Reinforces potential of nebokitug to become the first approved drug with disease-modifying activity for PSC--a deadly disorder that currently has no effective treatments Treatment in PSC patients with moderate/advanced disease for 48 weeks resulted in continued improvements across key biomarkers of liver injury, inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C3 Patients treated with...Read more
ATH434 is a Disease Modifying Drug Candidate Targeting Parkinsonian Disorders Topline Data Expected Mid-Year 2025 MELBOURNE, Australia and SAN FRANCISCO, March 27, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the last patient in...Read more
Experimental treatment with CAN-2409 was associated with a median overall survival (mOS) of 24.5 months in patients with advanced NSCLC who had an inadequate response to ICI treatment, failed several chemotherapy regimens, and presented with multiple negative prognostic factors at enrollment (90% of the patients had stage IV disease, most patients had low or undetectable PDL-1 expression, > 90% were current or former smokers, and...Read more
IGC-AD1 Could Offer Safer Alternative to Existing Sleep Medications for Alzheimer's POTOMAC, MD / ACCESS Newswire / March 26, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced additional positive interim results from its ongoing Phase 2 clinical trial on IGC-AD1, an investigational treatment for agitation in dementia due to Alzheimer's disease. Based on the interim analysis at week 2...Read more
NEWTON, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed...Read more
Statistically significant and clinically meaningful improvement of 3.8 seconds in Time-to-Rise vs. natural history with largest effect observed relative to any approved dystrophin restoration therapy at 48 weeks; additional functional benefits observed in other outcome measures including NSAA First-ever demonstration of substantial improvements in muscle health with exon skipping – statistically significant reduction in fibrosis driven...Read more
13-Week Study Evaluating the Safety and Efficacy of Oral VK2735 Dosed Once Daily Results Expected in 2H25 SAN DIEGO, March 26, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet...Read more
Updated data confirms statistically significant 32% higher ORR and 3.5 month longer PFS in second-line CRC patients with high DKK1 levels treated with sirexatamab plus bevacizumab and chemotherapy Statistically significant 22% higher ORR and 2.6 month longer PFS in patients who had not had prior anti-VEGF therapy Leap to host a conference call to present clinical data today, March 26, 2025, at 8:00 a.m. ET CAMBRIDGE,...Read more
Berubicin showed clinically relevant outcomes comparable to Lomustine across multiple endpoints, but not a statistically significant difference in overall survival, the primary endpoint. The safety profile continues to be favorable, including the absence of anthracycline related cardiotoxicity. Analysis of outcomes are ongoing, including advanced imaging review, PK, and clinical endpoints. The company also continues development of a...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
ATLANTA, March 25, 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 (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment...Read more
Company-hosted conference call and webcast to be held today at 8:00 a.m. ET Zetomipzomib treatment results in steroid-sparing biochemical remissions in accordance with AASLD treatment guidelines in a difficult-to-treat, refractory AIH patient population. In relapsed, steroid-dependent AIH patients, of the 21 of 24 entering screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical...Read more
Treatment with UBX1325 resulted in vision gains comparable to aflibercept at weeks 24 and 36 in difficult-to-treat patient population UBX1325 was non-inferior to aflibercept at week 24 (>90% confidence interval), but did not meet statistical non-inferiority on the average of weeks 20 and 24, the primary analysis endpoint (met at 88% confidence interval) UBX1325-treated patients had a +5.2 letter gain in visual acuity at 24 weeks...Read more
POTOMAC, MD / ACCESS Newswire / March 20, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the expansion of its ongoing Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada. This expansion marks a key milestone in IGC Pharma's strategy to advance IGC-AD1 toward commercialization, accelerating patient enrollment and expanding the...Read more
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 MDD subjects ATLANTA, March 18, 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 (“Alzheimer’s”), bipolar disorder...Read more
POTOMAC, MARYLAND / ACCESS Newswire / March 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the addition of a new trial site at BayCare's St. Anthony's Hospital in St. Petersburg, Florida as part of its ongoing Phase 2 CALMA trial evaluating IGC-AD1, the Company's lead therapeutic candidate, for the treatment of agitation in Alzheimer's dementia. IGC-AD1 is a combination therapy designed to...Read more
Open-label study at Psychiatric Centre Copenhagen found that alcohol consumption significantly decreased amongst participants dosed with Filament's botanical psilocybin drug candidate After a single dose of PEX010, the mean percentage of heavy drinking days was reduced by more than 50% over the 12-week observation period VANCOUVER, BC, March 17, 2025 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS)...Read more
Azenosertib median duration of response (mDOR) updated to 6.3 months in the ongoing DENALI Part 1b clinical trial in patients with platinum-resistant ovarian cancer (PROC) and continues to demonstrate an objective response rate (ORR) of ~35% in response-evaluable patients On track to initiate Part 2 of the ongoing DENALI clinical trial in 1H 2025, with registration-intent topline data anticipated by year end 2026 Company also presents...Read more
No significant clinical adverse event observed in Phase 1clinical study Pharmacokinetic profile established and range of doses selected for Phase 2a Clinical Efficacy Study First patient expected to be treated in the Phase 2a Clinical Efficacy Study on March 14, 2025 at the Montreal Heart Institute TORONTO, ONTARIO, March 13, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”),...Read more
Trial for this rare genetic disease to be conducted by NIH/NIAID in partnership with Corvus ITK inhibition intended to address dysregulation of T cells that causes ALPS and has been shown to be effective at treating the disease in preclinical models BURLINGAME, Calif., March 12, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the National...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
A new batch of neflamapimod capsules led to increased plasma drug concentrations and demonstrated improvement (p<0.001 vs. old capsules; p=0.003 vs. placebo) on the primary outcome measure, change from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Improvement (p=0.035 against either old capsules or placebo) also demonstrated on the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change...Read more
Clinical response rate of 63.5% and clinical remission rate of 30.2% achieved at Week 12 with the highest dose, which continued to improve through Week 28 All three doses met the primary endpoint of clinical response at Week 12, with a favorable safety profile These results in ulcerative colitis build on strong data recently reported for the plaque psoriasis Phase 3 program NEWARK, CALIFORNIA / ACCESS Newswire / March 10, 2025 /...Read more
HEROES is Natera’s first clinical trial using Signatera™ to guide de-escalation of therapy in patients with metastatic HER2+ breast cancer Approximately 170 patients are expected to enroll in up to 35 sites in France AUSTIN, Texas / Mar 10, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the enrollment of the first patients in the HEROES clinical trial. HEROES...Read more
Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and...Read more
Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001)...Read more
Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001) Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patients Patient reported and other secondary...Read more
Results presented in AAD late-breaker demonstrate bempikibart's encouraging improvement on SALT reduction at week 24 and continued effects after dosing cessation in patients with severe and very severe alopecia areata (AA) Durable, ongoing responses in multiple patients through week 36 follow-up period and beyond to week 55, despite only 24 weeks of dosing, suggestive of potential for remittive effect; multiple inbound patient requests...Read more
ESK-001 is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor currently under development in moderate-to-severe plaque psoriasis and systemic lupus Phase 2 OLE data of ESK-001 at 40 mg BID demonstrated sustained or increasing clinical responses through week 52 on PASI 90, PASI 100, and sPGA 0 ESK-001 was generally well-tolerated at one year, with no new safety findings Data further support ESK-001’s potential...Read more
PHILADELPHIA, March 06, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC). The SKNJCT-003 clinical study is currently underway in nine (9) clinical sites in United States and is expected to randomize 60 patients. The interim analysis was...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 06, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement. The study is a single-arm, multi-center, open-label, Phase II...Read more
The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial is evaluating the efficacy and safety of a single dose of BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression The open-label extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second dose of BPL-003 As previously reported, the Phase 2a study of BPL-003...Read more
Company will temporarily pause CONNECT2 and focus efforts on ongoing CONNECT1-EDO51 study of PGN-EDO51 in DMD, with 10 mg/kg results expected in the third quarter of 2025 No new safety issues have been observed in PGN-EDO51 program BOSTON / Mar 04, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the...Read more
ATLANTA, March 04, 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 (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment...Read more
CARMEL, Ind., March 03, 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 the completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company’s parathyroid hormone (PTH) peptide prodrug. Canvuparatide is...Read more
Pilavapadin achieved meaningful pain reduction versus placebo and was well-tolerated in the 10 mg dose, meeting the Company’s objectives for the study Advancement of 10 mg dose into Phase 3 development in DPNP supported by both PROGRESS and RELIEF DPN-1 studies, which collectively enrolled approximately 600 pilavapadin-treated patients Conference call and webcast at 8:00 a.m. ET THE WOODLANDS, Texas, March 03, 2025 (GLOBE NEWSWIRE)...Read more
Greatly improved patient quality of life and reduced disease impact in patients with CSU and CIndU 82% of CSU patients reported that symptoms no longer had an impact on their quality of life at Week 52 60% of CIndU patients reported that symptoms no longer had an impact on their quality of life at Week 12 HAMPTON, N.J., March 01, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive data on...Read more
Trial to begin enrolling in April; expected primary completion in mid-2027 Primary study endpoint of rate of major pathological response SAN DIEGO and SUZHOU, China, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced an investigator initiated (IIT) Phase 2 neoadjuvant trial of ADG126 for...Read more
Masked Analysis Shows Participants Receiving Oral Zervimesine for at Least 6 Months Experienced Slower Lesion Growth than Participants Receiving Placebo Following the Futility Analysis, Management Concluded the Phase 2 Study, Preserving Capital Full Analysis will be Provided in the Second Quarter of 2025 PURCHASE, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company...Read more
SAN FRANCISCO, Feb. 26, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as...Read more
Fully funded multi-center study initiated at University of Florida to further explore efficacy of isomyosamine for preventing progressive muscle loss and frailty Study builds on positive results achieved in earlier Phase 2a trial TNF-alpha inhibitor market estimated at $40+ billion with no FDA-approved oral treatments BALTIMORE / Feb 25, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a...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
ATLANTA, Feb. 25, 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 (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate the first of five highly anticipated phase II clinical studies of...Read more
Initial Data from this Phase 2 Trial Demonstrates Early Evidence of Clinical Activity of Elraglusib (9-ING-41) in Combination with FOLFIRINOX and Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) The Final Results from the Trial are Anticipated in 2026 CHICAGO and FORT WORTH, Texas, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage...Read more
Positive final survival data after additional follow-up showed notable improvement in estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Three of seven patients treated with CAN-2409 were still alive with survival of 66.0, 63.6 and 35.8 months after enrollment,...Read more
Originally planned as a two-year study, the trial has been extended by an additional year to collect three-year clinical outcome data The additional third year of EVX-01 dosing may provide further insights into potential enhanced treatment effects and durability of induced immune response The trial already yielded convincing one-year data and remains on track for two-year data readout in the second half of 2025 COPENHAGEN,...Read more
Topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed...Read more
Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already delivered Trial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approval Two patients in the ongoing phase 2 trial have now exceeded 17 months on stenoparib treatment Boston (February 24, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical...Read more
New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological- endoscopic mucosal improvement Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025 PARSIPPANY, N.J. and PARIS, Feb. 22, 2025 (GLOBE NEWSWIRE) -- Teva...Read more
Combination Achieved a 67% of Overall Response Rate, More than Double that of Zanubrutinib Alone; 83% Disease Control Rate in Difficult-to-Treat Non-GCB DLBCL (ABC DLBCL) Patients Median Overall Survival Not Reached Yet – 67% of Patients Still Alive NEW YORK, Feb. 20, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company...Read more
SANTA ANA, Calif., Feb. 19, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Anita Fletcher, M.D. has been appointed as the National Principal Investigator (“PI”) for its Phase 2a clinical trial of troculeucel,...Read more
Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo SPN-820 was well-tolerated with few adverse events, consistent with previously reported studies ROCKVILLE, Md., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing...Read more
NEW YORK, Feb. 18, 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 the dosing of an additional four patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) for patients with...Read more
NT219, a novel agent designed to overcome tumor resistance to drug therapy, will be evaluated in combination with the standard-of-care head and neck cancer drugs pembrolizumab (Keytruda) or cetuximab (Erbitux) The study is conducted in collaboration with the University of Colorado Anschutz Medical Campus and is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program REHOVOT, Israel, Feb. 18, 2025...Read more
The Company Is on Track to Complete the Interim Data Analysis Before the End of Q1 2025 and to Submit the Findings to the U.S. Food and Drug Administration (FDA) Philadelphia, Pennsylvania--(Newsfile Corp. - February 14, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is also pleased to announce that its phase 2 clinical study (SKNJCT-003), which is currently underway in nine (9) clinical sites in United...Read more
No adverse events related to TCB008 have occurred Evidence of stable disease following TCB008 infusion EDINBURGH, Scotland, Feb. 13, 2025 /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 that it has concluded dosing of Cohort A patients in...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that, per the charter of the trial’s independent Data Safety Monitoring Board (DSMB), the Company has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The panel, consisting of...Read more
Interim analysis resulted in a recommendation to continue the study with a total targeted biomarker population of ~200 patients in the final analysis sample Topline results are expected in mid-2026 The company recently reported an estimated preliminary 2024 year-end cash balance of approximately $168 million, which is expected to support planned operations into 2028 MOUNTAIN VIEW, Calif. / Feb 12, 2025 / Business...Read more
Completed Phase 2 enrollment with randomization of 51 subjects into treatment and control arms Phase 1/2 study (N=60) demonstrated favorable safety and tolerability profile with no serious adverse events related to OCU410, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization Subjects showed considerably slower lesion growth (44%) from baseline in treated...Read more
Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS-28 CRP across all rosnilimab doses vs. placebo Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA Demonstrated highest ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and...Read more
ENV105 can potentially address resistance in a wide range of cancers as they become resistant to standard treatments. LOS ANGELES / Feb 11, 2025 / Business Wire / Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, today announces the addition of Huntsman Cancer Institute in Salt Lake City, Utah for the Phase 2...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
LP-310 Treatment Demonstrates Clinically Meaningful Reductions in Pain, Ulceration, and Inflammation Across All Key Metrics Findings Highlight Favorable Safety Profile and Tolerability of Twice-Daily Oral Rinse Multicenter Phase 2a Trial Advancing to Higher Treatment Dose with Recruitment Expected to Conclude the First Half of 2025 Lipella Leadership to Present Findings at BIO CEO & Investor Conference on Tuesday, February 11,...Read more
Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate With these data, Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Feb 10, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult...Read more
First Cohort B patient received 4 doses (approx. 819 million Gamma Delta T-cells) Cohort B recruitment continues at multiple clinical sites across the United Kingdom EDINBURGH, Scotland, Feb. 10, 2025 /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,...Read more
3E10 vg/eye achieved an 83% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W, 70% required 0-1 supplemental injection, and 57% were injection-free through 52 weeks In the recently diagnosed subgroup, which most resembles the Phase 3 4FRONT-1 and 4FRONT-2 patient populations, 87% required 0-1 supplemental injection and 80% were injection-free through 52 weeks Durable and stable aflibercept expression...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
Investigator-initiated data from Houston Methodist Hospital showed LD IL-2 reduced proinflammatory factors, both systemically and within the central nervous system, while demonstrating statistically significant improvement in beta amyloid 42 clearance with stabilization of cognitive decline over a five-month treatment period Comprehensive data set will be presented and released throughout 2025 and in a peer reviewed...Read more
Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo Itolizumab was generally well tolerated consistent with prior clinical experience LA JOLLA, Calif. / Feb 06, 2025 / Business Wire /...Read more
Boston (February 6, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific patient selection technology—the Drug Response Predictor (DRP®)—today announced plans for the next step in advancing the clinical...Read more
Last Patient / Last Visit Completed Topline Data Readout Expected Later This Quarter CRANBURY, N.J., Feb. 6, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the completion of its Phase 2 BMT-801 clinical study of the co-administration of MC4R...Read more
Met primary endpoint of safety and tolerability in CCM patients with no treatment-related discontinuations or Grade 3 adverse events In comparison to placebo, treatment with REC-994 400 mg showed promising signals in both MRI-based lesion volume reduction and functional outcome as measured by changes in the modified Rankin scale (mRS) score In patients with cavernomas located in the brainstem, a subset of patients with...Read more
KOMET-001 registrational trial in R/R NPM1-m AML achieved primary CR/CRh endpoint; topline data submitted for presentation at an upcoming medical meeting NDA submission for ziftomenib on track for 2Q 2025 Registrational KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated approval and full approval Registrational...Read more
Advancement to Stage 2 of Infant Study Supported by Review of Stage 1 Safety and Tolerability Data Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93%...Read more
Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds Favorable safety profile continues with no DURAVYU-related ocular...Read more
Median overall survival (OS) from THIO treatment extends to 16.9 months Newest data strengthens regulatory strategy CHICAGO / Feb 04, 2025 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical...Read more
RADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for...Read more
NASHVILLE, Tenn., Feb. 4, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced positive top-line results from its Phase 2 FIGHT DMD trial. The study evaluated ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease – the leading cause of death in DMD patients. It marks...Read more
The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis The study is being financially supported by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor Lisa...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
Primary endpoint met, GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from baseline of -15.5 on Day 8 (p<0.0001) The majority of the patients treated with GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group (p<0.0001) All other secondary endpoints were met with clinically and statistically significant improvements on Day 8,...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
Clinically Meaningful Benefit Observed at Both ATH434 Doses Studied Achieved Statistical Significance with Up to 48% Slowing of Clinical Progression on UMSARS Rating Scale Key MRI Biomarker Shows Iron Stabilization in MSA Affected Brain Regions ATH434 Demonstrated a Favorable Safety Profile Webcast Held Yesterday with Access to the Recording Below MELBOURNE, Australia and SAN FRANCISCO, Jan. 30, 2025...Read more
BOSTON / Jan 29, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today provided recent updates on its CONNECT clinical program investigating PGN-EDO51 in Duchenne muscular dystrophy (DMD) for patients amenable to an exon-51 skipping...Read more
LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, today announces a clinical update and its interim results for the six months ended 30...Read more
35% objective response rate (ORR) in second-line colorectal cancer (CRC) patients treated with sirexatamab (DKN-01) plus bevacizumab and chemotherapy, compared to 23% ORR in the control arm DKK1 levels highly correlated with clinical activity in CRC population ORR benefit with sirexatamab observed across multiple potential Phase 3 CRC populations Preparations will begin for a registrational Phase 3 study in second-line CRC patients...Read more
A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months BPL-003 was well-tolerated with no serious or severe adverse events reported NEW YORK and BERLIN, Jan. 28, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical...Read more
Vancouver, British Columbia – TheNewswire - 28 January, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a clinical stage biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines to treat depressive disorders. The Company is delighted to report the outcome of a mandatory independent safety audit of its two currently dosing Phase 2B clinical...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
Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15% By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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