Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months) OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months) No treatment related discontinuations reported PHILADELPHIA and VANCOUVER, British Columbia, July 11, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW,...Read more
Metastatic Colorectal Cancer Cohort in NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage Design PRINCETON, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced patient...Read more
[IMAGES BELOW] Sustained complete resolution of temporal lobe brain metastasis and continued orbital tumor reduction after >18 months of treatment “Eye bulging” metastatic breast cancer patient had failed 8 prior regimens, including antibody-drug conjugate (ADC) therapy Patient remains on BriaCell’s Phase 2 study with 29 treatment cycles completed PHILADELPHIA and VANCOUVER, British Columbia, July 10, 2025 (GLOBE NEWSWIRE) --...Read more
CHICAGO / Jul 09, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly...Read more
Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks Post-hoc analysis showed BMI reductions in bivamelagon trial were consistent with BMI reductions achieved by setmelanotide in past trials in similar patient populations Patients in both 600mg and 400mg cohorts achieved mean reduction of -2.8 points in most hunger...Read more
Topline results from the CHASE trial expected by end of Q3 2025 Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results ARLINGTON, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for...Read more
GAITHERSBURG, Md., July 09, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD). Pemvidutide is a novel,...Read more
52% of BriaCell’s most-recent 25-patient cohort* have surpassed the one-year survival milestone, exceeding current standard of care in similar patients 11 patients remain alive as of recent contact, including one patient at 38.3 months and another at 30.3 months Survival benefit observed in heavily pre-treated patients, including those who failed treatment with checkpoint inhibitors (CPIs) and antibody-drug conjugates (ADCs)...Read more
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last...Read more
Dosing of the first patient in Phase 2b marks an important transition of the RESOLVE trial from a Phase 2a open-label study to a Phase 2b placebo-controlled study. This is a critical step required prior to proceeding to pivotal clinical trials necessary for regulatory approval Eupraxia plans to enroll a minimum of 60 patients in the Phase 2b portion of the RESOLVE study in up to 25 sites globally, assessing tissue health measured by...Read more
Global Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug administered every 12 or 24 weeks in moderate-to-severe COPD Broadens global development program for verekitug into third indication, strengthening pipeline across severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and COPD Program updates also include completion of enrollment in...Read more
LEXINGTON, Mass. / Jul 07, 2025 / Business Wire / Agenus Inc. (Nasdaq: AGEN) a leader in immuno-oncology innovation, today announced that its botensilimab and balstilimab (BOT/BAL) combination achieved a two-year survival rate of 42% along with a now more mature 21-month median overall survival (OS) in an expanded cohort of 123 patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases...Read more
Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients...Read more
APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including 71.0% decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposures with readout...Read more
JERSEY CITY, N.J. / Jul 02, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition...Read more
Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to...Read more
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival 2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025 LA JOLLA, CA,...Read more
PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of...Read more
Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8 BPL-003 was generally well-tolerated at all doses, with 99% of...Read more
ARCT-810 significantly and consistently reduces biomarker glutamine to levels within normal range 15N-ureagenesis data provide first evidence of an mRNA therapeutic improving urea cycle function Ammonia remained stable and within normal range Multiple administrations of ARCT-810 continue to be safe and well tolerated at all tested dose levels Virtual KOL Presentation at 12:00 p.m. ET Today SAN DIEGO / Jun 30, 2025 / Business Wire /...Read more
As recently announced, initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5% The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period...Read more
The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may...Read more
Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy THE WOODLANDS, TX, June 30, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device...Read more
TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC Initial 3-month complete response (CR) data expected to be reported in 1H 2026 CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor...Read more
In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and...Read more
In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”),the six-month radiographic progression free survival (“rPFS”) rate was 66% In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer (“mBC”), the objective response rate (“ORR”) was 43% No patients...Read more
TARPON SPRINGS, Fla., June 27, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor today announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or...Read more
The Independent Data Monitoring Committee (“IDMC”) has recommended to continue the study as planned as there are no safety concerns demonstrated in the data reviewed Interim results to date demonstrate GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated 6-week interim biomarker data (n=24) expected in July 2025 and topline data expected in Q3 2025 Currently available treatments for IPF are limited to only two...Read more
Initiation of patient recruitment marks a key milestone in the development of VAR 200, a potential first-in-class treatment for kidney disease addressing renal lipotoxicity. There are no available drugs targeting renal lipotoxicity that damages the kidneys’ filtration system, causing protein leakage into the urine (proteinuria) and disease progression. VAR 200, designed to alleviate renal lipid accumulation, has preclinical data in...Read more
Demonstrated target engagement and response prediction for ALTO-203 by theta/beta ratio, a commonly used EEG index of cortical arousal and attentional control ALTO-203, a non-stimulant compound which demonstrated pro-cognitive and wake-promoting effects, has the potential to address sustained attention abnormalities in EEG biomarker characterized patients Pharmacodynamic activity is aligned with the proposed mechanism of...Read more
First product candidate to demonstrate significant MASH effects and weight loss at 24 weeks Trial met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants in an ITT analysis Fibrosis improvement without worsening of MASH in up to 34.5% of participants in an ITT analysis Supplemental AI-based analysis demonstrated statistically significant reductions in liver...Read more
New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings Ongoing pivotal and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker Encouraging Phase 2 observations in Duchenne define the dose and inform design for Phase 3 Edgewise leadership to discuss these updates on Thursday, June 26...Read more
Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a 38% reduction in risk of death when treated with elraglusib plus GnP CHICAGO and FORT WORTH, Texas,...Read more
During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the...Read more
Treatment to Evaluate Effect of Food on Overdose Protection of MPAR Grant Funds from NIDA Accelerating Clinical Development Program SAN DIEGO, CALIFORNIA / ACCESS Newswire / June 24, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today...Read more
Achieved statistical significance on primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo Achieved statistical significance for key secondary endpoints at week 16 of disease reduction, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA Rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory...Read more
At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years NEW YORK, June 24, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally...Read more
Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation Laromestrocel HLHS program addresses...Read more
MariTide, the First Monthly or Less Frequently Dosed Obesity Treatment, Demonstrated Up to ~20% Average Weight Loss Without a Weight Loss Plateau, and Delivered Significant Cardiometabolic Improvements at 52 Weeks In People Living With Obesity With Type 2 Diabetes, MariTide Demonstrated Up to ~17% Average Weight Loss and Robust HbA1c Improvements Dose Escalation With Lower Starting Doses Substantially Improved Gastrointestinal...Read more
New pharmacokinetic and cardiac biomarker data further demonstrate ifetroban's potential to protect the heart and reduce cardiac damage in DMD patients NASHVILLE, Tenn., June 23, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company committed to developing new products for rare diseases, shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a...Read more
Enrollment in company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25% As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short...Read more
POTOMAC, MD / ACCESS Newswire / June 23, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the addition of a new clinical trial site at Tekton Research in Yukon, Oklahoma, for its Phase 2 CALMA study evaluating IGC-AD1 for agitation in Alzheimer's dementia. This expansion into the Oklahoma City metropolitan area underscores IGC's commitment to diversifying its trial population and addressing regional...Read more
Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the DKK1-high, VEGF-naïve and liver metastasis subgroups Board of Directors has initiated process to explore strategic alternatives to maximize shareholder value CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and...Read more
The study met its primary and all secondary efficacy endpoints for all dose groups Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo CD388 was well-tolerated with no safety signals observed End of Phase 2 meeting request has been submitted to the U.S. Food and Drug Administration (FDA) Cidara will host a conference call...Read more
Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER Study MENLO PARK, Calif., June 18, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational...Read more
90th participant enrolled in landmark clinical trial in patients with Major Depressive Disorder Targets October 2025 for initial results presentation Vancouver, British Columbia – TheNewswire - June 18, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is...Read more
Top-line results expected July 2025 as development of first-in-class OSA drug advances NEW YORK and MELBOURNE, Australia, June 18, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of...Read more
Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus tirzepatide alone (p=0.001) Patients receiving apitegromab with tirzepatide over 24 weeks lost 18.8 lbs of fat mass while those on tirzepatide alone lost 17.7 lbs of fat mass Patients receiving apitegromab with tirzepatide over 24 weeks lost 12.3% of body weight while those on tirzepatide alone lost 13.4%...Read more
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes...Read more
San Diego, California--(Newsfile Corp. - June 17, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric and inherited mitochondrial diseases, today announced the recent activation of its French clinical site for Thiogenesis' ongoing Phase 2 clinical trial evaluating TTI-0102 in patients with...Read more
Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p<0.0001) Lorundrostat demonstrated a favorable safety and tolerability profile Conference...Read more
Phase 2 study, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus will evaluate NT219 in combination with either pembrolizumab or cetuximab as a strategy to overcome tumor resistance REHOVOT, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune...Read more
The study met its primary goal of establishing safety and tolerability of VTX3232 in patients with early-stage Parkinson’s disease CSF and plasma exposures reinforce VTX3232’s potential as a once-daily oral therapy for neurodegenerative diseases VTX3232 treatment resulted in significant reductions in NLRP3-related biomarkers in CSF and plasma, demonstrating sustained target engagement VTX3232 is also being studied in a...Read more
94% OS and 72% PFS observed at 6 months for atebimetinib (IMM-1-104) in combination with modified Gemcitabine/nab-paclitaxel (mGnP), N=34; median OS and PFS not yet reached Striking tumor reductions with 39% overall response rate and 81% disease control rate observed as of the data cutoff, including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable Markedly...Read more
DALLAS / Jun 16, 2025 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today announces remarkable clinical observations for a patient in Lantern’s Phase 2 HARMONIC™ clinical trial. A 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) has achieved a durable complete response in their target cancer...Read more
Updated Phase 2 data evaluating ZYNLONTA® as a monotherapy demonstrate overall response rate (ORR) of 85% and complete response (CR) rate of 69% CR maintained in 17 of 18 patients who achieved CR, with longest duration of CR of 27 months from start of treatment ZYNLONTA was generally well tolerated and safety was consistent with known profile LAUSANNE, Switzerland, June 16, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE:...Read more
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs MILAN, June 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today new results from the Phase 2 RedirecTT-1 study evaluating the...Read more
77% of patients (150 mg Q4W) treated with barzolvolimab who had angioedema at baseline were angioedema free at Week 52 Data further support barzolvolimab clinical benefit to patients with CSU HAMPTON, N.J., June 14, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company’s Phase 2 clinical trial in chronic...Read more
NEW YORK, June 13, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing...Read more
Seven months after the completion of dosing: 41% of patients (150 mg Q4W) continue to experience complete response (UAS7=0) 48% of patients (150 mg Q4W) report that CSU no longer impacts their quality of life (DLQI=0/1) KIT related tolerability events demonstrated to be reversible Enrollment to Phase 3 CSU trials ongoing Company to host webcast today at 6:00 pm ET HAMPTON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Celldex...Read more
Vancouver, British Columbia – TheNewswire – June 11, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 85th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD). MB22001, MindBio’s...Read more
SHELTON, Conn., June 11, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces first few patients receiving INT230-6 achieved high levels of necrosis after 8 days...Read more
ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod RHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designation argenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA)...Read more
Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitis Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage...Read more
The Study Met Primary and All Secondary Efficacy Endpoints Statistically Significant 35% Placebo-Adjusted Reduction from Baseline in Pulmonary Vascular Resistance for the Primary Endpoint (p<0.001) 35.5 Meter Placebo-Adjusted Improvement in Six-Minute Walk Distance for the Secondary Efficacy Endpoint (p=0.003) 60% Placebo-Adjusted Reduction from Baseline in NT-proBNP Concentrations for the Secondary Efficacy Endpoint...Read more
For the TransCon CNP treatment-naïve cohort, combination treatment resulted in mean annualized growth velocity (AGV) of 9.14 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks For the TransCon CNP-treated cohort, combination treatment resulted in mean AGV of 8.25 cm/year, with an improvement in mean ACH height Z-score of +0.44 over 26 weeks The combination of TransCon hGH and TransCon CNP demonstrated...Read more
CHICAGO / Jun 05, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced a new partial response (PR) was identified in a patient after 20 months of treatment in its Phase 2 THIO-101 clinical trial evaluating ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor...Read more
Median overall survival (OS) from ateganosine (THIO) treatment extends to 17.8 months in latest data CHICAGO / Jun 05, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate,...Read more
June 4, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the recruitment of the first patient in a Phase 2 study of tolimidone in Type 1 Diabetes (“T1D”). The study is an Investigator Initiated Trial (IIT) conducted by the University of Alberta...Read more
Three out of four efzofitimod-treated diffuse SSc-ILD patients showed clinically important improvement based on the modified Rodnan Skin Score (mRSS) assessment at 12 weeks. Efzofitimod was generally safe and well tolerated at all doses. SAN DIEGO, June 04, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of...Read more
WATERTOWN, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced an update on the Phase 2 IGNITE open-label clinical trial evaluating iluzanebart, a monoclonal antibody TREM2 agonist, for the potential treatment of adult-onset leukoencephalopathy with axonal...Read more
Best-in-disease profile with JAK-like efficacy and monthly (Q4W) dosing in both three-month placebo-controlled and six-month blinded treatment period Favorable safety and tolerability, particularly when compared to standard of care biologics or JAKs Max response rates have not yet been observed; strict continuation criteria at three months in this Phase 2b trial excluded many patients who either achieved or were trending toward LDA...Read more
Median PFS at 6.8 months, Disease Control Rate of 77.3%, 15 months OS% at 78% in Metastatic NSCLC Patients after Progression on PD-1/L1 Therapies FLORHAM PARK, N.J., June 03, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing cancer therapies, today announces that it presented interim phase 2 data on the 303 Study, a...Read more
ROCKVILLE, Md. and SUZHOU, China, June 02, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that it has released the latest clinical data from its Phase II study of the MDM2-p53 inhibitor alrizomadlin (APG-115) as a single agent or in combination with PD-1 inhibitor toripalimab in patients with advanced adenoid cystic...Read more
CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, or FLT3/IDH co-mutations Favorable safety and tolerability profile in heavily pre-treated patients: limited myelosuppression; no clinically meaningful QTc prolongation; 3% of patients...Read more
Phase 2 trial results continue to show clinically meaningful efficacy and durable responses, including 36.5-month median overall survival after four years of follow-up, with a manageable safety profile Findings presented today at ASCO 2025 and concurrently published in The Lancet Oncology For U.S. media and investors only DUBLIN, June 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced...Read more
TARPON SPRINGS, Fla., June 2, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible...Read more
Trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass Combining semaglutide with muscle-preserving antibodies protected lean mass – sparing approximately 50%-80% of the lean mass lost with semaglutide alone – while also increasing loss of fat mass TARRYTOWN, N.Y., June 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced interim results from...Read more
Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups (108 and 54 mg BID p<0.0001; 27 mg BID p<0.01); a -43.3% placebo-adjusted change from Baseline was achieved at the 108 mg BID dose group Patients saw a rapid reduction in 24-hour cough frequency at Week 2, the first time point measured Haduvio was generally well-tolerated at all doses;...Read more
Bosakitug is a Potential Best-in-Class Investigational Monoclonal Antibody with Demonstrated Superior Potency, Residence Time, and Affinity to Thymic Stromal Lymphopoietin (TSLP) Top Line Results Expected in the Second Half of 2026 WAYNE, Pa., June 02, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for...Read more
Phase 2 (Actuate-1801 Part 3B) trial meets primary endpoint and demonstrates a clinically meaningful increase in median overall survival (10.1 months vs 7.2 months; log-rank p=0.01) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving elraglusib/GnP Risk of death was reduced by 37% (HR=0.63) in patients treated with elraglusib/GnP Data featured as an oral presentation at the ASCO Annual...Read more
26% preliminary objective response rate observed in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases Deep and durable responses ongoing for up to 37 weeks through the data cutoff, accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms MSS CRC patient with liver metastasis and previously reported confirmed partial response...Read more
Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end SOUTH SAN FRANCISCO, Calif. / May 30, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new,...Read more
Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, May 29, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease...Read more
Discontinues Development of Cibotercept in PAH Announces Corporate Restructuring to Align Operations with Ongoing Strategic Priorities LEXINGTON, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”, the “Company” or “we”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to...Read more
Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile compared to semaglutide alone Based on Phase 2b QUALITY trial efficacy and safety data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD)...Read more
Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine...Read more
Novel combination with efti has met the trial’s primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting SYDNEY, AUSTRALIA, May 27, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and...Read more
Conference call to be held later today at 8:30 a.m. ET CRANBURY, N.J. / May 27, 2025 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing an integrated pipeline of genetic therapies for rare diseases, today announced an update related to RP-A501, its investigational gene therapy for Danon disease. A patient participating in the Phase 2 pivotal trial of RP-A501...Read more
Trial is evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) with topline interim data expected in the first half of 2026 AUSTIN, Texas, May 27, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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