Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology...Read more
STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STOCKHOLM: CALTX) ("Calliditas") today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver...Read more
THRIVE-2 exceeded its enrollment target due to patient demand; 188 patients enrolled with approximately 40% from US sites THRIVE topline readout in patients with active TED on track for September 2024 THRIVE-2 topline readout on track for year-end 2024 WALTHAM, Mass. / Jul 25, 2024 / Business Wire / Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential...Read more
Confirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug (IND) filing and first patient dosed expected in 2025 CAMBRIDGE, Mass. / Jul 25, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders,...Read more
Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog MIAMI, FL / ACCESSWIRE / July 25, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new insights garnered from additional, recently received preclinical study data regarding the mechanism of action and toxicology...Read more
First-in-Class CCL24 Neutralizing Antibody CM-101 Demonstrated a Favorable Safety Profile and Was Generally Well-Tolerated Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC), Establishing Clinical Proof-of-Concept for the Disease-Modifying Potential of CM-101 Treatment with CM-101 Led to Statistically Significant Improvements in Liver...Read more
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United...Read more
Initiated Phase 2 clinical trial MALVERN, Pa., July 25, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being...Read more
Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment Topline results for both UC and CD now anticipated in Q4 2024 Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva...Read more
10 of 12 patients treated in HER2 expressing solid tumor Phase 1b trial were breast cancer patients Dose selected for ongoing Phase 2b clinical trial in Osteosarcoma was shown to be well tolerated in breast cancer patients Preclinical breast cancer efficacy models showed positive data to prevent breast cancer metastases to the brain, reduce tumor growth by over 90% in combination with HER2-targeted antibodies, and prevent the formation...Read more
Data indicates that SON-080 was well-tolerated at both doses, with no evidence of a pro-inflammatory cytokine response Pain and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo controls Sonnet intends to seek a partnership to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral...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
Safety, tolerability, pharmacokinetic and pharmacodynamic profile of VG-3927 supports continued development as potential once-daily oral therapy for Alzheimer’s disease (AD) VG-3927 achieved robust decrease of sTREM2 in CSF demonstrating clinical proof-of-target engagement New preclinical and clinical data from SAD cohorts to be presented at upcoming 2024 Alzheimer’s Association International Conference (AAIC) Company...Read more
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis NEW YORK / Jul 24, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A. The AFFINE study...Read more
SAGE-324 (BIIB124) did not demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with essential tremor No statistically significant differences were demonstrated between any dose of SAGE-324 and placebo in the change from baseline for the primary endpoint CAMBRIDGE, Mass. / Jul 24, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB) announced...Read more
SOUTH SAN FRANCISCO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic...Read more
PURPOSE 1 Data Showed Zero Infections and 100% Efficacy and Superiority of Lenacapavir to Background HIV Incidence and Daily Truvada® for PrEP If Approved, Lenacapavir Would be the First and Only Twice-Yearly PrEP Choice and Could Address Critical Gaps in Uptake and Adherence for Individuals Who Need or Want PrEP Gilead Commits to Prioritizing Swift Access and Enabling Efficient Paths for Regulatory Approval of Lenacapavir...Read more
KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation Company expects to provide an efficacy update on this expansion cohort in 1H 2025 SAN MATEO, Calif. and CAMBRIDGE, Mass., July 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today...Read more
Virios projects releasing top line results from this groundbreaking Proof of Concept study in October 2024 Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms ATLANTA, July 23, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology...Read more
LB54640 has shown targeted effect on MC4R without hyperpigmentation BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an...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
56.4% major response rate exceeded 20% primary endpoint 98.2% disease control rate achieved in heavily pretreated patients Responses shown in difficult-to-treat, high-needs patient populations with approximately 27% of patients refractory to all available therapies and 40% dual-class refractory (BTKi and rituximab) FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage...Read more
THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing CHICAGO / Jul 23, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies...Read more
SEATTLE, July 22, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the 12-patient 80mg pharmacokinetic (PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study has fully enrolled. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane plus goserelin...Read more
New findings highlight potential advantages of MIRA's novel oral ketamine analog for treating neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 22, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new preclinical study results for its novel oral ketamine analog, Ketamir-2. The additional data announced today...Read more
5 patients treated in "safety cohort" showed no drug related Serious Adverse Events Restart of trial after amendment approved by MHRA to increase dose level EDINBURGH, Scotland, July 22, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today...Read more
Study enrolled 268 patients, exceeding target enrollment. Largest interventional study ever to be conducted in pulmonary sarcoidosis. Topline data are expected in the third quarter of 2025. SAN DIEGO, July 22, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today...Read more
ION582 showed robust and consistent benefit in communication, cognition and motor function in a broad patient population evaluated with a comprehensive set of assessment tools that collect input from parents and clinicians 97% of patients in the medium and high dose groups saw improvement in overall Angelman syndrome symptoms as measured by the SAS-CGI-C Improvements on the Bayley-4 in cognition, communication and motor function...Read more
CAMBRIDGE, Mass., July 22, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). "HER2...Read more
NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration...Read more
Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis At three months post procedure, the study’s primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met Significant improvements were observed across primary and secondary outcome measures...Read more
The Tafenoquine for Babesiosis clinical trial will be conducted at three sites: Yale University, Rhode Island Hospital and Tufts Medical Center Patient enrollment has begun; interim results anticipated by September, 2025 In the Northeast U.S., the incidence of babesiosis has been increasing; babesiosis is an emerging, tick-borne, potentially life-threatening illness Case studies in recent medical literature suggest that tafenoquine...Read more
Community Health Network Has Begun Enrollment of the Prospective, Multi-Center Study to Assess the Real-World Clinical Impact of Galleri® in Addition to Currently Recommended Cancer Screenings Study Enrollment Includes Focus on Diverse and Underrepresented Populations Costs of Galleri and Related Items and Services for Study Participants Will be Covered by Medicare MENLO PARK, Calif., July 18, 2024 /PRNewswire/ -- GRAIL,...Read more
SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo Efficacy is consistent with AJOVY (fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed Full data to be presented at a medical meeting later in 2024 TEL AVIV, Israel / Jul 18, 2024 / Business Wire / Teva Pharmaceutical...Read more
BRAINTREE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of...Read more
Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors SOUTH SAN FRANCISCO, Calif. / Jul 18, 2024 / Business Wire / Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study...Read more
Pharmacokinetic and tissue data confirm NaviCap platform delivers topically through the entire colon, with lower systemic concentrations, as desired Data modeling suggests tofacitinib tissue concentrations greater than IC90 through at least 16 hours after dosing SAN DIEGO, July 18, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, presented supplemental data from...Read more
BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery...Read more
Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients in similar studies 1, 2, 3 Significant reduction of “Eye-Bulging” metastatic breast cancer tumor was previously reported Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British...Read more
Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR) Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a...Read more
Zilganersen is the first investigational medicine in clinical development for people with Alexander disease, a rare, life-threatening neurological condition CARLSBAD, Calif., July 18, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373), an investigational RNA-targeted medicine in development for the treatment of children...Read more
Topline results are expected in Q3 2025 ADELAIDE, Australia and CAMBRIDGE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a biotechnology company developing novel, potential first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced the initiation of patient...Read more
STAR-1 topline results expected in first quarter of 2025 About 30 million acne patients seek treatment in the U.S. each year DMT310, if approved, could be the first once-weekly topical product for the treatment of acne SAN DIEGO, CA / ACCESSWIRE / July 17, 2024 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of...Read more
ROCHESTER, N.Y., July 17, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present topline data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Alzheimer’s...Read more
43% of Participants Showed Improvement on the UMSARS Activities of Daily Living Scale 29% of Participants had Stable or Improved Neurological Symptoms Objective Biomarkers Demonstrated Improvement Consistent with Clinical Findings ATH434 was Well-Tolerated with No Safety Signals Detected MELBOURNE, Australia and SAN FRANCISCO, July 17, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE)...Read more
Robust reduction in anti-VEGF injection treatment burden through Week 24 achieved in 30 patients at planned Phase 3 dose (3E10 vg/eye) with 89% reduction in annualized injection rate; 93% of patients received 0 or 1 injection and 77% were injection-free Improvement in mean best corrected visual acuity (BCVA) from baseline through Week 24 achieved at 3E10 vg/eye dose (+4.2 letters); dose response in favor of 3E10 vg/eye dose...Read more
6E10 combined with local prophylaxis selected for Phase 3 pivotal trials, with a favorable safety profile and potential best-in-class product profile at 26 weeks Efficacy: 76% of 6E10 patients were injection free, with maintained visual acuity and fluid control Safety: 100% of 6E10 difluprednate-alone patients had no or minimal inflammation, and none received corticosteroids for treatment of inflammation beyond the scheduled...Read more
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-9961 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed1 SOUTH SAN FRANCISCO, Calif. / Jul 17, 2024 / Business Wire /...Read more
Three New Sites Join HT-001 Trial, GW University Hospital, UC Irvine and Northwell Health NEW YORK, July 16, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the...Read more
EMBARQ-CSU1 and EMBARQ-CSU 2 will enroll more than 1800 patients suffering from CSU Studies include both biologic naïve and experienced patients HAMPTON, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today the initiation of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in...Read more
Complete enrollment achieved nearly six months ahead of plan Top-line data now anticipated mid-2025 Addition of second-line cholangiocarcinoma arm to BOLSTER trial BASKING RIDGE, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases,...Read more
300 patients enrolled in the study, including patients with and without the cognitive biomarker On track to report topline data in October 2024 Alto to host investor day focused on ALTO-100 on September 9, 2024 MOUNTAIN VIEW, Calif. / Jul 16, 2024 / Business Wire / Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for...Read more
SAN DIEGO, July 15, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that enrollment has been completed and dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to...Read more
Bexotegrast at 320 mg was well tolerated up to 40 weeks of treatment with no treatment-related severe or serious adverse events 320 mg cohort demonstrated improvement in liver stiffness by transient elastography at Week 24 compared to placebo Statistically significant improvement in alkaline phosphatase (ALP) levels over 24 weeks compared to placebo Continued improvement in hepatocyte function and bile flow by...Read more
Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) Results consistent with those shown in earlier human volunteer studies and Phase 2a studies Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to...Read more
Testing confirms MIRA's preliminary beliefs regarding potential treatment for neurological and neuropsychiatric disorders MIAMI, FL / ACCESSWIRE / July 15, 2024 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical development company, today announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being...Read more
Achieved mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline >10% reduction in LVMI at 12 months in 75% of participants with elevated LVMI at baseline Sustained and consistent improvements in other key measures of cardiac status, including left ventricular wall thickness and troponin I, in majority of participants at 12...Read more
The post-dose average values for Total Pharyngeal Residue (i.e., the amount of solid food or liquid material remaining in the pharynx after the first swallow) remained meaningfully reduced at the 180-day post-dose assessment following the administration of the low dose of gene therapy BB-301 as compared to the pre-dose average values recorded for Subject 1 during the OPMD Natural History Study Critically, for three of the four food...Read more
GRAIL Completes Enrollment of More Than 35,000 Participants in the PATHFINDER 2 Study; Results From the First 25,000 Participants Expected in the Second Half of 2025 GRAIL Completes Final Study Visits for the NHS-Galleri Trial; Final Results Expected in 2026 MENLO PARK, Calif., July 15, 2024 /PRNewswire/ -- GRAIL, Inc. (NASDAQ: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today...Read more
GenFleet’s IND in China was cleared in June 2024; this is the first discovery program from the collaboration Verastem announced in 2023 to advance into human clinical trials Verastem plans to initiate development studies outside of China after evaluating initial dose escalation data from the Phase 1 study in China BOSTON / Jul 12, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to...Read more
Media Release Efti in combination with KEYTRUDA® (pembrolizumab) achieved a 35.5% response rate in evaluable patients (N=31), according to RECIST 1.1, among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1 High complete response rate of 9.7% with three patients showing a disappearance of cancer lesions post treatment Durability of responses tracks well and over 50% of patients...Read more
CARDIFF, UK / ACCESSWIRE / July 11, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is making good progress with eRapa™, its drug to treat Familial Adenomatous Polyposis (FAP). FAP is a mostly inherited condition that puts people at a much greater risk of developing...Read more
Tailwind is evaluating inhaled AP-PA02 in non-cystic fibrosis bronchiectasis (NCFB), its second patient population, following successful evaluation in patients with cystic fibrosis (SWARM-P.a.) in 2023 Phase 2 Topline data anticipated in 2H 2024 followed by potential initiation of a pivotal bronchiectasis trial in 2025 LOS ANGELES, July 11, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the...Read more
BASKING RIDGE, N.J., July 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announces promising preclinical results for its investigational candidate, certepetide (formerly LSTA1). The data, presented in a poster by Dr. Dan G. Duda of...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
Over 100,000 patients in the United States have IPF, with two approved therapies available that only slow the course of disease progression Top line data expected in the second half of 2025 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jul 10, 2024 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 2 study evaluating the use of Tyvaso®...Read more
Encouraging 68% improvement in responder rate results from patients who achieved both the conjunctival staining “sign” and ocular pain “symptom” endpoints from the 240 patient Phase 2 Dry Eye Disease (DED) trial Conjunctival staining and ocular pain represent potential co-primary endpoints to be explored in future trials LONDON and NEW YORK, July 10, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage...Read more
NeuroSense to submit the 12-month data to FDA to discuss path forward CAMBRIDGE, Mass., July 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. In the study, complication-free...Read more
Baptist Hospital of Miami is the second site to perform clinical procedures as part of the Company’s Pivotal Human Clinical Trial. The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System. BRAINTREE, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that Baptist Hospital of Miami, which...Read more
Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy SHELTON, Conn., July 9, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies...Read more
Development of Auxora in AKI is supported by both clinical and pre-clinical evidence Topline data expected in 2025 LA JOLLA, Calif., July 9, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses,...Read more
Study Supported by $2.6 Million FDA Orphan Products Development Grant PRINCETON, N.J., July 9, 2024 /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 an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™...Read more
Achieved statistically significant, dose-dependent, and durable evidence of potential therapeutic benefit; Patients receiving high-dose AMT-130 showed 80% slowing of disease progression in the composite Unified Huntington’s Disease Rating Scale (cUHDRS) at 24 months compared to a propensity score-weighted external control Achieved statistically significant lowering of CSF neurofilament light protein (NfL) compared to baseline at...Read more
Exceeded enrollment target due to patient demand; trial size increased to 121 patients Bempikibart topline results remain on track to be released in Q4'24 WALTHAM, Mass., July 9, 2024 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that it has completed enrollment in the SIGNAL-AD...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
GT-02287 Well Tolerated With No Serious Adverse Events or Other Safety Signals Reported Additional Topline Data To Be Presented Mid-August GT-02287 on Track To Initiate Clinical Trial in Parkinson’s Disease Patients in Q4 2024 BETHESDA, Md., July 09, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next...Read more
WILMETTE, Ill., July 09, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the enrollment of the first patient in its first-in-human Phase 1 dosimetry and imaging clinical trial of MNPR-101-Zr. This novel radiopharmaceutical imaging agent combines MNPR-101, Monopar’s antibody that selectively targets the...Read more
WATERTOWN, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee, Sanofi has informed Kymera that it intends to expand the ongoing Hidradenitis...Read more
Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Timing of milestone in-line with mid-2024 guidance Data from ex-US clinical trial reported at ASGCT 2024 showed a 92% overall response rate LOS ANGELES, July 08, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune...Read more
The first clinical case was performed at Brigham and Women’s Hospital The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical...Read more
Five sites across the U.S. are now participating in the Phase 1b study Marlborough, Massachusetts--(Newsfile Corp. - July 8, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL® siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced the addition of the University of Pittsburgh Medical Center (UPMC)...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 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 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L)...Read more
NAARDEN, The Netherlands and MIAMI, July 08, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today...Read more
The NEST-IN1 clinical study did not meet its primary or secondary efficacy endpoints, and the company will discontinue further development of HIL-214 in infants The company is exploring the potential for continued development of HIL-214 and HIL-216 in adults BOSTON, July 08, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines,...Read more
WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug +...Read more
MULHOUSE, France, and SUNNYVALE, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announce success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial...Read more
~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients ~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1 ~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage ~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reduction AE Profile: ~5.6% drug-related grade >3...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
MONTREAL, July 03, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), has successfully completed the BUENA Alzheimer’s disease (AD) study. The BUENA study was designed as a Phase 2a proof of concept study to investigate the extent to which different doses of Montelukast (MTK) could improve cognition in adults with AD as well as to provide...Read more
In a preclinical HCH model, TYRA-300 demonstrated increases in long bone length and binding against the HCH altered protein TYRA remains on track to submit ACH Investigational New Drug Application (IND) in 2H24 CARLSBAD, Calif., July 2, 2024 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in...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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