New clinical Precision Medicine population 48-week data demonstrates unprecedented cognitive stabilization in early Alzheimer’s disease Cognitive outcomes observed in the oral blarcamesine 30 mg Precision Medicine cohort move toward normal aging profiles across validated clinical scales, supporting its relevance in early-stage Alzheimer’s care 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the primary...Read more
LA JOLLA, Calif., Aug. 26, 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), announces that it successfully achieved enrollment of the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). MN-166 is currently in development for the treatment of...Read more
New clinical Precision Medicine population data demonstrates up to 84.6 Weeks (19.5 Months) ‘time saved’ by early-start ADAS-Cog13 difference: −5.43 (P = 0.0035), ADCS-ADL difference: +9.50 (P < 0.0001) Restoring impaired autophagy as early event, preceding amyloid-beta and tau Oral presentation at the Alzheimer’s Association International Conference (AAIC) 2025 NEW YORK, July 31, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences...Read more
MN-166 COMBAT ALS trial down to single digit required enrollment while MN-001 hypertriglyceridemia trial in type 2 diabetes patients requires final two patients LA JOLLA, Calif., July 24, 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) (the “Company”), today provides an update on...Read more
MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). “Dosing the first patient is...Read more
First patient in Cohort B achieved CR after 2nd dose of TCB008 EDINBURGH, Scotland, June 11, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, today announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following...Read more
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options First Phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival Data are being presented in an oral session at the 2025 ASCO Annual Meeting and simultaneously...Read more
RAHWAY, N.J. / May 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in combination with standard of care rituximab and gemcitabine-oxaliplatin (R-GemOx) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is an...Read more
BHV-8000 is a first-in-clinic, brain-penetrant, and selective inhibitor of TYK2 and JAK1 kinases — a novel investigational therapy with the potential to treat the neuroinflammation and immune dysregulation that drives disease progression in Parkinson's disease (PD) Currently, there are no approved disease-modifying therapies for the more than 10 million people living with PD NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ -- Biohaven...Read more
90% of Adults with Chronic Hepatitis Delta Virus (HDV) who Achieved Undetectable HDV RNA at 96 Weeks of Treatment with Bulevirtide Remained Undetectable for Almost 2 Years After Stopping Treatment FOSTER CITY, Calif. / May 07, 2025 / Business Wire / Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta...Read more
CIS with or without Papillary: Oral presentation from QUILT-3.032 study showed 71% complete response rate (N=100), with duration of response ranging up to more than 53 months, in BCG-unresponsive NMIBC CIS with or without papillary disease Probability of duration of complete response of at least 45 months in the FDA label population (N=77) is 51%, with median duration of complete response of 45.4 months Cystectomy avoidance rate in...Read more
LA JOLLA, Calif., April 08, 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 enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS). This significant milestone marks...Read more
ATTENTION-AD trial data through 192 weeks presented at AD/PDTM 2025 Conference Prespecified delayed-start analysis indicate disease-modifying effect of oral blarcamesine and importance of early and continued long-term treatment of chronic Alzheimer’s disease Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, April 05, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the...Read more
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose...Read more
Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel achieved a 17.1% overall response rate (ORR), including one complete response, compared to 5.3% ORR for paclitaxel alone, in patients with biliary tract cancer (BTC) treated in the second-line setting. The difference in ORR between the two treatment arms, the primary endpoint of the study, was statistically significant (p=0.031), and all responses have been...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), today jointly announce that the FRUSICA-2 Phase II/III clinical trial evaluating fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China has met its...Read more
Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch Dupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placebo Data support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation;...Read more
SOUTH SAN FRANCISCO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board (DSMB), as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial evaluating bexotegrast in patients with idiopathic pulmonary...Read more
MALVERN, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that alignment has been reached with the U.S. Food and Drug Administration (FDA) to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST which, if positive, can be the basis of a biologics license application...Read more
BOSTON, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell...Read more
Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current patients while data is reviewed SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the Company...Read more
Topline ATTENTION-AD trial: Patients showed improved cognition and function over three years Delayed-start analysis of treatment with oral blarcamesine was significant reflecting importance of early treatment initiation Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more
WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC). “On the heels of our BLA...Read more
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeks Overall, DNL343 was found to be safe and well tolerated Additional analyses, including neurofilament light (NfL) and other fluid biomarkers, prespecified sub-group analyses and analyses from the active treatment extension period are expected later in 2025 SOUTH SAN...Read more
Phase 2b/3 trial of izokibep did not meet primary endpoint; secondary endpoints also did not achieve statistical significance Company continues focus on development of subcutaneous lonigutamab in thyroid eye disease, with initiation of Phase 3 program on schedule for Q1 2025 $562.4 million in cash, cash equivalents, and short-term marketable securities on September 30, 2024 projected to provide runway to mid-2027, including completion...Read more
32% objective response rate (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing registrational REFRαME-O1 trial These data confirm luvelta’s robust response rate in patients with late-stage ovarian cancer expressing a broad range of folate receptor alpha (FRα) Neutropenia well-managed; no new safety findings Luvelta is positioned for an...Read more
LA JOLLA, Calif., Dec. 05, 2024 (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 study update and interim analysis results from the Company’s COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) will be presented at the 35th...Read more
Data of Blarcamesine confirm upstream SIGMAR1 activation Presented as Late Breaking Oral Communications at Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2024 Oral, once daily blarcamesine meaningfully slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp....Read more
ROCKVILLE, Md. / Oct 29, 2024 / Business Wire / GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced the Phase 2 analysis of the adaptive Phase 2/3 study of uproleselan being conducted by the National Cancer Institute (NCI) and the Alliance for Clinical Trials in Oncology in adults with newly diagnosed...Read more
Phase 3 DIAMOND-1 and DIAMOND-2 trials enrollment of OCS-01 in diabetic macular edema (DME) accelerated with great momentum DIAMOND program committees expanded with globally renowned retina experts If approved, OCS-01 has the potential to transform the treatment paradigm as the first topical eye drop to treat DME ZUG, Switzerland, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global...Read more
In the Phase 2b/3 trial, clesrovimab reduced RSV-associated hospitalizations (secondary endpoint) and RSV-associated lower respiratory infection hospitalizations (tertiary endpoint) by more than 84% and 90%, respectively, through 5 months Clesrovimab has the potential to become the first and only approved immunization designed to protect infants with the same single dose regardless of weight for the duration of their first RSV...Read more
First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied SAVANNAH, Ga., Oct. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents (aged 12 – 17 years)...Read more
Treatment with once-daily EFFEXOR® met primary and all secondary efficacy endpoints in outpatient adults with GAD EFFEXOR® was generally well tolerated, consistent with its known safety profile Pharmaceuticals and Medical Devices Agency (PMDA) submission targeted for 2025 PITTSBURGH and TOKYO, Oct. 9, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced positive top-line results of its...Read more
Findings from Part B and Part C of the DEVOTE study support the clinical benefits of a higher dose regimen of nusinersen (50/28 mg) in both individuals previously treated and treatment-naïve to nusinersen Investigational regimen also shows more rapid slowing of neurodegeneration, as measured by neurofilament Biogen plans to submit regulatory applications around the world for approval of the nusinersen higher dose regimen CAMBRIDGE,...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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