HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable...Read more
Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing Favorable safety profile confirmed Trial on track for one-year clinical efficacy readout in Q3 2024 COPENHAGEN, Denmark, April 17, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces that...Read more
TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that a research team from St. Michael’s Hospital, a site of Unity Health Toronto, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing...Read more
Topline results are expected in Q4 2024 BOSTON / Apr 16, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary...Read more
SEATTLE, April 15, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ today announced the initiation of a new study to evaluate Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. Atossa is a clinical stage...Read more
SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment...Read more
MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its...Read more
New Gene Expression Analysis from Ongoing Phase 2 Study Provides Strong Biomarker Evidence that Treatment with TFF TAC Results in Normalization of Rejection-Related Genes TFF TAC Prevented Rejection at 1/6 of Oral Tacrolimus Dose and with 2/3 of Oral Tacrolimus Systemic Trough Exposures 4 out of 4 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase FORT WORTH,...Read more
Partner Sanofi advances SAR443579 / IPH6101, ANKET® platform lead asset, a trifunctional anti-CD123 NKp46xCD16 NK cell engager, to Phase 2 dose expansion in blood cancers Dosing of the first patient in the dose expansion part of the trial triggers a €4m milestone payment to Innate MARSEILLE, France / Apr 15, 2024 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today...Read more
Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413) In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment. Efficacy: Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening,...Read more
LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a...Read more
Interim analysis, including eight participants assessed at Week 24, demonstrated improvements in pancreatic function and glycemic control, as measured by C-peptide and other markers of glucose metabolism, rather than worsening typically expected with disease progression All eight participants met prespecified responder criteria demonstrating either improvement or stabilization of disease according to both the Patient Reported Global...Read more
OCALA, Fla., April 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for...Read more
Preliminary data demonstrate FPI-2265 is active in heavily pretreated patients with progressive metastatic castration-resistant prostate cancer (mCRPC), including those who received prior lutetium-based radioconjugates HAMILTON, ON and BOSTON, April 9, 2024 /CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines,...Read more
Confirmed objective response rate (ORR) of 15.6% in all patients regardless of PD-L1 or HPV status Confirmed ORR of 17.4% in subset of patients with PD-L1+ disease Confirmed ORR of 22.2% in subset of patients with HPV+ disease Median duration of treatment in responders was 19.6 months at the time of data cutoff SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a...Read more
SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial. The EVANGELINE study is evaluating (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor...Read more
Promising preclinical results obtained in obesity support the OBA Phase 2 clinical study expected to start mid-2024 PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / April 8, 2024 / Biophytis SA (Nasdaq:BPTS)(Euronext Growth Paris: ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announces that it is launching a new clinical...Read more
Collaboration follows recent manufacturing/clinical process enhancements that have tripled monthly trial capacity Patient enrollment expected to be completed in 2024 MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient...Read more
SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial. MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will...Read more
Plozasiran reduced triglycerides and APOC3 up to a mean maximum of 86% and 90% respectively in patients with severe hypertriglyceridemia SHASTA-3 and SHASTA-4 Phase 3 studies to be initiated PASADENA, Calif. / Apr 07, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented final data from the double-blind treatment period of its Phase 2 SHASTA-2 study of investigational plozasiran (formerly ARO-APOC3) in...Read more
Study Met Primary Endpoint Demonstrating Clinically Significant Additive Reductions in Ambulatory Systolic Blood Pressure of Up to 12.1 mmHg Across Three Independent Study Cohorts at Month 3 A Single Dose of Zilebesiran Resulted in Clinically Significant Additive Reductions in Office Systolic Blood Pressure at Month 3 and in Time-Adjusted Office Systolic Blood Pressure at Month 6 Across Three Independent Study Cohorts Zilebesiran...Read more
Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single PAXTRAVA implant Generally well tolerated with no impact on corneal health observed Consistent durability of IOP reduction and implant bioresorption shows potential for repeat dosing without stacking of...Read more
TARA-002 demonstrated a complete response rate of 43% at three months in BCG-Unresponsive/Experienced patients in ongoing NMIBC program TARA-002 demonstrated a complete response rate of 63% at three months in CIS-only patients in ongoing NMIBC program TARA-002 demonstrated a favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events Preliminary data from six-month evaluable patients in...Read more
SOLANA BEACH, Calif. and REDWOOD CITY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced topline results from the primary analysis of the randomized Phase 2 KICKSTART trial which tested tomivosertib or placebo, each combined with pembrolizumab, as frontline treatment for...Read more
Updated positive interim data showed notable improvements in estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in control group in borderline resectable pancreatic ductal adenorcarcinoma (PDAC) At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the...Read more
Seasonal flu vaccine candidate boosted antibody titers at all dose levels and for all encoded seasonal influenza strains across younger and older adults Potentially differentiated, multivalent candidate encodes antigens matched to all four WHO-recommended flu strains For influenza A strains, geometric mean titers numerically exceeded those elicited by the licensed comparator vaccines consistently across all tested dose levels and age...Read more
Early interim safety data from Phase 2 TAMARACK study, including comparison to retrospective analysis from Phase 1 study, as submitted in ASCO abstract Company plans to provide updated interim data, including safety and preliminary efficacy, by May 31 Company plans to provide additional clinical data – including rPFS – in the Fall of 2024 ROCKVILLE, MD, April 03, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX),...Read more
SAN DIEGO, April 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder. NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing...Read more
Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024 Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR]) By comparison, no tumor responses have been observed in the control arm to-date (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by...Read more
Phase 2 study designed to evaluate the pharmacodynamic effects, pharmacokinetics, and tolerability of ALTO-203 in patients with major depressive disorder (MDD) and higher levels of anhedonia ALTO-203 demonstrated a favorable tolerability profile across three Phase 1 clinical trials and produced a variety of emotional and brain effects that support its unique antidepressant potential LOS ALTOS, Calif. / Apr 03, 2024 / Business Wire /...Read more
SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH). “Dosing the first...Read more
ENVASARC Trial is Fully Enrolled and Final Data are Expected in Third Quarter 2024 SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the independent...Read more
Namodenoson demonstrated anti-fibrosis, anti-steatosis and anti-inflammatory effects in former Phase IIa study Patient enrolment for Phase IIb study is ongoing in Europe and Israel RAMAT GAN, Israel / Apr 03, 2024 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today...Read more
TORONTO, April 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that Anesthesia Clinical Trials Unit (ACTU), an academic research organization in the Department of Anesthesia and Pain Management at the University Health Network (UHN), has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute...Read more
Nitrate patients subgroup demonstrated 100% correct self-selection when utilizing the web app technology with the drug facts label compared to 40% when using drug facts label alone (among 86% vs. 56% of all users) underscoring the significant potential benefits of technology assistance in an OTC setting (Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 2, 2024 / Petros Pharmaceuticals, Inc....Read more
TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that three additional clinical sites in Turkey have joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury...Read more
Met primary endpoint, demonstrating dose-dependent, statistically significant reductions in protoporphyrin IX (PPIX) compared to placebo in both 20 mg and 60 mg dose groups Improved measures of light tolerance, including the key secondary endpoint, in both 20 mg and 60 mg dose groups, but did not meet statistical significance compared to placebo Dose-dependent reductions in the rate of phototoxic reactions with pain, with statistical...Read more
Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., April 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of enrollment of Part 1 of its two-part, Phase 2a clinical trial evaluating the efficacy and safety, of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119)...Read more
Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities...Read more
First prospective trial of a glucagon-like peptide (GLP-2) analog in SR GI aGVHD Results up to Day 91 show that apraglutide in SR GI aGVHD was well-tolerated with an acceptable safety profile, the study’s primary objective Exploratory secondary efficacy data showed lower GI tract responses maintained through Day 91 in SR GI aGVHD patients treated with apraglutide and standard of care BOSTON / Mar 28, 2024 / Business...Read more
Topline data expected in 4Q24 could support sNDA filing in 1H25 Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity WALTHAM, Mass., March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101...Read more
Eight of Eight Patients Successfully Transitioned from Oral Tacrolimus to TFF TAC with No Sign of Acute Rejection at Reduced Systemic Exposures Data from TFF VORI Phase 2 and EAP Program Continue to Demonstrate Antifungal Activity and a Favorable Safety and Tolerability Profile TFF TAC Program Prioritized Based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial...Read more
SAN DIEGO, March 27, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at...Read more
Rezatapopt is a first-in-class precision oncology investigational therapy for patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type (WT) First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS WT advanced solid tumors PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a...Read more
A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12 BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported Acute effects resolved on average in less than...Read more
KP1077 demonstrates clinically meaningful benefits for key IH symptoms Top-line data provide key information for the design of a Phase 3 study CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety...Read more
Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April Phase 2a study of SLS009 in r/r AML: 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20%; 100% Response Rate in Patients with Identified Biomarkers to Date Median OS Has Not Been Reached in the Phase 2a Study of SLS009; First CR Patient Continues...Read more
IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation. “We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks...Read more
San Diego, California--(Newsfile Corp. - March 25, 2024) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing disulfides that are precursors to thiol-active compounds and that have the potential to treat unmet pediatric diseases, today announced that the European Medicines Agency ("EMA") has accepted its Clinical Trial Application ("CTA") Part I - Scientific and...Read more
Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY, March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic...Read more
FLORHAM PARK, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been dosed in a Phase 2 investigator-initiated trial (IIT) with Pembrolizumab, Plinabulin, BeyondSpring’s lead asset, plus Etoposide/Platinum (EP) for first-line (1L)...Read more
Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial. Conjunctival Staining improved as early as day 29 with a durable benefit throughout the trial. Tear Film Break-up Time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial. Burning/Stinging, and Blurred Vision improved as early as day 15...Read more
BNC210 demonstrated a statistically significant improvement in post-traumatic stress disorder (PTSD) symptom severity with a clinically meaningful effect size suggesting a potential advantage over approved medications. BNC210’s emerging safety and tolerability profile continues to support its differentiation over approved, available, and experimental psychoactive treatments. Bionomics will meet with the U.S. Food & Drug...Read more
Company to Prioritize Clinical Development of Tacrolimus Inhalation Powder (TFF TAC) based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity Company to Evaluate Strategic Options for TFF VORI, including Partnerships, Collaborations, and Grants following Positive Data from Phase 2 Study and the Expanded Access Program (EAP) Company to Discuss...Read more
LOS ANGELES / Mar 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug Application (IND) submission has been reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative (HER2-negative),...Read more
First doses of MB22001 administered in Phase 2B take-home trial in patients with Major Depressive Disorder. Follows successful Phase 2A trial where 53% of depressed patients were in complete remission from their depression at week 8 marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale), a 60% mean drop in depressive symptoms. VANCOUVER, BC / ACCESSWIRE / March 20, 2024 / MindBio Therapeutics...Read more
Screening of subjects has begun at clinical study sites The Phase 2a study is being led by Principal Investigator, Dr. Stephen Harrison Aligos anticipates dosing the first subject in Q2 2024 with topline safety and efficacy data expected in Q4 2024 SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel...Read more
Phase 2a trial is on track to begin in the first half of 2024. Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression. WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing...Read more
First patient screened ahead of schedule Trial to investigate positive, negative, and cognitive domains of schizophrenia ANAVEX®3-71’s differentiated dual novel mechanism of action offers the potential to synergistically activate both SIGMAR1 and M1 muscarinic receptors and treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Anavex Life...Read more
Anxiety disorders are the most prevalent mental health disorders globally1, contributing to over 28 million disability-adjusted life years (“DALYs”)2 Highly scalable intermittent treatment for Generalized Anxiety Disorder (“GAD”) with an expected treatment time of approximately 90-minutes from a single administration Proprietary deuterated dimethyltryptamine (“DMT”) molecule with U.S. composition of matter patent granted with protection...Read more
CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint Positive Data from CAHptain-205 Study of Tildacerfont in Pediatric Classic CAH Supports Further Dose-Ranging Across Additional Dosing Cohorts Topline Results from CAHmelia-204 Study of Tildacerfont in Adult Classic CAH Evaluating Glucocorticoid (GC) Reduction Anticipated in Third...Read more
Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024 Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 13, 2024 / Business Wire /...Read more
Blinded Safety Review Completed for the First 6 Months of the Phase 2a Clinical Trial Conduct; Recommending Trial Continue Without Modification Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., March 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced receipt of Safety Review...Read more
Significant improvement in steatohepatitis with >2 point improvement in NAS score without worsening fibrosis, the primary endpoint of the study Achieved key secondary endpoint of MASH resolution without worsening of fibrosis More ION224 treated patients had an improvement of >1 stage fibrosis compared to placebo ION224 was safe and well-tolerated in this study with once-monthly subcutaneous dosing CARLSBAD, Calif., March 13,...Read more
Paltusotine Treatment Demonstrated Rapid and Sustained Reductions in Frequency and Severity of Flushing Episodes and Bowel Movements Paltusotine was Generally Well-Tolerated and Showed an Overall PK Profile Consistent with Prior Studies Results Confirm Initial Positive Data Previously Reported Management to Host a Conference Call Today at 4:30 p.m. Eastern Time SAN DIEGO, March 12, 2024 (GLOBE NEWSWIRE) -- Crinetics...Read more
Study will inform on long-term safety profile and tissue frataxin levels OLE initiated with 25 mg daily subcutaneous injections of nomlabofusp Frataxin data and safety data from the OLE study are intended to help support a potential Biologics License Application (“BLA”) submission for accelerated approval targeted for H2 2025 Initial data expected in Q4 2024 BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar...Read more
Dose ordered and robust HiSCRs were rapidly demonstrated with about a third of patients achieving HiSCR100, or resolution of abscesses and nodules, by week 16 and through week 32 Deep and consistent HiSCR responses were observed for placebo patients switching to active treatment Marked reductions in draining tunnels and skin pain also contributed to clinically meaningful improvements in quality of life Potential for differentiation...Read more
First patient dosed with IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel for first-line treatment of pancreatic ductal adenocarcinoma (PDAC) Phase 2a portion of Phase 1/2a clinical trial will evaluate IMM-1-104 as monotherapy in PDAC, non-small cell lung cancer (NSCLC) and melanoma, and as combination therapy in PDAC Topline data from the Phase 1 portion of Phase 1/2a trial of IMM-1-104 expected in...Read more
Randomized Phase 2 study met the primary endpoint in patents with hidradenitis suppurativa (HS), reinforcing efficacy and safety profile of ruxolitinib cream Results presented as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting WILMINGTON, Del. / Mar 10, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of...Read more
Randomized Phase 2 study met its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, reinforcing povorcitinib’s potential role in treating prurigo nodularis (PN) Results presented as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting marks Incyte’s first presentation of data in PN WILMINGTON, Del. / Mar 10, 2024 / Business Wire / Incyte (Nasdaq:INCY)...Read more
TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury...Read more
Highlights: Immuron proceeding to Phase 3 registration strategy with the FDA Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose 36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group (primary endpoint) 66.7% protective efficacy against ETEC induced severe diarrhea was...Read more
Week 24 Results Support Continued Development as a Potential Long-Acting Oral Combination Treatment Option in Virologically Suppressed People with HIV Novel Investigational Combination Regimen has the Potential to be the First Oral Weekly HIV Treatment, Helping to Address Unmet Needs FOSTER CITY, Calif., & RAHWAY, N.J. / Mar 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside...Read more
Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC) ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy CHICAGO / Mar 06, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a...Read more
LAVAL, QC / ACCESSWIRE / March 6, 2024 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to...Read more
SAN FRANCISCO, March 5, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata. Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory...Read more
Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter Approximately 50% of participants have compensated cirrhosis SAN FRANCISCO / Mar 05, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic...Read more
Patients with Alzheimer’s Disease show improvement in brainwaves following 4 weeks of XPro™ therapy. Boca Raton, Florida, March 05, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) reports significant improvements in electroencephalography (EEG), a biomarker of...Read more
SARASOTA, Fla. / Mar 05, 2024 / Business Wire / Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device,...Read more
Study Met the Primary Endpoint Demonstrating Clinically Significant Systolic Blood Pressure Reductions at Month 3 When Zilebesiran Was Added to a Diuretic, Calcium-Channel Blocker or Angiotensin Receptor Blocker Zilebesiran Demonstrated an Encouraging Safety and Tolerability Profile When Added to Standard of Care Antihypertensives Study Results Support Potential for Biannual Dosing of Zilebesiran Full Study Results to...Read more
Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by the End of the First Quarter of 2025, Followed by Topline Data from Booster Dose by the End of 2025 VAX-24, a 24-Valent Pneumococcal Conjugate Vaccine (PCV), is Designed to Cover More Serotypes Than Any Infant Pneumococcal Vaccine On-Market or in U.S. Clinics Today Company’s Potential Best-in-Class,...Read more
MHRA authorization expands ongoing U.S. Phase 2a biomarker study evaluating lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”) with interim data expected H1 2024 and topline data H2 2024 UK enrollment to be supported by collaboration with UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration (“NIHR Respiratory TRC”) LA JOLLA, CA, March 04, 2024...Read more
BOSTON, March 04, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase...Read more
50mg (75%, p<0.001) and 28mg (46%, p=0.07) EFX groups demonstrated ≥1 stage improvement in fibrosis without worsening of MASH, approximately three- and two-fold the placebo rate (24%) 50mg (36%, p<0.01) and 28mg (31%, p<0.01) EFX groups demonstrated ≥2 stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate (3%) EFX-treated patients experienced statistically significant improvements on...Read more
Ethics and regulatory approvals finalized for world-first take-home use of a psychedelic medicine MB22001 in placebo-controlled trial in depressed patients n=90 Recruitment of clinical trial participants underway Follows successful Phase 2a trial where 53% of depressed patients in complete remission at week 8 of treatment Prior trials of MB22001 show statistically significant improvements in sleep and mood VANCOUVER, BC /...Read more
Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting Pfizer Ignite is responsible for the clinical execution of the trial Initial topline results expected in mid-2024 Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, will hold an investor conference on Monday, March 4 at 8:00 a.m. ET to share results after 96 weeks of treatment for its HARMONY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin...Read more
Accelerated pace of enrollment supports speed to market strategy Topline results from Stage 1 expected to be presented in the second quarter of 2024 followed by Stage 2 data in the third quarter of 2024 SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide,...Read more
Long-term CNM-Au8 treatment demonstrated significant and clinically meaningful improvement of vision as measured by low contrast letter acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from randomization, p<0.0001 Long-term CNM-Au8 treatment demonstrated improvement of cognition, measured by the Symbol Digit Modality Test (SDMT), through 35 months from randomization,...Read more
TORONTO / Feb 29, 2024 / Business Wire / Biomind Labs Inc. (“Biomind” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, today announced the successful conclusion of the Phase 2 clinical trial of its proprietary 5-Metoxi-N,N-dimethyltryptamine...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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