Efortless BioPharma Update

Featured highlights from today's Efortless Update: [Clinical Trials] 08/28 「Neurocrine Biosciences' phase 2 trial of NBI-1117568 in schizophrenia shows 7.5-point improvement in PANSS total score at week 6」 same day : ( ↓ NASDAQ: NBIX | -21.28% ) 08/28 「Egetis Therapeutics AB reports post-hoc analyses from Triac Trial I showing caregiver-reported outcomes in 40 patients with MCT8 deficiency treated with tiratricol」 08/28 「Novartis' phase III study shows Leqvio reduces LDL-C in low to moderate-risk ASCVD patients compared to placebo and ezetimibe」 same day : ( ↑ NYSE: NVS | +0.42% ) [Deals] 08/28 「Bayer and NextRNA Therapeutics enter $547M partnership to develop small molecule therapeutics targeting lncRNAs in oncology」 08/28 「中外製薬 / Chugai Pharmaceutical Co., Ltd. transfers secondary hyperparathyroidism drug OXAROL for Injection to LTL Pharma with marketing authorization effective October 1, 2024, and sales transfer by January 1, 2025」 08/28 「Innovate UK invests £10M in innovation projects with £1.5M awarded to Mestag Therapeutics to advance bispecific antibody MST-0300 for cancer treatment」 08/28 Flagship Pioneering and Quotient Therapeutics to explore somatic mutations in cardiovascular and renal diseases using Quotient's Somatic Genomics platform under partnership with Pfizer」 [Regulatory] 08/28 「SpringWorks Therapeutics' NDA for mirdametinib to treat NF1-associated plexiform neurofibromas accepted by FDA with European Medicines Agency also validating application」 same day : ( ↑ NASDAQ: SWTX | +2.99% ) 08/28 「Life Molecular Imaging's [18F]PI-2620 Injection granted FDA Fast Track Designation for clinical development in Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration」 08/28 「Destiny Pharma plc receives US FDA QIDP designation for XF-73 Dermal Gel to treat or prevent staphylococcal infections in burn wounds」 View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/27 「Invivyd announces 180-day data from phase 3 trial of pemivibart showing 84% relative risk reduction in symptomatic COVID-19 and no hospitalizations or deaths in immunocompetent participants」 same day : ( ↓ NASDAQ: IVVD | -5.43% ) 08/27 「COSCIENS Biopharma Inc.'s phase 3 AEZS-130-P02 DETECT-trial shows macimorelin stimulates growth hormone but fails primary efficacy endpoint due to high false positive rate in comparator tests」 same day : ( ↓ NASDAQ: CSCI | -27.3% ) [Deals] 08/27 「YolTech Therapeutics and Salubris Pharmaceuticals enter licensing agreement worth RMB 1.035B for YOLT-101 development and commercialization in Mainland China」 08/27 「GC Cell and Dewcell Biotherapeutics partner to develop and commercialize high-quality artificial platelets leveraging stem cell-based technology and advanced biopharmaceutical solutions」 08/27 「Navigator Medicines secures in-licensing deal for NAV-240 bispecific antibody from IMBiologics」 08/27 「Ensysce Biosciences receives $14M NIH and The National Institute on Drug Abuse (NIDA) grant for PF614-MPAR phase 1b clinical trial addressing opioid crisis, total federal support now $40M」 same day : ( ↑ NASDAQ: ENSC | +46.23% ) 08/26 「Dewpoint Therapeutics and Biospective Inc. receive second Target ALS Foundation grant for in vivo development of condensate-modifying drugs targeting TDP-43 condensatopathy in ALS」 [Venture Capital] 08/27 「Navigator Medicines secures $100M Series A financing to advance the clinical development of NAV-240 bispecific antibody」 [Regulatory] 08/27 「CAMP4 Therapeutics receives FDA Rare Pediatric Disease Designation for CMP-CPS-001 targeting urea cycle disorders」 08/27 「Avanzanite Bioscience receives European Commission marketing authorization for AKANTIOR to treat acanthamoeba keratitis following successful phase III ODAK trial results」 08/27 「JW Therapeutics 药明巨诺' supplemental biological license application for Carteyva approved in China for treating relapsed or refractory mantle cell lymphoma」 08/27 「Roche announces European Commission approval of PiaSky for PNH based on phase III studies, offering monthly subcutaneous self-administration option」 08/27 「Basilea Pharmaceutica Ltd extends Cresemba's use to pediatric patients and receives CHF 10 million milestone payment from Pfizer」 08/27 「European Commission approves extension for Rybrevant in combination with chemotherapy for advanced NSCLC with EGFR mutations after prior EGFR TKI therapy failure」 08/27 「Faron Pharmaceuticals receives FDA fast track designation for bexmarilimab in combination with azacitidine for relapsed or refractory myelodysplastic syndrome」 08/27 「FDA accepts Soleno Therapeutics, Inc.' drug application for DCCR for treating Prader-Willi syndrome with a PDUFA target action date of December 27, 2024」 same day : ( ↑ NASDAQ: SLNO | +4.34% ) View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/26 「Actinogen Medical's phase 2a trial of Xanamem shows 50% higher remission rate in depression at week 10 compared to placebo」 08/25 「PharmAust Limited's study on ALS shows monepantel at 10 mg/kg daily improved survival by 80.3% and slowed disease progression」 [Deals] 08/26 「Cessatech A/S and Proveca Ltd enter agreement for worldwide commercialization of CT001 with upfront payment and double-digit royalties while exploring CT002 program for pediatric needs」 08/26 「GI INNOVATION and Merck sign clinical trial agreement to evaluate GI-102 and Keytruda in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma」 same day : ( ↑ NYSE: MRK | +0.74% ) 08/26 「Tonix Pharmaceuticals and Bilthoven Biologicals collaborate to advance TNX-801 mpox vaccine candidate in the manufacturing processes」 same day : ( ↑ NASDAQ: TNXP | +12.88% ) 08/26 「IMMORNA Biotherapeutics receives grant from Bill & Melinda Gates Foundation for JCXH-108 RSV vaccine clinical development with commitment to supply low-income regions if approved」 08/26 「BridgeBio Pharma collaborates with Yale School of Medicine to enhance early detection of ATTR-CM using AI-based screening tools」 same day : ( ↑ NASDAQ: BBIO | +1.98% ) [Regulatory] 08/26 「Celltrion Inc receives European Commission approval for SteQeyma ustekinumab biosimilar to treat chronic inflammatory diseases based on phase III study in plaque psoriasis demonstrating similarity to Stelara」 08/26 「European Commission approves AKANTIOR for treatment of acanthamoeba keratitis in patients aged 12 and older」 08/26 「Regeneron Pharmaceuticals receives European Commission approval for Ordspono in relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma」 same day : ( ↓ NASDAQ: REGN | -0.02% ) 08/26 「BeiGene receives FDA Fast Track Designation for BGB-16673 in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after two prior lines of therapy」 same day : ( ↑ NASDAQ: BGNE | +2.41% ) 08/23 「Invenra's antibody INV724 for neuroblastoma receives Rare Pediatric Disease and Orphan Drug Designations from FDA」 View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/23 「Viatris phase 2 study shows 2 mg and 4 mg doses of cenerimod are safe and well-tolerated with reversible decrease in lymphocyte counts and improvement in disease activity for systemic lupus erythematosus in Japanese patients」 same day : ( ↓ NASDAQ: VTRS | -0.13% ) 08/23 「Arthrosi Therapeutics, Inc. announces data from phase 2 program showing 83% of patients achieved serum urate levels below 5 mg/dL with AR882 in gout treatment」 [Deals] 08/23 「AnGes Inc. terminates exclusive distribution license agreements in Japan and the United States with Mitsubishi Tanabe Pharma Corporation for HGF gene therapy product Collategene」 [Venture Capital] 08/22 「TEVOGEN BIO enters $6.0 million Series C Preferred Stock investment agreement with The Patel Family, LLP to support T cell therapies development」 same day : ( ↓ NASDAQ: TVGN | -0.82% ) [Regulatory] 08/23 「Moderna's mRNA vaccine mRESVIA granted marketing authorization by European Commission for RSV in adults aged 60 years and older based on phase 3 ConquerRSV trial involving 37000 adults」 same day : ( ↑ NASDAQ: MRNA | +0.96% ) 08/23 「GenFleet Therapeutics receives approval for Dupert in treating advanced non-small cell lung cancer with KRAS G12C mutation after prior therapy」 08/23 「European Commission approves erdafitinib as monotherapy for unresectable or metastatic urothelial carcinoma with FGFR3 genetic alterations based on THOR phase 3 study results」 08/22 「FDA grants Orphan Drug Designation to Ractigen Therapeutics' saRNA product RAG-18 for Duchenne Muscular Dystrophy」 08/22 「Liquidia Corporation files lawsuit challenging FDA's 3-year exclusivity decision for Tyvaso DPI delaying YUTREPIA approval until May 2025」 same day : ( ↓ NASDAQ: LQDA | -3.51% ) 08/22 「Pfizer and BioNTech SE announce FDA approval and emergency use authorization for Omicron-adapted COVID-19 vaccine for various age groups」 same day : ( ↓ NASDAQ: BNTX | -1.98% ) 08/22 「Ractigen Therapeutics receives FDA rare pediatric disease designation for RAG-18 in treating Duchenne muscular dystrophy」 08/22 「Moderna receives FDA approval for Spikevax 2024-2025 formula for ages 12 and up and emergency use authorization for ages 6 months to 11 years」 same day : ( ↑ NASDAQ: MRNA | +0.96% ) 08/22 「Liquidia Corporation files lawsuit challenging FDA's 3-year exclusivity decision for Tyvaso DPI delaying YUTREPIA approval until May 2025」 same day : ( ↓ NASDAQ: LQDA | -3.51% ) View the full newsletter contents for free via the link in the comments. Today's Efortless Update: https://lnkd.in/eiAataiN

[Clinical Trials] 08/22 「Cognition Therapeutics, Inc.' SEQUEL study of CT1812 in 16 adults with mild-to-moderate Alzheimer's disease shows EEG-measured brain wave improvements and reports no severe adverse events」 same day : ( ↑ NASDAQ: CGTX | +3.24% ) 08/21 「Virogin Biotech's VG201 phase I trial on HSV-1 oncolytic virus shows partial response in 3 patients and stable disease in 8 with no severe adverse events」 [Deals] 08/22 「Oblique Therapeutics AB (publ.) enters research collaboration agreement with Eli Lilly and Company to generate antibodies using AbiProt technology aiming to accelerate innovative treatments development」 same day : ( ↑ NYSE: LLY | +1.94% ) 08/22 「Rafael Holdings, Inc. and Cyclo Therapeutics, Inc. enter definitive merger agreement to develop Trappsol Cyclo for Niemann-Pick Disease Type C1」 same day : ( ↑ NYSE: RFL | +3.6% ) ( ↓ NASDAQ: CYTH | -28.59% ) 08/22 「Bridge Biotherapeutics, Inc. and HitGen Inc. enter joint research agreement to develop novel cancer therapeutics leveraging DNA-encoded library technology」 [Venture Capital] 08/21 「PhotonPharma completes $2.5 million seed financing for phase I clinical trial of Innocell for advanced ovarian cancer treatment」 08/21 「Retension Pharmaceuticals secures $10.4 million in Series A funding to advance phase 2 clinical study for RTN-001 in hypertension patients」 [Regulatory] 08/22 「Clarity Pharmaceuticals' ⁶⁴Cu-SAR-bisPSMA granted FDA fast track designation for PET imaging of PSMA-positive prostate cancer lesions as phase III trials are underway」 08/22 「CK Life Sciences announces FDA Fast Track designation for WEX Pharmaceuticals' Halneuron in treating chemotherapy-induced neuropathic pain」 08/22 「Abata Therapeutics granted FDA Fast Track designation for ABA-101 to treat progressive multiple sclerosis」 08/22 「Henlius' trastuzumab biosimilar HLX02 receives approval from Health Canada for treatment of early and metastatic cancers under trade name Adheroza」 08/22 「Eisai Co., Ltd. and Biogen's lecanemab granted Marketing Authorization by MHRA for Alzheimer's treatment based on phase 3 clinical trial data」 08/21 「Innovent Biologics NMPA approval of Dupert for advanced NSCLC with KRAS G12C mutation based on phase 2 study showing 49.1% ORR and 90.5% DCR」 View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/21 「Timber Pharmaceuticals, Inc., a LEO Pharma company' phase 3 trial of TMB-001 for moderate to severe congenital ichthyosis fails to meet endpoints with no statistically significant difference observed」 08/21 「Annexin Pharmaceuticals AB (publ)' phase 2a trial of ANXV in retinal vein occlusion shows 12 of 14 patients with improvement or stable disease」 08/21 「Egetis Therapeutics AB reports tiratricol treatment in MCT8 deficiency linked to three times lower risk of mortality from international real-world study on 228 patients across 173 sites in 48 countries」 08/20 「Innovo Therapeutics announces phase 2 trial results showing safety and significant scar reduction with INV-001 in 77 Korean patients following thyroidectomy」 [Deals] 08/21 「Pharmazz Inc. signs agreement with Sun Pharmaceutical Industires Limited for $15M investment in phase 3 trial of Sovateltide for acute cerebral ischemic stroke and expands marketing rights to Emerging Market countries」 08/21 「Tokyo Medical and Dental University and Celaid Therapeutics sign joint research agreement for novel gene-modified cell therapies using human bone marrow HSCs for inborn errors of immunity」 08/20 「Dr. Reddy's Laboratories, Aurigene Pharmaceutical Services Limited, and Kainomyx sign MoU for affordable anti-malarial drug development」 [Venture Capital] 08/21 「Vandria SA secures $30.7M in Series A financing to support first-in-man phase 1 study and three parallel phase 1b/2a efficacy studies of VNA-318 in 2025」 [Regulatory] 08/20 「FDA issues Complete Response Letter for Regeneron's linvoseltamab application in relapsed/refractory multiple myeloma due to findings at third-party manufacturer facility awaiting reinspection」 same day : ( ↑ NASDAQ: REGN | +0.5% ) View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/20 「Eli Lilly and Company reports tirzepatide phase 3 study results with 22.9% average weight loss and reduced progression to type 2 diabetes」 same day : ( ↑ NYSE: LLY | +4.61% ) [Deals] 08/20 「Shanghai Henlius Biotech and Convalife Pharmaceuticals partner for exclusive commercialization of neratinib in China and other regions」 08/20 「Adcendo and Multitude sign licensing agreement for ADCE-T02 targeting Tissue Factor with Multitude receiving over $1B in payments and royalties; phase I study set to begin in Q4 2024」 08/20 「BerGenBio ASA collaborates with Tempus AI to enhance bemcentinib development for first line NSCLC patients with STK11 mutations using real-world data」 08/20 「Organon expands agreement with Eli Lilly and Company for $22.5M to distribute and promote Emgality in Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey, and UAE」 same day : ( ↑ NYSE: LLY | +4.61% ) ( ↑ NYSE: OGN | +1.19% ) 08/19 「Visiox Pharmaceuticals enters definitive merger agreement with Ocuvex Therapeutics to accelerate commercialization and enhance eye care portfolio」 [Venture Capital] 08/20 「Talus Bioscience raises $11.2M to advance therapeutic programs targeting Brachyury-driven cancers and a transcription factor in prostate cancer, expanding MARMOT platform for transcription factor modulation」 08/20 「Pathalys Pharma secures $105 million funding to finalize phase 3 trials and prepare NDA filing for ESKD treatment upacicalcet」 [Regulatory] 08/20 「AstraZeneca's Fasenra receives approval in China for maintenance treatment of severe eosinophilic asthma based on MIRACLE phase III trial results showing significant reduction in asthma exacerbation rate」 same day : ( ↑ NASDAQ: AZN | +0.8% ) 08/20 「FDA approves Johnson & Johnson's RYBREVANT plus LAZCLUZE for first-line treatment of EGFR-mutated NSCLC following phase 3 study showing significant clinical benefits over osimertinib」 same day : ( ↑ NYSE: JNJ | +0.33% ) 08/20 「Astellas Pharma's PADCEV approved in China for advanced urothelial cancer following prior chemotherapy and PD-1/PD-L1 inhibitor treatment based on data from EV-301 and EV-203 trials」 08/20 「FDA grants breakthrough therapy designation for GSK5764227 targeting small-cell lung cancer by GSK after progression on chemotherapy」 08/20 「Opus Genetics receives Rare Pediatric Disease designation from FDA for OPGx-LCA5 gene therapy for Leber congenital amaurosis」 08/19 「ReAlta Life Sciences receives FDA orphan drug and fast track designation for RLS-0071 to treat hospitalized patients with steroid-refractory acute graft-versus-host disease」 08/19 「Arthrosi Therapeutics, Inc.' AR882 receives FDA Fast Track Designation for treating clinically visible tophi in gout patients」 View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/19 「CANbridge Pharmaceuticals Inc. ' pivotal trial of CAN103 shows significant reductions in spleen volume for Gaucher disease at nine months」 08/19 「MindBio Therapeutics Corp. phase 2A trial of LSD microdose MB22001 shows 62.8% reduction in depressive symptoms three months post-treatment」 [Deals] 08/19 「Sonnet BioTherapeutics enters into master clinical collaboration agreement with Sarcoma Oncology Center to advance SON-1210 development for metastatic pancreatic cancer」 same day : ( ↑ NASDAQ: SONN | +1.17% ) 08/16 「SciSparc signs exclusive patent license agreement with Polyrizon Ltd. for SCI-160 program in pain treatment, with SciSparc to receive Polyrizon securities worth $3M, potential milestone fees of $3M, and royalties」 same day : ( ↑ NASDAQ: SPRC | +12.92% ) [Regulatory] 08/19 「Bristol Myers Squibb application to expand Breyanzi indication validated by EMA for adults with relapsed or refractory follicular lymphoma based on phase 2 TRANSCEND FL study data」 same day : ( ↑ NYSE: BMY | +0.95% ) 08/19 「European Medicines Agency validates Type II Variation application for ENHERTU in HER2 low or ultralow breast cancer based on DESTINY-Breast06 trial results showing improved progression-free survival」 08/19 「FDA grants tentative approval for Liquidia Corporation's YUTREPIA inhalation powder to treat PAH and PH-ILD, pending Tyvaso DPI's regulatory exclusivity expiration and Liquidia's challenge」 same day : ( ↓ NASDAQ: LQDA | -38.31% ) 08/16 「FDA grants orphan drug designation to Phanes Therapeutics, Inc.' PT217 for neuroendocrine carcinoma」 View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/16 「Pfizer and BioNTech SE phase 3 trial of combination mRNA vaccine meets immunogenicity objective for influenza A and COVID-19 but not for influenza B」 same day : ( ↓ NYSE: PFE | -2.8% ) 08/15 「Incyte's phase 3 inMIND trial meets primary endpoint in patients with relapsed or refractory follicular lymphoma evaluating tafasitamab combined with lenalidomide and rituximab」 same day : ( ↑ NASDAQ: INCY | +0.13% ) [Deals] 08/16 「IMBiologics signs deal with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. for IMB-101 regional rights in 383M agreement including 8M upfront and additional royalties, continues collaboration with Navigator Medicines」 08/16 「Immuron Limited secures $3.5M from U.S. Department of Defense for research agreement with Naval Medical Research Command and Walter Reed Army Institute of Research to enhance Travelan for military-relevant diarrheal pathogens」 same day : ( ↓ NASDAQ: IMRN | -1.0% ) 08/15 「EnPlusOne Biosciences and Wyss Institute at Harvard University receive up to 27M from ARPA-H for RNA therapeutic development targeting cancer and infectious diseases using ezRNA platform and DNA nanotechnology for drug delivery」 08/15 「Nuntius Therapeutics enters collaboration agreement with Taiho Pharmaceutical Co., Ltd., to develop novel mRNA cancer immunotherapies utilizing peptide dendrimer- and lipid-based nanocarriers」 [Regulatory] 08/16 「AstraZeneca's IMFINZI combined with chemotherapy approved by FDA for resectable early-stage NSCLC without EGFR mutations or ALK rearrangements based on AEGEAN trial data」 same day : ( ↓ NASDAQ: AZN | -0.28% ) 08/16 「FDA accepts priority review for NDA for vimseltinib by Deciphera Pharmaceuticals for tenosynovial giant cell tumor with target action date February 17 2025 based on phase 3 MOTION study results showing objective response rate」 08/15 「FDA approves pediatric indication for Vericel® Corporation's NexoBrid in eschar removal for deep partial-thickness and full-thickness burns based on phase 3 trial and additional pediatric data」 same day : ( ↑ NASDAQ: VCEL | +1.83% ) View the full newsletter contents for free via the link in the comments.

Featured highlights from today's Efortless Update: [Clinical Trials] 08/15 「Niaid's PALM 007 trial of SIGA Technologies’ tecovirimat in monkeypox patients shows safety but does not meet primary endpoint for lesion resolution improvement」 same day : ( ↓ NASDAQ: SIGA | -38.18% ) 08/15 「DermBiont, Inc.'s phase 2a study shows clinical response in 7 subjects with basal cell carcinoma treated with SM-020 1% gel」 08/14 「Turnstone Biologics' phase 1 STARLING trial of TIDAL-01 in metastatic microsatellite stable colorectal cancer shows 25% overall response rate and 50% disease control rate」 same day : ( ↓ NASDAQ: TSBX | -48.85% ) [Deals] 08/15 「Abata Therapeutics receives equity investment from Bristol Myers Squibb to advance Treg cell therapy products for progressive multiple sclerosis and type 1 diabetes」 same day : ( ↑ NYSE: BMY | +1.24% ) 08/15 「Aarvik Therapeutics Inc and ArriVent Biopharma announce exclusive license agreement for novel ADC molecule 」 same day : ( ↓ NASDAQ: AVBP | -0.63% ) 08/15 「Pathos AI licenses PRT811 from Prelude Therapeutics, raises $40M to develop P-500 following promising phase 1 trial results in high-grade glioma and uveal melanoma」 same day : ( ↑ NASDAQ: PRLD | +8.62% ) 08/15 「Nanoform Finland Plc enters pre-clinical development agreement with Plasma-derived Therapies Business Unit of Takeda Pharmaceuticals to develop nano-formulations of biologics for rare conditions」 same day : ( ↑ NYSE: TAK | +0.91% ) [Regulatory] 08/14 「Gilead Sciences' Livdelzi receives FDA accelerated approval for primary biliary cholangitis in adults with inadequate response to or intolerance of UDCA based on phase 3 RESPONSE study data」 same day : ( ↑ NASDAQ: GILD | +0.22% ) 08/14 「FDA approves Niktimvo for treatment of chronic graft-versus-host disease in patients after failure of at least two prior therapies」 same day : ( ↑ NASDAQ: INCY | +1.05% ) View the full newsletter contents for free via the link in the comments.