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
Data and Safety Monitoring Board (DSMB) recommends the continuation, without modifications, of the adaptive Phase 2b/3 NAVIGATE study of belapectin in metabolic dysfunction-associated steatohepatitis (MASH) liver cirrhosis Fifth positive recommendation further supports favorable tolerability and safety profile of belapectin Interim Phase 2b efficacy readout anticipated in Q4 2024 NORCROSS, Ga., April 09, 2024 (GLOBE NEWSWIRE) --...Read more
Data transferred for independent statistical analysis Top-line data expected in April 2024 RADNOR, Pa., April 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, as forecast...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Apr 03, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial...Read more
Early progression-free survival (PFS) trends favor GRANITE recipients with hazard ratios of 0.82 in the overall population ([95% CI, 0.34-1.67]; 62% censored) and 0.52 (48% relative risk reduction of progression or death with GRANITE vs. control) in a high-risk group, where clinical data are more mature ([95% CI, 0.15-1.38]; 44% censored); >90% of high-risk patients have liver metastases Short-term molecular response (as...Read more
45 mg once daily oral dose selected for Phase 3 Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S. BOSTON / Apr 01, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that inaxaplin (VX-147) has advanced into...Read more
First of its kind study in muscle-invasive urothelial cancer, with both escalation and de-escalation arms Approximately 1,000 patients will be enrolled at more than 300 sites AUSTIN, Texas / Apr 01, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China. This follows positive data from the proof-of-concept Phase II stage of the trial and...Read more
NEW YORK, March 19, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. This study was performed in collaboration with The Sean M. Healey and AMG Center, which is viewed as an influential force...Read more
Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance and is expected to be the first of two registrational trials in psoriatic arthritis Robust clinical responses achieved for the high hurdles of ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity Favorable safety profile consistent with the IL-17A class and previous izokibep experience LOS ANGELES,...Read more
Data from the safety lead-in of the AIPAC-003 trial shows 90mg efti in combination with paclitaxel is safe and well tolerated Encouraging initial efficacy in six metastatic breast cancer patients, who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrated by a 50% overall response rate, including one complete response, and a 100% disease control rate SYDNEY, AUSTRALIA, March 05, 2024 (GLOBE NEWSWIRE) -- Immutep...Read more
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported. Positive data and FDA comment would trigger the next $4...Read more
AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment. Additional information can be obtained at www.stop-pc.com. An explainer video is available at https://www.youtube.com/watch?v=C4ZsE3fulIU. STOP-PC is a Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in...Read more
Enrolled patients allowed to continue on study MENLO PARK, Calif. / Feb 12, 2024 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the company’s decision to voluntarily pause Phase 3 enrollment in the seamless Phase 2/3 clinical trial (EBO-301) evaluating...Read more
Patient Reported Outcomes (PROs) based on a May 16, 2022 data cutoff in the QUILT 3.032 trial indicate stability of physical function and global health in patients who completed PRO questionnaires and reached month 24 on-study Overall, participants with complete responses (CRs) to combination therapy with the novel interleukin-15 (IL-15) superagonist N-803 and bacillus Calmette-Guerin (BCG) reported better physical function than those...Read more
Pamrevlumab has now completed Stage 2 of the trial and topline data from this registration study in ~175 pamrevlumab treated patients is anticipated in 2Q 2024 Pamrevlumab is the first experimental arm to meet its required threshold for graduation in the seamless Phase 2/3 adaptive platform trial SAN FRANCISCO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced graduation and completion of the pamrevlumab...Read more
Exceeded originally target enrollment (70) with n=74 Last patient, last visit expected in approximately six weeks; data to follow shortly thereafter Positive data triggers milestone payment from Alvogen, as previously announced. RADNOR, Pa., Jan. 22, 2024 /PRNewswire/ -- NRx Pharmaceuticals,...Read more
MELBOURNE, Australia and NEW YORK, Jan. 17, 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 an independent Institutional Review Board (IRB) has approved the protocol for the Company’s Phase 2/3 clinical trial to be conducted in the...Read more
Topline data from LIFT-AD on track for second half of 2024 Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases BOTHELL, Wash., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage...Read more
Anavex Announces Topline Results from Phase 2/3 EXCELLENCE Clinical Study in Pediatric Rett Syndrome Validation from Real World Evidence (RWE) of Rett Syndrome Patients under Compassionate Use Authorization NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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