100% LLDAS response rate observed in patients with SLE who received Descartes-08 in Phase 2 open-label trial reaching Month 3 follow-up (n=3) Disease remission reported as DORIS response seen in 2 out of 3 patients reaching Month 3 follow-up (n=3) Descartes-08 in SLE patients was observed to have a favorable safety profile supporting outpatient administration without the need for lymphodepleting chemotherapy Myositis seamless...Read more
Vancouver, British Columbia – TheNewswire - Nov 13, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a biotechnology company leading clinical health research and product development has completed its initial assessment of results from its recently completed Phase 2B clinical trial in patients with Major Depressive Disorder (MDD). Background Theories suggest that repeatedly taking low...Read more
Investigational ZORYVE cream 0.05% was formulated for the delicate skin of infants and young children with mild to moderate atopic dermatitis Topline results anticipated in Q1 2026 The U.S. FDA approved ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years in October 2025 Atopic dermatitis impacts 9.6 million children in the U.S., with up to 60% developing symptoms within their first...Read more
Study conducted in collaboration with the Alzheimer’s Clinical Trials Consortium PURCHASE, N.Y., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study. A number of...Read more
Alixorexton is the First Oral Orexin 2 Receptor Agonist to Demonstrate Efficacy in a Large Phase 2 Study in Patients With Narcolepsy Type 2, Supporting Advancement to Phase 3 Alixorexton Met the Study's Dual Primary Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Improvements in Wakefulness and Excessive Daytime Sleepiness Compared to Placebo in Patients With Narcolepsy Type 2 Alixorexton Was Generally...Read more
SAN DIEGO, Nov. 10, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 2 study evaluating the efficacy, safety and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder did not meet the primary endpoint compared to placebo. NBI-1070770 was generally well tolerated This Phase 2 signal-seeking study enrolled 73 adult patients with a diagnosis of major...Read more
Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo Observed expected pharmacology, including ~90% depletion of pathogenic T cells, however lack of adequate efficacy at Week 12 does not support further development of rosnilimab in UC and trial will be discontinued, resulting in at least $10 million in savings Will provide update in H1 2026 on advancement of rosnilimab in RA, which would be funded by...Read more
SHELTON, CONNECTICUT / ACCESS Newswire / November 10, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today reported that it has received approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC). The proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease...Read more
Phase 2a data support oral C5aR inhibitor INF904 as a potentially transformational and best-in-class immunomodulatory agent, indicating strong potential for efficacy and no safety signals of concern In HS, over 4 weeks of therapy, InflaRx observed rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period,...Read more
A 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 12 mg, 8 mg or 0.3 mg dose in the core study of the Phase 2b clinical trial produced additional rapid, clinically meaningful antidepressant effects that were sustained for up to eight weeks Patients who received an active dose of BPL-003 in the core study of the Phase 2b clinical trial (either 8 mg or 12 mg) met response and remission...Read more
Statistically significant and clinically meaningful improvements in mean ACQ-5 scores were reported at week 16 versus placebo in patients who had atopic dermatitis and a history of asthma Extended dosing with rezpegaldesleukin q2w supports 24-week induction period for planned Phase 3 studies with improvement across major efficacy endpoints from Week 16 to 24, including EASI-75, EASI-90, and vIGA-AD Data from long-term maintenance...Read more
Proof-of-concept trials confirm robust anti-clotting effects for Regeneron’s two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement Trial results consistent with prospective design of these antibodies to have distinct profiles – one to provide stronger anticoagulation and the other to have a lower risk of bleeding – potentially allowing physicians to tailor anticoagulant therapy for...Read more
40% ORR in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma tumor mutational burden (TMB) Estimate 55% of patients with MSS CRC have high plasma TMB, representing a meaningful population with high unmet need Company to host conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET with leading cancer experts to review the data WALTHAM, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) --...Read more
SITC abstracts highlight updated immunogenicity results from the Phase 2 AMPLIFY-7P trial of ELI-002 7P and preclinical data on the use of intratumoral ELI-004 (AMP-CpG) for solid tumor immunotherapy ELI-002 7P induced mKRAS-specific T cell responses in 99% of evaluable patients (89/90), demonstrating potent and consistent immune activation Robust immune responses were elicited across all seven mKRAS antigens, with >80% response...Read more
COPENHAGEN, Denmark, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that a new pooled analysis showed sustained and clinically meaningful improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide) through Year 3 of the Company’s Phase 2 PaTH Forward and Phase 3 PaTHway trials. The data, which confirm results for each individual trial presented at...Read more
Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m² Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Supports advancement into Phase 3 development as a potential...Read more
In patients with advanced chronic kidney disease (CKD) and diabetes, treatment with rilparencel resulted in statistically significant and clinically meaningful slowing of CKD progression Bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 (n=24) patients No rilparencel-related serious adverse events were...Read more
Vancouver, British Columbia – TheNewswire - Nov 6, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a clinical stage biopharma company developing novel take-home microdose formulations for treating depressive disorders, is delighted to announce dosing in its landmark Phase 2B clinical trial in patients with Major Depressive Disorder (MDD) has completed. The trial and the Company’s two...Read more
HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting...Read more
VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic Syndrome SAN DIEGO, Nov. 6, 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 that new clinical data from the company's VK2735...Read more
Mind Medicine Australia clinic joins Psyence BioMed’s expanding network of clinical sites as enrollment accelerates in the landmark Phase IIb study for Adjustment Disorder in palliative care NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today...Read more
Based on these trial results, Lilly will begin enrolling Phase 3 clinical studies for the treatment of obesity next month INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one...Read more
TORONTO, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Fraser Health Research Ethics Board (“REB”) has granted approval for the Royal Columbian Hospital (RCH) to participate in Arch’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With this ethics...Read more
Milestone advances two-part study evaluating novel, locally administered gene therapy designed to increase anti-inflammatory IL-1Ra production in the knee joint BRISBANE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it has concluded patient...Read more
Trial achieved biological proof-of-concept, dose discovery and biomarker improvement San Diego, California--(Newsfile Corp. - November 4, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing sulfur-based therapeutics for pediatric diseases, predominantly those involving mitochondrial dysfunction, today announced interim results from its...Read more
First patient dosed, with topline results expected in 2027 pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the first patient has been dosed...Read more
LA JOLLA, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announces the completion of patient enrollment in its Phase 2 clinical trial, MN-001-NATG-202, evaluating MN-001 (Tipelukast) for the treatment of hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD)...Read more
FDA lifts clinical hold following review of Company’s Complete Response submission. Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites. Early data suggests that LTI-03 may not only slow fibrosis but also promote lung healing. AUSTIN, Texas, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class...Read more
Enrollment completed ahead of schedule, underscoring strong interest from patient community in a potential new therapeutic option On track to complete the 24-week treatment period and announce topline results in 2026 GAITHERSBURG, Md., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic...Read more
26% Objective Response Rate Median Duration of Response Not Reached after 25 Months Follow Up Lifileucel Launch in Previously Treated Advanced NSCLC Expected in Second Half of 2027 SAN CARLOS, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies...Read more
Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in 2026 Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously...Read more
WAYNE, Pa., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced that the Company has completed enrollment in its Phase 2 LOTUS trial of AVTX-009 in adults with hidradenitis suppurativa (HS). The LOTUS trial exceeded target enrollment of 222 patients with approximately...Read more
Relative to Baseline, Signal-Finding Molecule ADX‑629 Demonstrated Statistically Significant Improvement in Liver Function in Patients with Alcohol-Associated Hepatitis RASP Modulator Product Candidate Pipeline Focused on ADX‑248 and ADX‑246 for Dermatologic, Metabolic, and Retinal Immune-Mediated Diseases Cash Runway Extended into the Second Half of 2027 LEXINGTON, Mass. / Oct 28, 2025 / Business Wire / Aldeyra Therapeutics, Inc....Read more
Trial initiation in food allergy follows promising results in Phase 2 trial in chronic spontaneous urticaria, another IgE-driven condition RAPT seeks to develop a differentiated anti-IgE therapy for the many patients with food allergies SOUTH SAN FRANCISCO, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing...Read more
ELI-002 7P demonstrated robust mKRAS-specific T cell responses across a broad range of HLA types, highlighting its potential for use among a diverse patient population Patients treated with ELI-002 7P represented a diverse HLA repertoire including 1,132 unique types identified among 1,398 total HLA backgrounds in assessed patients 99% (88/89) of patients assessed for HLA background induced mKRAS-specific T cell responses after...Read more
Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and...Read more
Obexelimab met primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo, p=0.0009 WALTHAM, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients...Read more
Data presented today as an oral presentation at 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6...Read more
100% response rate in 1L left-sided mCRC (n=8, confirmed and unconfirmed) 62% response rate in 2L left- and right-sided mCRC (n=13, confirmed and unconfirmed) UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®,...Read more
Outstanding measure of efficacy relative to high-risk cancers with limited treatment options CHICAGO, Oct. 23, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in...Read more
No targeted treatments are currently FDA approved for high-grade IDH1-mutant gliomas After a favorable meeting with FDA, protocol amendment will make G203 a Phase 3 trial to support potential registration NEW YORK / Oct 23, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced enrollment of the first patient into part 2...Read more
VTX3232 demonstrated significant reductions in cardiovascular risk factors, with additional benefits when combined with semaglutide VTX3232 monotherapy achieved ~80% reduction in hsCRP within the first week VTX3232 monotherapy reduced IL-6 levels at Week 12 below the threshold for cardiovascular risk of ≤1.65ng/L1 Statistically significant reductions in Lp(a) and liver inflammation No effect on weight either as a monotherapy or as...Read more
LOS ANGELES, Oct. 22, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today highlighted positive results from its recently completed Phase 2a diSArm study of AP-SA02 as a...Read more
New York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced additional overall and event free survival data generated from the Company's 41-patient Phase 2b clinical trial of its off-the-shelf immunotherapeutic candidate OST-HER2 in recurrent, fully resected,...Read more
CLEVELAND CLINIC ABU DHABI (CCAD) IS THE PRINCIPAL INVESTIGATOR IN THIS 36 PARTICIPANT STUDY PHILADELPHIA, PA / ACCESS Newswire / October 22, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce the enrollment of the first patient in United Arab Emirates...Read more
ARCT-032 generally safe and well tolerated Meaningful trends of clinical activity observed via high resolution CT scans After only 28 days of treatment with ARCT-032 (10 mg), 4 out of 6 Class I CF participants exhibited encouraging reduction of mucus plug number and mucus volume 12-week study enrolling up to 20 CF participants planned to begin first half of 2026 SAN DIEGO / Oct 22, 2025 / Business Wire / Arcturus Therapeutics...Read more
600 mg once daily bexobrutideg oral dose cleared by global regulators for pivotal monotherapy trials in relapsed/refractory chronic lymphocytic leukemia (r/r CLL) Phase 2 DAYBreak trial initiated for potential Accelerated Approval New preclinical data support bexobrutideg as potential best-in-class BTK degrader profile Nurix will host an investor webcast today, Wednesday, October 22nd, at 8:00 a.m. EDT SAN FRANCISCO, Oct. 22, 2025...Read more
Results show maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related Company will not advance TERN-601 or invest in other metabolic assets Reiterates focus on TERN-701, a potential best-in-class allosteric BCR-ABL inhibitor,...Read more
SIGNAL-AA Part B exceeded target enrollment based on demand from patients; trial size increased to 33 patients WALTHAM, Mass., Oct. 21, 2025 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and other autoimmune and inflammatory diseases, today announced that it has completed enrollment in Part B of its SIGNAL-AA...Read more
Novel combination including eftilagimod alfa (efti) in neoadjuvant setting drives 51.5% tumour hyalinization/fibrosis in patients with soft tissue sarcoma (p<0.001) High level of tumour hyalinization/fibrosis, achieved across multiple STS subtypes, over 3-fold greater than historical results from standard-of-care radiotherapy alone Data from investigator-initiated Phase II selected for Proffered Paper oral presentation SYDNEY,...Read more
RPT904 at both Q8W and Q12W dosing showed comparable efficacy and safety to omalizumab at Q4W dosing Efficacy sustained at Week 16 after a single dose of RPT904 Well tolerated with no serious adverse events related to study drug Jeyou to advance RPT904 to Phase 3 development in China RAPT to discuss Phase 3 development path with FDA RAPT to host conference call at 8:30 am ET today SOUTH SAN FRANCISCO, Calif. and SHANGHAI, Oct....Read more
83% (78/94) of patients demonstrated ocular tumor shrinkage, with 54% (51/94) achieving ≥20% tumor shrinkage 57% (24/42) eye preservation rate in enucleation (EN) recommended patients, which increased to 95% (19/20) in patients achieving ≥20% ocular tumor shrinkage 70% (26/37) of plaque brachytherapy (PB) eligible patients achieved a reduction in predicted radiation dose to the eye from baseline, resulting in 65% (24/37) of patients...Read more
Combination demonstrated median overall survival (OS) of 21.1 months, compared to reported historical mOS of approximately 12 months in published meta-analysis of metastatic uveal melanoma in the first-line setting Median progression free survival (PFS) of 7.0 months Confirmed overall response rate (ORR) by RECIST 1.1 of 34%, median duration of response (mDOR) of 9 months and disease control rate (DCR) of 90% SOUTH SAN FRANCISCO,...Read more
BRAFTOVI + MEKTOVI continued to show a substantial median overall survival benefit of 47.6 months in treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer after approximately four years Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population NEW YORK / Oct 19, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced...Read more
Conference Call October 20, 8:45am EST QUEENSBURY, N.Y. / Oct 18, 2025 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented by Principal Investigator and Lead Author Professor Ellen Kapiteijn, MD, from Leiden University Medical...Read more
75% Objective Response Rate as 12 out of 16 advanced melanoma patients had objective clinical responses, with 11 of the 12 responders continuing to respond at 24 months follow-up Immune activation observed in all patients with 81% of EVX-01’s vaccine targets triggering a specific response Treatment was well tolerated Data is presented today at the ESMO Congress and will be discussed at a webinar with key opinion leader Professor...Read more
ATRN-119 (ATR Inhibitor): RP2D of 1,100 mg once daily identified in ongoing ABOYA-119 dose-escalation study Further ATRN-119 monotherapy enrollment paused with strategic focus on high-value combination Company is prioritizing its lead program, WEE1 kinase inhibitor APR-1051 DOYLESTOWN, Pa., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical...Read more
POTOMAC, MD, 1734 / ACCESS Newswire / October 14, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease. The trial has officially opened a...Read more
Non-inferiority trial versus PAXLOVID® assessing safety and efficacy, including rates of disease rebound and incidence of Long COVID development, of ratutrelvir, a ritonavir-free anti-viral treatment Separate single-arm trial assessing safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant, vulnerable population with few available treatment options Top-line data from both trials expected by year-end...Read more
First overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study will be presented on October 18 at the European Society for Medical Oncology (ESMO) 2025 Congress These data support the ongoing development of domvanalimab plus zimberelimab and chemotherapy in the Phase 3 STAR-221 study in the same patient population HAYWARD, Calif. / Oct 12, 2025 / Business Wire / Arcus Biosciences, Inc. (NYSE: RCUS), a...Read more
75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001) 100% of patients who achieved 12 month event free survival achieved 2 year overall survival New York, New York--(Newsfile Corp. - October 10, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology...Read more
Company engaged patients diagnosed with chronic babesiosis via social media in a nationwide naming competition A $5K donation from the Company was split between ILADEF and GLA to recognize the winning name B-FREE, a Phase 2 trial, will commence in early November and run for approximately 12 months WASHINGTON, Oct. 09, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or...Read more
Significant improvement relative to placebo on primary outcome measure, change in Clinical Dementia Rating Sum of Boxes (CDR-SB), demonstrated in a within-subject analysis in participants with low likelihood of having Alzheimer’s disease (AD) co-pathology Significant reduction in plasma levels of a well-established biomarker of neurodegeneration, plasma glial fibrillary acidic protein (GFAP), correlated to treatment response assessed...Read more
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated achieving endoscopic improvement and 30.2% achieving clinical remission at the highest dose at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active...Read more
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis SPRING HOUSE, Pa.,...Read more
Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of...Read more
OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1 The trial also met all six secondary endpoints.2 Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1 NORTH CHICAGO, Ill., Oct. 6,...Read more
CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced new positive findings based on plasma samples from its Phase-2b PARADIGM study. These results indicate that PrimeC produced robust, statistically significant reductions in multiple microRNAs that...Read more
Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans SEATTLE, Oct. 6, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in...Read more
Nimacimab monotherapy did not meet its primary endpoint for weight loss; preliminary pharmacokinetic analysis showed lower than expected drug exposure, potentially indicating the need for higher dosing as a monotherapy. Clinically meaningful additional weight loss observed with combination of nimacimab, a peripheral CB1 inhibitor, and semaglutide compared to semaglutide alone. Nimacimab alone and in combination demonstrated a clean...Read more
Tulisokibart, an investigational anti-TL1A monoclonal antibody currently in Phase 3 trials for ulcerative colitis and Crohn’s disease, to be studied in hidradenitis suppurativa, radiographic axial spondyloarthritis and rheumatoid arthritis RAHWAY, N.J. / Oct 06, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced it has initiated three Phase 2b trials evaluating the safety and...Read more
ANAVEX3-71-SZ-001 achieved its primary endpoint demonstrating safety and tolerability in adults with schizophrenia Encouraging trends observed in biomarkers support continued development NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative,...Read more
Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that...Read more
Placebo-subtracted mean weight loss up to 14.1% after 28 weeks with no plateau Potential for best-in-class tolerability with minimal diarrhea signal, 13% nausea, and 11% vomiting High study and treatment retention in both VESPER-1 and VESPER-3 trials Data support Phase 3 initiation in late 2025 NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from VESPER-1 and...Read more
Patients who switched from placebo or pirfenidone to deupirfenidone in the open-label extension study achieved stabilization of lung function with favorable tolerability Findings further substantiate safety and efficacy results from the randomized, placebo- and active-controlled 26-week trial and highlight opportunity to address patients inadequately served by current therapies Regulatory engagement underway; update on Phase 3 trial...Read more
6.7-Day Improvement in Time to Complete Resolution of All RSV Symptoms for Patients with Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), or Age ≥75 Statistically Significant Improvement in Patient Global Impression of Severity Score Lower Hospitalization Rate for Patients Treated with Zelicapavir (1.7%) vs. Placebo (5%) 4- to 5-Day Faster Median Time to Undetectable Viral Load with Zelicapavir vs....Read more
POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. Hafner, M.D. Dr. Hafner brings years of experience in...Read more
Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance KPI-012 was well-tolerated with no treatment-related serious adverse events observed KALA to cease clinical development of KPI-012, preserve cash and explore strategic options ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage...Read more
86% overall survival (OS) observed at 9 months; standard of care benchmark is ~47% 53% progression-free survival (PFS) observed at 9 months; standard of care benchmark is ~29% Company expects regulatory feedback on pivotal trial plans in Q4 2025 and, subject to that feedback, expects to initiate pivotal trial by the end of 2025 and begin dosing patients by mid-2026 NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) --...Read more
FG-3246 Phase 2 dose optimization trial to enroll 75 patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor signaling inhibitor (ASRI) and pre-chemotherapy setting FG-3180 to be evaluated in the Phase 2 trial as a companion PET imaging agent and a potential predictive patient selection biomarker Interim analysis expected in 2H 2026 SAN FRANCISCO, Sept. 24, 2025 (GLOBE NEWSWIRE) --...Read more
Open-label study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) in patients with treatment-resistant depression and demonstrated rapid, clinically meaningful and durable antidepressant effects, which are sustained for up to 3 months The second dose of BPL-003 led to further reductions in MADRS scores from baseline, indicating that this regimen has the potential to enhance the clinical...Read more
POTOMAC, MD / ACCESS Newswire / September 22, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage pharmaceutical company focused on therapies for Alzheimer's disease, today announced it has reached a key enrollment milestone of 50% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease. This milestone marks a significant step in advancing IGC-AD1, the Company's...Read more
SAN DIEGO, Sept. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new data from the Phase 2 SAVITRI™ study, which showed statistically significant and clinically meaningful improvement in depression severity at Day 28 and Day 56 with once-daily oral administration of 1 mg osavampator (NBI-1065845). In recognition of the data presentation, Neurocrine was honored with the...Read more
ZUG, Switzerland and BOSTON and SAN DIEGO and SHANGHAI, Sept. 22, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Sirius Therapeutics, a clinical stage biotech company developing innovative small interfering RNA (siRNA) therapies for global markets, today announced that the first...Read more
The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS) Patients completing the initial 24-week treatment will be invited to participate in a 24-week blinded extension period, during which all participants will receive COYA 302 The ALSTARS Trial will enroll 120 ALS participants at approximately 25 centers in...Read more
Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue therapy (PRN) and further improvement sustained in open-label extension (OLE) Positive findings in bone and kidney biomarkers All patients completed the 12-week AvailTM trial and 94% entered the OLE Once-weekly canvuparatide was generally well tolerated, with no treatment-related serious adverse events or discontinuations during the...Read more
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19* Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech”...Read more
Interim efficacy analysis highlights potential value of combination therapy of apalutamide and ENV105 following positive safety data Company to host virtual KOL discussion today to provide additional perspective on data and the Company’s lead program LOS ANGELES / Sep 18, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today...Read more
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE...Read more
ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients BOSTON,...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
CLICK TO LEARN MORE