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
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck &...Read more
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study...Read more
Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union TARRYTOWN,...Read more
Phase 2/3 of the DRAGON II trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and Japan Phase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completed Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1 Pivotal...Read more
Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational dose regimen Higher dose nusinersen regimen showed statistically significant improvement compared to a prespecified matched sham control group Among key measures of clinical efficacy, higher dose regimen showed positive trends compared to...Read more
RAHWAY, N.J. / Sep 04, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent,...Read more
LIFT-AD trial did not meet primary endpoint of GST and key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23) In pre-specified subgroups of patients with moderate Alzheimer’s disease or who are APOE4 carriers, fosgonimeton showed a numerically greater treatment effect All biomarkers associated with Alzheimer’s disease pathology showed changes with fosgonimeton treatment consistent with the broad...Read more
EBO-301 study to be discontinued following topline results from Phase 2 part of the study in treatment-refractory patients with MAC lung disease AN2 plans to shift focus to internal boron chemistry platform and ongoing pipeline programs Company restructuring and cost savings associated with discontinuation of the EBO-301 study expected to extend cash runway through 2027 MENLO PARK, Calif. / Aug 08, 2024 / Business Wire / AN2...Read more
Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced Metastatic or Recurrent Biliary Tract Cancers (BTC) Approved an Investigator Sponsored Trial (IST) of CTX-009 in the first-line setting in patients with Biliary Tract Cancer BOSTON, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc....Read more
IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone. bioavailability/bioequivalence (‘BA/BE’) clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan. Analysis of data underway, however, no serious adverse events were reported. Phase...Read more
Oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events Clinical benefit of blarcamesine consistently observed for both 30 mg and 50 mg treatment groups Benefits of blarcamesine on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease EMA submission expected...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 24, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5,...Read more
Clesrovimab met all primary safety and efficacy endpoints RAHWAY, N.J. / Jul 23, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease....Read more
GBM AGILE trial data shows clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma SYDNEY, July 10, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib...Read more
Reporting of Topline Results Targeted by End of Third Quarter 2024 Results to be presented in oral presentation at Clinical Trials on Alzheimer’s Disease (CTAD) on October 29, 2024, in Madrid, Spain BOTHELL, Wash., July 09, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today...Read more
SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm Safety was consistent with previous studies, however we intend to halt the trial due to reduced efficacy compared to the...Read more
Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo Company will discontinue clinical program in NP and explore strategic alternatives STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the...Read more
14-month data show treatment with setrusumab resulted in a large, sustained 67% reduction in annualized fracture rate and persistent median annualized fracture rate of 0.00 (p=0.0014) Treatment resulted in continued, substantial improvements in bone mineral density (BMD) with a mean increase from baseline of 22% (p<0.0001) and a mean improvement in Z-score of +1.25 (p<0.0001) NOVATO, Calif. and LONDON, June 11, 2024...Read more
NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that patient dosing has commenced in the Company’s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep...Read more
Almost half a million people diagnosed each year across the globe Collaboration based on synergistic potential of inhibiting angiogenesis and tumor-associated macrophages with HUTCHMED’s surufatinib and anti-PD-1 activity with Hengrui’s camrelizumab, promoting the immune response against tumor cells HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”)...Read more
SOUTH SAN FRANCISCO, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases, today announced that the Sean M. Healey & AMG Center in collaboration with the Northeast ALS Consortium (NEALS) completed enrollment...Read more
NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076) Both NRX-101...Read more
Significantly higher rate of improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD Improvement in cognition measured by ADAS-Cog 11 at three months is 3.3 points as compared to 0.3 for placebo, consistent with our previous Phase II AD/PD and Discover studies Plasma Tau protein levels are reduced, consistent with our previous Phase II biomarker data Based on the findings of this...Read more
Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligned with FDA feedback HB-200 accepted for oral abstract presentation at ASCO 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab Two additional abstracts for HB-200 and HB-700 accepted for the ASCO...Read more
MINNEAPOLIS / Apr 17, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today announced the first patient being dosed in DiaMedica’s relaunch of its pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the treatment of acute ischemic stroke. The company continues to work closely with its contract...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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