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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
44-48% Mean Reductions in LDL-C Achieved on Top of Continued Standard of Care Phase 3 Planning is Ongoing PASADENA, Calif. / May 23, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented interim data from the ongoing Phase 2 GATEWAY clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic designed to reduce expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous...Read more
BOSTON, May 23, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced the last dosing of the last patient in the GALACTIC-1 Phase 2b trial of its most advanced product candidate, GB0139, for the treatment of idiopathic pulmonary fibrosis (IPF). GALACTIC-1 is a randomized,...Read more
Ethics approval received for take-home LSD-Microdosing clinical trial in depressed patients Clinical trial has been approved by the Clinical Trials Registry One of two approved take home Phase 2 LSD-Microdosing Clinical Trials running in 2023 VANCOUVER, BC / ACCESSWIRE / May 23, 2023 / MindBio Therapeutics Corp. (CSE:MBIO) (Frankfurt:WF6), (the "Company" or "MindBio") is pleased to announce that ethics approval has been received...Read more
Nalbuphine ER resulted in a rapid and marked reduction in recorded daytime cough among patients suffering from IPF-related cough The mean change in 24-hour objective cough frequency was similar in patients with concomitant anti-fibrotic therapy and without concomitant anti-fibrotic therapy NEW HAVEN, Conn., May 22, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company...Read more
Phase 2 study shows 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 62% relative reduction in the rate of decline in percent predicted forced vital capacity (ppFVC) versus placebo BMS-986278 was well tolerated with rates of adverse events and treatment discontinuation comparable to placebo Data demonstrate potential of BMS-986278 in pulmonary fibrosis and support progression into Phase 3 PRINCETON, N.J....Read more
Improvements in physiologic liver function and key NASH biomarkers including ALT, ProC3, PIIINP and ELF Results reinforce rencofilstat’s direct antifibrotic mode of action; increases confidence for reductions in fibrosis in ongoing Phase 2b ‘ASCEND-NASH’ paired biopsy trial EDISON, N.J., May 22, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused...Read more
IRVINE, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced planned enrollment of the PEERLESS II trial, Inari’s third randomized controlled trial (RCT) in venous thromboembolism (VTE). The trial design was presented at the Society for Cardiovascular Angiography &...Read more
FREMONT, CA, May 22, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS) disorders, and ophthalmology, today announced that the Vitrargus® Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne...Read more
Treatment of Aficamten was Well-Tolerated and Associated with Statistically Significant Improvements in KCCQ, Angina Frequency, NYHA Class, NTpro-BNP and High-Sensitivity Troponin I Phase 3 Clinical Trial in Non-Obstructive HCM To Begin in 2H 2023 SOUTH SAN FRANCISCO, May 20, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of...Read more
The Phase 2a, proof-of-concept study, called FAST-AA (FArudodstat STudy in Alopecia Areata), will enroll approximately 60 adult patients in the US; interim topline readout is expected in 1Q 2024 Farudodstat is a potent, oral DHODH inhibitor with the potential to be a novel, first-in-class treatment for alopecia areata (AA) SAN MATEO, Calif. and SINGAPORE, May 18, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN), a...Read more
FLORHAM PARK, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the completion of enrollment in the immune checkpoint inhibitor naïve group (ICI naïve) of its VERSATILE-002 Phase 2 trial for the treatment of recurrent or metastatic human papillomavirus...Read more
Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo The safety...Read more
Over 50% of patients dosed across 20 active clinical sites On Track for Topline Results in late 2023 NEW YORK / May 17, 2023 / Business Wire / Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that the company’s Phase 2b study evaluating MM-120...Read more
Immuno-oncology combination of eftilagimod alpha (efti) and the leading anti-PD-1 therapy generates meaningful long-term survival in non-small cell lung cancer patients in Phase II TACTI-002 trial Initial median Overall Survival of 25 months in non-small cell lung cancer patients with >1% PD-L1 expression, a key area of focus for future development of efti Result is above reported rates of anti-PD-1 monotherapy and various immune...Read more
Research Supports Direct Role for Restoring Neuroplasticity and Upsets Previously Held Beliefs About the Significance of Neurotransmitters in Treating Depression Findings Explain Why Tianeptine Is Not Associated with Sexual Dysfunction and Weight Gain Mechanism Supports Development of TNX-601 ER for a Broad Range of Neurodegenerative Diseases and Psychiatric Disorders CHATHAM, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Tonix...Read more
Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in Liver Fat from Baseline to Week 12 in Patients Receiving VK2809 as Compared to Placebo Up to 52% Mean Liver Fat Reduction Observed in VK2809-Treated Patients Up to 85% of Patients Experienced at Least a 30% Relative Reduction in Liver Fat Statistically Significant Reductions in LDL-C, Triglycerides, and Atherogenic Lipoproteins Observed Adverse...Read more
BOSTON and ATLANTA, May 16, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that the first patient has been dosed in its Phase 2 '201' trial evaluating IkT-148009, the Company's novel Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson's...Read more
QUEBEC CITY / May 16, 2023 / Business Wire / Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD; OTCQB : DVHGF), a clinical late stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, today announced that results from phase 2 clinical study in mild-to-moderate atopic dermatitis (‘‘AD’’) will be presented at the upcoming 25th World...Read more
96% of participants who completed the trial opted to receive treatment with PrimeC in a 12-month open label extension Topline results expected Q4 2023 CAMBRIDGE, Mass., May 15, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the completion of enrollment in PARADIGM, a multinational, randomized, double-blind,...Read more
STRIVE is the first Phase 2 sub-protocol trial initiated under Vir’s new PREVAIL platform trial investigating the Company’s novel therapies in two chronic hepatitis B virus patient populations SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in the Phase 2 STRIVE sub-protocol clinical trial evaluating the safety and efficacy of...Read more
Topline data are expected in second half of 2023. EMBARK will be the first completed randomized study of an IBAT inhibitor for the treatment of biliary atresia. FOSTER CITY, Calif. / May 11, 2023 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed enrollment of its Phase 2b EMBARK study for pediatric patients with biliary atresia, the most common indication for pediatric liver transplant. The...Read more
Top line data read-out on track for July 2023 BOCA RATON, Fla., May 11, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed patient screening in its ongoing Phase 2 SPAN clinical trial...Read more
Ethics approval granted The clinical trial protocol has been submitted for publication and the trial registered A Phase 2 clinical trial assessing the effectiveness of psychedelic (LSD) Microdosing and Meaning Centred Psychotherapy in advanced stage cancer patients One of two Phase 2 LSD-Microdosing Clinical Trials running in 2023 VANCOUVER, BC / ACCESSWIRE / May 11, 2023 / MindBio Therapeutics Corp. (CSE:MBIO); (the "Company" or...Read more
Study designed to determine if a different dosing protocol for all indications might enhance the risk profile of LB1148 while simultaneously providing efficacy Company expects enrollment to be completed in Q3 2023 Carlsbad, CA, May 11, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today...Read more
For the primary objective, 65% of Evaluable Patients (Patients evaluated by a Principal Investigator ("PI")) achieved a Complete Response ("CR") at any assessment date post primary Study Treatment and 30% of Evaluable Patients achieved a CR at 450 days. TORONTO, ON / ACCESSWIRE / May 10, 2023 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the...Read more
On-Target Effect of Trilaciclib Reduces Rates of Multiple Adverse Events Associated with Sacituzumab Govitecan-Hziy by Over 50% Including Neutropenia, Anemia, and Diarrhea Most Enrolled Patients Received Prior PD-(L)1 Inhibitor Treatment; Initial Objective Response Rate (ORR) in Overall Study Population Consistent with ORR in Checkpoint Inhibitor Pretreated Population in ASCENT Trial Initial ORR Higher in Patients with...Read more
MELBOURNE, Australia and SAN FRANCISCO, May 10, 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 the first participant in Australia has been treated in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating...Read more
Actively recruiting in three Phase 1b/2 clinical trials (one of which is in Phase 2) Recently completed first cohort in Phase 1b/2 trial evaluating Annamycin in combination with cytarabine (Ara-C) for the treatment of acute myeloid leukemia (AML); Preliminary results show a durable complete response at starting dose level in an elderly subject Multiple expected milestones and interim data readouts expected in 2023 HOUSTON, May...Read more
First interim Phase 2 data of an IL-23p19 antagonist in pediatric patients New analysis from the pivotal Phase 3 LUCENT-1 and LUCENT-2 studies INDIANAPOLIS, May 9, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today new investigational data for mirikizumab in patients with moderately to severely active ulcerative colitis (UC) that further support the efficacy and safety seen in previous pivotal...Read more
SOUTH SAN FRANCISCO, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept, a next generation CD47 blocker, in combination with liposomal doxorubicin and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1...Read more
This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89% higher for A strains compared to Fluzone...Read more
The clinical research and development program will be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University. TEL AVIV, Israel, May 9, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced the initiation...Read more
Exploratory, small, open-label study aims to assess potential efficacy of Namodenoson following strong preclinical results in pancreatic cancer Namodenoson, now in a pivotal Phase 3 liver cancer study, has completely cleared liver cancer in a patient who remains cancer-free 6 years after starting treatment PETACH TIKVA, Israel / May 09, 2023 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology...Read more
Study Met Primary Endpoints of Safety and Tolerability Dose-Dependent Improvement in Total Symptom Score Observed with EDP-235 Treatment Compared to Placebo, Achieving Statistical Significance as Early as One Day After First Dose No Difference in Viral Load Reduction; Rapid Decline Observed in All Study Arms Conference Call and Webcast Today at 4:30 p.m. ET WATERTOWN, Mass. / May 08, 2023 / Business Wire / Enanta Pharmaceuticals,...Read more
New York State’s largest health care provider will participate in BRTX’s clinical trial Expansive universe of patients and clinical sites from which to recruit high quality subjects Leverage Northwell’s “Center for Regenerative Orthopedic Medicine” Potential future collaborations to be explored in connection with basic science research MELVILLE, N.Y., May 08, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc....Read more
BOSTON, MA / ACCESSWIRE / May 4, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder...Read more
Scilex Holding Company, an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced complete enrollment of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute low back pain. Top-line data from the Phase 2 study is expected in Q3-2023. The Phase 2, randomized, double-blind,...Read more
Relapsed/Refractory MDS Patients Achieved Median Overall Survival of 8.7 months Historically, Median Overall Survival in this Hard to Treat Patient Population is Only 4-6 Months1,2 Results Indicate Potential Single Agent Activity of Eltanexor in Patients with R/R MDS NEWTON, Mass., May 3, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer...Read more
DUBLIN / May 02, 2023 / Business Wire / Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in a Phase 2 randomized placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7) that depletes certain dendritic cells, to treat people with active proliferative lupus nephritis...Read more
Rapid and sustained efficacy demonstrated in GPP patients after only a single dose, achieving primary endpoint at Week 4 Flare control sustained on monthly subcutaneous doses through Week 16 Imsidolimab was generally safe and well tolerated with low overall ADA incidence Top-line GEMINI-1 Phase 3 trial data expected in Q4 2023 SAN DIEGO, May 02, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage...Read more
Statistically significant decreased levels of novel biomarker AGO2 (p= 0.002) observed in newly diagnosed people living with Parkinson's disease (PD) compared to healthy individuals NeuroSense's combination platform has been observed in a clinical trial to induce an increase of AGO2 in ALS patients, indicating therapeutic potential in PD NeuroSense is exploring co-development of PD asset with potential collaborators CAMBRIDGE,...Read more
The Company previously announced positive interim results from the trial meeting its primary endpoints TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of...Read more
Trial designed with pre-specified primary efficacy endpoints discussed previously with FDA If successful, this phase 2 trial may serve as one of the two required phase 3 studies necessary to support FDA approval Top-line data from trial anticipated before end of 2023 LONDON and NEW YORK, May 02, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is...Read more
Adult patients with atopic dermatitis treated with Opzelura experienced rapid and substantial improvement in itch, which was sustained through Day 28 WILMINGTON, Del. / May 01, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced new data from the Phase 2 SCRATCH-AD trial evaluating the short-term clinical benefits of Opzelura® (ruxolitinib) cream 1.5% to control pruritus (itching) and reduce disease severity in adult patients...Read more
With these results, Breyanzi has now demonstrated clinically meaningful benefit across the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy, underscoring the company’s leadership in advancing innovative therapies for many types of hematological malignancies PRINCETON, N.J. / May 01, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from two studies, TRANSCEND...Read more
Bexotegrast was well tolerated up to 40 weeks of treatment with no drug-related serious adverse events Combination of bexotegrast with standard of care reduced FVC decline by 80% relative to standard of care alone at Week 24 89% of bexotegrast-treated patients with an increase in FVC from baseline at Week 12 maintained an increase at Week 24 Stabilization of fibrosis as measured by QLF imaging was observed in the...Read more
ADELAIDE, Australia, April 27, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today announced that the Company has completed target enrollment of approximately 200 participants in its randomized, double-blind,...Read more
CAMBRIDGE, MA / ACCESSWIRE / April 27, 2023 / Recently, Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced plans to speed up its Phase 2 clinical trial for IXEMPRA®, the clinical-stage pharma company's metastatic breast cancer treatment. Already approved by the Food and Drug Administration (FDA) for patients in the United States, the company is sponsoring this current trial as part of its work to get IXEMPRA® and IXEMPRA-DRP® the...Read more
Registration-Directed RAMP-201 Trial Designed to Address High Unmet Need in Low-Grade Serous Ovarian Cancer, a Unique and Distinct Type of Ovarian Cancer with Limited Treatment Options BOSTON / Apr 26, 2023 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that an abstract highlighting updated interim results from Part A...Read more
Day 400 non-relapse mortality was 0% Previously reported data from the 14-week primary endpoint showed low rates of clinically significant viral infections and diseases in this high-risk patient population despite the expected high rates of viral reactivation Global Phase 3 pivotal posoleucel trials continue to progress with robust patient enrollment in the US, Europe and Asia with data readouts on track for 2024 WALTHAM, Mass. / Apr...Read more
Fremont, CA, April 26, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the site initiation visits (SIV) at the University of California San Francisco (UCSF) Medical Center was conducted on March 29, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, at...Read more
State-of-the-art biomarker analyses a hallmark of the 201 study BOSTON and ATLANTA, April 26, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today reported updates in...Read more
Topline Data from fourth cohort of EDP1815 Phase 2 trial in atopic dermatitis did not meet primary endpoint Company will focus on development of extracellular vesicles (EVs) First EV candidate, EDP2939, in Phase 2 moderate psoriasis study fully enrolled; data anticipated in early Q4 2023 Management to host conference call today at 8:30 a.m. ET CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo...Read more
Tinlarebant (aka LBS-008) continues to be safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at the 18-month time point A continued trend of slowing expansion of autofluorescence was observed The growth rate of incident atrophic retinal lesions was reduced compared to a natural history study of the disease (“ProgStar”) Visual acuity was stabilized with no significant loss, and no clinically significant changes...Read more
TORONTO / Apr 25, 2023 / Business Wire / Biomind Labs Inc. (“Biomind Labs” 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, is pleased to announce that it has commenced a Phase II clinical trial for its proprietary 5-Metoxi-N,N-dimethyltryptamine...Read more
MORF-057 demonstrates statistically significant reduction of 6.4 points (p=0.002) from baseline at Week 12 in the Robarts Histopathology Index (RHI) Score MORF-057 achieves 25.7% clinical remission by Modified Mayo Clinic Score (mMCS) MORF-057 generally well tolerated with no safety signal observed MORF-057 achieves saturation of α4β7 receptor and demonstrates changes in α4β7 lymphocyte subsets that are consistent with Phase 1...Read more
All Patients in Three BX1000 Treatment Cohorts Met Criteria for Good or Excellent Intubation Conditions at 60 Seconds Results to be Discussed in Key Opinion Leader Webinar Today at 10:00am Eastern Time MALVERN, Pa., April 25, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today announced positive top-line results...Read more
Topline safety and clinical efficacy data from NEST-IN1 expected in the first quarter of 2024 HIL-214 is the most advanced vaccine candidate for norovirus infection There are currently no approved vaccines for norovirus BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced completion of enrollment...Read more
SOLANA BEACH, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced it has initiated the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 for the treatment of...Read more
Three U.S. clinical trial sites actively screening and enrolling patients Top line data of adrulipase in Cystic Fibrosis patients expected in July 2023 BOCA RATON, Fla., April 25, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI)...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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