Treatment with adjuvant TAGRISSO reduced the risk of death by more than half WILMINGTON, Del. / Jun 04, 2023 / Business Wire / Positive results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth...Read more
Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual Meeting PRINCETON, N.J. / Jun 04, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced...Read more
Results from MIRASOL Also Show ELAHERE is the First Treatment to Demonstrate an Overall Survival Benefit in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer Compared to Chemotherapy Clinically Meaningful Improvements in Progression Free Survival and Overall Survival Observed with ELAHERE Regardless of Prior Bevacizumab Status Data Further Support Potential of ELAHERE to Become the New Standard of Care for Patients with FRα-Positive...Read more
Phase 2 Mechanism of Action Trial Results Demonstrate the Immunomodulatory Effects of Trilaciclib in the Tumor Microenvironment Trilaciclib Enhances Expression of Genes Associated with Memory T Cells Trilaciclib Increases Multiple Surrogate Immune Markers for Memory CD8+ T Cell Differentiation, Infiltration,and Function RESEARCH TRIANGLE PARK, N.C., June 04, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a...Read more
Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in October 2023 Conference call and webcast today at 6:00 p.m. CT BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to...Read more
LOS ANGELES / Jun 04, 2023 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held...Read more
Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients; data immature to estimate progression free survival (PFS) Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile Cogent to...Read more
Met Primary Endpoint with 63.4% Median Reduction in LDL-C (p<0.0001) 87.1% of Patients Treated with Combination of Obicetrapib and Ezetimibe Met Guideline-Recommended LDL-C Goal of <55 mg/dL compared to 0% of Patients Treated with Placebo (p<0.05) New Data Demonstrate Statistically Significant and Clinically Meaningful Improvements in Additional Lipid and Lipoprotein Parameters Predictive of Cardiovascular Disease Risk, Such...Read more
PRGN-2009 combined with an investigational checkpoint inhibitor resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers that were naïve or resistant to checkpoint blockade with prolonged duration of responses Recurrent/metastatic HPV-associated cancers (cervical, anal, oropharyngeal, etc.) are incurable by current therapies PRGN-2009 was safe and well-tolerated with only Grade 1 or 2 treatment related adverse...Read more
The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients Higher EVX-01 dose induced a stronger...Read more
Initial data showed promising signs of efficacy, including a 47.1% ORR in patients with resistant/refractory gastric cancer expressing Claudin 18.2, with a well-tolerated safety profile Elevation Oncology on track to initiate Phase 1 clinical trial in the US in the second half of 2023 NEW YORK, June 3, 2023 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and...Read more
Long Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrate Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous Therapies Presentation Focused on Patients (n=12) Treated with Phase 2 Regimen 67% Overall Response Rate (ORR) and 58% Complete Response (CR) Rate Five Patients (42%) Maintained a CR at Month 6; Four of Five CRs (80%) Ongoing Beyond Six Months, Including Two...Read more
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone RAHWAY, N.J. & KINGSTON, Ontario / Jun 03, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial...Read more
WILMINGTON, Del. / Jun 03, 2023 / Business Wire / Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of LYNPARZA® (olaparib), IMFINZI® (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with...Read more
Marked increases in overall survival observed across soft tissue sarcoma patients Demonstrated improvement of median progression free survival in patients with dedifferentiated liposarcoma (DDLPS) DDLPS expansion cohort enrolling to inform a potential Phase 3 registration trial SAN CARLOS, Calif., June 03, 2023 (GLOBE NEWSWIRE) -- Apexigen, Inc. (Nasdaq: APGN) a clinical-stage company focused on developing innovative antibody-based...Read more
Zevra is a corporate sponsor of the Hypersomnia Foundation and Beyond Sleepy Conference CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological...Read more
ELI-002 was shown to be well-tolerated with no dose limiting toxicity or cytokine release syndrome A high proportion of patients had tumor biomarker reduction (77%) with 32% having complete clearance Robust mKRAS-specific T cell responses induced in 87% of patients BOSTON, June 03, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for...Read more
Early on-treatment ctDNA reduction in stable disease patients treated with KIMMTRAK was associated with longer overall survival (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md, 3 June 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases,...Read more
Results presented today at ASCO 2023 and concurrently published in The Lancet Oncology demonstrate meaningful clinical benefit including antitumor activity, confirmed objective response rate (cORR) of 41.3%, median duration of response (DOR) of 12.9 months, and median progression-free survival (PFS) of 5.5 months (median study follow-up time of 12.4 months) Biliary tract cancers (BTC) are an aggressive group of cancers with no...Read more
First global Phase III trial of immunotherapy and chemotherapy combination to demonstrate clinical benefit in this setting Trial will continue to assess event-free survival WILMINGTON, Del. / Jun 02, 2023 / Business Wire / Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI® (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin,...Read more
Additional data from Phase 1 combination with FOLFIRI continues to show encouraging activity in median third-line metastatic colorectal cancer patients Progression-free survival of 5.6 months in median third-line colorectal cancer patients without bevacizumab Promising safety profile in combination with FOLFIRI and bevacizumab Randomized combination trial in second-line colorectal cancer patients initiated in Q1 2023 MOUNTAIN...Read more
BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC) Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable...Read more
NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. A link to the oral presentation is included below. Michael S. Weiss, Chairman and Chief...Read more
76% of patients treated with obe-cel in the FELIX study achieved a response (CR/CRi), primary endpoint has been met based on previously communicated interim analysis Potential best in class tolerability, with very low levels of high-grade CRS and ICANS Robust and reliable manufacturing and logistics, with 84% of enrolled patients receiving obe-cel Analyst call to be held today, June 2, 2023 at 4.00 pm ET/9.00 pm BST LONDON, June...Read more
Tel-Aviv, June 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today announced positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (“IMCA”), which suggest that the...Read more
CLEVELAND / Jun 01, 2023 / Business Wire / Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) cell therapy for critical care indications, announces patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem® in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health...Read more
Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. Icanbelimod continued to be well-tolerated, consistent with observed induction period safety data. SAN DIEGO, CA and TAICANG, China, June 01, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”...Read more
Data support that antibiotic aztreonam-avibactam (ATM-AVI) is effective and well-tolerated in treating infections caused by Gram-negative bacteria, with a similar safety profile to aztreonam alone NEW YORK / Jun 01, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and...Read more
Two-year treatment with donidalorsen in the Phase 2 open label study resulted in consistent, sustained protection from HAE attacks Completed enrollment in the Phase 3 OASIS-HAE study Topline Phase 3 results expected in H1 2024 CARLSBAD, Calif., June 1, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for...Read more
Topline Phase 1 monotherapy and initial combination data expected in 2024 BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced...Read more
EDMONTON, Alberta / Jun 01, 2023 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high...Read more
U.S. Clinical Sites Screening Treatment-Experienced Participants with Wet AMD ODYSSEY Topline Results Expected in Q3 2024 ALPHARETTA, Ga., June 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that enrollment has opened in ODYSSEY, its Phase 2b...Read more
Patient in 520 mg/m2 cohort, previously unresectable, experienced tumor shrinkage and had tumor resected following camsirubicin treatment 3 of 3 patients in the 520 mg/m2 cohort achieved stable disease WILMETTE, Ill., June 01, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, today announced an update...Read more
Study is Investigating RenovoGem™ as Potential New Option for Pancreatic Cancer Treatment Recent Positive Interim Data Analysis from Study Revealed 60% Survival Benefit and 65% Side Effect Reduction Versus Systemic Chemotherapy LOS ALTOS, Calif. & DALLAS / Jun 01, 2023 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies,...Read more
HAT-301 is the Pivotal Efficacy Study to Support Upcoming NDA Filing Top Line Results Planned for Release in July 2023 TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable...Read more
Linebacker fully inhibited lung cancer cell growth and significantly limited colon cancer cell growth in two separate clonogenic models Development ahead of schedule with mice studies well underway and full toxicology screening soon to follow Garden City, NY, June 01, 2023 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a next generation biotech, genomics and diagnostics company, today provided an update...Read more
AUSTIN, Texas, June 01, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action for cancer, announced today that the U.S. Food and Drug Administration...Read more
GAITHERSBURG, Md., June 1, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its PIKA Rabies Vaccine (the "Vaccine") was granted Phase 3 clinical trial approval from the Food and Drug...Read more
HB-200 in combination with pembrolizumab doubled the objective response rate of 1st-line pembrolizumab for patients with recurrent/metastatic head and neck cancer HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024 Initial cohort of heavily pre-treated patients who received HB-200 monotherapy showed preliminary...Read more
At week 24, upadacitinib 30 mg given alone or as a combination therapy (ABBV-599 high dose [elsubrutinib 60 mg and upadacitinib 30 mg]) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day in patients with moderately to severely active SLE receiving standard lupus therapies1 Upadacitinib maintained greater improvements...Read more
HAMPTON, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. Celldex plans to develop CDX-585 for the treatment of solid tumors either as monotherapy or in combination with other oncologic...Read more
Data from the four patients treated with the highest dose of pegtibatinase showed a clinically meaningful 67.1% mean relative reduction in total homocysteine from baseline Pegtibatinase has been generally well-tolerated to date The Company is engaging with regulators and expects to initiate a pivotal Phase 3 Study by year-end 2023 Company to host conference call and webcast today at 8.30 a.m. ET SAN DIEGO, May 31, 2023 (GLOBE...Read more
HOUSTON, May 31, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced pre-clinical data from the Company’s multiple tumor-associated antigens (multiTAA)-specific T cell product candidate MT-601 in lymphoma cells, including...Read more
BOTHELL, Wash., May 31, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces approval from the Australian Human Research Ethics Committee (HREC) to conduct a Phase 1 study with its novel, oral, broad-spectrum 3CL protease inhibitor CDI-988 as a potential treatment for COVID-19. The Phase 1 randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety,...Read more
Time to maximum blood concentration (median Tmax) for Anaphylm was 10 minutes with a range of 5 to 20 minutes Early drug exposure at 10 minutes (partial area under the curve, or pAUC0-10min) for Anaphylm was similar to Auvi-Q® (epinephrine injection) auto-injector 0.3mg and over 4 times higher than epinephrine 0.3mg manual injection, while lower than both EpiPen® (epinephrine) auto-injector 0.3mg and the generic equivalent...Read more
Hyalofast – a single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair – is marketed in over 35 countries outside the U.S. where it has been clinically demonstrated to be safe and effective Hyalofast has been designated as a breakthrough device by FDA, allowing prioritized interaction and review; Anika to begin filing modular PMA in 2024 with final module filing expected in 2025 Hyalofast...Read more
BOSTON, May 30, 2023 (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 Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to...Read more
Engineered IL2-Fc Cytokine is Well-tolerated and Selectively Expands Regulatory T Cells PASADENA, Calif. / May 30, 2023 / Business Wire / Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today announced the presentation of results from its Phase 1a single-ascending dose study of XmAb®564 in healthy...Read more
Study demonstrates statistically significant and clinically relevant reduction in annualized bleeding rate compared to prophylaxis and on-demand intravenous regimens Marstacimab, if approved, has the potential to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B A novel, investigational anti-tissue factor...Read more
ATH434 now being evaluated in early and more advanced Multiple System Atrophy New trial expected to generate data before ongoing Phase 2 trial MELBOURNE, Australia and SAN FRANCISCO, May 30, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it...Read more
Healthy subjects have been dosed with Filament's botanical psilocybin and psilocin drug candidates VANCOUVER, BC, May 30, 2023 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical–stage natural psychedelic drug development company, today announced interim safety reporting from its Phase I clinical trial in partnership with the University of California, San Francisco (UCSF)'s...Read more
First subject dosed in Phase 1 trial of PYX-106, a fully human immunotherapy antibody candidate Second dose level initiated in Phase 1 trial of PYX-201, an antibody-drug conjugate (ADC) candidate Preliminary data from both trials on track for late-2023/early-2024 timeframe Company to present and host investor meetings at Jefferies Healthcare Conference in NYC on June 7, 2023 BOSTON, May 30, 2023 (GLOBE NEWSWIRE) -- Pyxis...Read more
STAMFORD, Conn., May 30, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has achieved full enrollment in its Phase 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian...Read more
TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) evaluating the safety and efficacy of...Read more
Results from Phase 1 Portion Indicate Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer AUSTIN, Texas, May 30, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that it has completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial...Read more
Reports significant uptick in enrollment activities Tigris trial enrollment at 61 patients TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES...Read more
Phase 2 of study will further investigate the peptides’ method, optimization, and binding affinity in human tissue ENGLEWOOD CLIFFS, NJ, May 30, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced its entry into a research agreement expanding the study of its novel joint...Read more
Highlights: Immuron receives approval from U.S. Army Medical Research and Development Command Recruitment and screening of healthy volunteers for Travelan® Controlled Human Infection Model (CHIM) Clinical Trial is in progress Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military will commence shortly Travelan® is known to protect against the onset of Travelers diarrhea (TD), the most common illness...Read more
The research conducted at Cedar Clinical Research in Draper is part of the first ever phase 3 program of psilocybin therapy, and the largest of its kind VANCOUVER, BC, May 30, 2023 /CNW/ - Numinus Wellness Inc. (TSX: NUMI) is pleased to announce that Cedar Clinical Research (CCR) has begun studying COMP360 psilocybin therapy, an investigational new therapy for treatment-resistant depression (TRD), as part of the largest-ever...Read more
HORSHAM, Pa., May 30, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced that the first six patients have been treated in the TheraClear®X open label, single-arm, clinical research study led by Glynis Ablon, MD, FAAD. The purpose of the study titled, “A...Read more
SAR’579/IPH6101, ANKET® platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi Preliminary data published show SAR’579 was well tolerated and induced 3 complete responses in the 8 patients at 1 mg/kg as highest dose Phase 1/2 data will be presented as an oral presentation at the ASCO 2023 Annual...Read more
As of the data cutoff date, nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five confirmed partial responses (PRs) and three durable stable disease (DSD) responses, two of which have tumor burden reductions of -18% and -24% and remain on treatment 100% of patients treated with CUE-101+ pembrolizumab at the recommended phase 2 dose (RP2D) of 4mg/kg (n=16) remain alive...Read more
Encouraging preliminary anti-tumor activity observed in a patient with PD-L1 negative advanced non-small cell lung cancer Favorable preliminary safety profile for XTX101 observed at the recommended Phase 2 dose of 150 mg once every six weeks WALTHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology...Read more
Positive clinical response as demonstrated in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor The study met primary endpoints for tolerability and safety COPENHAGEN, Denmark, May 25, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, to present promising...Read more
THE-630 demonstrates encouraging safety profile through Cohort 6 (18 mg), supportive of continued dose escalation Dose-dependent reductions observed in ctDNA KIT-mutant allele fractions for both major classes of KIT resistance mutations at exposures consistent with preclinical predictions observed in Predictive Resistance Assay™ Evidence of clinical activity observed in heavily pre-treated patient population at exposures...Read more
12-week Phase 2a and Phase 1b multiple ascending dose (MAD) topline results expected to be announced in latter half of fourth quarter 2023 Ethnobridging study initiated in Japanese individuals and formulation bridging study planned to evaluate tablet formulation in preparation for global Phase 2b study of GSBR-1290 in 2024 SAN FRANCISCO and SHANGHAI, China, May 25, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ:...Read more
WALTHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Phase 2 MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival (CAFS) rank score at Week 52. The study also did not meet key secondary efficacy endpoints. Systemic pegcetacoplan was...Read more
WASHINGTON, May 25, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its Phase III study of tradipitant in motion sickness, confirming the previously reported results demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. The Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States...Read more
NEWTOWN, Pa., May 25, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who have progressed...Read more
Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates seen in SERENITY I and II BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use SERENITY III Part 2 planned as an adaptive trial design with 60mcg and 80mcg to potentially...Read more
SYDNEY, AUSTRALIA, May 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating...Read more
VICTORIA, BC, May 25, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has reached the last patient last visit in its Phase 2 clinical trial of EP-104IAR for osteoarthritis ("OA"). Dr. James Helliwell, CEO of Eupraxia, commented, "Our team has worked effectively to rapidly...Read more
256-patient enrollment target met plus 11% over-enrollment; Primary endpoint based on patient reported outcomes from study expected in October 2023 SAN FRANCISCO, CA / ACCESSWIRE / May 25, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that the Company has successfully over-enrolled its global, pivotal, Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer...Read more
PLYMOUTH MEETING, Pa., May 25, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) has completed enrollment nine...Read more
Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 2023 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland open and enrolling patients HOUSTON, TX / ACCESSWIRE / May 25, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of...Read more
ARCHER data support ANX007 as the first complement therapy to preserve visual acuity, achieving statistically significant protection against vision loss in both foveal and non-foveal patients through 12 months Reduction in rate of geographic atrophy lesion growth did not reach statistical significance ARCHER results support ANX007’s neuroprotective mechanism of protecting photoreceptor cells, synapses and function Company plans to...Read more
SAN DIEGO, May 24, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial-stage oncology company, today announced that the SAPPHIRE study did not meet its primary endpoint of overall survival at the final analysis. SAPPHIRE is a Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO®)1 versus docetaxel in patients with second or third line advanced non-squamous non-small cell lung cancer...Read more
Patient treated in trial achieved a remission after eight weeks of treatment, demonstrating a significant reduction in proteinuria ELX-02 well-tolerated in study, with no discontinuations to date WATERTOWN, Mass., May 24, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the company intends to advance ELX-02 into a...Read more
Efti plus standard-of-care anti-PD-1 therapy and doublet chemotherapy in 1st line non-small cell lung cancer is well tolerated and continues to show promising initial signals of efficacy Triple combination therapy has achieved a 67% response rate and 91% disease control rate in metastatic 1st line non-small cell lung cancer patients (N=21) despite 81% of patients having low or negative PD-L1 expression SYDNEY, AUSTRALIA, May 24,...Read more
CYB004, a deuterated dimethyltryptamine (“dDMT”) molecule, has potential to overcome existing limitations of DMT and is protected by a composition of matter patent through 2041 Parts A and B of Phase 1 study complete; Part C to determine safety, pharmacokinetic (“PK”) and pharmacodynamic (“PD”) of escalating doses of CYB004 in healthy volunteers Phase 1 topline safety and efficacy data expected in Q3 2023 TORONTO /...Read more
ASHBURN, Va., May 24, 2023 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, announces that its open label study evaluating QRX003 as a treatment for Netherton Syndrome has reached 50% enrollment. The company’s open label study is investigating the safety and efficacy of QRX003 topical lotion in Netherton...Read more
Bentrio® meets primary efficacy endpoint in NASAR clinical trial in seasonal allergic rhinitis Clinically relevant and statistically significant improvement in Total Nasal Symptom Score over saline nasal spray control (p = 0.012) Bentrio efficacy and tolerability rated as "good" or "very good" by 63.5% and 73.5% of study participants NASAR concludes Altamira's clinical development program for Bentrio in allergic rhinitis HAMILTON,...Read more
Company approaching Phase 2 topline data readout for prevention of post-surgical abdominal adhesions Continued momentum with execution of ongoing dose optimization study with 25% enrollment complete Carlsbad, CA, May 24, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today...Read more
One of two newly announced clinical trials for its lead product candidate, PH-762 MARLBOROUGH, Mass., May 24, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced its clinical development partner, AgonOx, Inc, in collaboration with Providence...Read more
ATLANTA, May 24, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announces that it has completed enrollment for the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to generate prospective data for...Read more
Target enrollment increased to 155 subjects with the addition of a cohort testing a second dose of LSTA1 Results to be used to explore possible conditional approvals globally Futility analysis results expected in the third quarter of 2023 BASKING RIDGE, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative...Read more
Conference call and webcast to be held at 5:00 pm EDT SOUTH PLAINFIELD, N.J., May 23, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today reported topline results from the MOVE-FA trial of vatiquinone in patients with Friedreich ataxia. The study did not meet its primary endpoint of statistically significant change in mFARS score at 72 weeks in the primary analysis population. However, vatiquinone treatment...Read more
LONDON, May 23, 2023 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on rare diseases today announced that data from the Phase 2 “ASTRAEUS” trial of alvelestat for the treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), as well as post-hoc analyses demonstrating the association between biomarker reductions with...Read more
Potent and durable target engagement observed across cohorts, including with 10 mg doses administered every 12 weeks which were also generally safe and well-tolerated WVE-004 did not show clinical benefit compared with placebo; additionally, poly(GP) reductions did not correlate with clinical outcomes -- Wave to discontinue development of WVE-004 Wave to host investor conference call at 8:30 a.m. ET today CAMBRIDGE, Mass., May 23,...Read more
ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline treatment durations compared to placebo Cytisinicline demonstrated 6x increase in odds of continuous smoking abstinence at 6 months Cytisinicline treatment well tolerated with low rates of adverse events reported Management to host conference call today, May 23 at 8:30AM...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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