NEW HAVEN, Conn., Dec. 24, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for the treatment of major depressive disorder (MDD). The study did not meet...Read more
In the CIRRUS-HCM trial, including interim safety results from Part D, EDG-7500 was generally well tolerated; no clinically meaningful reductions in LVEF or LVEF <50% On track to deliver full 12-week Part D readout in 2Q 2026 and Phase 3 start in 4Q 2026 BOULDER, Colo., Dec. 24, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), today announced positive updates from the ongoing CIRRUS-HCM, Phase 2...Read more
Improvements observed in key non-invasive markers of fibrosis across treatment arms versus placebo, with continued reductions from 24-week timepoint Additional weight loss from 24 to 48 weeks with 1.8 mg dose, without plateauing Favorable tolerability profile of pemvidutide preserved at 48 weeks, reinforced by low treatment-related discontinuation rate End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3...Read more
LA JOLLA, Calif., Dec. 18, 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 announced the successful completion of patient enrollment in the randomized, placebo-controlled Phase 2 clinical trial, the OXTOX study (Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer)....Read more
Phase 2b BiRCh Study of Brensocatib in CRSsNP Did Not Meet Primary or Secondary Efficacy Endpoints; Safety Consistent with Previous Studies; Insmed Discontinues CRSsNP Program Company Acquires Phase 2 Ready Monoclonal Antibody for Potential Respiratory and Immunological & Inflammatory Indications BRIDGEWATER, N.J., Dec. 17, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company...Read more
First Patient Dosed with Intranasal Foralumab in Randomized, Placebo-Controlled Phase 2 Trial Builds on Recent Evidence of Persistent Neuroinflammation in Alzheimer’s Patients Treated with Anti-Amyloid Therapies BOSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development...Read more
Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine Company on track to conduct formal interim analysis in early 2026 VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today...Read more
Optimized Gel Formulation Demonstrates Clinical Success in Third Cohort of Patients PRINCETON, N.J., Dec. 17, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today extended results of its ongoing Phase 2a trial of SGX302 (synthetic...Read more
Ratutrelvir shows a differentiated profile versus PAXLOVID™ with fewer adverse events and no viral rebounds Activity shown in Paxlovid®-ineligible patients, representing a significant population with few effective treatment options Final data analysis to be reported in January 2026 NEWTOWN, Pa., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage...Read more
Achieved target product profile on the primary endpoint, with a mean percent reduction in SALT score at 36 weeks of 28.2% in the 24 µg/kg arm versus 11.2% in placebo Mean percent reduction in SALT scores at 36 weeks was 30% for both treatment arms versus 6% for placebo, achieving statistical significance (p<0.05) when excluding four patients that did not meet major study eligibility criteria at baseline Safety profile showed...Read more
THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) -- 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...Read more
Orelabrutinib is the first BTK inhibitor to demonstrate significant clinical activity in a Phase 2 clinical trial for SLE Zenas acquired the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of Multiple Sclerosis globally, and non-oncology fields in all territories outside Greater China and Southeast Asia, in October 2025 license agreement with InnoCare WALTHAM, Mass., Dec. 15, 2025...Read more
Landmark results could pave the way for miv-cel to become the first FDA-approved CAR T-cell therapy for autoimmune disease; Company on track to submit BLA for stiff person syndrome in 1H 2026 Miv-cel achieved statistically significant clinical benefit across all primary and secondary endpoints, reversing disability and eliminating immunotherapies after a single dose Miv-cel was generally well-tolerated with no...Read more
First Patient Expected to be Dosed Next Week with Intranasal Foralumab PET Scan Shows Presence of Untreated Neuroinflammation in Alzheimer’s Patient on Leqembi® (Lecanemab) Anti-Amyloid Therapy BOSTON, Dec. 12, 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...Read more
Patients treated with 0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo group These findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal pain Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy LONDON and NEW YORK, Dec. 11, 2025...Read more
BOSTON, Dec. 11, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform. The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with...Read more
Antigen spreading was evaluated in a subset of Phase 2 patients to assess the ability of ELI-002 7P to broaden immune responses to personalized tumor neoantigens not present in the targeted immunotherapy 87% (13/15) of evaluated patients demonstrated induction of T cell responses to tumor neoantigens beyond mKRAS following ELI-002 7P therapy The induction of non-mKRAS antigen-specific T cell responses supports the potential for...Read more
BMI and hyperphagia reductions have been observed in patients with PWS treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5); 17 of 18 enrolled patients remain on therapy Promising results supportive of Phase 3, registrational trial of setmelanotide in PWS Company initiated Phase 1, Part D study to evaluate weekly MC4R agonist RM-718 in patients with PWS Company to hold conference call on Thursday, December...Read more
Results show, for the first time, that targeting underlying a-syn pathology with an active immunotherapy could slow the rate of progression of Parkinson’s disease Clear safety profile with no clinically relevant safety issues reported Targets met for immunogenicity (100% responder rate), pharmacodynamic effect, target engagement and clinical assessments Underlines potential and importance of active immunotherapies in precision...Read more
POTOMAC, MARYLAND / ACCESS Newswire / December 9, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's...Read more
The ALSTARS Trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of COYA 302 in patients with amyotrophic lateral sclerosis (ALS) being conducted at clinical sites in the United States and Canada Dosing of ALS patients has commenced in the ALSTARS Trial and signifies a key milestone for the Company. COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, is...Read more
Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression...Read more
VT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002). Patient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002) VT-1953 was well-tolerated, with no new safety concerns observed. Based on these...Read more
Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and...Read more
Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose...Read more
Following internal analysis and Data Monitoring Committee (DMC) feedback, the Company has elected to discontinue the BX004 Cystic Fibrosis (CF) Phase 2b trial BiomX continues to see potential in BX011, its phage program for Staphylococcus aureus (S. aureus) infections associated with diabetic foot infections (DFI). The Company is also implementing cost cutting measures, while evaluating strategic alternatives NESS ZIONA,...Read more
NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95% NEXICART-2 final readout and BLA submission planned in 2026 LOS ANGELES, CA, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”,...Read more
Combination of evorpacept plus rituximab and lenalidomide (R2) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R2 alone Data indicates combination of evorpacept plus R2 was well-tolerated and provides impressive anti-tumor activity in frontline treatment setting While longer follow up matures, minimal residual...Read more
96% Overall Response Rate, 74% Stringent Complete Response/Complete Response, and 95% Minimal Residual Disease Negativity Observed at a Median 15.9-months of Follow-up, with Responses Continuing to Deepen Over Time Observed Safety Profile is Predictable and Manageable to Date; No Delayed Neurotoxicities or Immune Effector Cell-Associated Enterocolitis across Phase 1 and 2 (iMMagine-1) Studies Data from Investigational Agent Anito-cel...Read more
Anito-cel demonstrated 96% ORR and 74% CR/sCR at a median follow-up of 15.9 months; responses continue to deepen over time Overall MRD negativity was 95% and sustained MRD negativity for >6 months was 83%, both at 10-5 sensitivity level 12-month PFS and OS rates were 82.1% and 94.0%; 18-month PFS and OS rates were 67.4% and 88.0%; 24-month PFS and OS rates were 61.7% and 83.0% To date, no delayed or non-ICANS neurotoxicities,...Read more
Lisaftoclax monotherapy demonstrated significant and durable clinical efficacy and a manageable safety profile in patients with heavily pretreated BTK-refractory R/R CLL/SLL, underscoring its utility as a potential new treatment option Lisaftoclax achieved a 62.5% objective response rate (ORR) in heavily pretreated, BTKi-refractory patients, nearly half with complex karyotype Lisaftoclax monotherapy demonstrated a median...Read more
Demonstrated meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status Anemia response was seen independent of concomitant JAK inhibitor therapy use WATERTOWN, Mass., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients...Read more
New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation RARITAN, N.J., Dec. 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today that...Read more
Post-hoc analysis of RAP-219 Phase 2a data showed early onset of action and consistency of median response over the entire treatment period, along with consistent efficacy data regardless of patients’ disease severity RAP-219 demonstrated meaningful improvements in patient-reported seizure severity among those with moderate or greater baseline impairment BOSTON and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Rapport...Read more
An independent Data Safety Monitoring Board (DSMB) confirms EB103’s favorable safety profile with no treatment-related serious adverse events (SAEs) even in high-risk patients who are ineligible for currently available commercial CD19 products DSMB recommends advancement of STARLIGHT-1 to Phase II at the Recommended Phase II Dose (RP2D) High-dose cohort of Phase I achieved a 100% complete response (CR) rate at Month 1 Data supports...Read more
Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome Milestone payment to Evotec expected upon first dosing of first study participant in early 2026 HAMBURG, DE / ACCESS Newswire / December 4, 2025 / Evotec SE (Frankfurt Stock Exchange:EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ:EVO) today announced that its partner Bayer AG has initiated a Phase 2...Read more
BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involved in the progression of kidney damage in Alport Syndrome (AS), a rare genetic disorder Bayer explores opportunity to address high unmet medical need of patients suffering from AS and advances research efforts through close cooperation with AS patient organizations Derived from the strategic...Read more
TARA-002 demonstrates 72% complete response rate at any time in BCG-Naïve patients TARA-002 demonstrates a 69% complete response rate at the 6-month landmark and a 50% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile observed with no Grade 3 or greater treatment-related adverse events reported Company obtained written feedback from FDA on registrational path forward for...Read more
Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to date PFS data for 1L NSCLC patients expected in Q2 2026; Company continues to explore partnership opportunities for pivotal development of silevertinib Based on encouraging CNS activity of silevertinib in...Read more
Strengthening our Advisory Board with addition of Mark McKenna as Strategic Advisor and Peter Libby, MD as a Clinical Advisor Expanding the Phase 2 recurrent pericarditis study into Canada, EU and the UK to evaluate QD dose ranging in preparation for the global Phase 3 development plan Interim analysis for the ongoing Phase 2 recurrent pericarditis study to now be presented as part of Ventyx’s R&D Day planned for Q1 2026 SAN...Read more
Proof-of-concept study underway for investigational oral therapy in Fragile X syndrome; top-line data from Phase 2 expected in 2027 FOSTER CITY, Calif. / Dec 01, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that the first participant has been enrolled in the BLOOM Phase 2 clinical study evaluating MRM-3379 in Fragile X syndrome (FXS). Caused by a mutation of the...Read more
Phase II ARCHER trial showed a significant reduction in left ventricular (LV) mass (p=0.0117) and improvements in multiple key cardiac MRI (CMR) measures of structural heart recovery in patients with acute myocarditis. Results provide clinical evidence that CardiolRx™ reduces inflammation-driven structural damage in the heart, an important cause of heart failure progression. The ARCHER data strengthen the scientific and...Read more
The Company continues working with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial An independent Data Monitoring Committee (DMC) completed a safety review following adverse events identified in the BX004 Phase 2b trial and recommended that the study continue with revised dosing Following the DMC...Read more
BOSTON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass...Read more
Data from the KT-621 BROADEN2 Phase 2b AD patient trial expected to be reported by mid-2027 KT-621 BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 Completed dosing in KT-621 BroADen Phase 1b AD trial with data to be reported in December 2025 WATERTOWN, Mass., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small...Read more
Updated data expands clinically meaningful results available from FIREFLY-1 pivotal trial 77% of patients who entered the treatment-free observation period following OJEMDA treatment remained off therapy for at least 12 months The median time to next treatment (TTNT) following initiation of OJEMDA exceeded 3.5 years BRISBANE, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One”...Read more
PIPE-307 demonstrated an acceptable safety and tolerability profile PIPE-307 treatment did not result in a significant change in binocular 2.5% low contrast letter acuity (LCLA) SAN DIEGO / Nov 20, 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...Read more
Topline data expected in first quarter of 2026 Head-to-head studies of AL001 versus a marketed lithium carbonate product was conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, Nov. 19, 2025 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of...Read more
80% of patients that completed treatment and 100% of patients that completed the eight-week response assessment achieved clinical success Clinical success achieved with one or two doses of TARA-002 in 88% of patients TARA-002 demonstrated favorable safety and tolerability profile with no serious adverse events reported Company to host conference call and webcast featuring Key Opinion Leader Dr. Jesse Jones at 8:30 a.m. ET NEW...Read more
Pivotal Phase III liver cancer study enrolling in Europe and Israel RAMAT GAN, Israel, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, announced today that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete...Read more
WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the primary endpoint of pulmonary vascular resistance (PVR) compared to placebo, improving the ability of blood to transition through the lungs to the heart These data support proof-of-concept to inform Phase 3 development for WINREVAIR in this population RAHWAY, N.J. / Nov 18, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
Vanda's Tradipitant Study Success Positions it as Key Adjunct in $50B+ Global GLP-1 Agonist Market WASHINGTON, Nov. 17, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leading biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced positive topline results from its randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant, an...Read more
NEWTON, Mass., Nov. 17, 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 that the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in...Read more
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
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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