Conn. / Sep 25, 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 the completion of...Read more
AUSTIN, Texas / Sep 25, 2025 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the “Company” or “Anebulo”), today announces the first subjects dosed in its Phase 1 single ascending dose (“SAD”) study of intravenous (IV) selonabant in healthy young adults. The study is supported by a...Read more
53.7% mean splicing correction observed following a single 15 mg/kg dose of PGN-EDODM1, with all patients showing an improvement in splicing PGN-EDODM1 was generally well-tolerated at 15 mg/kg, with drug-related adverse events mild or moderate in severity BOSTON / Sep 24, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies...Read more
Third patient in the first cohort is now advancing through protocol-defined evaluations as Company anticipates additional results from second dosing of second patient in the cohort SOUTH SAN FRANCISCO, Calif, Sept. 22, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company, today announced that it has dosed the third patient in the starting dose...Read more
Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine. MIAMI, FLORIDA / ACCESS Newswire / September 22, 2025 / MIRA Pharmaceuticals,...Read more
PIPE-791 achieved high LPA1 brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients PIPE-791 showed a safety and tolerability profile consistent with previous clinical studies Topline data affirms planned doses for future Phase 2 clinical proof-of-concept trials SAN DIEGO / Sep 18, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a...Read more
Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days of dosing in December 2025 Early results from the Phase 1b study to be presented at the International Congress of Parkinson’s Disease (PD) and Movement Disorders in...Read more
PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns Phase 1b data demonstrated 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis (UC) using FDA-defined endpoints Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s...Read more
Results Support Potential for STAR-0310 to be Best-in-Class OX40 Antagonist STAR-0310 Exhibits Longest-in-Class Half-Life of 68 Days and Cytokine Suppression Lasting At Least 20 Weeks After a Single 300 mg SC Injection, Supporting Potential Every-Six-Month Administration STAR-0310 Was Well-Tolerated, with no ADCC-Related Treatment-Emergent Adverse Events, Supporting a Wider Therapeutic Window with the Potential to Drive...Read more
LP-184 achieves all primary endpoints and demonstrates a favorable safety and tolerability profile positioning it for both monotherapy or synergistic combinations with PARP inhibitors and immunotherapies. Clinical benefit observed in 48% of evaluable cancer patients at or above the therapeutic dose threshold. Durable clinical benefits were observed in hard-to-treat tumors like glioblastoma multiforme (GBM), gastrointestinal stromal...Read more
First patient in South Korea dosed MIAMI, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and...Read more
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2...Read more
GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more
Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company’s previous Phase 2b challenge study SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported...Read more
Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients Gemini could potentially revolutionize the treatment of acute and chronic inflammatory disease Data discussion webcast/conference call will be held on Wednesday, September 10th at 8:30 am Eastern Time SAN DIEGO, CA / ACCESS Newswire / September 9, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or...Read more
CID-103 is a potential best-in-class, clinical stage anti-CD38 monoclonal antibody Safety profile observed in first four dose cohorts supports continued development No serious adverse events or dose-limiting toxicities have been reported SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / September 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative...Read more
Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic...Read more
Continue to observe a positive safety profile—no dose limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity SAN JOSE, Calif., Sept. 8, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical...Read more
Recommendation that trial escalate to next dose level of 8mg tablet Initial interim clinical data from first two cohorts expected in Q1 2026 MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced that the external Safety Review Committee...Read more
80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion...Read more
Decoy20 monotherapy induces Partial Response in patient with urothelial cancer and liver metastases Decoy20 combination with PD-1 inhibitor, tislelizumab, demonstrates safety profiles consistent with each agent NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more
Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291 CARMEL, Ind., Sept. 04, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced dosing of the first participant...Read more
New longer-term post hoc analysis results of responders (n=6)1 showed long-lasting, durable pain reduction of nearly 66%, or a mean 5.08 reduction on the VAS pain scale, in patients with severe pancreatic cancer pain 100% of responders (n=7) 1 showed zero opioid use at their 3-month post-procedure follow-up2 Quality of life markers further improved including sleep quality, energy level and ability to lead normal daily and leisure time...Read more
Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a...Read more
As previously communicated, Prothena plans to explore potential partnership interest to advance PRX012 and its preclinical PRX012-TfR (transferrin receptor) antibody Phase 1 ASCENT clinical program established proof-of-mechanism for PRX012 as a once-monthly, subcutaneous anti-amyloid beta antibody with high binding potency, dose- and time-dependent reduction of amyloid plaque, although with a non-competitive ARIA-E profile in...Read more
ABCL575 is an Fc-silenced, half-life extended investigational antibody therapy that is being developed for the treatment of atopic dermatitis VANCOUVER, British Columbia / Aug 27, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) today announced it has dosed the first participants in its Phase 1 clinical trial of ABCL575, a next-generation investigational antibody therapy being developed for the treatment of moderate-to-severe atopic...Read more
First chemotherapy-free trial combining ANKTIVA, an IL-15 agonist, natural killer (NK) cell therapy, and Optune immune-stimulating device for patients with glioblastoma (GBM) brain tumors who have failed current standard of care Encouraging early results observed to date, including response in 3 of the subjects with 2 responders at near complete response and 2 with ongoing stable disease, representing 100 percent disease...Read more
Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed 66% of Non-Hodgkin Lymphoma (NHL) patients achieving objective response rates, with 50% demonstrating complete response (CR) Favorable safety profile observed in study participants with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort Dose expansion phase...Read more
Safety and Pharmacokinetic Data Support Dosing of ART26.12 in Fed or Fasted Conditions Completion of Positive Single Ascending Dose Study with a Preliminary Food Effect Assessment Advances ART26.12 Toward Multiple Ascending Dose Trial SOLANA BEACH, Calif., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop...Read more
Dosing Completion Expected by End of August; Phase 2 Trial Expected to Begin in 1Q 2026 NEW YORK, NY / ACCESS Newswire / August 21, 2025 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel neuro-active peptide therapies, today announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to...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
Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the successful completion of the Single Ascending...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
Fourth Cohort Receiving 30x Initial Dose with No Dose-Limiting Toxicities Observed to Date SAN JOSE, Calif., Aug. 18, 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 the second patient in the fourth dose cohort has been treated in the ongoing Phase 1 clinical trial evaluating the Company's novel...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
SHELTON, CONNECTICUT / ACCESS Newswire / August 18, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, reports that its broad-spectrum antiviral drug NV-387 could help reduce resurgence of metastatic cancer caused by awakening of...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
Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma Second patient maintains an ongoing complete response at six months with CD19 CAR-NK in combination with rituximab and a third WM patient has been enrolled in the study First study to demonstrate the potential for complete responses with a chemotherapy-free immunotherapy in late-stage WM...Read more
First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of...Read more
The CTMX-2051-101 study has enrolled 73 colorectal cancer patients to-date, aligned with the Company’s goal of providing a Phase 1 data update in Q1 2026 The CTMX-2051-101 study remains active and patients continue to be dosed with CX-2051 across all expansion doses SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally...Read more
Preclinical studies in nonhuman primates naturally infected with T. cruzi have shown AN2-502998's curative potential in chronic Chagas disease No FDA approved treatment for adults with Chagas disease Phase 2 planning underway with recently announced DNDi collaboration; initiation expected in 2026, data in 2027 MENLO PARK, Calif. / Aug 12, 2025 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program...Read more
Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd ROCKVILLE, Md., Aug. 11, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that...Read more
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observedThe company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a...Read more
94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period Favorable safety and tolerability profile observed...Read more
PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs) Extended half-life and local bioactivation support convenient once-daily dosing in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) Colon tissue drug levels exceeded target thresholds 36 hours post-dose in completed Phase 1a MAD cohort Company advancing toward IND submission for Phase 2 study in H1 2026 Carlsbad, CA, Aug. 07,...Read more
Data to date in single- and multiple-ascending dose cohorts of healthy participants demonstrate a four-day half-life for ABI-6250, supporting target daily oral dosing profile and dose-dependent elevations in biomarker of target engagement Further pharmacological assessment to be conducted in parallel with Phase 2 preparation SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more
Proof-of-activity now established for PBGENE-HBV, the first and only clinical modality designed to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated DNA, with the goal of complete cure Cohort 1, the lowest dose cohort (0.2 mg/kg) of ELIMINATE-B, established a safe and well-tolerated profile across multiple dose administrations for all patients PBGENE-HBV demonstrated substantial antiviral activity in all three...Read more
Continued progress positions Company to report topline data for Phase 1 clinical trial of SENTI-202 before year-end SOUTH SAN FRANCISCO, Calif., Aug. 05, 2025 (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 platform, today announced it has confirmed the recommended Phase 2 dose (RP2D)...Read more
LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual...Read more
TORONTO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has received the clinical study report (CSR) for the trial entitled “A Phase 1, Randomised, Double-Blind,...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
Second patient in the first cohort is now advancing through protocol-defined evaluations as Company provides promising update on first patient pharmacokinetic results SOUTH SAN FRANSCISCO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ...Read more
Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types NXP900 successfully completed a clinical drug-drug...Read more
Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, today announced the...Read more
Robust and clinically meaningful absolute mean fetal hemoglobin (HbF) induction of 8.6% from baseline at 12 weeks of treatment; 7 of 16 patients achieved absolute HbF levels greater than 20% Evidence of pan-cellular induction of HbF based on an increase in F-cells (red blood cells containing HbF) from a mean of 34% at baseline to 67% at 12 weeks of treatment Meaningful improvements in key markers of hemolysis coupled with...Read more
DehydraTECH-semaglutide reduces overall side effects by 36.5% as compared to Rybelsus® DehydraTECH-semaglutide reduces gastrointestinal side effects by 43.5% as compared to Rybelsus® DehydraTECH-GLP-1 study arms evidencing patient safety and tolerability consistent with the primary study endpoint KELOWNA, BC / ACCESS Newswire / July 28, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or...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
AI-guided, synthetic lethal therapy achieves complete metabolic response after just two cycles in patient who failed three prior state-of-the-art treatment regimens. Complete response in an aggressive, recurring B-cell cancer underscores how AI development can accelerate meaningful patient outcomes in global oncology therapeutic markets where billions are spent on therapies. DALLAS / Jul 23, 2025 / Business Wire / Lantern Pharma Inc....Read more
SINGAPORE, July 21, 2025 (GLOBE NEWSWIRE) -- Further to our announcement filed on Form 6-K on November 20, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the affordable treatment of blood and solid cancers, is pleased to announce...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
Announces Completion of Phase 1 Study of Elraglusib in Pediatric Patients Prolonged and Durable Complete Responses (CRs) Observed in Two of Ten Refractory Ewing Sarcoma Patients Two Additional Patients Had Durable Stable Disease in Notoriously Difficult-to-Treat Cancer Confirmed Partial Response (PR) in a patient with a desmoplastic small-round-cell tumor (DSRCT) Company Initiating Planning of Phase 2 Trial of Elraglusib in...Read more
Sample analysis and data collection ongoingData expected during Q3 2025 SAN DIEGO / Jul 16, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company focused on rebalancing inflammation to optimize health, today announced dosing has been completed for the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of...Read more
Additional complete response (CR) observed in patient with multiple tumors Confirmed overall response rate (ORR) of 50% in patients with combined positive score (CPS) ≥1, including 50% ORR in patients with low CPS (1-19) 12-month overall survival of 88% and median overall survival (mOS) of 32 months BOSTON, July 16, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company...Read more
End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program Scientific Advice Meetings confirmed with global regulators in major markets - including the United Kingdom and European Union All patients enrolled in its Phase 1 clinical study of OST-504 in second line prostate cancer have completed treatment, with data expected to be announced later in 2025 New...Read more
SYDNEY, July 9, 2025 /PRNewswire/ -- Kazia Therapeutics (NASDAQ: KZIA) is pleased to announce preliminary results from the first patient in its Phase 1b trial evaluating a combination regimen of Paxalisib, pembrolizumab (Keytruda®), and standard chemotherapy after completing Cycle 1 (21 days) of dosing. The patient, a 61-year-old woman with metastatic triple-negative breast cancer localized to the left upper lobe of the lung, has shown...Read more
NMRA-861 has potential best-in-class pharmacology, which may enable a more favorable therapeutic profile No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits WATERTOWN, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including three...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
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1 MAD study on track for completion in Q3 2025 NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1...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
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or...Read more
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET ROCKVILLE, Md. & EDMONTON, Alberta / Jun 30, 2025 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today...Read more
New Phase 1 clinical data for CTX310™ continues to demonstrate dose-dependent reductions in triglycerides (TG) and low-density lipoprotein (LDL), with peak reduction of up to 82% in TG and up to 86% in LDL, with a well-tolerated safety profile Complete Phase 1 data presentation for CTX310 anticipated at a medical meeting in the second half of 2025 Data update for CTX320™, targeting the LPA gene, now expected in the first half of...Read more
SAN DIEGO / Jun 25, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1)...Read more
Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated Trial completion triggers opt-in...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
Phio's lead clinical siRNA compound PH-762 demonstrates supportive safety profile in fourth cohort, permitting dose escalation in expected final cohort Marlborough, Massachusetts--(Newsfile Corp. - June 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today that...Read more
Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen Based on these encouraging Phase 1...Read more
Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression Six-Month Patient Follow-up Results Demonstrate that Sana’s Transplanted Pancreatic Islet Cells Modified with its Hypoimmune (HIP) Technology are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient Function and...Read more
SOUTH SAN FRANSCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an immunotherapy company developing the next generation of engineered T cell therapeutics targeting TIM4L with phagocytic mechanisms, today announces the completion of the initial evaluation of the first patient in its Phase 1 clinical trial of lead compound CER-1236. Following an evaluation from the...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
Initial pharmacological data from placebo-controlled, double-blind Phase I study shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases Single ascending dose levels will continue with 2.5, 7 and 14 mg/kg Additional data from the Phase I to follow in second half of...Read more
12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure Median weight remained stable through 3 months (0.46% / ~ 1 pound weight change within the margin of error for daily weight measurement), compared to expected 5–6% weight regain (10–15 pounds) after stopping GLP-1 therapy Revita continued to demonstrate excellent tolerability...Read more
Phase 2 Celiac Disease Trial Initiating with Topline Readout Expected in 2026 Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET DALLAS / Jun 23, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive data from a Phase 1b trial in celiac disease for lead...Read more
16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients Robust central nervous system (CNS) activity; 41% (7/17) confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients by BICR in overall cohort Enrollment of first patient in a randomized, global pivotal Phase 3 (ALPACCA) study in first-line...Read more
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
CLICK TO LEARN MORE