February 02, 2026

Venglustat Shows Positive P3 Results in Type 3 Gaucher Disease (GD3)

Sanofi reported positive data from P3 LEAP2MONO study of Venglustat that met its primary endpoints and 3 of 4 key secondary endpoints in adults and pediatric patients (≥12 years) with neurological manifestations of GD3, showing significant improvement in neurological symptoms vs. enzyme replacement therapy, based on SARA & RBANS scores at week 52 (p=0.007). Venglustat also matched ERT in non-neurological outcomes. Data will be presented at the 22nd annual WORLDSymposium, and plans to file global regulatory approval for venglustat in GD3.

Safety Results:

P3 PERIDOT study for Fabry disease showed reductions in neuropathic and abdominal pain in both treatment arms but failed to achieve the primary endpoint, and further analyses are ongoing. Another P3 study, CARAT, is currently ongoing to assess venglustat’s effect on left ventricular mass index in patients with Fabry disease.

Source: Sanofi PR Feb 02, 2026

February 06, 2026

50% Enrolment Achieves in Immutep’s Global P3 study for 1L NSCLC

The registrational P3 (TACTI-004/ KEYNOTE-F91) study of eftilagimod alfa (efti) + Keytruda for 1L NSCLC has reached 50% enrolment (378 patients) globally. Ongoing recruitment over 140 clinical sites across 27 countries. This study includes a dual primary endpoint (PFS & OS). The target is to enrol ~756 pts. across 150 clinical sites globally. The futility analysis is expected in the Q1 CY2026, with full enrolment anticipated by the Q3 CY2026.

Source: Immutep PR Feb 06, 2026

February 07, 2026

Genentech Releases Data from P3 Studies of Fenebrutinib at ACTRIMS’26

Genentech released data of fenebrutinib from P3 FENtrepid study that met its primary endpoint of non-inferiority vs. Ocrevus (ocrelizumab) in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS). Fenebrutinib reduced the risk of 12-week composite confirmed disability progression by about 12 % vs. Ocrevus and showed notable benefits in upper limb function (as early as 24 weeks).

Safety Results:

Also shared P3 FENhance 2 study in RMS met its primary endpoint. Genentech is expected to release readout data from P3 FENhance 1 study in 1H 2026.

Source: Genentech PR Feb 07, 2026

February 09, 2026

Part C Result of an Ongoing P1/2 Study of Chugai’s NXT007 in Hemophilia A

Chugai released data from Part C of the P1/2 NXTAGE study, showing that its next-generation bispecific antibody NXT007 for hemophilia A was well tolerated and showed promising efficacy when patients were switched directly from emicizumab to NXT007 without a washout period. The results were presented at EAHAD’26. The study showed favorable tolerability, no SAEs leading to discontinuation, and achieved plasma concentrations with potential to provide factor VIII-equivalent activity in high-dose cohorts, with no treated bleeding events observed with only injection site reaction being the most common AE. Part C, a MAD part of the study in people aged 12 to <65 years with hemophilia A, both with and without factor VIII inhibitors, who had already been taking emicizumab continuously for at least 12 wks. Participants were split into 4 groups. After finishing their emicizumab treatment, they were switched directly to SC NXT007, without a washout period between the two treatments. And three P3 studies are planned to initiate in 2026 in collaboration with Roche.

Source: Chugai PR Feb 09, 2026

February 13, 2026

InnoCare Starts P2/3 Study of Soficitinib in Chronic Spontaneous Urticaria

InnoCare Pharma has completed patient enrollment in P2/3 study in China of its oral TYK2 inhibitor soficitinib (ICP-332) to treat chronic spontaneous urticaria (CSU). The same molecule is already in an advanced dermatology program: P3 enrollment is complete in moderate to severe atopic dermatitis and P2 in vitiligo, while additional studies in psoriasis and nodular prurigo are underway, indicating a broad autoimmune/dermatology positioning. CSU as a chronic, relapsing condition with recurrent hives and intense itching often lasting 2-5 years or longer, highlights China’s large patient burden, and cites estimates of about 50M CSU patients globally with a projected CSU drug market of around $3B by 2029 to underline commercial potential.

Source: InnoCare Pharma PR Feb 13, 2026

February 01, 2026

FDA Issues CRL for Joenja in Pediatric APDS

The U.S. FDA issued a Complete Response Letter (CRL) to Pharming Group for an sNDA of JOENJA (leniolisib) in children (4-11 years) with APDS based on P3 data showing 12-week reductions in lymphadenopathy, increased naïve B cells, mild-moderate AEs, and no serious drug-related events. Joenja has already received Priority Review on Oct 01, 2025, by the FDA. Pharming Group plans a Type A meeting with the U.S. FDA to address issues and resubmit, with the existing approval for patients aged 12 years and older unaffected. CRL was issued to see additional PK data to re-evaluate pediatric dose and substantiate the appropriate exposure in the lower-weight pediatric patients vs the approved indication in adults and adolescents.

Source: Pharming Group PR Feb 01, 2026

February 03, 2026

Saphnelo SC Formulation Struck by FDA’s CRL

The U.S. FDA has issued a CRL to AstraZeneca for its BLA to expand the use of Saphnelo (anifrolumab) SC formulation in adults with systemic lupus erythematosus, and a decision is expected in 1H 2026. The FDA review was based on data from P3 TULIP-SC study, which showed that SC Saphnelo met its primary endpoint with a safety profile consistent with the existing IV formulation. The data were published in Arthritis & Rheumatology in Jan 2026. The IV form of Saphnelo remains available, and the SC version was already approved in the EU in Dec 2025.

Source: AstraZeneca PR Feb 03, 2026

February 04, 2026

FDA Clears IND Application for AFTX-201

The U.S. FDA has cleared an IND application for Affinia Therapeutics’ AFTX-201 (once only IV) to be assessed in P1/2 UPBEAT study to treat BAG3-related dilated cardiomyopathy (DCM), assessing safety, tolerability, PD & preliminary efficacy. The study is expected to begin in 1H 2026. In preclinical models, AFTX-201 boosted BAG3 protein levels in the heart and fully restored cardiac function.

Source: Business Wire PR Feb 04, 2026

February 05, 2026

IND submission for P2a to US FDA for CRC

TransCode Therapeutics and Quantum Leap Healthcare have submitted an IND amendment for P2a dose-expansion study of TTX-MC138 in ctDNA +ve 1L+ colorectal cancer (N=45) patients. The study, to be conducted by Quantum Leap through its PRE-I-SPY program, represents the program’s first expansion into colorectal cancer and is expected to initiate in 1H 2026 at MD Anderson.

Source: TransCode PR Feb 05, 2026

February 10, 2026

US FDA Accepts NDA Application and Issues Priority Review to Takeda’s Oveporexton (TAK-861)

Takeda received Priority Review and acceptance of NDA from the U.S. FDA for oveporexton (TAK-861) to treat Narcolepsy Type 1 (NT1), and set the PDUFA date in 3Q 2026. The application is based on results from P3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies, which showed significant improvements in key NT1 symptoms with a generally consistent safety profile. If approved, Oveporexton could become the first orexin agonist therapy for NT1. The NDA filing will not have a major effect on full year consolidated forecast for the FY ending Mar 31, 2026. Oveporexton was granted BTD for the treatment of EDS in NT1 by the FDA and the CDE of China’s NMPA, and also received Sakigake designation from Japan’s MHLW.

Source: Takeda PR Feb 10, 2026

February 11, 2026

Novocure Receives Approval for Optune Pax from the FDA

Optune Pax, a portable device that delivers TTFields, got approval from the U.S. FDA for use with gemcitabine and nab-paclitaxel in adults with locally advanced pancreatic cancer, marking the first new treatment for this population in decades. The approval is based on results from the P3 PANOVA-3 study, which showed a statistically significant improvement in OS when Optune Pax was added to chemotherapy, and the data were published in the Journal of Clinical Oncology.

Efficacy Results:

Safety Results: No new safety signals were observed. Prior safety- 76.3% experiences skin related AEs, 7.7% with Grade>3.

Source: Business Wire Feb 11, 2026

February 15, 2026

FDA Clears CStone’s Trispecific Antibody CS2009 for P2 study

U.S. FDA has approved the IND application of CS2009, a trispecific antibody targeting PD‑1, VEGF, and CTLA‑4 to initiate P2 study for advanced solid tumors, advancing its global development. The ongoing global P2 study, already enrolling in Australia and China, includes 15 cohorts testing the drug alone and in combinations across 9 solid tumor types, such as NSCLC, CRC, TNBC, ES‑SCLC, and platinum‑resistant ovarian cancer. P1 study data already presented at ESMO 2025 showed a manageable safety profile and early signs of antitumor activity, with more detailed data from P1 and P2 expected at upcoming ASCO and ESMO meetings later this year.

Source: PR Newswire PR Feb 15, 2026

February 08, 2026

Innovent & Eli Lilly Sign Strategic Collaboration for Advance Next-Generation Oncology and Immunology Medicines

Innovent Biologics and Eli Lilly have entered their 7th strategic collaboration to strengthen the novel medicines in Oncology and immunology medicines globally. Under the agreement, Innovent will receive up to ~$8.5B (incl. $350M upfront + milestones) + tiered royalties on net sales of products (ex. Greater China). Innovent will lead the discovery, development, manufacturing, and commercialization of the programs in China, while Eli Lilly will be responsible for development and commercialization in all markets (Ex China).

Source: Innovent PR Feb 08, 2026

February 12, 2026

Elora Imaging System Gets AUD 27M Boost for Global Expansion

OncoRes Medical has secured AUD 27M (~US $19.21) in a private funding round to advance its Elora intraoperative imaging system for breast-conserving surgery. The fresh capital will support upcoming breast cancer clinical trials in Australia, progression toward key U.S. regulatory milestones following its BTDD from the FDA in 2020, and manufacturing scale-up for a pivotal U.S. study. The funding round was led by Brandon Capital Partners’ BB6 Fund, with participation from Morgans, Radar Ventures, several Australian and international family offices, and The Table Club. Also, plans to explore additional oncology indications, such as prostate cancer into U.S. market.

Source: OncoRes PR Feb 12, 2026

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