Recursion unveils post-combination technology-enabled portfolio with more than 10 clinical and preclinical programs, 10 advanced discovery programs, and more than 10 partnered programs Platform will focus on first and best-in-class drug discovery and development, demonstrating the ability to find novel insights and dramatically reduce the time and cost of discovery Recursion will host an update call today, November 20, 2024 at 7:30...Read more
Phase 2 data establish proof-of-concept of efgartigimod SC in myositis Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIA Potential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment options November 20, 2024, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company...Read more
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only DUBLIN, Nov....Read more
IRVINE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that four Trials in Progress Posters highlighting cretostimogene, in addition to the recently announced late breaking abstract on BOND-003, will be presented at the...Read more
Achieved all co-primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies versus each of placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy at day 84 with statistical significance (p<0.001) Obicetrapib and ezetimibe fixed-dose combination observed to lower LDL-C by approximately 50% at day 84, compared to placebo, with over 70% of patients achieving LDL-C levels below 55...Read more
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF)...Read more
The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation Pivotal trials of NX-5948 are planned to initiate in 2025 SAN FRANCISCO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory...Read more
Kura to receive a $330 million upfront payment and up to $1.2 billion in total milestone payments, including $420 million in near-term milestone payments and opt-in right for solid tumors Companies to jointly develop and commercialize ziftomenib; 50/50 profit share in the U.S.; Kura to lead U.S. development and commercial activities and book sales; Kyowa Kirin has exclusive commercialization rights outside the...Read more
SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). The...Read more
Lead Independent Director at Microsoft and former Group Worldwide Chair for Johnson & Johnson brings extensive experience in life sciences innovation, governance and operations BOSTON / Nov 20, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, (“Seaport”) a biopharmaceutical company that...Read more
The Phase 2 DIMENSION Study did not meet its primary endpoint Dalzanemdor was generally well-tolerated; no new safety signals were observed Based on these data, the Company does not plan further development of dalzanemdor CAMBRIDGE, Mass. / Nov 20, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive...Read more
Candidate VY1706 demonstrates significant reductions of tau at low doses in NHP study; IND and CTA filings anticipated in 2026 VY1706 is the fifth neuro gene therapy development candidate nominated leveraging Voyager’s IV-delivered, CNS-penetrant TRACER capsids LEXINGTON, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic...Read more
THE WOODLANDS, Texas, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Ivan H. Cheung has been elected to its Board of Directors. Mr. Cheung is a biopharmaceutical executive with more than 25 years of experience in the healthcare industry and a proven track record of shareholder value creation. He is currently the chief executive officer and a director of NextPoint Therapeutics, and he...Read more
Hoerter Brings Over Three Decades of Oncology Commercialization and Leadership Experience Appointment Underscores Continued Transformation of Board to Lead C4T into Next Phase of Pipeline Progress WATERTOWN, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the continued evolution...Read more
MALVERN, Pa., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease,...Read more
PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25 Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting...Read more
DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis DiffuSphere™ has shown its versatility with various...Read more
SEATTLE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that five abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), taking place...Read more
LOS ANGELES / Nov 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast...Read more
Celularity is collaborating with its strategic partner, Genting Berhad, to bring Celularity placenta-derived allogeneic stem cell therapeutics to the Asia Pacific region Genting Berhad announced groundbreaking on a new, state-of-the-art wellness and health center in Bali, Indonesia, that will utilize Celularity products Strategic partnership positions Celularity to be a key supplier of innovative stem cell and regenerative medicine...Read more
Nemvaleukin was generally well tolerated in ARTISTRY-1, a completed phase 1/2 clinical trial, with durable responses observed in both monotherapy and combination therapy across a range of heavily pretreated advanced solid tumors, including in platinum-resistant ovarian cancer (PROC), which does not typically respond to immunotherapies Safety profile and anti-tumor activity observed in ARTISTRY-1 supported the company’s two potentially...Read more
WEST CHESTER, Pa., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and in either case, accompanying warrants to purchase...Read more
Prof. Robert Sutton to deliver plenary presentation on Phase 2b CARPO trial of Auxora™ in Acute Pancreatitis (AP) at American Pancreatic Association (APA) 2024 Annual Meeting Poster presentation on Phase 2b CARPO trial at Emergencies in Medicine (EIM) 2024 Meeting LA JOLLA, Calif., Nov. 20, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on...Read more
DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation were the top performing groups in the Study outperforming the Rybelsus® control group in both body weight-loss, by 11.53% and 10.65% respectively, and in blood sugar, by 11.13% and 3.35% respectively. DehydraTECH-semaglutide compositions with and without SNAC technology outperformed Rybelsus® control in body weight Weight-control improvement demonstrated in ALL...Read more
The Northwell Health Cancer Institute is the Most Recent Clinical Site to Join the TIGeR-PaC Study, and RenovoRx Aims to Reach Full Patient Enrollment in the First Half of 2025 Phase III Clinical Trial is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer LOS ALTOS, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”)...Read more
SINGAPORE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Further to an announcement on October 7, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of blood and solid cancers, is pleased to announce that the first patient has been dosed in...Read more
CARSON CITY, Nev., Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that an abstract on the design of its planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted as a poster presentation at the...Read more
DALLAS / Nov 20, 2024 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced an oversubscribed $53 million equity financing to support the continuing clinical advancement of FB102. “We are appreciative of the support from new and existing investors including OrbiMed, Janus Henderson Investors, Tybourne...Read more
VANCOUVER, British Columbia, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) is proud to announce the publication of a pivotal research article in the prestigious Journal of Cosmetic Dermatology. About the Study The article, titled “TFC-1326 Compound Reduces Clinical Signs of Skin Aging: Evidence From In Vitro Human Adipose and Skin Models and Pilot Clinical Trial,” highlights the groundbreaking efficacy...Read more
VANCOUVER, British Columbia, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (“Rakovina” or the “Company”), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response targeting technologies, is pleased to announce an upcoming poster presentation highlighting preliminary results of its Deep Docking and generative Artificial Intelligence (AI) drug development program...Read more
TUSCANY study is open to enroll patients to receive TUS+VEN+AZA triplet at select US sites Favorable safety and broad clinical activity make tuspetinib an ideal agent to combine with venetoclax and azacitidine to potentially address larger AML populations Study execution update is expected during ASH 2024 SAN DIEGO and TORONTO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX:...Read more
SRC recommended that the trial escalate to the next dose level of 15mg capsule No dose-limiting toxicities (DLTs) observed to date No rash observed to date MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis...Read more
License includes Genprex's Reqorsa® Gene Therapy in Combination with ALK-Inhibitors for the Potential Treatment of ALK-Positive Lung Cancer AUSTIN, Texas, Nov. 20, 2024 /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 it has entered into an exclusive license...Read more
Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a multi-mechanism strategy for potential improved patient outcomes Favorable early safety, efficacy, tolerability and durability of remission data informed Aptevo's ongoing RAINIER Phase 1b/2 trial SEATTLE, WA / ACCESSWIRE / November 20, 2024 / Aptevo Therapeutics ("Aptevo")...Read more
Strokes affect 795,000 people annually in the US. Obesity, a top risk factor for strokes, is associated with around one out of five strokes. Cardiac complications following a stroke are a leading cause of mortality and morbidity, second only to acute neurological injury. The pathomechanism underlying cardiac dysfunction following a stroke includes a surge of catecholamines, such as epinephrine, which induces inflammasome activation...Read more
Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025 Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Septerna, Inc....Read more
Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics Up to €490 Million in Commercial Milestone Payments, with Tiered Royalties on Future Sales SOUTH SAN FRANCISCO, Calif. and BERLIN, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) and Bayer today announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of...Read more
Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary Endpoints Data Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and Safety SAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a...Read more
High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024 Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM CULVER CITY, Calif. / Nov 19, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a...Read more
Webcast and conference call to be held be on Thursday, November 21st at 4:30 pm ET, dial in information below NEWARK, CA / ACCESSWIRE / November 19, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that the company will host a conference call and webcast to announce its oral peptide IL-17 antagonist development candidate and to share in vitro and pre-clinical proof-of-concept study...Read more
Sangamo plans to initiate enrollment of patients in the Phase 1/2 study for ST-503 in mid-2025 RICHMOND, Calif. / Nov 19, 2024 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable...Read more
MALVERN, Pa., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry...Read more
Alpha DaRT® accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market access to the Alpha DaRT® for patients with recurrent glioblastoma multiforme (GBM) First patient treated in Recurrent Lung Cancer study in Israel, which will assess the safety and feasibility of delivering Alpha DaRT® sources into the lung using an endobronchial ultrasound procedure FDA approval of an...Read more
IPH6501 is a first-in-class tetra-specific NK cell engager armed with a variant of IL-2, targeting CD20 and developed for B-NHL IPH6501 boosts NK cell proliferation and cytotoxicity, showing activity in vitro against a range of B-NHL cell lines, in vivo in various preclinical models and ex vivo in samples from R/R B-NHL patients In vivo studies further validated that IPH6501 augments the ability of peripheral NK cells to migrate and...Read more
Protects the use of onvansertib in combination with standard of care in the KRAS mutated mCRC setting through 2043 SAN DIEGO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the United States Patent and Trademark Office (USPTO) has issued to Cardiff Oncology U.S. patent...Read more
Carlsbad, CA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN) ("Qualigen" or the "Company"), Qualigen Therapeutics, Inc., is a life science company focused on developing platform treatments for adult and pediatric cancers, with the potential for orphan drug designations, announced today that it has entered into definitive securities purchase agreements with several institutional and accredited investors (the...Read more
CORAL GABLES, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer (CEO), will present at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024. Jefferies London Healthcare Conference...Read more
HOUSTON, Nov. 19, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) , a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the filing of a patent application covering methods for treatment of splenomegaly using a cell-based therapeutic...Read more
LOS ANGELES, Nov. 19, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that Dr. Deborah Birx, Chief Executive Officer, will deliver a presentation at 1:15pm ET at the 5th Annual Phage Futures Annual Meeting,...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM)...Read more
Cannabinol modulates distinct endocannabinoid system elements and exerts anti-inflammatory effects Supports therapeutic potential of cannabinol for inflammatory skin diseases such as psoriasis, atopic dermatitis and pruritus Anti-inflammatory effects of cannabinol show potential for therapeutic and cosmetic application Vancouver, British Columbia--(Newsfile Corp. - November 19, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM)...Read more
BELTSVILLE, Md., Nov. 19, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced the presentation of preclinical data demonstrating that treatment with NC605, a novel anti-Siglec-15 (S15) antibody, resulted in enhanced generation of quality bone with better mechanical...Read more
Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries...Read more
Clinical Data from Phase 2 SPRING Trial Shows that CM-101 Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis TEL AVIV, Israel, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet...Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19...Read more
FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the “Meeting”) scheduled...Read more
OCALA, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen® (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The...Read more
Conduit Pharmaceuticals strengthens its Board of Directors with the addition of Simon Fry, a seasoned investment banking executive with over 30 years of experience in asset management, capital markets, and strategy development. NAPLES, Fla. and CAMBRIDGE, United Kingdom, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Conduit Pharmaceuticals Inc. (Nasdaq: CDT) (“Conduit” or the “Company”), a multi-asset, clinical stage, disease-agnostic life...Read more
Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies At a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders Data will guide...Read more
Six sites across the U.S. are now engaged in Phase1b study Marlborough, Massachusetts--(Newsfile Corp. - November 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company exploring new pathways towards a cancer-free future, today announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San...Read more
WILMINGTON, Del. / Nov 18, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine...Read more
MINNEAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced a strategic partnership with ALZpath, Inc to accelerate breakthroughs in neurodegenerative disease research and treatment, including Alzheimer's disease. The collaboration leverages Bio-Techne's Ella™ fully automated, multiplexing immunoassay platform and ALZpath's proprietary pTau217 antibody to provide the Simple Plex Human Phospho-Tau...Read more
Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at Month 36 within the Open Label Extension The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of early intervention...Read more
In Cohort 5 of PROPEL 2, daily oral treatment of infigratinib at 0.25mg/kg resulted in statistically significant and sustained increases in annualized height velocity (AHV), with a mean change from baseline of +2.50cm/year at Month 18 (P=0.001) Data also presented at European Society of Paediatric Endocrinology on November 18th at 10 am GMT To date, infigratinib has received Breakthrough Designation from the U.S. Food and Drug...Read more
Four Pediatric patients treated in French early-access program achieved meaningful weight reduction at three months on setmelanotide therapy Rhythm announced plans for a new substudy to evaluate setmelanotide therapy in patients with congenital hypothalamic obesity BOSTON, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming...Read more
ICONIC-LEAD achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16; 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24 ICONIC-TOTAL achieved its primary endpoint of IGA score of 0 or 1 at week 16 in patients with plaque psoriasis in difficult-to-treat areas Protagonist has earned a $165 million milestone under the terms of recently amended agreement, inclusive of $50 million in accelerated...Read more
The New Drug Application is based on positive results from the Phase 3 PALISADE study People living with familial chylomicronemia syndrome have extremely high triglyceride levels and a substantially higher risk of developing acute pancreatitis and associated long-term complications, including poor quality of life There are currently no FDA approved therapies to treat familial chylomicronemia syndrome PASADENA, Calif. / Nov 18, 2024 /...Read more
Plozasiran induced deep and sustained reductions in triglycerides and impacted a wide spectrum of lipoproteins that may be involved with atherosclerotic cardiovascular disease Similar responses were observed in patients with genetically confirmed and clinically diagnosed FCS Mean reductions in triglycerides of up to -73% in patients from MUIR and -86% in patients from SHASTA-2 with favorable reductions in remnant cholesterol and...Read more
Met primary endpoint with LDL-C mean reduction versus placebo of 36.3% at day 84 and 41.5% at day 365 Lp(a) mean reduction versus placebo of 45.9% at day 84 and 54.3% at day 365 Total LDL-P mean reduction versus placebo of 52.5% at day 180, with small LDL-P reduction of 102.4% Safety results comparable to placebo NAARDEN, the Netherlands and MIAMI, Nov. 18, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or...Read more
RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Ireland will have access to the first oral,...Read more
WALTHAM, Mass., Nov. 18, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ: SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced that it has commenced an underwritten public offering...Read more
All six evaluable Phase 1 patients with Danon disease are alive and transplant-free up to age 25 years RP-A501 demonstrated safety and meaningful efficacy; all evaluable patients show cardiac LAMP2 expression and ≥10% reduction in LV mass index at 12 months and sustained through most recent follow up (up to five years) First patient treated shows preliminary evidence of robust protein expression in heart on five-year biopsy All...Read more
Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical need Phase 2 SOLSTICE 24-week primary endpoint data for tobevibart and elebsiran in chronic hepatitis delta to be presented today at AASLD The Liver Meeting Positive opinion on E.U. orphan drug designation follows U.S. FDA fast track designation, highlighting growing...Read more
Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin...Read more
The Company will now target five major cancer types with its four clinically active compounds across both TCR-T cell therapies and TCR-based Bispecifics Today, Company discloses first clinical data from the TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in the Phase 1 dose escalation trial, demonstrating a favorable tolerability profile and signs of dose-dependent and PRAME expression-dependent clinical activity,...Read more
INTEGRIS-PSC featured in an oral late breaker presentation SOUTH SAN FRANCISCO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced the presentation of clinical data at The Liver Meeting® 2024 of the American Association for the Study of Liver...Read more
sdATEVs maintained sustained patency throughout the six-month study sdATEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch between the sdATEV and the animal’s native artery DURHAM, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at...Read more
Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026 Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosed Phase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomes Functional improvements seen in all patients treated with dose level 1 and dose...Read more
An Exploratory Analysis Reports Patients with PAD Who Took Bempedoic Acid Were 36% Less Likely to Experience a Major Adverse Limb Event Compared to Placebo ANN ARBOR, Mich., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take statin medications. These data...Read more
FOSTER CITY, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced the appointment of Heather Turner, J.D., former Chief Executive Officer at Carmot Therapeutics, Inc., to the Company’s Board of...Read more
SAN DIEGO / Nov 18, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the Company will present at Jefferies London Healthcare Conference in London, on Wednesday, November 20, 2024, at 9:30 am GMT. A...Read more
ALLO-329 Induces Deep, Transient Depletion of CD19+ B Cells and CD70+ T Cells, and Reduction in IgG and IgM without Lymphodepletion in Humanized Murine Models Proprietary Dagger® Technology Enables ALLO-329 to Overcome Rejection and Expand the Presence of Alloreactive T Cells Presented Data Demonstrates that ALLO-329 Could Be Effective in Treating Autoimmune Diseases with Reduced or No Lymphodepleting Chemotherapy ALLO-329...Read more
Treatment with nomlabofusp modified gene expression and lipid profiles in addition to increasing frataxin (FXN) levels in study participants with Friedreich’s ataxia (FA) Modeling and simulation predict that, in most patients with FA, 50 mg of nomlabofusp administered daily is likely to achieve FXN levels that are ≥50% of levels observed in healthy controls and similar to mean FXN levels reported in asymptomatic heterozygous...Read more
PDUFA Date is April 2, 2025 LEXINGTON, Mass. / Nov 18, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a...Read more
WAYNE, Pa., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS) (the “Company” or “Aclaris”), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of 35,555,555 shares of common stock at a purchase price of $2.25...Read more
Enhances Aclaris’ pipeline with complementary biologics portfolio Expands leadership team with addition of seasoned biotech executives Management to host conference call today at 8:30 AM ET WAYNE, Pa., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that...Read more
Biosion receives over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials, and 19.9% shares of common stock of Aclaris Therapeutics; additional regulatory and sales milestone payments exceed $900M with tiered single digit sales royalty Aclaris Therapeutics will be responsible for development and commercialization of BSI-045B, a novel anti-TSLP monoclonal antibody,...Read more
Phase 1b study for the potential treatment of osteoarthritis and low back pain expected to commence in the first quarter of 2025 Initial data readout planned for early 2026 Neuropathic component of chronic pain linked to LPA1 activation SAN DIEGO / Nov 18, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing...Read more
27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD Reconstituted B Cell Compartment Predominantly Consists of Naïve,...Read more
Phase 1 Basket Study for B Cell-mediated Autoimmune Diseases to Assess FT522 as Add-on to Standard-of-care Induction and Maintenance Regimens without Conditioning Chemotherapy Initial Phase 1 Clinical Data in Relapsed / Refractory B-cell Lymphoma Show Favorable Safety Profile, Complete Responses, and Persistence of FT522 Live Cells Selective Targeting and Reduction of CD19+ B Cells Observed with Each FT522 Dose in Study’s First...Read more
| Company | Change | Last Trade |
|---|---|---|
| argenx | 17.28 3.01 | $591.82 |
| Alnylam Pharmaceuticals | 14.52 6.20 | $248.79 |
| Finch Therapeutics | 9.65 536.11 | $11.45 |
| Forte Biosciences | 7.50 126.48 | $13.43 |
| BeiGene | 6.24 3.32 | $194.01 |
| Exicure | 5.22 89.69 | $11.04 |
| Sarepta Therapeutics | 4.24 3.98 | $110.86 |
| Neurocrine Biosciences | 4.16 3.49 | $123.29 |
| United Therapeutics | 3.62 1.00 | $364.33 |
| Soleno Therapeutics | 3.04 5.87 | $54.83 |
| Disc Medicine | 3.00 5.04 | $62.55 |
| Vertex Pharmaceuticals | 2.99 0.67 | $451.00 |
| Madrigal Pharmaceuticals | 2.92 0.93 | $317.09 |
| Jazz Pharmaceuticals | 2.42 2.07 | $119.24 |
| Bio-Techne | 2.35 3.54 | $68.72 |
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including a small-molecule GLP-1 receptor...
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Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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