Agreement supports the upcoming launch of LYMPHIR for the treatment of cutaneous T-cell lymphoma CRANFORD, N.J., June 9, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has entered into a distribution services... Read more
Results demonstrated that nicotinamide riboside (NR) significantly elevated NAD+ levels and improved multiple clinical markers in people with Werner Syndrome
Niagen Bioscience expands rare disease research portfolio, supporting further investigation of NAD+ augmentation with NR as a therapeutic strategy in rare progeroid diseases LOS ANGELES / Jun 09, 2025 / Business Wire / Niagen Bioscience, Inc. (NASDAQ: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+... Read more
New Drug Submission filed by Lipocine's licensing partner Verity Pharma
Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity SALT LAKE CITY, June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity... Read more
BOSTON, June 9, 2025 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that it has entered into a definitive merger agreement (the "Merger Agreement") with Concentra Biosciences, LLC ("Concentra"), whereby Concentra will acquire Elevation Oncology for $0.36 in cash... Read more
SAN JOSE, Calif., June 9, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa's ovarian cancer CAR-T immunotherapy, will present an e-poster at the European Society for Medical... Read more
Event to Discuss the Changing Landscape of HNSCC in context with the Merck KN-689 study and the Rapidly Increasing Incidences of HPV16-positive HNSCC in the United States and Europe
Webinar to be held Tuesday, June 17, 2025, 12:00 PM ET PRINCETON, N.J., June 09, 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... Read more
Benefits of Humacyte’s Acellular Tissue Engineered Vessel Over Autologous Arteriovenous Fistula (AVF) in High-Risk Patients with End-Stage Kidney Disease Observed in Data Presented in Plenary Session DURHAM, N.C., June 09, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced today that the results from its V007 Pivotal... Read more
New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025
ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma
BioRestorative to release new clinical data to the public prior to market open on June 13th MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the... Read more
Company Is Advancing Use of Novel Doxorubicin-containing Microneedle Array (D-MNA) Patch in Veterinary Oncology as an Orphan Drug Philadelphia, Pennsylvania--(Newsfile Corp. - June 9, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce submission of a comprehensive product development plan to treat external squamous cell carcinoma (SCC) under Investigational New Animal Drug (INAD File No.013880).
The Company, in December... Read more
Results are from Acurx's ongoing scientific collaboration with Leiden University Medical Center (LUMC) partially under a grant from Health Holland to further study the mechanism of action of DNA pol IIIC inhibitors
LUMC highlighted Acurx's new class of promising antimicrobials, ibezapolstat and related analogues Novel chemotype specifically targeting gram-positive bacteria through an unexploited target Ibezapolstat ready to enter pivotal Phase 3 clinical trials... Read more
D-PLEX100 successfully met the primary efficacy endpoint, with statistically significant results (p<0.005) in 798 patients with large abdominal surgery incisions.
The trial successfully met all key secondary efficacy endpoints, including a 58% reduction in the rate of surgical site infections (“SSI”) in patients treated with D-PLEX100 arm versus standard of care (“SoC”) arm (p<0.005).
The Company expects to submit a New Drug Application (“NDA”) to... Read more
Patent issuance expands United States patent coverage for AVERSA™ transdermal abuse deterrent technology
AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. ORLANDO, Fla., June 09, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged... Read more
Unprecedented data from FORTITUDE™ dose escalation cohorts for del-brax treated participants, compared to placebo, demonstrate improvement in function, strength and PROs as well as rapid and significant reduction in biomarkers
Data support planned accelerated approval BLA submission in H2 2026
Data being presented at the 32nd Annual FSHD Society International Research Congress (IRC); Investor and analyst webcast event today, Monday, June 9 at 8:00 a.m.... Read more
CollPlant's proprietary rhCollagen to be used in clinical and commercial applications REHOVOT, Israel, June 9, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its plant-derived, Type I recombinant human collagen (rhCollagen) for tissue regeneration and medical aesthetics, today announced the expansion of its agreement with STEMCELL Technologies,... Read more
Planning accelerated approval BLA submission in H2 2026, following topline data fromFORTITUDE™ biomarker cohort in Q2 2026
Initiated global, confirmatory Phase 3 FORWARD™ study of del-brax 2mg/kg every six weeks
Investor and analyst webcast event today, Monday, June 9, 2025 at 8 a.m. ET SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA... Read more
Pre-specified analyses show that obicetrapib treatment leads to statistically significant and clinically meaningful reductions in the primary outcome measure of Alzheimer’s disease biomarker in both the full ITT population (p<0.002) and in ApoE4 carriers (p=0.0215), supporting the emerging link between CETP-inhibition and prevention of AD pathology
NewAmsterdam to present results during the AAIC conference in July NAARDEN, The Netherlands and MIAMI,... Read more
HOUSTON, June 09, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTC:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today announced Peter Nielsen, Chief Executive Officer, will present a corporate overview at the Life Sciences Virtual Investor Forum on Thursday, June 12 at 12:00 p.m. ET.
A live stream of the presentation will... Read more
SAN MATEO, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 2:00 PM ET. To register, click here.
The event will feature key opinion leader (KOL) Neal Bhatia, MD (Director of Clinical Dermatology... Read more
Placebo-subtracted mean weight loss up to 8.4% at Day 36
19-day observed half-life supports once-monthly dosing as monotherapy and potential first-in-category monthly GLP-1 + Amylin combination
Well-tolerated with no safety signals
Company to host conference call and webcast today at 8:00 A.M. ET NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long... Read more
Patient with a grade 4, IDH-mutant, MGMT-methylated glioma remains alive and progression-free for four years after receiving treatment with the INB-200 gamma-delta T cell therapy in glioblastoma trial NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, announced that Patient 009 in the Phase 1 trial of INB-200 for n... Read more
NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.
The FDA states that upon preliminary review, it found that the NDA was not... 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 accelerated improvement in body pro... Read more
First and Only RNAi Therapeutic Approved by the European Commission for the Treatment of Wild-Type or Hereditary ATTR Amyloidosis with Cardiomyopathy
Novel RNAi Mechanism Delivers Rapid Knockdown of Transthyretin (TTR), Addressing the Disease at its Source
Approval Based on HELIOS-B Phase 3 Study, Which Showed Up to 36% Reduction in All-Cause Mortality, With Preservation of Functional Capacity and Quality of Life, with Four Quarterly Doses Per Year
Decision... Read more
Montreal, Quebec--(Newsfile Corp. - June 9, 2025) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a leading biotechnology company specializing in drug delivery technologies, is pleased to announce that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its U.S. patent application covering one of its next-generation antibody-drug conjugate (ADC) technologies. The allowance of... Read more
SAN DIEGO, June 09, 2025 (GLOBE NEWSWIRE) -- Maravai LifeSciences Holdings, Inc. (NASDAQ: MRVI), a global provider of life science reagents and services to researchers and biotech innovators, today announced the appointment of Bernd Brust as Chief Executive Officer (CEO) and a member of the Board of Directors, effective immediately. Mr. Brust succeeds William “Trey” Martin III in these roles.
“This leadership transition reflects Maravai’s commitment to accelerating... Read more
MOUNTAIN VIEW, Calif. / Jun 09, 2025 / Business Wire / Aditxt, Inc. (Nasdaq: ADTX) (“Aditxt” or the “Company”), a social innovation platform accelerating promising health innovations, today announced the appointment of Saundra Pelletier, CEO of Evofem Biosciences, Inc. (OTCPK: EVFM) (“Evofem”), to Aditxt’s Board of Directors.
“We believe that Saundra’s background as a CEO and entrepreneur, coupled with her deep industry expertise and knowledge, will complement... Read more
Atopic dermatitis is a chronic disease that disproportionately impacts communities of color
Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients
Patients experienced substantial reductions in hyperpigmentation, dry skin and itch from baseline
Results support commitment to enhance clinical understanding of chronic diseases in communities of color TARRYTOWN, N.Y. and PARIS,... Read more
SOUTH SAN FRANCISCO, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune disease, today announced the appointment of Shawn Rose, M.D. Ph.D., as its next Chief Medical Officer (CMO) and Head of Research and Development (R&D) starting on June 23, 2025. He replaces David R. Shook, M.D., who will be stepping down from the role to pursue... Read more
VANCOUVER, British Columbia, June 06, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO) (“Rakovina” or the “Company”), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, is pleased to announce the closing of its previously announced non-brokered private placement for gross proceeds of $4,905,150 - consisting of $3,555,150 of Units and $1,350,000 of Debenture... Read more
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m.... Read more
FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen Petition filed on December 11, 2024 and communicated the Agency’s intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032.
About Phathom Pharmaceuticals, Inc.
Phathom... Read more
Oral presentation on outcomes following treatment with CFTR modulators show that improvements in CFTR function, as measured by lower sweat chloride, correlate with better outcomes for people with cystic fibrosis
Oral presentation on new post hoc data from randomized, controlled and open-label trials suggest improved quality of life results with ALYFTREK compared to TRIKAFTA® BOSTON / Jun 06, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)... Read more
Boltz-2 is the first biomolecular co-folding model to combine structure and binding affinity prediction, approaching the accuracy of physics-based free energy perturbation (FEP) calculations but at speeds up to 1000x faster in standard benchmarks
The development of this open source model for academic and commercial use was a collaborative effort, combining MIT’s deep academic expertise with Recursion's AI research and NVIDIA-accelerated supercomputer, BioHive-2 Salt... Read more
Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observed
New data presented at late-breaking session at the European Renal Association Congress
Marketing applications for EMPAVELI are under review with the FDA and EMA WALTHAM, Mass. and STOCKHOLM, June 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today presented new data... Read more
Appointment of seasoned strategic industry executive strengthens the Board of Directors as Candel advances toward Biologics License Application submission and commercial development NEEDHAM, Mass., June 06, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the appointment of Maha... Read more
BOSTON / Jun 06, 2025 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present four posters at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress, taking place June 13-16, 2025 in Glasgow, United Kingdom. Dr. William Yang, M.D., FRCPC, FAAAAI, Managing Director and Chair, Ottawa Allergy Research... Read more
HAMPTON, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that Denice M. Torres has been elected to the company’s Board of Directors.
"We are excited to welcome Denice to the Celldex Board of Directors," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. "Denice’s extensive leadership experience across both the pharmaceutical and consumer healthcare sectors brings a deep operational and... Read more
Aytu enters the over $22 billion United States prescription major depressive disorder ("MDD") market with the first-in-class oral selective serotonin 5HT1a receptor agonist for adults with MDD.
EXXUA has demonstrated significant improvement in depression symptoms in clinical trials involving more than 5,000 patients and, notably, the incidence of sexual side effects experienced with EXXUA was comparable to placebo.
EXXUA is expected to serve as a major growth catalyst... Read more
New data from the Phase 3 INTEGUMENT-OLE long-term open label study show durable improvement in the signs and symptoms of atopic dermatitis (AD), including almost half of participants achieving no or minimal itch with ZORYVE cream 0.15% or ZORYVE cream 0.05%
New data demonstrate that for children ages 2 to 5 who achieved disease clearance and switched to proactive twice-weekly application of investigational ZORYVE cream 0.05%, the median duration of disease control was... Read more
Robert Infarinato named VP, Strategic Development
Lisa Carson named as new VP, Finance and Administration Marlborough, Massachusetts--(Newsfile Corp. - June 6, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to treat cancer. Phio announced today a strategic initiative to heighten awareness of potential applications of the broader... Read more
If awarded, OST-HER2 would become the first listeria investigational medicinal product to be awarded the RMAT designation
RMAT designation reduces BLA application review time and permits augmented interactions with FDA to inform market access NEW YORK / Jun 06, 2025 / Business Wire / OS Therapies Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced it has... Read more
ORLADEYO® (berotralstat) now reimbursed in the Netherlands RESEARCH TRIANGLE PARK, N.C., June 06, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO® (berotralstat) has been approved for the routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. This reimbursement approval in the Netherlands marks national... Read more
This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine
VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced... Read more
SAN FRANCISCO, June 06, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced that the company will host a webcast conference call at 8:00 a.m., ET, on Thursday, June 12, 2025, to discuss new data from the ongoing Phase 1 clinical trial of bexobrutideg (NX-5948) that will be presented at the European... Read more
Total gross proceeds of up to $150.0 million before the end of 2026 if all Series B warrants and Series C warrants are exercised for cash
Xilio may elect to cancel unexercised Series B or Series C warrants proportionately to the amount of non-dilutive capital received, under certain circumstances
Financing co-led by new investors Coastlands Capital and Frazier Life Sciences and included participation from Gilead Sciences, Inc., Logos Capital, Samsara BioCapital and... Read more
NEW HAVEN, Conn., June 5, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced the closing of its previously announced underwritten public offering of 20,010,000 shares of its common stock... 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 (CPI) cemiplimab (Libtayo®)... Read more
The regulatory approval marks a key milestone toward the potential acquisition of Pincell, removing a major condition precedent under the option agreement and allowing Scinai to advance toward finalizing the transaction, subject to customary remaining conditions. JERUSALEM, June 5, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and providing CDMO... Read more
SOLANA BEACH, Calif., June 05, 2025 (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, dermatological or neurological conditions, today announced its presentation of new data at the British Pain Conference held in Newport, Wales, UK on June 3-5, 2025 (https://bpsasm.org/) that further validates the therapeutic potential... Read more
Treatment restored gene control, extended telomere length beyond healthy levels, reversed muscle and weight loss, reduced oxidative stress, and resulted in 100% survival - highlighting Telomir-1's potential to reverse key hallmarks of aging MIAMI, FL / ACCESS Newswire / June 5, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), or the "Company," an emerging leader in age-reversal science, today announced compelling new preclinical data demonstrating that its lead... Read more
