Bio-Research.AI

# ?????????????? ?????????????????? ???????? ?????? ???????????? ???????? #???????? ?????????????????????????????? [Deals] 02/28 Magnet Biomedicine partners with Eli Lilly and Company to develop molecular glue targeting difficult-to-drug proteins with $40M upfront and $1.25B milestones 02/28 Eisai Co., Ltd. licenses FGFR inhibitor to SciClone Pharmaceuticals for cancer treatment in Greater China with milestone payments [Regulatory] 02/28 Regeneron Pharmaceuticals' linvoseltamab receives EMA recommendation for multiple myeloma treatment 02/28 Vertex Pharmaceuticals receives positive CHMP opinion to expand KAFTRIO label for cystic fibrosis treatment 02/28 Novartis' Fabhalta receives European recommendation for C3 glomerulopathy after showing significant reduction in proteinuria 02/28 European Medicines Agency recommends AbbVie's upadacitinib for giant cell arteritis in adults 02/28 The European Medicines Agency recommends HSV vector delivering COL7A1 for treating wounds in dystrophic epidermolysis bullosa

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 02/27 YolTech Therapeutics' trial shows in vivo PCSK9 gene editing therapy reduces plasma LDL-C levels with strong safety profile 02/27 Cogent Biosciences reports 65% improvement in symptom score at 48 weeks for c-kit inhibitor trial 02/27 LEO Pharma’ Phase 3 trial meets its endpoint with its JAK inhibitor cream, showing eczema severity improvement 02/26 Cognition Therapeutics, Inc.’ Phase 2 trial with its sigma-2 receptor modulator shows slower lesion growth in geographic atrophy patients same day : ( ↓ NASDAQ: CGTX | -4.26% ) [Deals] 02/27 Medigene AG and EpimAb Biotherapeutics, Inc. partner to co-develop bispecific TCR-TCEs for immune disorders 02/27 Cassava Sciences secures rights from Yale University for a filamin A modulator in treating neurodevelopmental disorders same day : ( ↑ NASDAQ: SAVA | +6.96% [ pre-market ] ) 02/27 Zevra Therapeutics sells priority review voucher for $150M same day : ( ↑ NASDAQ: ZVRA | +6.9% [ pre-market ] ) 02/26 Renovaro Biosciences Inc. and BioSymetrics to merge, integrating AI for precision medicine in oncology same day : ( ↑ NASDAQ: RENB | +53.95% ) [Venture Capital] 02/26 Enveda advances AI-driven drug discovery platform and treatment for atopic dermatitis to clinical trials with Sanofi investment 02/26 Renovaro Biosciences Inc. secures $15 million in equity for AI and biotechnology advancements same day : ( ↑ NASDAQ: RENB | +53.95% ) [Regulatory] 02/27 BlueRock Therapeutics' iPSC-derived cell therapy receives Fast Track designation for primary photoreceptor diseases 02/27 Adicet Bio, Inc Bio receives Fast Track Designation for CAR-T therapy targeting CD20 in autoimmune diseases same day : ( ↑ NASDAQ: ACET | +2.22% [ pre-market ] ) View the full newsletter contents for free via the link in the comments.

#??????7/8 ?????????????? 350?? ?????????????? #?????? ?????? ???????? #???????? ???????? 2 ?????????? ???????????????? [Clinical Trials] 02/26 Madrigal Pharmaceuticals' Phase 3 trial shows Rezdiffra reducing liver stiffness by 6.7 kPa in MASH cirrhosis over two years 02/26 Alligator Bioscience AB's Phase 2 study of CD40 mAb shows a 29.4% 24-month survival rate in metastatic pancreatic cancer 02/25 Emalex Biosciences' phase 3 study shows D1/5 receptor antagonist significantly reduces relapse rate in Tourette syndrome, with 41.9% of subjects relapsing. [Deals] 02/26 HBM Alpha Therapeutics partners for global rights on CRH mAb potentially earning up to 395M [Venture Capital] 02/26 Eikon Therapeutics raises $350.7 million to advance clinical portfolio, including TLR7/8 agonist for melanoma [Regulatory] 02/26 FDA accepts Regeneron's resubmission for odronextamab targeting relapsed/refractory follicular lymphoma

#???????????? ?????????????????????????????? ??????????????. #?????????? ?????? ???????????????? ???????? #?????????????????? ?????? ?????????????????? ???? ?????????????? ???????? [Clinical Trials] 02/25 Candel Therapeutics reports its oncolytic virus therapy expressing HSV-tk extends survival to 31.4 months in pancreatic cancer trial 02/25 Eupraxia Pharmaceuticals Inc.' phase 1b/2a trial shows improved symptom scores in Cohort 6 for EP-104GI 02/24 Regeneron Pharmaceuticals phase 1/2 trial shows improved hearing in most of 12 children with dual AAV vector gene therapy expressing Otoferlin gene same day : ( ↑ NASDAQ: REGN | +1.87% ) [Deals] 02/25 Eli Lilly and Company to acquire Organovo Holdings, Inc.'s FXR program and advance FXR314 in phase 2 trials for IBD treatments 02/25 Ligand Pharmaceuticals and partners secure $75M deal with Castle Creek for phase 3 trial of D-Fi 02/25 BridGene Biosciences, Inc. and Takeda in agreement to utilize chemoproteomics platform for drug discovery for undruggable targets in immunology and neurology 02/25 Hyloris Pharmaceuticals licenses 5-HT3 antagonist from RedHill Biopharma Ltd. with $60M potential milestone payments [Regulatory] 02/25 FDA accepts Priority Review for Precigen's adenovirus-based gene therapy for recurrent respiratory papillomatosis 02/25 Merck's application for KEYTRUDA in head and neck cancer receives FDA priority review View the full newsletter contents for free via the link in the comments.

#????-1/???????? ?????????? ??????????????. #?????? ?????????????????? ???????? ?????????????????? [Clinical Trials] 02/24 OSE Immunotherapeutics' phase 2 trial of IL-7R mAb Antagonist shows significant clinical remission in ulcerative colitis after 10 weeks 02/24 Hengrui Medicine's Phase III trial shows that CDK4/6 inhibitor significantly reduces the risk of recurrence in a large breast cancer trial 02/24 Axsome Therapeutics, Inc.' phase 3 trial shows COX-2 inhibitor/5-HT agonist Combi more effective in migraine relief within 2 hours 02/24 PepGen's Phase 1 trial shows splicing correction of 12.3% and 29.1% with ASO targeting DMPK RNA in early cohorts of patients with myotonic dystrophy type 1 [Deals] 02/24 Summit Therapeutics, Inc. and Pfizer to test PD-1/VEGF bsAb with antibody drug conjugates in solid tumors [Regulatory] 02/24 Auron Therapeutics, Inc. receives FDA Fast Track for KAT2A/B degrader in relapsed or refractory acute myelogenous leukemia 02/24 Takeda receives EMA approval for 2 mL pre-filled pen of TAKHZYRO for hereditary angioedema

Featured highlights from today's Bio-Research.AI Update: [Clinical Trials] 02/20 SELLAS Life Sciences Group, Inc. Group phase 2a shows 67% response rate in non-GCB DLBCL with SLS009 and zanubrutinib same day : ( ↑ NASDAQ: SLS | +3.97% ) [Deals] 02/21 The Carlyle Group and SK Capital Partners to acquire bluebird bio, offering $3.00 per share plus contingent value same day : ( ↓ NASDAQ: BLUE | -41.05% [ pre-market ] ) 02/20 Photys Therapeutics secures global rights to develop PHT-776 under agreement with Polymed Biopharmaceuticals [Regulatory] 02/20 Elixirgen Therapeutics, Inc.'s EXG-34217 receives Orphan Drug Designation for Telomere Biology Disorders gene therapy trial 02/20 European Commission approves seladelpar for primary biliary cholangitis with biochemical improvements same day : ( ↑ NASDAQ: GILD | +0.07% [ pre-market ] ) View the full newsletter contents for free via the link in the comments.

#??????1 ?????? ???????? #???? ???????? ?????????????????? ???????? [Clinical Trials] 02/20 Hengrui Pharma Co.,Ltd's phase I study of Nectin4-targeting ADC shows 50.0% response rate in urothelial carcinoma 02/19 IMUNON's Phase 2 study of its plasmid vector-based therapy shows a 20% increase in IL-12 levels in the treatment of advanced ovarian cancer same day : ( ↑ NASDAQ: IMNN | +3.49% ) [Deals] 02/20 FibroGen, Inc. sells China subsidiary to AstraZeneca for $160M, retains U.S. rights to roxadustat same day : ( ↓ LSE: AZN | -1.35% ) ( ↑ NASDAQ: AZN | +0.01% [ pre-market ] ) ( ↑ NASDAQ: FGEN | +58.59% [ pre-market ] ) 02/20 Incyte and Genesis Therapeutics form strategic collaboration using GEMS AI platform for drug discovery 02/20 UroGen Pharma acquires IconOVir Bio's oncolytic virus in a deal worth $19M plus royalties same day : ( ↑ NASDAQ: URGN | +0.74% [ pre-market ] ) 02/20 HARBOUR BIOMED and Insilico Medicine form collaboration for AI-driven therapeutic antibodies 02/19 Radiance Biopharma and CSPC Megalith partner for ROR1-targeting ADC with up to 1B in commercial milestones [Venture Capital] 02/20 EG 427 raises €27 million to fund phase 1b/2a study of genetic treatment for neurogenic detrusor overactivity [Regulatory] 02/20 Daiichi Sankyo gains partial change approval in Japan for Lixiana tablets to prevent clots in pulmonary hypertension same day : ( ↓ JPX: 4568 | -2.43% ) 02/20 Japan approves EPKINLY for relapsed or refractory follicular and large B-cell lymphomas 02/20 Chugai Pharmaceutical Co., Ltd. secures approval for expanded indication of Tecentriq in unresectable alveolar soft part sarcoma View the full newsletter contents for free via the link in the comments.

#?????????????? ???????? ?????? ???????????? ?????? ???????? #???????? ?????? ????15 ???????????????? $12?? ?????????????? #??????????1 ?????????????????? ???????? ???? ???????????????????? [Clinical Trials] 02/19 Ascletis Pharma Inc. reports 6.3% weight reduction in obesity study's cohort 2 after 28 days with oral GLP-1R agonist 02/19 Bristol Myers Squibb's phase 3 CheckMate-816 study shows significant improvement in overall survival for lung cancer same day : ( ↑ NYSE: BMY | +0.13% [ pre-market ] ) 02/18 Supernus Pharmaceuticals, Inc.' phase 2b study of SPN-820 shows no significant improvement in depression same day : ( ↓ NASDAQ: SUPN | -15.42% [ pre-market ] ) [Deals] 02/19 Epitopea and MSD Partner to Identify Shared, Non-Mutated Antigens from Non-Coding DNA same day : ( ↑ NYSE: MRK | +0.23% [ pre-market ] ) [Venture Capital] 02/19 Reverb Therapeutics raises $12 million to advance its bispecific antibody approach for IL15 delivery in cancer treatments 02/19 PERCEIVE PHARMACEUTICAL PRIVATE LIMITED raises $15 million Series A funding for neuroprotective therapies development [Regulatory] 02/19 Boehringer Ingelheim's zongertinib receives FDA priority review for unresectable metastatic NSCLC

#??????-2α ?????????????????? ???????????????? #?????? ?????????????????? ??????1?? ???????? ???????? #?????????????????????????????????? ?????????????????? ???????????? ???????? [Clinical Trials] 02/18 Ventyx Biosciences' phase 2 trial of Allosteric TYK2 Inhibitor shows dose-dependent endoscopic improvements in Crohn's disease 02/18 Solid Biosciences phase 1/2 trial shows 110% microdystrophin expression, no serious adverse events same day : ( - NASDAQ: SLDB | 0.00% [ pre-market ] ) [Deals] 02/18 Biogen and Stoke Therapeutics partner to develop ASO targeting SCN1A gene for Dravet syndrome with $165M upfront for Stoke same day : ( - NASDAQ: BIIB | 0.00% [ pre-market ] ) ( - NASDAQ: STOK | 0.00% [ pre-market ] ) 02/18 KYORIN Pharmaceutical Co., Ltd. signs option agreement with Cyrano Therapeutics for a Phosphodiesterase Inhibitor in Japan same day : ( ↓ JPX: 4569 | -0.44% ) [Regulatory] 02/18 FDA accepts Priority Review for an IL-4/IL-13 inhibitor antibody application to treat adults with bullous pemphigoid 02/18 European Commission approves Merck's HIF-2α inhibitor for the treatment of von Hippel-Lindau tumors in adults same day : ( ↑ NYSE: MRK | +0.02% [ pre-market ] ) View the full newsletter contents for free via the link in the comments.

#???????? ???????????? ???????? $90?? ?????????????? #?????? ?????????????? 5-???????????? ???????????????????? ?????????????? #5-???????? ??????2 ?????????????????? ???????????????? ???????????????????? [Clinical Trials] 02/17 Arcus Biosciences' phase 1/1b trial shows 9.7-month median progression-free survival for HIF-2a inhibitor 02/16 Bristol Myers Squibb's five-year trial of TYK2 allosteric inhibitor shows nearly half of patients maintained a PASI 90 clinical response in plaque psoriasis 02/14 AstraZeneca's phase III trial shows IMFINZI with chemotherapy reduces disease progression risk by 42% in bladder cancer [Venture Capital] 02/14 Bambusa Therapeutics secures $90 million in Series A financing to advance long acting bispecific antibody development [Regulatory] 02/17 FDA Approves ONO PHARMACEUTICAL CO., LTD. and Deciphera Pharmaceuticals's CSF1R inhibitor for Advanced Treatment of Tenosynovial Giant Cell Tumor 02/17 The FDA approves GSK's PENMENVY vaccine targeting five major serogroups of Neisseria meningitidis for individuals aged 10 to 25 02/17 Innate Pharma's KIR3DL2 mAb receives Breakthrough Therapy Designation from FDA for relapsed or refractory Sézary syndrome