FDA Calendar

Inspira™ Technologies OXY B.H.N. Ltd. announced that that its FDA-cleared ART100 system adoption has begun to positively impact commercialization interest and efforts, representing a key milestone and significantly contributes to the Company's commercial validation.

Fate Therapeutics, Inc. announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain.

Avidity Biosciences, Inc. announced that the company will be presenting two oral and one poster presentations at the 32nd Annual FSHD Society International Research Congress, being held June 12-13, 2025, in Amsterdam, the Netherlands.

Intensity Therapeutics, Inc. announces first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen as shown in Figure 1.

TC BioPharm announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008.

Pacira BioSciences, Inc announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee.

Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.

Harmony Biosciences Holdings, Inc. announced that topline clinical data is anticipated in 2026

Harmony Biosciences Holdings, Inc announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1.

Johnson & Johnson announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1

Cellectar Biosciences, announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma (pHGG) patients.

Chemomab Therapeutics today reported that it has obtained confirmation from the FDA on two significant development milestones as the company continues to finalize the nebokitug Phase 3 program.

Kazia Therapeutics Limited announced the publication of transformative preclinical research in the journal Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research that underscores the powerful potential of its lead asset, paxalisib, in reshaping the treatment landscape for triple-negative breast cancer (TNBC), one of the most aggressive and treatment-resistant cancer subtypes.

Novavax, Inc. announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid® and Fluzone HD, respectively.

Adial Pharmaceuticals, Inc announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day).

BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial titled, "Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial."

Travere Therapeutics, Inc. announced that the Company will present three abstracts on the effect of FILSPARI (sparsentan) in rare kidney disease at the upcoming International Podocyte Conference in Hamburg, Germany, June 10-13, 2025.

Corvus Pharmaceuticals, Inc announced preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis will be presented today in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is taking place June 11-14, 2025 in Barcelona.

Ionis Pharmaceuticals, Inc. announced that Completion of enrollment anticipated in 2026

Ionis Pharmaceuticals, Inc. announced that the first participant has been dosed in the global Phase 3 REVEAL study, which is designed to evaluate the efficacy and safety of ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS), a serious and rare neurodevelopmental disorder that leads to significant physical and cognitive impairments.

Axsome Therapeutics, Inc. announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington.

Monopar Therapeutics Inc. announced that the physician-sponsored Expanded Access Program ("EAP") for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration ("FDA").

Pasithea Therapeutics Corp. announced the appointment of Dr. James Lee to its scientific advisory board (SAB) to help guide development of PAS-004 for the treatment of ETS2 pathway inflammatory diseases including inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, primary sclerosing cholangitis and ankylosing spondylitis.

Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD).

Cabaletta Bio, Inc. announced new clinical and translational data from the ongoing RESET-Myositis™, RESET-SLE™ and RESET-SSc™ trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201).

argenx SE announced the presentation of positive results from Phase 2 studies evaluating VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain.

INmune Bio, Inc. a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease is collaborating with Kirsty Dixon PhD, Assoc Prof. of Surgery at Virginia Commonwealth University in Richmond, Virginia on the interaction of TBI and AD. Prof Dixon and her team presented a poster at the Keystone Symposia's Neurodegeneration section: Linking Cellular Pathways to Therapeutic Strategies in Whistler, British Columbia, Canada.

Celldex announced that data from the Company's Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland.

Profound Medical Corp. , is pleased to announce that the first commercial benign prostatic hyperplasia ("BPH") treatment utilizing the TULSA-PRO® system's new TULSA-AI® Volume Reduction Module was successfully conducted yesterday by Naveen Kella, M.D., Founder of The Urology Place and an Adjunct Assistant Professor for the UT Health Science Center San Antonio.

Outlook Therapeutics, Inc announced the Scottish Medicines Consortium (SMC) acceptance of LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD).

Vanda Pharmaceuticals Inc. announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S).

X4 Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to mavorixafor, an oral CXCR4 antagonist, for the treatment of chronic neutropenia (CN).

Arcutis Biotherapeutics, Inc announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a four-week period.

OS Therapies Inc. a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has selected EVERSANA®, a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma.

Jazz Pharmaceuticals plc announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review

Monte Rosa Therapeutics, Inc. announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1β.

Axsome Therapeutics, Inc. announced that SYMBRAVO® (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults.1 SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple brain pathways underlying a migraine attack.

Gyre Therapeutics announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ("ETA") receptor antagonist, for the treatment of pulmonary arterial hypertension ("PAH").

Insmed Incorporated announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1).

Unicycive Therapeutics, announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.

Jaguar Health, Inc. today provided a recap on the company's assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration (FDA) to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial.

Acadia Pharmaceuticals Inc announced that the U.S. Court of Appeals for the Federal Circuit affirmed a decision issued by the U.S. District Court for the District of Delaware in December 2023 confirming validity of the NUPLAZID® (pimavanserin) '740 composition of matter patent.

Merck announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season.

MannKind Corporation announced that it will showcase inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago.

Aethlon Medical, Inc announced that an abstract has been accepted for poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes being held at Eldorado Hotel & Spa, Santa Fe, NM, United States, August 10-13,2025

Humacyte, Inc. announced that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25), held in New Orleans, LA, on June 6, 2025.

TuHURA Biosciences, announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.

Lipocine Inc. announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada.

Daiichi Sankyo and AstraZeneca announced that The first patient has been dosed in the DESTINY-Endometrial01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.

BioRestorative Therapies, Inc. announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong.

Palvella Therapeutics, Inc. announced it has received the initial proceeds from a previously announced grant from the FDA Office of Orphan Products Development.

- Acurx Pharmaceuticals, Inc. s a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international pivotal Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI).

PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA.

IN8bio, Inc announced that Patient 009 in the Phase 1 trial of INB-200 for newly-diagnosed GBM has recently reached a significant clinical milestone.

NewAmsterdam Pharma Company N.V. announced positive topline data from prespecified Alzheimer's Disease ("AD") biomarker analyses in the Phase 3 BROADWAY clinical trial (NCT05142722).

Jade Biosciences, Inc announced a detailed preclinical characterization of JADE101, its anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody, in development for IgA nephropathy (IgAN), a chronic autoimmune kidney disease.

Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i.

Ascendis Pharma A/S announced Week 26 interim analysis results from its ongoing COACH Trial, the first clinical trial to evaluate combination treatment with once-weekly investigational TransCon CNP (navepegritide) and once-weekly TransCon hGH (lonapegsomatropin) in children with achondroplasia.

Axsome Therapeutics, Inc. 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.

Avidity Biosciences, Inc. announced the accelerated approval regulatory pathway in the United States is open for delpacibart braxlosiran (del-brax) in the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Avidity Biosciences, Inc. announced that it has initiated its global, confirmatory, Phase 3 FORWARD™ study intended to support a subsequent full approval package for del-brax for people living with FSHD in the U.S. and additional countries around the world.

Merck announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin.

Alnylam Pharmaceuticals, Inc. announced that the European Commission (EC) has granted approval for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) as an additional indication for its orphan RNAi therapeutic AMVUTTRA® (vutrisiran).

PolyPid Ltd. 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. ET.

Phathom Pharmaceuticals, Inc. 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.

Vertex Pharmaceuticals Incorporated announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland.

Apellis Pharmaceuticals, Inc today presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).

Arcutis Biotherapeutics, Inc. announced that it will present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, which is taking place in Nashville, TN, from June 6-7, 2025.

OS Therapies Inc announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma.

Arvinas, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc.

Nurix Therapeutics, Inc 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 Hematology Association Congress in Milan, Italy.

AVITA Medical, Inc. announced the first clinical publication evaluating Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, published in the Journal of Surgery (Akpunonu et al., 2025).

Scilex Holding Company announced a publication on GLOPERBA® dosing adjustments in peer-review journal.

Valneva SE announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children.

Arvinas, Inc. announced that new preclinical data for ARV-393 will be presented at the European Hematology Association (EHA) meeting, June 12-15, 2025 in Milan, Italy. ARV-393 is Arvinas' investigational orally bioavailable PROteolysis TArgeting Chimera (PROTAC) degrader targeting the B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas.

Hoth Therapeutics, Inc. announced a Key Opinion Leader (KOL) event showcasing HT-001, its novel topical therapeutic, designed to treat debilitating skin toxicities caused by EGFR inhibitor cancer therapies.

NRx Pharmaceuticals, Inc. announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management.

Kazia Therapeutics Limited announced that the first patient has been dosed in a Phase 1b clinical trial sponsored by Kazia

Estrella Immunopharma, Inc announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS® T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

MAIA Biotechnology, Inc nnounced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron's immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.

Moleculin Biotech, Inc., announced the release of its Soft Tissue Sarcoma (STS) Lung Mets KOL Webcast discussing the final data from its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases (MB-107).

Clearmind Medicine Inc announced the enrollment of the first patient in its Phase I/IIa clinical trial for CMND-100, a proprietary MEAI-based oral drug candidate aimed at treating Alcohol Use Disorder (AUD).

Avadel Pharmaceuticals plc announced that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH).

Dyne Therapeutics, Inc. announced that it will be presenting new preclinical data demonstrating the potential of DYNE-302 to achieve functional improvement in facioscapulohumeral muscular dystrophy (FSHD).

REGENXBIO Inc announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial.

Kiniksa Pharmaceuticals International, plc announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β).

KalVista Pharmaceuticals, announced the acceptance of six scientific abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 taking place in Glasgow, United Kingdom from June 13–16, 2025.

Tonix Pharmaceuticals Holding Corp announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, being held June 11-14, 2025, in Barcelona, Spain. .

Immunic, Inc announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results.

Corcept Therapeutics Incorporated presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting.

Senseonics Holdings, announced it will host an in-person and virtual analyst event in conjunction with the American Diabetes Association 85th Scientific Sessions (ADA 2025), on Saturday, June 21, 2025 at 8:00am CT at the Marriot Marquis Chicago.

Sarepta Therapeutics, Inc. announced that the rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the U.S. Food & Drug Administration.

60 Degrees Pharmaceuticals, Inc. announced the introduction of a new 8-count bottle format for ARAKODA® (tafenoquine). The 8-count bottle format may be suitable for use with patients who are making shorter trips to areas of the world where malaria is endemic.

MetaVia Inc. announced that an abstract highlighting pre-clinical data on DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, has been accepted for a poster presentation at the American Diabetes Association's 85th Scientific Sessions, taking place June 20-23, 2025 at the McCormick Place Convention Center in Chicago, Illinois.

Moleculin Biotech, Inc today reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases ("STS lung mets") (MB-107).

Biodexa Pharmaceuticals PLC announced the recruitment of the first patient in a Phase 2 study of tolimidone in Type 1 Diabetes ("T1D").

Conduit Pharmaceuticals Inc announced that it has entered into a joint development agreement with Manoira Corporation ("Manoira"), a privately held specialty animal health company specializing in proprietary reformulation technologies to create novel therapeutics for veterinary and livestock applications. Under the terms of the joint development agreement, Manoira will evaluate Conduit's AZD1656 and AZD5658, both clinical-stage glucokinase activators, in animal health indications, providing Conduit with high-value translational data across human and veterinary applications.

Cellectar Biosciences, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).

- Akebia Therapeutics®, announced that the Journal of the American Society of Nephrology (JASN) has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials in patients with non–dialysis-dependent CKD (NDD-CKD; PRO2TECT).

aTyr Pharma, Inc. announced findings from an interim analysis of eight patients in the ongoing Phase 2 EFZO-CONNECT™ study evaluating its lead therapeutic candidate, efzofitimod, in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD).

Profound Medical Corp announce that it has entered into a consulting agreement with Leonard Wheeler, a former NFL player turned entrepreneur, author, corporate consultant, co-Executive Director of the NFL Legends Community, and more recently, national podcaster.

Sionna Therapeutics, announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers.

Corvus Pharmaceuticals, Inc announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.

Purple Biotech Ltd. announced a poster presentation on its novel CAPTN-3 tri-specific antibody platform, will be featured at the Annual Congress of the European Association for Cancer Research (EACR) 2025, being held in Lisbon, Portugal from June 16 – 19, 2025.

Design Therapeutics, Inc. announced that the first Friedreich ataxia (FA) patient has been dosed via intravenous (IV) infusion in its RESTORE-FA (Reactivating Expression Suppressed Through Overcoming Repeat Expansion for FA) open-label Phase 1/2 multiple-ascending dose (MAD) clinical trial of DT-216P2.

Vigil Neuroscience, 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 spheroids and pigmented glia (ALSP).

Ascletis Pharma Inc announced that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264).

Taysha Gene Therapies, Inc. announced details for three oral presentations reviewing recent updates supporting its TSHA-102 program in clinical evaluation for Rett syndrome, and a Taysha-hosted symposium on the Company's analysis of the natural history study data at the 2025 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting, taking place in Boston from June 9-11, 2025.

Travere Therapeutics, Inc. announced that the Company will present seven abstracts at the upcoming European Renal Association (ERA) Congress in Vienna, Austria, June 4-7.

AnaptysBio, Inc. announced that investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, demonstrated a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA).

Immix Biopharma, Inc. announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois.

Biofrontera announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book).

Johnson & Johnson announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Legend Biotech Corporation announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients.

Takeda announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma.

Connect Biopharma Holdings Limited announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually.

Kairos Pharma, Ltd. announces its presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting highlighting data on its investigational small molecule GITR ligand agonist KROS101. ASCO is being held May 30-June 3, 2025 at McCormick Place in Chicago, Ill.

Johnson & Johnson announced first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA

IMUNON, Inc. announced positive data from the Company's Phase 2 OVATION 2 Study showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including overall survival (OS), progression-free survival (PFS), chemotherapy response score and surgical response.

Jasper Therapeutics, announced that four abstracts have been accepted for presentation at the EAACI Congress 2025, to be held June 13-16, 2025 in Glasgow, United Kingdom. Jasper will present initial clinical data from patients enrolled in the 180mg cohort of the SPOTLIGHT Phase 1b/2a study evaluating briquilimab in subcutaneous briquilimab in cold urticaria (ColdU) or symptomatic dermographism (SD) during an oral session on Saturday, June 14.

Chemomab Therapeutics, announced that its lead product nebokitug (formerly CM-101) has been awarded new patent protections in China and Russia.

Incannex Healthcare Inc. announced the recent appointment of four distinguished experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board

Cognition Therapeutics announced today it has received an anonymous philanthropic donation to substantially fund an expanded access program (EAP) for people with dementia with Lewy bodies (DLB).

Cybin Inc. announced that the United States Patent and Trademark Office has granted U.S. patent 12,318,477 in support of its CYB004 deuterated DMT program in development for the treatment of generalized anxiety disorder ("GAD").

Amylyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS).

Traws Pharma, Inc. announced the publication of key clinical efficacy data for rigosertib, a legacy Traws Pharma oncology asset for which development and commercialization partners are being actively sought, in patients with RDEB SCC.

BeyondSpring Inc. announces that it presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy (NCT05599789), with financial support from Merck's (Rahway, NJ USA) Investigator Studies Program and provision of study drug, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, on May 31st, 2025 in Chicago, IL.

Amicus Therapeutics announced the publication of a post-hoc analysis of data from the ERT-experienced cohort of the PROPEL study of cipaglucosidase alfa-atga + miglustat (cipa+mig) in adults with late-onset Pompe disease (LOPD) in Muscle and Nerve.

Cardiff Oncology, Inc. announced positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30-June 3, 2025, in Chicago, Illinois.

Rapport Therapeutics, Inc today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy.

Genmab A/S announced new data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha(FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC).

Jazz Pharmaceuticals plc announced long-term data, including the first report of median overall survival (OS) from the Phase 2 trial evaluating Ziihera® (zanidatamab-hrii), a dual HER2-targeted bispecific antibody, in combination with chemotherapy for the investigational use in first-line HER2-positive (IHC 3+ or IHC 2+/FISH+) locally advanced nonresectable gastroesophageal adenocarcinoma (mGEA).

Corcept Therapeutics Incorporated today shared data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the ASCO 2025 (American Society of Clinical Oncology) Annual Meeting.

UroGen Pharma Ltd today highlights the presentation of the uTRACT Registry study design at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

UroGen Pharma Ltd announced results from the ENVISION and ATLAS clinical studies exploring investigational therapy UGN-102 (mitomycin) for intravesical solution for the treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

Verastem Oncology announced positive updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.).

ImmunityBio, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield™ platform, anchored by ANKTIVA® (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy.

Actuate Therapeutics, Inc. announced key takeaways from its Key Opinion Leader (KOL) event held on May 31, 2025 discussing the positive topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Neurocrine Biosciences, Inc. announced new data from the Phase 4 KINECT-PROTM open-label study demonstrating robust and sustained improvements in physical, social and emotional functioning in patients with tardive dyskinesia taking once-daily INGREZZA® (valbenazine) capsules.

Vistagen provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder (SAD).

Erasca, Inc announced clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ERAS-4001, a potential first-in-class and best-in-class pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant (KRASm) solid tumors.

Hyperfine, Inc announced FDA clearance of its most significant technological advancement to date.

Mersana Therapeutics, announced additional interim Phase 1 clinical data for emiltatug ledadotin (Emi-Le; XMT-1660), the company's B7-H4-directed Dolasynthen ADC.

Pasithea Therapeutics Corp announced updated interim results from its ongoing dose escalation Phase 1 study evaluating PAS-004 in advanced cancer patients in a poster presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

Calidi Biotherapeutics Inc. announced the presentation of its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Opus Genetics, Inc. announced positive topline results from LYNX-2, a pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.

Ascendis Pharma A/S announced that the U.S. Food & Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia

Indaptus Therapeutics, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne's (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab.Inc.

Allarity Therapeutics, Inc 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 ovarian cancer.

PDS Biotechnology announced publication of three Versamune® HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website.

Humacyte, Inc announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for high-risk patients with end-stage renal disease was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM25).

SELLAS Life Sciences Group, announced preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer lines.

BioAtla, Inc. announced data in a poster titled, "Phase 2 Trial of Ozuriftamab Vedotin (Oz-V), a Conditionally Binding CAB-ROR2-ADC, in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck."

Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. Results will be presented today during a special late-breaking oral session (LBA #1008) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting.

AstraZeneca and Daiichi Sankyo announced Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.

Context Therapeutics Inc. announced that that it is presenting a Trial in Progress poster for the Phase 1 clinical trial evaluating CTIM-76 in ovarian, endometrial, and testicular cancers at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30 – June 3, 2025 in Chicago, IL.

IN8bio, Inc. announced new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM).

Arrowhead Pharmaceuticals, Inc. announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity.

uniQure N.V. today provided a regulatory update on AMT-130, its investigational gene therapy for the treatment of Huntington's disease.

REGENXBIO Inc announced that it will host a webcast to discuss new interim functional data from the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, the company's next-generation investigational gene therapy for the treatment of Duchenne muscular dystrophy.

BioCryst Pharmaceuticals, Inc. announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Glasgow, United Kingdom, from June 13 to 16, 2025.

Relay Therapeutics, Inc. announced updated interim clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα.

Zai Lab Limited announced that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating zocilurtatug pelitecan, or ZL-1310, the Company's potential first-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for patients with extensive-stage small cell lung cancer (ES-SCLC), will be presented today during a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Trevi Therapeutics, Inc. is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165).

Kymera Therapeutics, announced positive clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine.

Jade Biosciences, Inc.announced new preclinical data on JADE101, its anti-APRIL monoclonal antibody being developed for the treatment of IgA nephropathy (IgAN), will be presented in an oral session during the 62nd European Renal Association (ERA) Congress, taking place in Vienna from June 4-7, 2025.

Outlook Therapeutics, Inc. announced that LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD).

Guardant Health, Inc announced that the results of the Phase III SERENA-6 trial - sponsored by AstraZeneca - demonstrate the clinical value of the Guardant360® CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer.

Lyra Therapeutics, Inc. announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS.

Reviva Pharmaceuticals Holdings, Inc. announced a positive full dataset and successful completion of the Company's Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia.

Regeneron Pharmaceuticals, Inc. announced interim results from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity.

Aclaris Therapeutics, Inc. announced that it has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD).

BioNTech and Bristol Myers Squibb announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types.

Pharvaris announced a summary of data that were presented at the 14th C1-Inhibitor Deficiency and Angioedema Workshop.

Vera Therapeutics, Inc. announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults.

HUTCHMED (China) Limited announces primary results from the interim analysis of the SACHI Phase III study.

Kura Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted Kura's New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.

Trevi Therapeutics, announced a conference call and live webcast taking place tomorrow, Monday, June 2nd, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2b CORAL trial of Haduvio in patients with IPF chronic cough.

Bicara Therapeutics Inc. presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Arcus Biosciences, Inc today presented the first data for casdatifan plus cabozantinib in an oral presentation by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Allogene Therapeutics, Inc. presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting.

Replimune Group, today presented two posters highlighting data updates for RP1 (vusolimogene oderparepvec) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago.

Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO).

AstraZeneca announced Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI®(durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) versus chemotherapy alone.

Protagonist Therapeutics, Inc and Takeda announced detailed results from the Phase 3, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints.

Kite, a Gilead Company announced real-world data evaluating the safety and effectiveness of Yescarta® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital.

AstraZeneca announced Positive results from the SERENA-6 Phase III trial showed that camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). T