PARIS (dpa-AFX) - The biotech industry witnessed several key clinical trial data readouts across multiple therapeutic areas, including lung cancer, cardiovascular risk, Alzheimer's, and hepatitis.
- ScinoPharm secures FDA nod for Glatiramer Acetate Injection in the treatment of adult patients with multiple sclerosis
- Genelux announced durable responses in systemic Olvi-Vec lung cancer trials
- Neumora demonstrated positive data for NMRA-511 in Phase 1 Alzheimer's disease agitation study.
- GSK unveiled encouraging results in chronic Hepatitis B trial of Bepirovirsen
- HUTCHMED's Sovleplenib met primary endpoint in Warm Autoimmune Hemolytic Anaemia
- GLUE unveiled promising Phase 1 data for MRT-8102 in cardiovascular risk participants
Let's unpack the specifics and significant milestones in biotech space this week.
FDA Approvals
ScinoPharm Wins First FDA Nod with Glatiramer Acetate Injection
ScinoPharm Taiwan (TWSE:1789) received FDA approval for its Glatiramer Acetate Injection for the treatment of adult patients with multiple sclerosis. Glatiramer Acetate, originally marketed as Copaxone by Teva, remains a key product globally despite revenue erosion from generics. The approval marks the company's first finished drug approval, with regulatory submission planned in Europe and Asia, positioning the product for broader commercialization.
TWSE:1789 closed Thursday's (Jan 08, 2025) trading at TW$23.40, up 3.08%.
Clinical Trials - Breakthroughs
Zenas' Obexelimab Met Primary Endpoint In Phase 3 INDIGO Trial
Zenas BioPharma (ZBIO) reported positive results from the Phase 3 INDIGO trial of Obexelimab in immunoglobulin G4-related disease. Obexelimab met the primary endpoint, demonstrating 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period.
The company expects to present the full data from the INDIGO trial at a future medical meeting.
ZBIO closed Thursday's trading at $16.41, down 0.61%.
Genelux Reported Durable Responses In Systemic Olvi-Vec Lung Cancer Trials
Genelux Corporation (GNLX) announced promising interim data showing partial responses of up to 85% tumor shrinkage in platinum-relapsed small cell lung cancer patients treated with systemically administered Olvi-Vec immunochemotherapy.
The ongoing Phase 1b/2 SCLC trial, conducted in China, reported a 33% overall response rate (3/9 patients), including two partial responses in the highest dose cohort with tumor reductions of approximately 55% and approximately 85%.
Disease control was achieved in 67% of patients, with exploratory durability signals showing progression-free survival extending beyond prior treatment lines.In parallel, a U.S.-based Phase 2 VIRO-25 trial in NSCLC demonstrated a 60% disease control rate in early cohorts, with Olvi-Vec generally well tolerated across both studies.
GNLXclosed Thursday's trading at $2.72, down 19.76%
NMRA Announced Clinically Meaningful Results In Phase 1 Alzheimer's Disease Agitation Study
Neumora Therapeutics Inc. (NMRA) announced positive Phase 1b results for its lead candidate NMRA-511 in Alzheimer's disease agitation, along with a pipeline strategy that promises multiple clinical readouts across its neuroscience programs.
NMRA-511 demonstrated a 15.7-point reduction on mean CMAI total score, representing a clinically meaningful effect. Patients treated with the drug showed a favourable tolerability profile, with no reports of sedation or somnolence.
Building on this success, Neumora plans to evaluate higher doses of NMRA-511 via initiation of a multiple ascending dose expansion cohort in 2026 with a Phase 2/3 program later year.
NMRAclosed Thursday's trading at $2.30, up 1.75%
GSK Reported Positive Phase III Results For Bepirovirsen In Chronic Hepatitis B
GSK plc (GSK, GSK.L) reported positive outcomes from its two pivotal phase III trials, B-Well 1 and B-Well 2, which evaluated bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB) in more than 1,800 patients across 29 countries.
The trials successfully met their primary endpoint, with bepirovirsen demonstrating a statistically significant and clinically meaningful functional cure rate. The studies also confirmed an acceptable safety and tolerability profile consistent with earlier findings.
GSK closed Thursday's trading at $50.22, down 0.79%.
HUTCHMED's ESLIM-02 Trial of Sovleplenib Met Key Goal in Warm Autoimmune Hemolytic Anemia
HUTCHMED (China) Ltd. (HCM) announced that Phase III registration part of its ESLIM-02 clinical trial of sovleplenib met the primary endpoint in adult patients with warm antibody autoimmune hemolytic anaemia in China.
The primary endpoint of the study was the durable haemoglobin response rate within weeks 5 to 24 of treatment. Full results of the ESLIM-02 study will be submitted for presentation at an upcoming scientific conference.
HCMclosed Thursday's trading at $14.77, up 0.75%
Acrivon's ACR-368 Shows Promising Response Rate in Endometrial Cancer in phase 2b Study
Acrivon Therapeutics, Inc. (ACVR) announced encouraging Phase 2b data for its lead candidate ACR-368, showing a 52% confirmed overall response rate (cORR) in patients with serous endometrial cancer who have received two or fewer prior treatments.
In biomarker-positive patients, the response rate climbed to 67%, underscoring the potential of the company's precision medicine approach.
ACVR closed Thursday's trading at $1.93, down 34.58%.
Zymeworks' Ziihera Demonstrates Positive Results In Gastroesophageal Adenocarcinoma Study
Zymeworks Inc. (ZYME), announced positive efficacy and safety results from its Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) in HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
The positive results of HERIZON-GEA-01 included a greater than four-month improvement in median progression-free survival (PFS) prolongation compared to the control arm for Ziihera plus tislelizumab and chemotherapy and Ziihera plus chemotherapy, a greater than seven-month improvement in median overall survival or OS and a 28% reduction in the risk of death versus trastuzumab plus chemotherapy.
The data was presented at the oral presentation at the 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco on Jan 8, 2026.
ZYME closed Thursday's trading at $23.20, down 7.04%
Monte Rosa Therapeutics Unveiled Postive Phase 1 Data For MRT-8102 In Cardiovascular Risk Participants
Monte Rosa Therapeutics, Inc. (GLUE) announced positive interim results from its ongoing Phase 1 study of MRT-8102, a NEK7-directed molecular glue degrader in development for NLRP3/IL-1/IL-6 driven inflammatory diseases.
In subjects with elevated cardiovascular disease (CVD) risk, MRT-8120 demonstrated rapid and durable reductions in systemic inflammation. After four weeks of treatment, Part 3 C-reactive protein (CRP) levels were reduced by 85%, and 94% of study participants achieved CRP values below 2 mg/L, a threshold associated with reduced cardiovascular risk.
GLUE closed Thursday's trading at $25.31, up 8.72%.
Protara Dosed First Patient In Phase 3 THRIVE-3 Trial Of IV Choline Chloride
Protara Therapeutics, Inc. (TARA) has dosed the first patient in its pivotal Phase 3 registrational THRIVE-3 trial evaluating intravenous (IV) Choline Chloride in patients dependent on long-term parenteral support.
The study aims to establish IV choline as the first FDA-approved therapy to address choline deficiency in this underserved population.
The primary endpoint of the THRIVE-3 trial will measure the change in plasma choline concentration from baseline compared to placebo. Patients completing each phase will be eligible to enter an open-label extension to evaluate long-term outcomes.
TARA closed Thursday's trading at $5.61, down 1.41%.
Abivax Outlines Key Milestones Related to Obefazimod
Abivax SA (ABVX) reported a positive outlook for its lead candidate, Obefazimod, in ulcerative colitis and Crohn's disease with key highlights from ABTECT Phase 3 maintenance trial.
The ABTECT maintenance trial is a phase 3 study evaluating the long-term efficacy and safety of Obefazimod as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.
Data Safety Monitoring Board (DSMB) for its ABTECT Phase 3 maintenance trial found no new safety signals, with more than 80% of participants completing the 44-week double-blind maintenance period as of December 2025.
ABVX closed Thursday's trading at $115.49, down 8.69%.
Enliven Reports Promising Phase 1b Data In Chronic Myeloid Leukaemia
Enliven Therapeutics Inc. (ELVN) unveiled positive initial data from the ongoing Phase 1b ENABLE trial evaluating company's investigational drug ELVN-001 in patients with chronic myeloid leukemia that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors.
The company expects to present additional Phase 1 ENABLE trial data in mid-year and to initiate ENABLE-2, the Phase 3 trial of ELVN-001, in the second half of 2026.
ELVN closed Thursday's trading at $23.25, up 50.29%.
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