Enrollment Completed in C-BEYOND Phase 3 Trial with More Than 880 HCV Treatment-Naïve Patients in US and Canada C-BEYOND Topline Results Expected Mid-2026 C-FORWARD Phase 3 Trial, Conducted Outside North America, Enrollment Completion Expected Mid-2026 with Topline Results Anticipated Year-End 2026 C-BEYOND AND C-FORWARD are the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for Treatment of HCV BOSTON, Dec....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
Enrollment will begin in January 2026 Participants will be treated with buntanetap for 36 months The study aims to enroll 500 patients MALVERN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced...Read more
Toronto, Ontario--(Newsfile Corp. - December 18, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo"), a leader in diagnostic and prognostic innovation through advanced telomere analytics, today announced the initiation of a new multiple myeloma (MM) Minimal Residual Disease (MRD) clinical trial in collaboration with the University of Athens. This retrospective study is a key component of Telo's expanding,...Read more
Enrollment momentum accelerates as Company advances toward full enrollment White Bear Lake, Minnesota--(Newsfile Corp. - December 18, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant has achieved yet another milestone by...Read more
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071 There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs) Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2...Read more
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with...Read more
Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Cambridge, Massachusetts, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company...Read more
Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD) KOL event planned for early January to...Read more
Data expected in Q2 2026 DUBLIN, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind,...Read more
The combination of denifanstat and resmetirom was generally well-tolerated Pharmacokinetic (PK) results support further development of the combination A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics...Read more
In ATTAIN-MAINTAIN, orforglipron achieved the primary and all key secondary endpoints for weight maintenance vs. placebo at 52 weeks following weight loss on Wegovy or Zepbound Participants who switched to orforglipron from Wegovy maintained all but 0.9 kg of their previously achieved weight loss on average Lilly has submitted orforglipron to the U.S. Food and Drug Administration for the treatment of obesity INDIANAPOLIS, Dec. 18,...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
Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psoriasis More than half of study participants treated with zasocitinib achieved clear or almost clear skin (PASI 90), and on average about 30 percent achieved completely clear skin (PASI 100) by week 16 Zasocitinib was generally well-tolerated with a safety profile consistent with previous...Read more
End-of-Phase 2 interactions with FDA complete; scientific advice received from EMA Company expects to dose first patient in global Phase 3 registrational trial, MAPKeeper 301, in mid-2026 Overall survival update for Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients planned in coming weeks NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage...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
Planned Review of Standard Deviation Demonstrates No Need to Increase Size of Ongoing LEVEL Study LEVEL On Track to Complete Enrollment in First Half of 2026; Topline Data Expected in Second Half of 2026 Global Phase 3 LEVEL-2 Study Initiated; Company Estimates Completion of Enrollment by End of 2027 CHAPEL HILL, N.C., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the...Read more
Completion of Enrollment Positions CELZ for Near-Term Data Catalysts and Accelerates Path Toward Commercialization of a Transformative, Non-Opioid Therapy for Chronic Lower Back Pain PHOENIX, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced the successful completion of patient enrollment...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
Emory University physician-sponsored clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta Results demonstrated WP1066 induces anti-tumor immune responses and were recently published in the Journal of Clinical Investigation Insight WP1066 found to be safe and effective, warranting a Phase 2 trial HOUSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX)...Read more
Study did not demonstrate statistically significant improvement on primary endpoint of reduction in anxiety as measured by SUDS scores compared to placebo Favorable safety and tolerability data were consistent with previous studies Company’s cash preservation measures expected to provide runway into 2027 SOUTH SAN FRANCISCO, Calif. / Dec 17, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical...Read more
SAN FRANCISCO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671, the company’s lead oral small molecule amylin receptor agonist for the treatment of obesity. ACCG-2671 was...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
Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Data support 4D-710’s potential to be a durable, redosable, variant-agnostic, disease-modifying treatment for people with cystic fibrosis lung disease with high unmet need Webcast today at...Read more
NESS ZIONA, Israel, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease. Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept...Read more
The study is designed to evaluate the safety and clinical activity of NXP900 in combination with osimertinib in patients with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC) whose cancers initially responded to treatment with osimertinib but subsequently acquired resistance to treatment Fort Lee, NJ, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage...Read more
PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of...Read more
First and only immunotherapy plus ADC regimen, used perioperatively, to extend survival for cisplatin-eligible patients with MIBC RAHWAY, N.J. / Dec 17, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based...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
First-in-human trial of candidate from the next-generation ATTC platform Simultaneous China and global clinical development strategy to expedite development process HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class...Read more
SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology today announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda® (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma...Read more
VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm Safety results were consistent with the safety profile observed in the VIASKIN Peanut...Read more
Results from the QUILT-3.032 study of 80 subjects, published in The Journal of Urology, showed 96% disease-specific survival and 83% progression-free survival at 36 months, demonstrating the long-term duration of effect of ANKTIVA® in patients with high-grade papillary NMIBC without CIS1 High cystectomy avoidance rates of 92% and 82% were seen at 12 months and 36 months1, validating the durable response and bladder sparing effect of...Read more
Vancouver, Canada, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the successful completion of patient enrollment for the second cohort in its ongoing FDA-approved Phase I/IIa clinical trial...Read more
Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026 Topline results on track for the second quarter of 2026 SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical...Read more
The registrational TACTI-004 Phase III has enrolled 289 patients globally, over 38% of the trial’s targeted enrolment Strong operational progress continues globally with over 120 activated clinical sites and 27 countries having received full regulatory approvals including the United States Futility analysis remains on track for the first quarter of CY2026 and completion of patient enrolment in the third quarter of CY2026 SYDNEY,...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
In mCRPC patients with androgen receptor (AR) mutations, treatment with MRT-2359 in combination with enzalutamide led to a 100% PSA response rate (4 of 4 patients) and a 100% disease control rate, including 2 patients with RECIST responses and 2 with stable disease Combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 adverse events Company plans to initiate a new, signal-confirming...Read more
Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Dec 15, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment...Read more
SOUTH SAN FRANCISCO, Calif. / Dec 15, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that the last patient has completed their last visit in the company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP in Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial of its...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
Registrational trial met primary endpoint, with varegacestat significantly improving progression-free survival vs. placebo (hazard ratio = 0.16, p<0.0001) Trial also met all key secondary endpoints, with varegacestat delivering an objective response rate of 56% Varegacestat was generally well tolerated with a manageable safety profile New Drug Application submission to U.S. FDA planned for Q2 2026 Company to host conference call...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
STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01. A preliminary analysis of...Read more
15 December, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued. The...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
As monotherapy, imlunestrant demonstrated an 11.4-month numeric improvement in median OS versus endocrine therapy in patients with ESR1-mutated disease In all patients, the imlunestrant plus abemaciclib combination achieved a median PFS of 10.9 months, demonstrated a favorable OS trend, and extended time to chemotherapy by more than a year These data were published simultaneously in Annals of Oncology and will be presented today at...Read more
ATNM-400's target antigen is overexpressed in breast cancer and its expression is further increased in breast cancer cells resistant to standard of care endocrine therapy, tamoxifen and the HER2 therapy trastuzumab The Actinium-225 alpha-emitter payload of ATNM-400 induced irreversible double-strand DNA breaks and has the potential to produce potent localized tumor killing with reduced off-target lung toxicity that limits the use of...Read more
The Phase 3 STAR-221 study evaluating a domvanalimab-based combination in upper gastrointestinal cancers will be discontinued due to futility Arcus is continuing to expand its development program for casdatifan, a potential best-in-class HIF-2a inhibitor with robust single-agent activity, and multiple data readouts are expected in 2026 Arcus’s early development efforts will focus on five programs targeting inflammatory and autoimmune...Read more
Consistent OS benefit in an Asian subset with a strong HR of 0.69 for non-squamous patients, and meaningful safety advantage position Plinabulin as a late-stage candidate showing survival improvement in 2L/3L EGFR WT NSCLC. FLORHAM PARK, N.J., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced...Read more
Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose Results Support Advancement of the Program into Phase 2 Development Combination of Keytruda® and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients SAN JOSE, Calif., Dec. 11, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"...Read more
Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH SAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor...Read more
MyPEAK-1 Protocol Amendments Agreed Upon with FDA; Tenaya Implementing Changes with Sites SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced it has received official notification from the U.S....Read more
TN-401 was Well Tolerated at 3E13 vg/kg dose Robust Transduction and Demonstrated Increases in PKP2 Protein Levels in First Two Patients at Week 8 Clinically Meaningful Reductions in Arrhythmia Burden Observed in First Two Patients with More Than Six Months of Follow-Up Tenaya Management to Host a Webcast Conference Call Thursday, December 11 at 5:00 pm ET to Review Preliminary Results SOUTH SAN FRANCISCO, Calif., Dec. 11,...Read more
For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrant For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the...Read more
Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy CHICAGO, Dec. 11, 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 that the first patient has been dosed...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
Ra’anana, Israel, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced new results from its ongoing preclinical evaluation of its proprietary intranasal naloxone hydrogel formulation, demonstrating promising permeation kinetics that complement the Company’s previously reported stability and...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
Inhibiting prolactin receptor (PRLR) signaling with the ABS-201 anti-PRLR antibody promotes human hair follicle growth ex vivo Human ex vivo data validate ABS-201’s potential to reverse follicular miniaturization and drive vellus-to-terminal hair regeneration by demonstrating that it prolongs anagen, stimulates keratin synthesis, and modulates the stem cell niche Full dataset will be presented during today’s ABS-201 Key Opinion...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
In DUBLIN-3 non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1, Plinabulin + docetaxel showed consistent and clinically meaningful improvements in OS, PFS, and ORR, reinforcing Plinabulin as a late-stage therapy with consistent survival benefit in anti-PD-(L)1-progressed NSCLC patients. Supported by anti-cancer efficacy and safety in significant reduction exposure-adjusted grade 3/4 adverse events in DUBLIN-3,...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
CRB-913 was safe and well-tolerated across all doses studied Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participants A placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12) A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026 Company to host conference call and live webcast today...Read more
Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET REDWOOD CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by...Read more
Data demonstrates the significant and sustained tumor regression achieved by the CAPTN-3 platform across two distinct tri-specific antibodies, IM1240 and IM1305, targeting different tumor antigens Transcriptomic analysis across ~11,000 TCGA samples shows NKG2A expression is strongly associated with tumor expression of 5T4 or TROP2, supporting inclusion of the NKG2A arm in CAPTN-3 designs NKG2A arm significantly contributes to IM1240...Read more
In TRIUMPH-4, participants with obesity and knee osteoarthritis taking retatrutide 12 mg lost an average of 28.7% of their body weight at 68 weeks Retatrutide reduced WOMAC pain scores by up to an average of 4.5 points (75.8%) and significantly improved measures of physical function, with more than 1 out of 8 retatrutide-treated patients completely free from knee pain at the end of the trial Seven additional Phase 3...Read more
Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its...Read more
Multiple active sites and strong US enrollment continue to support Q3 2026 timing for topline data readout Clinical trial sites in Canada and the United Kingdom have received regulatory clearance to enroll All patients who have completed HERO trial to date have successfully enrolled and remain in the Open Label Extension trial SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a...Read more
Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or...Read more
TUKYSA, trastuzumab, and pertuzumab reduced the risk of disease progression or death by 36% compared to trastuzumab and pertuzumab alone in Phase 3 HER2CLIMB-05 study The combination demonstrated a manageable safety profile as a first-line maintenance therapy NEW YORK / Dec 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA®...Read more
Momentum continues to build for Company as series of clinical milestones are met, design choices cement differentiation from competition, and timeline comes into focus White Bear Lake, Minnesota--(Newsfile Corp. - December 10, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the completion of the first set of...Read more
First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters SYDNEY, Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today...Read more
VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial VTP-1000 was well-tolerated with no treatment-related SAEs The MAD portion of the trial, which includes a gluten challenge, is ongoing GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and...Read more
MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on...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
Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its...Read more
Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer Significant unmet need in pancreatic cancer where median overall survival...Read more
Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number...Read more
Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical...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
No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2...Read more
TECVAYLI® and DARZALEX FASPRO® combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up Combination regimen granted Breakthrough Therapy Designation by U.S. FDA ORLANDO, Fla., Dec. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the...Read more
The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a front-line CLL study These data will be simultaneously published in the Journal of Clinical Oncology and highlighted in a late-breaking oral presentation at the 2025 American Society of Hematology Annual Meeting and Exposition, and were featured as part of the meeting's press...Read more
Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC) Enrollment exceeding expectations with strong clinical site and patient interest Topline interim data readout expected in 1H2026 Phase 3 combination regimen continues under FDA Fast Track designation PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell...Read more
City of Hope to Evaluate PEDMARK® for Reducing Ototoxicity in Adult Men with Stage II-III Metastatic Testicular Germ Cell Tumors Initiation of Study Reflects Growing Clinical Interest in Addressing the Burden of Hearing Loss Among Patients Receiving Cisplatin-Based Chemotherapy RESEARCH TRIANGLE PARK, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical...Read more
ASH 2025 oral presentation on SENTI-202 in 20 Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients (18 response evaluable) shows high efficacy: 50% ORR and 42% CR/CRh (100% of CRs and 83% of all responses were MRD negative) at RP2D, 7.6 months median duration of composite Complete Remission across all patients, and a favorable safety profile Pharmacodynamic data from these patients validate SENTI-202’s novel OR/NOT Logic Gate...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...
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