Key Outcomes:
- TREMFYA met primary endpoint in P3 FUZION study for perianal fistulizing Crohn’s disease – first RCT to show an approved IBD therapy works in this population
- Tovorafenib (OJEMDA) P3 FIREFLY-2 completed enrollment in frontline pLGG; preliminary results expected 2027
- Ligufalimab triplet showed improved survival in P2 AML study with comparable safety to standard of care
- VEPPANU (vepdegestrant) approved for ESR1-mutated ER+/HER2- 2L+ metastatic breast cancer – first-in-class PROTAC therapy
- NEREUS (tradipitant) launched for motion sickness – oral NK-1 receptor antagonist, available at $85/dose (discounted) vs. $255 list price
- IBI363 (PD-1/IL-2 bispecific) received third Chinese NMPA Breakthrough Therapy Designation, this time in MSS/pMMR mCRC
- Zoci (DLL3-targeting ADC) received second FDA Fast Track Designation, now for extrapulmonary neuroendocrine carcinomas
- Gazyva filed in Japan for childhood-onset idiopathic nephrotic syndrome after P3 INShore study showed superior sustained remission vs. standard therapy
- GSK licensed Halozyme’s ENHANZE SC delivery technology for oncology/ADC development
- Boehringer Ingelheim acquired global rights to Immunitas’s preclinical antibody program for up to $479.6M
- Hengrui – BMS: $15.2B collaboration across 13 programs in oncology, hematology, and immunology; $600M upfront
- Fosun Pharma – AriBio: $60M option for Alzheimer’s candidate AR1001 (PDE5 inhibitor) in P3 trials
- Kanvas Biosciences: $48M Series A for microbiome-based immuno-oncology
- Cerevance: $20M Series C to advance P3 Parkinson’s study (topline data expected late Q3 2026)
- Isomorphic Labs: $2.1B Series B to scale AI drug discovery platform
- Eli Lilly added $4.5B to Indiana manufacturing, bringing total commitment since 2020 to $21B+, focused on GLP-1 therapies and genetic medicines
May 05, 2026
TREMFYA Demonstrates Significant Fistula Remission in P3 Crohn’s Disease Study
J&J reported results from the P3 FUZION study evaluating TREMFYA (guselkumab) in adults with active perianal fistulizing Crohn’s disease. At wk 24, TREMFYA achieved significantly greater combined fistula remission rates vs. placebo, meeting a stringent endpoint that included complete closure of draining fistulas and no detectable fluid collection on MRI. The study represents the first RCT to demonstrate the efficacy of an approved IBD therapy in this difficult-to-treat patient population. The late-breaking findings were presented as part of 32 company-sponsored abstracts at DDW’26.
Efficacy Result – combined fistula remission at wk 24:
Source: J&J PR May 05, 2026
May 08, 2026
Day One Biopharmaceuticals Completes Enrolment in P3 FIREFLY-2 study of Tovorafenib in Frontline pLGG
Day One Biopharmaceuticals completed the enrolment in the P3 FIREFLY-2 study, which is assessing the efficacy, safety, and tolerability of Tovorafenib vs SOC CTx as a 1L treatment for patients (age: 0.5 to 25 years) with pediatric low-grade glioma (pLGG). The global study is being conducted in partnership with the European Society for Paediatric Oncology Brain Tumor Group LOGGIC Consortium across approximately 140 sites worldwide. Tovorafenib, marketed as OJEMDA, is already approved for patients aged 6 months and older with R/R pLGG harboring BRAF alterations. The study’s primary endpoint is ORR, including DOR, based on RAPNO-LGG criteria. Key secondary endpoints include PFS, EFS, time to next treatment (TTNT), OS, and PROs. Preliminary results are expected in 2027.
Source: PR Newswire PR May 08, 2026
May 15, 2026
Akeso Reports Promising Survival Benefit with Ligufalimab-Based Triplet in P2 AML Study at EHA 2026
Akeso reported updated data from the randomized P2 AK117-206 study of ligufalimab (AK117) + azacitidine and venetoclax in treatment-naïve AML patients ineligible for intensive chemotherapy, to be presented at the EHA Congress 2026. Data from the abstract showed that the ligufalimab-based triplet regimen demonstrated encouraging efficacy with notable improvements in survival outcomes, while maintaining a manageable safety profile, highlighting its potential as a better-tolerated treatment option for this high-risk patient population.
Efficacy Results:
Safety Profile: Safety profiles were comparable between treatment arms, with TEAEs consistent with expected AML and AZA+VEN toxicities. Anemia rates were similar, occurring in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Additional Information: Ligufalimab has also received FDA ODD for AML and is being further developed across hematologic malignancies and solid tumors.
Source: PR Newswire May 15, 2026
May 01, 2026
Arvinas and Pfizer Receive FDA Approval for VEPPANU in ESR1-mut Breast Cancer
Arvinas and Pfizer received FDA approval for VEPPANU (vepdegestrant) for the treatment of adults with ESR1-mutated, ER-positive/HER2-negative 2L+ advanced or metastatic breast cancer. VEPPANU is FIC PROTAC (proteolysis targeting chimera) therapy. The approval was supported by P3 VERITAC-2 study data, in which vepdegestrant demonstrated significantly improved PFS vs. fulvestrant in patients with ESR1 mutations. VEPPANU is an oral estrogen receptor a heterobifunctional protein degrader designed to target resistance-driving ESR1 mutations, which are common in advanced breast cancer following endocrine therapy and CDK4/6 inhibitor treatment.
Source: Arvinas PR May 01, 2026
May 04, 2026
NEREUS Launch Marks New Era in Motion Sickness Treatment
Vanda launched NEREUS (tradipitant), which is a novel prescription treatment for motion sickness. Approved by the FDA in Dec 2025 for preventing motion-induced vomiting in adults, NEREUS is an oral NK-1 receptor antagonist that blocks substance P-signalling in the brain’s vomiting pathway, taken an hour before travel. Approval was supported by positive P3 Motion Syros and Motion Serifos study results showing significantly reduced vomiting rates vs placebo during sea travel. The therapy is now available through retail pharmacies and DTC platform nereus.us, where patients can access it at a discounted cash-pay price of $85/dose vs the $255 list price. Vanda is also evaluating tradipitant for gastroparesis and GLP-1-associated nausea and vomiting.
Source: PR Newswire PR May 04, 2026
May 10, 2026
IBI363 Gains Third NMPA BTD in CRC
Innovent Biologics reported that its investigational therapy IBI363, a FIC PD-1/IL-2α-bias bispecific fusion protein, has received its third BTD from NMPA (China) for the treatment of advanced MSS/pMMR mCRC who have failed 3L+ therapy in combination with bevacizumab. IBI363 is designed to simultaneously block the PD-1/PD-L1 pathway and selectively activate IL-2 signalling in tumor-specific T cells, aiming to improve antitumor activity while reducing toxicity. IBI363 is being evaluated in a pivotal P2 study in melanoma, a global P3 study in squamous NSCLC, and multiple P1/2 studies across NSCLC, CRC, and other solid tumors. In Oct 2025, Innovent partnered with Takeda to co-develop IBI363 (TAK-928) globally, with joint commercialization in the U.S., while Takeda holds exclusive rights outside the U.S. and greater China.
Source: PR Newswire PR May 10, 2026
May 11, 2026
Zai Lab Receives FDA FTD for DLL3-Targeting ADC Zoci in epNEC
Zai Lab received U.S. FDA Fast Track Designation (FTD) for zocilurtatug pelitecan (zoci; formerly ZL-1310), a potential FIC DLL3-targeting ADC, for patients with extrapulmonary neuroendocrine carcinomas (epNECs) whose disease progressed after 1L therapy. The designation was supported by encouraging early P1b/2 study data presented at AACR 2026, where zoci demonstrated an ORR of 38.2% in heavily pretreated epNEC and other solid tumor patients, along with a manageable safety profile. Neutrophil count decrease was the only Gr≥3 TRAE reported in more than one patient. This marks the second FDA FTD for zoci, following its earlier designation in May 2025 for extensive-stage small cell lung cancer (ES-SCLC).
Source: Zai Lab PR May 11, 2026
May 14, 2026
Chugai Files Gazyva in Japan for Childhood-Onset Idiopathic Nephrotic Syndrome
Chugai Pharmaceutical and Nippon Shinyaku reported that Chugai has filed a regulatory application with MHLW (Japan) for an additional indication of the anti-CD20 monoclonal antibody Gazyva (obinutuzumab) to treat idiopathic nephrotic syndrome (INS). The filing is supported by results from the global P3 INShore study in patients aged 2-25 years with childhood-onset INS, including frequently relapsing or steroid-dependent nephrotic syndrome. In the study, Gazyva combined with oral steroids showed significantly better sustained complete remission rates through 52 wks vs. conventional therapy using mycophenolate mofetil + oral steroids, while also enabling steroid reduction without introducing new safety concerns.
Source: Chugai PR May 14, 2026
May 07, 2026
GSK Licenses Halozyme’s ENHANZE Technology for SC Oncology Drug Development
Halozyme Therapeutics entered into a global licensing agreement with GSK for Halozyme’s ENHANZE drug delivery technology to develop and commercialize the SC administration for multiple oncology targets, including ADCs, as well as an option for additional future drug targets. GSK will provide an undisclosed upfront payment to Halozyme, along with potential milestone-based payments. Halozyme will also receive royalties tied to the net sales of products utilizing the ENHANZE technology.
Source: PR Newswire PR May 07, 2026
May 12, 2026
Boehringer Ingelheim Acquires Global Rights to Immunitas’s Preclinical Antibody Program
Immunitas Therapeutics and Boehringer Ingelheim entered into a global licensing agreement for a preclinical antibody program targeting chronic inflammatory and autoimmune diseases. The FIC antibody program is designed to selectively target pathogenic immune cells that drive chronic inflammation, with the potential to provide deeper and longer-lasting disease control than current therapies. Boehringer Ingelheim will gain global rights to develop and commercialize the program, further strengthening its immunology pipeline. Immunitas is eligible to receive undisclosed upfront, development, regulatory, and commercial milestone payments totalling up to $479.6M (€407.5M), along with tiered royalties on future sales.
Source: Boehringer Ingelheim PR May 12, 2026
May 12, 2026
Hengrui Pharma and BMS Enter $15.2B Strategic Collaboration Across Oncology, Hematology, and Immunology
Hengrui Pharma and BMS have entered into global strategic collaboration and licensing agreements to advance a portfolio of 13 early-stage programs across oncology, hematology, and immunology, aiming to accelerate the development of innovative medicines worldwide. The collaboration includes 4 oncology and hematology assets from Hengrui, 4 immunology assets from BMS, and 5 jointly discovered programs leveraging Hengrui’s discovery platforms and technologies. BMS will obtain exclusive worldwide rights to Hengrui-originated assets outside mainland China, Hong Kong, and Macau, while Hengrui will gain exclusive rights to BMS-originated assets within those territories. Hengrui will lead early clinical development activities to accelerate proof-of-concept studies, while also retaining options to co-develop and potentially commercialize select assets globally with BMS. Financially, BMS will pay Hengrui up to $950M, including a $600M upfront payment and a $175M first anniversary payment, and a second contingent anniversary payment of $175M in 2028, with the total deal value potentially reaching approximately $15.2B through milestone payments and royalties. The total potential value of the agreement could reach approximately $15.2B, including options tied to the joint discovery programs as well as development, regulatory, and commercial milestone payments. In addition, Hengrui will be eligible to receive tiered royalties on net sales of products commercialized outside its designated territory. The transaction is expected to close in Q3 2026, subject to regulatory approvals and customary closing conditions.
Source: PR Newswire PR May 12, 2026
May 13, 2026
Fosun Pharma Signs Global Option Agreement with AriBio for Alzheimer’s Therapy AR1001
Fosun Pharma and AriBio have signed an exclusive global option agreement for AR1001 (oral) therapy for Alzheimer’s disease, currently being evaluated in the global P3 POLARIS-AD study. Fosun Pharma will pay AriBio a $60M option fee for the rights to develop, manufacture, register, and commercialize AR1001 globally, including in the US, Europe, and Japan, with the potential to pay up to an additional $180M in upfront and regulatory milestone payments if the option is exercised. Sales milestone payments will also be triggered upon achieving certain commercial thresholds. AR1001 is a once-daily phosphodiesterase-5 (PDE5) inhibitor with disease-modifying potential that has enrolled more than 1,500 patients globally in P3 trials, with topline data expected in 2026. The agreement expands the companies’ previous regional collaboration and further strengthens Fosun Pharma’s global neuroscience and Alzheimer’s disease strategy.
Source: PR Newswire PR May 13, 2026
May 06, 2026
Kanvas Biosciences Raises $48M Series A to Advance Microbiome Cancer Therapies
Kanvas Biosciences has raised $48M in a Series A financing round co-led by DCVC and Lions Capital LLC, with participation from the Gates Foundation, ATHOS KG, Germin8, Ki Tua Fund, and Pangaea Ventures, bringing the company’s total funding to $78M. The investment will support the advancement of its microbiome-based therapeutics platform and clinical development of KAN-001, an immuno-oncology candidate designed to improve response rates to immune checkpoint inhibitors in patients with solid organ cancers. The company plans to use the funding to expand its pipeline of microbiome-based therapeutics targeting cancer and inflammatory diseases, while further developing its proprietary technologies that map microbial interactions within the tumor microenvironment to identify novel therapeutic targets. The funding will also be used to expand the company’s live biotherapeutic product platform and accelerate the development of additional microbiome therapeutics targeting cancer and inflammatory diseases.
Source: Business Wire PR May 06, 2026
May 12, 2026
Cerevance Secures Oversubscribed $20M Series C Financing to Advance Neuroscience Pipeline
Cerevance has closed an oversubscribed $20M Series C financing round to extend its cash runway into mid-2027 and is backed by existing investors, including Google Ventures, SV Health Investors’ Dementia Discovery Fund, Double Point Ventures, and UPMC, supporting the continued advancement of Cerevance’s neuroscience pipeline. Cerevance has completed patient enrolment in its pivotal P3 ARISE study evaluating solengepras for Parkinson’s disease. The global study enrolled 341 patients across the US, Europe, the UK, and Australia to assess solengepras, a potential FIC oral non-dopaminergic therapy targeting the GPR6 receptor, as an adjunctive treatment for patients experiencing motor fluctuations and daily OFF periods. Topline data from the study are expected in late Q3 2026.
Source: GlobalNewswire PR May 12, 2026
May 12, 2026
Isomorphic Labs Raises $2.1B Series B to Scale AI-Driven Drug Discovery
Isomorphic Labs has raised $2.1B in a Series B funding round led by Thrive Capital, with participation from existing investors Alphabet and GV, alongside new investors including MGX, Temasek, CapitalG, and the UK Sovereign AI Fund, to expand its AI-powered drug discovery platform and accelerate the development of new medicines. The funding will support the scaling of its proprietary AI drug design engine, IsoDDE, the advancement of its therapeutic pipeline toward clinical trials, and the expansion of its global workforce across AI, engineering, and clinical development. The investment further highlights growing confidence in AI-driven healthcare innovation, particularly following the success of AlphaFold and Isomorphic Labs’ partnerships with Eli Lilly and Company and Novartis.
Source: Isomorphic Labs PR May 12, 2026
May 06, 2026
Eli Lilly Expands Indiana Manufacturing Investment by $4.5B
Eli Lilly disclosed an additional $4.5B investment across two of its manufacturing sites in Lebanon, Indiana, bringing its total Indiana capital commitments since 2020 to more than $21B. The expansion will enhance production capabilities at Lilly Lebanon API and Lilly Lebanon Advanced Therapies, the company’s first dedicated genetic medicine manufacturing facility. The investment is aimed at supporting Lilly’s growing pipeline and anticipated demand for key therapies, including obesity and diabetes medicines such as Zepbound, Mounjaro, and the recently approved oral weight-loss drug Foundayo, as well as investigational candidate retatrutide. Lilly expects the Lebanon API facility to be operational by or before 2027.
Source: Eli Lilly PR May 06, 2026
Thank you for your attention! For any queries, contact us at bd@octavusconsulting.com
Babli Singh is a Senior Analyst with strong analytical skills and a deep understanding of the biopharmaceutical and healthcare industries. She specializes in monitoring emerging trends and distilling complex information into concise, insightful summaries that deliver clear value and actionable intelligence for a global professional audience.
