January 25, 2026

Argo Starts P2b Dosing for siRNA BW-20829

Argo Biopharma dosed its first patient in the Novartis-sponsored P2b study of BW-20829 (DII235), an siRNA from its RADS™ platform targeting elevated Lp(a) in adults with Atherosclerotic Cardiovascular Disease (ASCVD). Under this exclusive license and collaboration with Novartis, Argo Biopharma will receive milestone payments upon BW-20829 advancing to P2b, supporting R&D across its hepatic and extra-hepatic siRNA portfolio. BW-20829 is the sixth Argo asset to reach mid-stage global clinical development.

Source: PR Newswire Jan 25, 2026

January 28, 2026

P2 Readout for Apecotrep in Primary FSGS

Boehringer Ingelheim released data from P2 study of Apecotrep (BI 764198) in patients with primary focal segmental glomerulosclerosis (FSGS). The drug achieved a 40% reduction in proteinuria in 20 mg dose group vs. placebo. Data has been published in The Lancet and presented at Kidney Week 2025. P3 study is currently recruiting adults and adolescents with primary FSGS, and another P2 study in other proteinuric kidney diseases is planned to initiate in the 1Q 2026. Apecotrep has also received BTD (China’s NMPA) and ODD (EMA, Japan’s MHLW) for primary FSGS.

Source: Boehringer Ingelheim PR Jan 28, 2026

January 16, 2026

Eylea 8 mg Approves in the EU Market

Bayer received approval for Eylea 8 mg (aflibercept 8 mg) from the EC for the treatment of visual impairment due to macular edema following retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion, as a 3rd indication based on P3 QUASAR study, where Eylea 8 mg showed non-inferior visual acuity and fluid resolution vs. Eylea 2 mg, while requiring fewer injections (average 8.4 vs. 11.7 by week 64) and enabling extended intervals over 60% of patients reached 4+ mos between doses by week 64, with 40% at 5 mos. The treatment-maintained efficacy and safety were similar to those in prior trials after the initial monthly doses, allowing for a reduction in treatment frequency. Eylea 8 mg, already authorized in over 60 markets for wet AMD and DME with up to 6-month intervals. Eylea 8 mg (Eylea HD in the U.S.) is co-developed by Bayer and Regeneron. Regeneron holds exclusive rights to Eylea 2 mg and Eylea HD in the U.S., while Bayer has exclusive marketing rights outside the U.S., sharing profits equally with Regeneron for both Eylea 2 mg and Eylea 8 mg.

Source: Bayer PR Jan 16, 2026

January 18, 2026

D3 Bio to Assess D3S‑003, D3S‑001 + D3S‑002 as FDA Approved IND

D3 Bio received US FDA clearance for two IND applications, one for D3S‑003 to initiate P1 FIH trial in patients with advanced solid tumors with KRAS G12D mutations, and the second one for D3S‑001 (elisrasib) in P2 with the expectation to initiate in 1H 2026 in combination with D3S‑002 in patients with KRAS G12C‑mutant NSCLC who have progressed on prior KRAS G12C‑targeted therapies, evaluating safety, pharmacokinetics, and efficacy.

Source: PR Newswire Jan 18, 2026

January 19, 2026

NouvNeu001 Receives RMAT Designation

iRegene Therapeutics received Regenerative Medicine Advanced Therapy (RMAT) designation for NouvNeu001 in Parkinson’s disease by the U.S. FDA. NouvNeu001 is the first allogeneic iPSC-derived cell therapy to receive both FDA Fast Track (Aug’25) and RMAT designations. These are based on clinical data, chemical induction platform, and the potential to alter Parkinson’s progression.

Source: PR Newswire Jan 19, 2026

January 20, 2026

Chinese NMPA Accepts NDA for Illuccix (Telix Pharma)

Telix Pharmaceuticals announces the NDA acceptance by NMPA (China) for Illuccix (TLX591-Px, or 68Ga-PSMA-11 kit) for prostate cancer imaging through partner Grand Pharma, based on the P3 study that already released positive top-line data on Dec 21, 2025. The study met its primary endpoint, achieving 94.8% positive predictive value (PPV) for detecting tumors in prostate cancer patients with biochemical recurrence using TLX591-Px2 PSMA-PET imaging that showed comparable results in Chinese patients to non-Chinese studies, including in low-PSA (prostate-specific antigen) patients and various metastatic sites. More than 67.2% of patients had their treatment plans altered due to TLX591-Px PSMA-PET imaging, indicating a significant influence on clinical decision-making among Chinese patients.

Source: Telix Pharmaceuticals PR Jan 20, 2026

January 23, 2026

U.S. FDA Grants IND approval to ISM8969

Insilico Medicine received IND approval from the U.S. FDA for ISM8969, an oral NLRP3 inhibitor, for the treatment of Parkinson’s disease. The P1 study will evaluate the safety and tolerability of ISM8969 in healthy volunteers and determine the most favorable dose levels. To speed up worldwide development of ISM8969, Insilico Medicine has partnered with Hygtia Therapeutics under a co-development agreement, granting both companies 50-50 rights to research, develop, manufacture, and commercialize ISM8969. Insilico will receive up to $66M upfront and milestone payments.

Source: PR Newswire Jan 23, 2026

January 26, 2026

Eisai Files EMA Variation for LEQEMBI Q4W IV Maintenance Dosing

Eisai submitted an EMA Marketing Authorisation Variation for LEQEMBI (lecanemab), proposing Q4W IV maintenance dosing (10 mg/kg) after initial 18-month Q2W infusions in early Alzheimer’s (MCI/mild dementia) ApoE ε4 non-carriers/heterozygotes with amyloid pathology, and should be discontinued at the moderate stage. Lecanemab is approved in 53 countries and under review in 7 others. The Q4W IV maintenance regimen is already cleared in the UK, China, the U.S.A., and additional markets. On Jan 25, 2026, the U.S. FDA granted Priority Review to Eisai’s sBLA for SC starting dose with Leqembi Iqlik, setting a PDUFA date of May 24, 2026.

Source: BioArctic AB PR Jan 26, 2026

January 29, 2026

Seysara Approves in China for Acne Vulgaris

Almirall has received approval from China’s NMPA for Seysara, an oral antibiotic for inflammatory lesions in non-nodular moderate-to-severe acne vulgaris in patients aged 9 years and above. The decision was supported by real-world evidence from the PROSES study along with additional clinical trials conducted in the U.S. and China. Under the partnership agreement, Almirall has granted Sinomune exclusive rights to commercialize and distribute Seysara in China, with a commercial launch planned for 2026.

Source: Business Wire PR Jan 29, 2026

January 18, 2026

AstraZeneca also Acquires China Rights to a GPC3 therapy from AbelZeta

AstraZeneca acquired AbelZeta Pharma’s 50% share of the development and commercialization rights for C-CAR031 (a GPC3-targeted therapy) in China, gaining sole global rights to develop, manufacture, and commercialize the product. AZ to pay up to $630M to AbelZeta, including an upfront payment plus milestones for development, regulatory, and sales for the GPC3 program in China. Based on a previous agreement, AZ already holds the rights to develop, manufacture, and commercialize C-CAR031 in the rest of the world. AbelZeta will receive further milestone payments and royalties related to development and sales in markets outside China.

Source: PR Newswire Jan 18, 2026

January 27, 2026

Boehringer Ingelheim Licenses Simcere’s SIM0709 for IBD

Boehringer Ingelheim has signed a licensing and collaboration deal with Simcere Pharmaceutical Group to develop SIM0709, a preclinical bispecific antibody targeting TL1A/IL23p19 for inflammatory bowel disease (IBD). Boehringer gains worldwide rights outside Greater China. Simcere will receive an upfront payment with development, regulatory, and sales milestones up to €1,058M (~$1,255M), along with royalties on net sales outside of Greater China.

Source: Boehringer Ingelheim PR Jan 27, 2026

January 30, 2026

AstraZeneca Collaborates with CSPC for Weight Management Portfolio

AstraZeneca is partnering with CSPC to develop multiple next‑generation obesity and T2D therapies, initially progressing 4 programmes by utilizing once‑monthly injectable GLP-1-based drugs from CSPC’s AI peptide and LiquidGel platforms. AstraZeneca gets rights outside China to lead asset SYH2082 progressing into P1 and three preclinical programmes. This deal further strengthens AstraZeneca’s growing obesity portfolio, adding to existing next‑generation assets such as elecoglipron, AZD6234, AZD9550 and multiple early‑stage candidates. CSPC keeps Greater China rights and will receive $1.2B upfront + up to $3.5B in milestones, along with royalties and other commercial payments, which is expected to close in the 2Q 2026.

Source: AstraZeneca PR Jan 30, 2026

January 22, 2026

PAQ Therapeutics closes its Series B extension with total funding of $77M

PAQ Therapeutics has closed a Series B extension, bringing its total Series B funding to $77M. The company has also dosed the first patient in its P1 study of PT0511, which targets KRAS-driven cancers. Funding will be used to continue its ongoing P1 study of PT0253, which targets the KRAS G12D mutation, and to further advance PT0511 in clinical development.

Source: PR Newswire Jan 22, 2026

January 21, 2026

U.S. Patent Protection for PrimeC Combination in Alzheimer’s Disease

NeuroSense Therapeutics has been granted U.S. Patent No. 12,527,768, entitled “Compositions Comprising an Anti-Inflammatory Drug and a Dicer Activator for Use in the Treatment of Neuronal Diseases” by the U.S. PTO, covering the use of its PrimeC drug combination in Alzheimer’s disease and providing intellectual property protection in this indication until 2043. PrimeC is an extended‑release, oral, FDC of ciprofloxacin + celecoxib, originally developed for ALS, and is designed to act on several disease‑relevant mechanisms, including neuronal degeneration, inflammation, iron accumulation, and disturbed RNA regulation. NeuroSense has completed the P2 RoAD study of PrimeC in Alzheimer’s disease, with top‑line data indicating favorable safety and tolerability, with detailed clinical and biomarker analysis expected in Q1 2026.

Source: NeuroSense Therapeutics PR Jan 21, 2026

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