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
King of Prussia, Pennsylvania--(Newsfile Corp. - November 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today the completion of enrollment in its ongoing Phase 1b clinical trial of INTASYL siRNA PH-762. In connection with completing enrollment, Phio continues to...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
PSA is a validated FDA-recognized clinical endpoint in assessing prostate cancer treatment response; Telomir-1 lowered PSA levels in a dose-related manner. MIAMI, FLORIDA / ACCESS Newswire / November 25, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today...Read more
First patient recruited at leading Israeli site accelerating enrollment momentum across global study of CMND-100 Vancouver, Canada, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced that Tel...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
Vancouver, Canada, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced that its independent Data and Safety Monitoring Board (DSMB) has completed a scheduled interim review of the Company’s ongoing...Read more
November 24, 2025 - Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who currently have no...Read more
New Drug Application to be submitted in early 2026; target PDUFA in Q1 2027 Utility patent applications filed with potential exclusivity to 2044 PLYMOUTH MEETING, Pa. / Nov 24, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive findings from both the pivotal BE and...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
Target enrollment of 6,000 participants completed in the Northern Hemisphere Planned interim analysis in Q1 2026 will determine potential need for additional enrollment during Southern Hemisphere flu season SAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it has...Read more
CAMBRIDGE, Mass. / Nov 24, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today shared progress in the Phase 1/2 multiple ascending dose (MAD) clinical study of SRP-1003 (formerly ARO-DM1), an investigational small interfering RNA (siRNA) therapeutic for the treatment of type 1 myotonic dystrophy (DM1). Cohorts 1 (1.5 mg/kg) and 2 (3 mg/kg) of the study are...Read more
Week 16 follow-up data, coupled with blinded exit interviews conducted up to 364 days after the study period, confirm durable and wide-ranging upper and lower-body improvements compared to placebo Participant-reported outcomes highlight substantial improvements in bladder control and muscle spasticity compared to placebo Statistically significant reduction of hyperactive reticulospinal signaling in upper and lower limbs (via...Read more
Zero Treatment Related Adverse Events observed during Cohort 7 (37mg capsules) DLT period Cohort 7 Pharmacokinetic (PK) profile continues to demonstrate dose-proportionality and Cmax/Cmin ratio <2. Achieved exposures (AUC) of 6,690 ng·h/mL Pharmacodynamic (PD) data support continuous suppression of MAPK pathway throughout the 24-hour cycle Safety Review Committee recommended that trial escalate to the next dose...Read more
First patient randomized into HELIOS-3, which along with HELIOS-2 form the basis of AXPAXLI’s registrational program in non-proliferative diabetic retinopathy (NPDR) HELIOS-2 and HELIOS-3 are global, complementary superiority trials using a novel ordinal diabetic retinopathy severity scale (DRSS) primary endpoint Targeting a broad diabetic retinopathy (DR) label by including patients with non-center-involved diabetic macular edema...Read more
Nes-Ziona, Israel, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. ( Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra™ trial (ENX-CL-05-001) in patients with moderate to severe knee osteoarthritis (OA). The six-month follow-up has now been completed for...Read more
Company Announces Approximately $30 Million in Cash and Short-Term Investments Following Its October 27th Registered Direct Offering MILAN, Italy and NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a clinical-stage biotechnology company developing a cell-based platform for targeted delivery of therapeutic payloads in oncology, today announced an update from its ongoing TEM-GBM study in newly diagnosed...Read more
OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor Bayer will globally engage with health authorities in preparation for the submission of marketing authorization...Read more
Tablet PK exposure increases proportionally with an increase in dose More favorable PK properties in tablets enable a lower dose to achieve the same exposure as the capsule formulation, with improved predictability and reduced variability Tablet steady state showing Cmax/Cmin ratio <2 MIAMI, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a...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
CAREFNDR underscores the potential clinical value of paltusotine beyond acromegaly, and demonstrates progress in Crinetics’ commitment to addressing unmet needs in the neuroendocrine tumor community SAN DIEGO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind,...Read more
Evidence of Monotherapy Activity: Partial response observed in a MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation who remains on trial for more than 11 months A second MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation has achieved stable disease and remains on trial for more than 6 months Initial Disease Control Rate in efficacy evaluable patients of 71.4% with BRAF-mutated tumors: 5 of 7...Read more
HOUSTON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for...Read more
Prestigious Hadassah Medical Center Joins Yale, Johns Hopkins, Tel Aviv Sourasky and IMCA, in Evaluating the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate Vancouver, Canada, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to...Read more
BP1.15205 is a differentiated chemical scaffold, demonstrating high potency and selectivity in preclinical studies with a favorable safety profile and the potential for once-daily dosing Topline clinical data expected in 2026 PLYMOUTH MEETING, Pa. / Nov 19, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced dosing of the first participant in a Phase 1 clinical trial of BP1.15205, an...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
50 of 80 patients enrolled in FLASH2 study Blinded Response Rate to Date Exceeds Trial Estimate PRINCETON, N.J., Nov. 19, 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 that it has completed the planned enrollment...Read more
New Clinical Trial Site Added for Clinical Studies of Reqorsa® Gene Therapy to Treat Lung Cancer Acclaim-1 and Acclaim-3 Clinical Trials Supported by FDA Fast Track Designation AUSTIN, Texas, Nov. 19, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the Company has...Read more
No changes in protocol recommended for LUGANO and LUCIA clinical trials Masked safety data continues to show no safety signals, consistent with previous clinical trials for DURAVYU On track to report topline 56-week data for LUGANO in mid-2026 with LUCIA data to closely follow WATERTOWN, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and...Read more
Trial met primary endpoint of hemoglobin response and key secondary endpoints of change from baseline in hemoglobin concentration and indirect bilirubin Trial showed trend favoring mitapivat but did not meet statistical significance in primary endpoint of annualized rate of SCPCs (pain crises), and the key secondary endpoint of change from baseline in PROMIS Fatigue was not met Patients in the mitapivat arm who achieved hemoglobin...Read more
Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug,...Read more
78-Week Study Evaluating Subcutaneous VK2735 in Adults with Obesity Enrollment Completed Ahead of Schedule and Above Target Size, Indicating Strong Interest in VK2735 SAN DIEGO, Nov. 19, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of patient...Read more
IRVINE, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced preliminary results from an investigator-initiated trial conducted at the University of Chicago Medicine’s Transplant Institute and presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, held November 14-17, 2025 at City of Hope in Los Angeles, California. The ongoing trial, which has been...Read more
Vancouver, Canada, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced positive top-line results from the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary...Read more
The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods RAMAT-GAN, Israel, Nov. 18, 2025 /PRNewswire/...Read more
The trials expansion highlights the Company's clinical momentum and growing confidence in the device's adoption and Company's commercial strategy White Bear Lake, Minnesota--(Newsfile Corp. - November 18, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that all 10 patients in the first stage of its pivotal clinical...Read more
Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:...Read more
Data demonstrate a favorable bioavailability profile of INM-901 oral formulation Data will support design and planning of first in human clinical trials Preparing for pre-IND meeting with the FDA Vancouver, British Columbia--(Newsfile Corp. - November 18, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company developing a pipeline of proprietary small-molecule drug candidates for...Read more
First Patient Dosed at The Ohio State University Wexner Medical Center in this Multi-Center Trial Active component of HCW9302 is interleukin-2 -- cytokine that maintains proper numbers and functions of regulatory T cells to control excessive inflammation Gateway to development of a first-in-kind immunotherapeutic for autoimmune and pro-inflammatory diseases MIRAMAR, Fla., Nov. 18, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB”...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
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting Data to be presented at an upcoming medical meeting and shared with health authorities around the world lidERA is the second positive Phase III readout for...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
First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/...Read more
Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical...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
Multicenter, randomized, controlled study will evaluate Company’s next-generation multichannel TMS technology in reducing heavy drinking and cravings BURLINGTON, Mass. and JERUSALEM, Nov. 17, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced the launch of a multicenter clinical trial investigating...Read more
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively In the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively Neladalkib demonstrated...Read more
Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus the PD-1 inhibitor Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS...Read more
Ziihera® plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab...Read more
The 52-week symptom data reported for Cohort 6 patients is consistent with the long-term durability data previously reported from Cohort 5; Cohorts 5 & 6 are the only groups to reach 52 weeks thus far. In Cohort 6, a durable clinical symptom response was observed 52 weeks after a single administration of EP-104GI. All 3 patients in Cohort 6 maintained a clinical benefit and 2 out of 3 patients remain in clinical remission 52 weeks...Read more
Efficacy data remain consistent with prior disclosure and continue to demonstrate broad and deep PSA responses, with 55% PSA50 response rate and 20% PSA90 response rate Rapid and deep ctDNA reductions were observed in 76% of patients and ctDNA clearance was observed in 59% of patients, underscoring potential for long-term treatment and survival benefit PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels...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
RA'ANANA, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the “Company”), a pioneer in innovative life-support and diagnostic technologies, today announced the completion of the clinical study for its HYLA, non-invasive blood sensor, toward regulatory submission and future commercialization. Based on the clinical trial results and ongoing lab...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
Completion of treatment for the first 45 patients on pace for Q1 2026 with initial unblinded data thereafter; blinded response activity tracking within expected range HOUSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an enrollment update with 60% of the target number of subjects for the first planned interim unblinding of data having consented to its...Read more
The study demonstrated that personalizing the stimulation parameters to each user dramatically enhanced autonomic effects FREMONT, CA / ACCESS Newswire / November 13, 2025 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a diversified immunotherapeutics company, announced today it has optimized key device and treatment parameters including frequency, amplitude, electrode positioning, and duration of stimulation as a result of its...Read more
The Novel HIV Therapy has the Potential to Expand Options for Virologically Suppressed Adults Treated with Complex ART Regimens Phase 3 Results from ARTISTRY-1 and 2 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Nov 13, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the...Read more
NEW YORK CITY, NY / ACCESS Newswire / November 13, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel therapeutics for stress-related neuropsychiatric and neurodegenerative disorders, today announced the successful completion of enrollment and dosing in its Multiple Ascending Dose (MAD) Phase 1 study evaluating its lead compound, known as PT00114. The study, conducted in healthy volunteers, was...Read more
Publication of Interim Results and Presentation at Recent Industry Event Demonstrate Clinical Benefit Associated with Use of EPIEFFECT When Compared to Standard of Care (“SOC”) Publication Adds to Large Compendium of Evidence for MIMEDX’s Leading Product Portfolio Trial Enrollment Ongoing MARIETTA, Ga., Nov. 13, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced the publication...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
Multidomain, durable gains with continued skill acquisition over time All 8 participants showed functional gains across spectrum of disease severity 35 total developmental milestones/skills acquired across 8 participants NGN-401 at the registrational dose continues to be generally well-tolerated, with no evidence of HLH Neurogene management to discuss results during Stifel 2025 Healthcare Conference webcast today at 4:40 p.m....Read more
New live-cell imaging data show that Telomir-1 markedly lowers intracellular iron levels at submicromolar concentrations in human keratinocytes, demonstrating potent cell penetration and iron-modulating activity - key to its broader epigenetic mechanism of action. MIAMI, FL / ACCESS Newswire / November 12, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company...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
32 patients with autoimmune disease treated with AlloNK plus anti-CD20 monoclonal antibody (mAb) as of October 1, 2025, data cutoff All patients received AlloNK as outpatients, and the majority were treated in community rheumatology trial sites with no specialized oncology oversight, demonstrating the feasibility of administering this regimen outside the hospital setting No cytokine release syndrome (CRS), or immune effector...Read more
Company to host conference call and webcast today, November 12, at 8:30 am EST/2:30 pm CET IMA402 and IMA401 TCR Bispecifics showed favorable tolerability at RP2D as well as deep and durable responses in heavily pre-treated, last-line patients with a range of solid tumors IMA402 PRAME Bispecific at RP2D range resulted in a 30% cORR (6/20) across all indications, including 29% (4/14) in melanoma and 2/3 confirmed responses in ovarian...Read more
WALTHAM, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced data from a post hoc analysis of the GALE extension study following five years of continuous treatment with SYFOVRE® (pegcetacoplan injection), the leading treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The results demonstrate that both every-other-month and monthly SYFOVRE...Read more
Company remains on track for VITESSE topline data in Q4 of this year Châtillon, France, November 11, 2025 - DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced that the last patient visit has been completed in the Company’s Phase 3 VITESSE clinical trial of the VIASKIN® Peanut patch in peanut allergic children aged 4-7...Read more
PBGENE-HBV, the first gene editing therapy designed to treat chronic Hepatitis B by directly targeting HBV cccDNA and integrated HBV DNA, showcased as the final oral presentation in the late-breaking AASLD session at 5:45pm EST on Monday, November 10, 2025 PBGENE-HBV was well-tolerated across pre-planned repeat administrations at doses of 0.2mg/kg, 0.4 mg/kg, and 0.8mg/kg with no dose-limiting toxicities Data to date from the Phase 1...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
No safety concerns identified by independent data and safety monitoring board, which recommends continuation of study without any modifications SOUTH SAN FRANCISCO, Calif. / Nov 10, 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 the positive outcome of its pre-planned...Read more
One-time treatment of nex-z led to consistently rapid, deep and durable reduction in serum TTR through three years of follow-up Consistent trend in disease stability or improvement in multiple measures of cardiomyopathy, regardless of NYHA Class, at 24 months compared to baseline Longer-term safety data consistent with previously reported Phase 1 data CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc....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
SUNNYVALE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure of reduced ejection fraction (“HFrEF”). “The CardiAMP-HF trial, in which...Read more
Milestone advances MEAI-based therapy targeting a global Alcohol Use Disorder treatment market projected to surpass $20 billion by 2032 Vancouver, Canada, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems,...Read more
MannKind has made the decision to discontinue the ICoN-1 Phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease, following a futility determination based on medical monitoring data This outcome does not impact the development of MNKD-102, MannKind’s dry powder inhalation (DPI) formulation of clofazimine, which remains under consideration for future clinical...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
16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) Safety profile of bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared...Read more
Interim Phase 1 results for APG333 exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6- month dosing Results support development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications APG333 was well tolerated across all cohorts with doses of up to 1,000 mg...Read more
The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance...Read more
Baxdrostat demonstrated a statistically significant placebo-adjusted reduction of 13.9 mmHg in night-time ambulatory systolic blood pressure at 12 weeks with a safety profile consistent with the BaxHTN trial Full results presented at the American Heart Association Scientific Sessions 2025 WILMINGTON, Del. / Nov 09, 2025 / Business Wire / Positive full results from the Bax24 Phase III trial showed baxdrostat demonstrated a...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
48-week data show a 64% decrease from baseline in proteinuria in IgA nephropathy, 82% decrease from baseline in proteinuria in primary membranous nephropathy, and stabilization of estimated glomerular filtration rate across both diseases Vertex on track to initiate rolling submission of Biologics License Application for potential accelerated approval to the U.S. Food and Drug Administration this year; full enrollment completed for Phase...Read more
Deep, stable and durable reductions in kallikrein observed Among 32 patients who received a 50 mg dose of lonvo-z as of data cutoff: 31 (97%) were attack-free and long-term prophylaxis (LTP)-free 24 (75%) were attack-free and LTP-free for at least seven months (up to 32 months) Among the 11 patients who originally received a 50 mg dose in Phase 2, 10 were attack-free and LTP-free Continue to observe a well-tolerated...Read more
Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular (CV) epidemic RAHWAY, N.J. / Nov 08, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first...Read more
Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints Data presented as late-breaking oral...Read more
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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