Bio-Research.AI (formerly Efortless Update)

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/17 Merck's phase 2b/3 trial reveals clesrovimab reduces RSV-associated illness and hospitalization rates by 84% and 90%, respectively same day : ( ↓ NYSE: MRK | -0.78% ) 10/17 Marinus Pharma' phase 3 RAISE Trial Shows IV Ganaxolone Reduces Seizures Quicker in RSE Patients but Fails Some Primary Endpoints same day : ( ↓ NASDAQ: MRNS | -3.33% ) 10/17 AgeneBio's HOPE4MCI phase 2B Study Finds AGB101 Reduces Clinical Decline by 40% in Non-ApoE-4 Alzheimer's Patients 10/17 SpyGlass Pharma, Inc.'s Intraocular Lens Drug Delivery Platform Leads to 43.7% Reduction in Mean IOP in Glaucoma Patients at 18-Month Study Follow-Up 10/17 Supernus Pharmaceuticals, Inc. Reports Reduced Depressive Symptoms in phase 2a SPN-820 Clinical Study same day : ( ↑ NASDAQ: SUPN | +0.28% ) [Deals] 10/17 ClearB Therapeutics inks deal with Adjuvance Technologies, plans to use novel adjuvant TQL-1055 in Hepatitis B cure development 10/17 Xenetic Biosciences, Inc. and Tokyo Medical University collaborate for systemic DNase Program targeting Ewing Sarcoma in landmark agreement same day : ( ↓ NASDAQ: XBIO | -0.81% ) [Venture Capital] 10/18 LaNova secured $42 million in Series C1 funding, which will push the clinical development of its pipeline, including LM-299 [Regulatory] 10/18 CHMP issues positive opinion on Alhemo, a prophylactic treatment for haemophilia A or B from Novo Nordisk, based on phase 3 trials same day : ( ↓ NYSE: NVO | -0.64% ) 10/18 CHMP re-evaluates decision on renewal of Translarna's conditional marketing authorization for treating nmDMD, European Commission review pending same day : ( ↑ NASDAQ: PTCT | +0.46% ) 10/18 CHMP recommends Novartis's Kisqali for high-risk early breast cancer based on phase III NATALEE trial results same day : ( ↓ NYSE: NVS | -0.03% ) 10/18 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT)' ZORYVE receives Canadian approval for seborrheic dermatitis treatment based on phase 3 study outcomes 10/17 EMA Denies Conditional Marketing Authorization for AB Science' Masitinib in ALS Treatment 10/17 Avadel Pharmaceuticals PLC secures FDA approval for supplemental application of LUMRYZ in narcolepsy patients aged seven and older same day : ( ↑ NASDAQ: AVDL | +5.14% ) 10/17 FDA approves AbbVie's VYALEV for treatment of motor fluctuations in advanced Parkinson's disease patients: phase 3 study results same day : ( ↓ NYSE: ABBV | -0.99% ) View the full newsletter contents for free via the link in the comments.

[Clinical Trials] 10/17 Innovent Biologics' phase 2 Trial of Picankibart Achieves Primary and Secondary Endpoints in Chinese Ulcerative Colitis Patients 10/17 Noema Pharma AG's phase 2a trial of NOE-105 in Tourette Syndrome patients hits primary and key secondary endpoints with 57% improvement reported 10/16 Akeso Biopharma's COMPASSION-16 Study Reveals 50% Reduction in Risk of Death with Cadonilimab in Cervical Cancer Treatment 10/16 Athos Therapeutics Inc Announces phase 1 Clinical Trial Results of ATH-063 for Inflammatory Bowel Disease Treatment: Increase in Regulatory T Cells Observed [Deals] 10/17 Eterna Therapeutics and Factor Bioscience Inc. Partner to Advance iPSC-Based Cell Therapy for Oncology and Rare Diseases same day : ( - NASDAQ: ERNA | 0.00% ) 10/17 Sanofi Partners with Orano Med to Invest €300M for 16% Stake in New Entity Developing Radioligand Therapies for Rare Cancers, Valued at €1.9B same day : ( ↑ NASDAQ: SNY | +0.28% ) 10/16 Lexicon Pharmaceuticals, Inc. Licenses Sotagliflozin to Viatris for $25M Upfront Payment, Retains Rights in US and Europe same day : ( ↓ NASDAQ: VTRS | -0.42% ) ( ↑ NASDAQ: LXRX | +3.93% ) [Regulatory] 10/16 Sanofi's FLUBLOK flu vaccine shows no increased risk for pregnancy-related issues, according to FDA updated label data from a large safety study same day : ( ↓ NASDAQ: SNY | -0.24% ) View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/16 Merck's STRIDE-8 trial reveals CAPVAXIVE's immunogenicity for 21 pneumococcal strains, comparable immune responses, and decreased adverse events in adults with chronic conditions same day : ( ↓ NYSE: MRK | -0.68% ) 10/16 Wave Life Sciences Reports RNA Editing in phase 1b/2a Trial of WVE-006 for Alpha-1 Antitrypsin Deficiency same day : ( ↑ NASDAQ: WVE | +59.35% ) 10/16 HUTCHMED Reports Efficacy of TAGRISSO and ORPATHYS Combination in phase II Trial for EGFR-Mutated Lung Cancer same day : ( ↑ NASDAQ: HCM | +4.63% ) 10/16 BioVersys AG Completes phase 2 Clinical Trial for Antibiotic BV100, Lowers Mortality Rates in VABP; Collaborates Further with GSK on BV200 and BV500 Development [Deals] 10/16 ExpreS2ion Biotechnologies Announces Term Sheet to License Malaria Vaccine Product Lines in Development to Serum Institute of India Pvt. Ltd., Assured to Reach Millions at Risk 10/16 Orasis Pharmaceuticals Licenses Presbyopia Treatment to Optus for $18M, Paving Way for Qlosi's Launch in South Korea by 2026 10/16 Ability Biologics teams up with Mila - Quebec Artificial Intelligence Institute to develop safer, more efficient antibody therapeutics 10/16 Matica Biotechnology, Inc. Partners with Mongoose Bio Inc. to Develop Lentivirus for TCR-T Cancer Treatments in Key Texas Biotech Move [Venture Capital] 10/16 TenNor Therapeutics secures over 300 million RMB in Series E funding for development of treatments for H. pylori infection and prosthetic joint infections 10/16 Nuclera secure £57 million for expansion of eProtein Discovery system in US and Europe [Regulatory] 10/16 FDA accepts GSK's gepotidacin application for urinary tract infections based on EAGLE-2 and EAGLE-3 trial results 10/16 Astria Therapeutics, Inc. secures Orphan Medicinal Product Designation for Navenibart in the EU and US following phase 1b/2 results 10/16 Theriva Biologics, Inc.'s VCN-01 for retinoblastoma treatment receives orphan medicinal product designation from the European Commission View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/15 Jazz Pharmaceuticals Reports Improved Survival in phase 3 Trial of Zepzelca and Atezolizumab for ES-SCLC Patients same day : ( ↑ NASDAQ: JAZZ | +4.64% ) 10/15 Johnson & Johnson's phase 2/3 trial shows sustained control of generalized myasthenia gravis with nipocalimab over 24 weeks same day : ( ↑ NYSE: JNJ | +1.96% ) 10/15 Amgen's phase 3 MINT Trial Meets Primary Endpoint, Evaluating UPLIZNA in Treating Generalized Myasthenia Gravis at Week 26 same day : ( ↑ NASDAQ: AMGN | +0.66% ) 10/15 Topas Therapeutics GmbH Announces phase 2a Trial Results: TPM502 Safe and Efficacious in Celiac Disease Patients [Deals] 10/15 TRIANA Biomedicines Partners with Pfizer on $1.5B Deal for Molecular Glue Degraders Discovery and Development same day : ( ↑ NYSE: PFE | +1.0% ) 10/15 Ripple Therapeutics and Glaukos Corporation enter evaluation and licensing agreement for sustained release implants development in glaucoma treatment same day : ( ↓ NYSE: GKOS | -0.03% ) 10/15 Molecure S.A. Licenses Selective YKL-40 Inhibitor Program to OCEAN BIOMEDICAL Inc. for $32M with Joint Oversight on Research and Commercialization Process 10/14 MEDIC Life Sciences and Hanmi Pharmaceutical collaborate to identify cancer biomarkers for clinical trials 10/14 LG Chem and Hanmi Pharmaceutical Invest $5M in MEDIC Life Sciences for Cancer Drug Discovery and Biomarker Technology Enhancement [Venture Capital] 10/15 Tolerance Bio Secures $17.2 Million Seed Financing to Advance Immune Tolerance Therapies Using iPSC Technologies 10/15 INVIOS GmbH secures €8.2 million funding, advances INV441 and INV501 anti-cancer programs with Dana-Farber Cancer Institute [Regulatory] 10/15 SELLAS Life Sciences Group, Inc. earns Rare Pediatric Disease Designation for Galinpepimut-S in pediatric acute myeloid leukemia treatment from FDA same day : ( ↑ NASDAQ: SLS | +3.2% ) 10/15 FDA grants orphan drug designation to Immuneering Corporation's IMM-1-104 for pancreatic cancer treatment same day : ( ↑ NASDAQ: IMRX | +11.25% ) 10/15 FDA grants Rare Pediatric Disease designation to Papillon Therapeutics for Friedreich's ataxia therapy PPL-001 View the full newsletter contents for free via the link in the comments.

[Clinical Trials] 10/14 Eli Lilly and Company's phase 3 Study Shows More Crohn's Disease Patients Achieve Histologic Response with Mirikizumab than Ustekinumab at Week 52 same day : ( ↓ NYSE: LLY | -0.47% ) 10/14 GSK's phase III Trials for Depemokimab Meet Primary Endpoints at 52 Weeks in Treatment of CRSwNP 10/14 Jasper Therapeutics' SPOTLIGHT Study Reports Response in 14 of 15 Patients Using Briquilimab for Cold Urticaria and Symptomatic Dermographism same day : ( ↑ NASDAQ: JSPR | +18.22% ) 10/12 Benitec Biopharma Inc. reports interim data from BB-301 phase 1b/2a study showing improvement in swallowing function in two OPMD patients [Deals] 10/14 Lundbeck to Acquire Longboard Pharmaceuticals for $2.5B, Enhancing Neuro-Rare Disease Portfolio with Late-Stage Asset Bexicaserin same day : ( ↑ NASDAQ: LBPH | +51.12% ) 10/14 Exelixis and Merck ink clinical development collaboration for phase 3 trials of zanzalintinib in head, neck cancers and renal cell carcinoma same day : ( ↑ NASDAQ: EXEL | +0.15% ) ( ↓ NYSE: MRK | -0.69% ) [Venture Capital] 10/14 Inventiva nets €348 million in equity financing to advance phase 3 trial of lanifibranor, sees changes in key leadership positions same day : ( ↑ NASDAQ: IVA | +34.92% ) [Regulatory] 10/12 Shanghai Junshi Biosciences Co Ltd gains approval for ongericimab injection for primary hypercholesterolemia treatment following phase 3 clinical trials 10/11 FDA approves Pfizer's therapy HYMPAVZI for hemophilia A and B, demonstrating reduced bleeding frequency in BASIS trial same day : ( ↓ NYSE: PFE | -0.61% )

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/11 Cantargia AB's Drug Candidate CAN10 Blocks IL-1 and IL-36 Signaling in phase 1 Clinical Trial with 68 Participants 10/11 Perspective Therapeutics Unveils Initial phase 1/2a Results of [²¹²Pb]VMT01 with No Reported Dose-Limiting Toxicities in Melanoma Research Society Study 10/10 Allakos Inc. Reports 77% Bioavailability in phase 1 Study of AK006 with No Severe Side Effects Observed same day : ( ↑ NASDAQ: ALLK | +1.54% ) [Deals] 10/10 Janssen Inc. to Use XtalPi's AI Software, XtalFold™, for Drug Discovery under New Licensing Agreement 10/10 Eli Lilly and Company and KeyBioscience Expand Collaboration on DACRA Obesity Treatment; Deal Includes $1.4B in Milestone Payments and Royalties on Sales same day : ( ↓ NYSE: LLY | -0.98% ) [Regulatory] 10/11 FDA advisory committee supports approval of Stealth BioTherapeutics' elamipretide for Barth syndrome treatment 10/11 Dong-A ST's Imuldosa secures FDA approval as second approved biosimilar after Sivextro in 2014 10/10 FDA Approves Genentech's Itovebi for Hormone Receptor-Positive Breast Cancer with PIK3CA Mutation Following phase III Trial Results View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/10 VICO Therapeutics B.V. Reports Interim Data from phase 1/2a Trial of VO659, Showing Mean Reduction in Mutant HTT Protein in Huntington's Disease Patients 10/10 Johnson & Johnson's TREMFYA® shows high endoscopic remission rates in phase 3 Crohn's disease and ulcerative colitis studies same day : ( ↓ NYSE: JNJ | -0.08% ) 10/10 Immatics N.V. Reports 54% Objective Response Rate from phase 1b Trials on ACTengine IMA203, Plans Phase 3 for 2024 same day : ( ↓ NASDAQ: IMTX | -9.67% ) 10/10 Pfizer's TALZENNA in combination with XTANDI improves survival in metastatic prostate cancer study same day : ( ↓ NYSE: PFE | -2.05% ) 10/09 Vanqua Bio's phase 1 Trials Show VQ-101 Activates GCase Enzyme by Over 75% in Healthy Volunteers [Deals] 10/10 Tempest Therapeutics and Roche partner for phase 3 trial of cancer drug Amezalpat in combination with Atezolizumab and Bevacizumab same day : ( - NASDAQ: TPST | 0.00% ) 10/10 ONO PHARMACEUTICAL CO., LTD. Licenses 리가켐바이오 Ligachembio's Antibody-Drug Conjugate LCB97 for $700M, Partners for Future ADC Development 10/09 Nona Biosciences and OverT Bio join forces to develop advanced cell therapies for solid tumors using HCAb Harbour Mice and NonaCarFx platforms [Venture Capital] 10/10 Booster Therapeutics initiates its journey with $15 million financing for developing proteasome activator medicines 10/09 Arda Therapeutics raises $43 million in Series A financing round for cell-depletion therapies development, appoints Scott Turner as chief scientific officer [Regulatory] 10/10 FDA grants Breakthrough Therapy Designation to volixibat for cholestatic pruritus in primary biliary cholangitis patients based on phase 2b study results same day : ( ↑ NASDAQ: MIRM | +0.05% ) 10/10 Janssen-Cilag S.p.A. applies to European Medicines Agency for DARZALEX indication extension based on phase 3 CEPHEUS study data View the full newsletter contents for free via the link in the comments.

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Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/09 Viatris' phase 3 Trial of EFFEXOR for Generalized Anxiety Disorder in Japanese Adults Meets Primary Objective and Seven Secondary Endpoints same day : ( ↑ NASDAQ: VTRS | +0.75% ) 10/09 Viking Therapeutics, Inc.' phase 1b clinical trial reveals VK0214's safety and reductions in plasma VLCFA and lipid levels in X-ALD patients same day : ( ↓ NASDAQ: VKTX | -3.39% ) 10/09 Clearside Biomedical, Inc.' ODYSSEY phase 2b Trial of CLS-AX Shows Stable Visual Acuity in 67% Participants Over Six Months same day : ( ↓ NASDAQ: CLSD | -1.69% ) 10/09 InnoCare Pharma's ICP-488 Achieves Primary Endpoint in phase II Clinical Study for Moderate to Severe Plaque Psoriasis 10/08 Aurigene Oncology Limited Reports Successful phase 1 Trial of DRL-1801 in Refractory Multiple Myeloma Patients; Approval Received for Phase 2 10/08 Insmed Incorporated Presents phase 3 Trial Data of Brensocatib, Demonstrating Reduced Lung Function Decline in Non-Cystic Fibrosis Bronchiectasis Patients at CHEST 2024 same day : ( ↓ NASDAQ: INSM | -0.48% ) [Deals] 10/09 Bio-Thera and Gedeon Richter Pharma GmbH ink $110M exclusive deal for BAT2206, targeting EU and UK markets 10/09 Boehringer Ingelheim and Circle Pharma, Inc. ink $607M deal for cancer trials using MXMOTM platform 10/09 Sonnet BioTherapeutics and Alkem Laboratories Ltd. ink $2M licensing agreement for DPN treatment SON-080 in India, sharing clinical trials data for further collaborations same day : ( ↓ NASDAQ: SONN | -1.23% ) [Venture Capital] 10/09 Purespring Therapeutics secures £80m in Series B funding round to advance kidney disease-focused gene therapies and initiate phase I/II clinical trial 10/09 a:head bio AG Raises Funds for Preclinical to Clinical Drug Development Link; Former Minister and Founding Member Join Supervisory Board 10/08 City Therapeutics secures $135 million in Series A funding, plans RNA interference-based medicine advancement [Regulatory] 10/09 FDA issues complete response letter for Zealand Pharma's dasiglucagon due to manufacturing inspection timing 10/09 Alnylam Pharmaceuticals submits sNDA to FDA for vutrisiran following phase 3 HELIOS-B study in treatment of ATTR amyloidosis with cardiomyopathy same day : ( ↑ NASDAQ: ALNY | +0.1% ) 10/09 FDA grants Orphan Drug Designation to Namodenoson of Can Fite BioPharma (CANFY) for pancreatic cancer treatment 10/09 European Commission authorizes Novavax's updated Nuvaxovid COVID-19 vaccine for individuals aged 12 and older, based on clinical trial data same day : ( ↓ NASDAQ: NVAX | -1.92% ) 10/09 FDA grants Breakthrough Therapy Designation to Biogen's felzartamab for kidney transplant rejection treatment same day : ( ↑ NASDAQ: BIIB | +0.67% ) 10/09 FDA accepts Bayer's application for elinzanetant based on phase III studies for treating menopausal vasomotor symptoms View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 10/08 Sage Therapeutics' phase 2 Alzheimer's Study of Dalzanemdor Fails to Show Significant Difference, Halts Development same day : ( ↑ NASDAQ: SAGE | +0.89% ) 10/08 GSK's phase III Trial of Arexvy Shows 67.4% Efficacy Against Severe RSV-LRTD in Adults Aged 60 and Above 10/08 Merck's phase 3 KEYNOTE-689 trial for KEYTRUDA meets primary endpoint in advanced head and neck squamous cell carcinoma treatment 10/08 Biogen reveals DEVOTE study results: High-dose regimen of nusinersen shows motor function improvements in spinal muscular atrophy patients same day : ( ↓ NASDAQ: BIIB | -0.36% ) 10/07 Biomed Industries Inc Achieves 6.8% Weight Reduction with NA-931, Quadruple Receptor Agonist, in Phase 1 Obesity Trial [Deals] 10/08 SK bioscience Invests USD 3M in FINABIO to Leverage Proprietary CRM197 Technology for Improved Vaccine Efficacy 10/08 AviadoBio and Astellas Pharma sign $2.18B deal to develop and commercialize gene therapy AVB-101 for frontotemporal dementia 10/08 Bayer partners with MOMA Therapeutics for small molecule oncology program, access to proprietary KNOMATIC™ platform granted 10/08 Mestag Therapeutics Partners with MSD for $1.9B Collaboration on Inflammatory Disease Therapies Using Novel Fibroblast Technology same day : ( ↓ NYSE: MRK | -0.08% ) 10/08 MiNK Therapeutics and Autonomous Therapeutics collaborate for a novel therapy aimed at treatment-resistant metastatic solid tumors same day : ( ↓ NASDAQ: INKT | -2.67% ) 10/08 Tonix Pharmaceuticals Collaborates with X-Chem, Inc. for Accelerated Development of $34M TNX-4200 Program Using AI and ML Technology same day : ( ↑ NASDAQ: TNXP | +9.29% ) 10/07 MediLink Therapeutics and Amgen Collaborate for Clinical Trial of YL201 and IMDELLTRA™ in Extensive-Stage Small Cell Lung Cancer Treatment same day : ( ↓ NASDAQ: AMGN | -0.69% ) [Venture Capital] 10/08 Orasis Pharmaceuticals completes $78 million financing to launch Qlosi, a corrective eye drop for presbyopia in adults [Regulatory] 10/08 Boehringer Ingelheim's survodutide gets FDA Breakthrough Therapy designation for MASH treatment, phase III clinical trials underway View the full newsletter contents for free via the link in the comments.