Drug Development

Viking Launches Phase 2 Study of Oral VK2735 Maintenance Dosing

Image
Viking Launches Phase 2 Study of Oral VK2735 Maintenance Dosing

San Diego – October 06, 2026 -- Viking Therapeutics (NASDAQ: VKTX) has initiated Part 2 of a maintenance dosing study for VK2735, its dual GLP-1/GIP receptor agonist, testing oral tablet regimens alongside subcutaneous options to sustain weight loss after initial treatment.

Trial enrolls 195 obese adults to test five maintenance pathways

The randomized, double-blind, placebo-controlled study will enroll approximately 195 adults with obesity (BMI ≥30 kg/m2). All participants first receive 21 weeks of weekly subcutaneous VK2735 or placebo before transitioning to one of five maintenance arms: daily oral doses, weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. The study runs through Week 33, tracking safety, tolerability, pharmacokinetics, and body weight change from baseline and from Week 21.

Mozart Therapeutics Data Backs MTX-101 for Type 1 Diabetes

Image
Mozart Therapeutics Data Backs MTX-101 for Type 1 Diabetes

SEATTLE – October 05, 2026 -- Mozart Therapeutics presented three new data sets on its lead candidate MTX-101 at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), held September 28–October 2, 2026, in Milan, Italy, advancing the bispecific antibody toward a planned Phase 2a trial in Stage 3 type 1 diabetes with enrollment targeted for the first half of 2027.

Phase 1a/b data show MTX-101 is well tolerated and may affect C-peptide levels

The first presentation detailed safety, pharmacokinetic and pharmacodynamic results from a Phase 1a/b study in healthy adults and type 1 diabetes patients. Clinical data collected to date indicate MTX-101 has been relatively safe and well tolerated, with early signals suggesting a positive effect on C-peptide levels in patients with Stage 3 disease.

Moberg Pharma: MOB-015 Cures Nail Fungus Despite Terbinafine Resistance

Stockholm – October 05, 2026 -- Moberg Pharma AB (OMX: MOB) reported that its topical onychomycosis treatment MOB-015 achieved mycological cure in 74.3% of evaluable Phase 3 patients regardless of baseline antifungal susceptibility, according to new peer-reviewed data published in the Journal of Fungi.

Researchers screened 506 dermatophyte isolates for terbinafine resistance markers

The analyses draw on the company's completed North American Phase 3 trial of MOB-015, a once-daily treatment applied for 48 weeks. The work was conducted with Professor Mahmoud Ghannoum at Case Western Reserve University in Cleveland, Ohio, examining in vitro terbinafine susceptibility across the full isolate population.

AnnJi Advances AJ201 into Phase 3 for Rare Kennedy's Disease

Taipei – October 05, 2026 -- AnnJi Pharmaceutical Co., Ltd. (TPEx: 7754) is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial for AJ201, an oral small molecule targeting spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's disease, a rare inherited neuromuscular disorder with no FDA-approved treatment.

AJ201 becomes the only investigational SBMA therapy in Phase 3 development worldwide

AnnJi submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now move to activate U.S. trial sites. The global, multicenter, randomized, double-blind, placebo-controlled ROMA-KD study is designed to evaluate efficacy and safety in ambulatory patients with symptomatic SBMA, with approximately 200 patients expected to enroll worldwide and the United States serving as a key region.

XtalPi Advances AI-Designed Hair Loss Drug to IND-Enabling Studies

Image
XtalPi Advances AI-Designed Hair Loss Drug to IND-Enabling Studies

Cambridge/Shenzhen – October 02, 2026 -- XtalPi (HKEX: 2228) has moved its proprietary hair loss drug program into IND-enabling studies, with pharmacology, safety, and chemistry, manufacturing and controls (CMC) work underway to support a future Investigational New Drug application.

Candidate matches minoxidil's efficacy at 1/100 the dose

In a DHT-induced mouse model of androgenetic alopecia, XtalPi's lead candidate achieved a hair-growth score comparable to 5% topical minoxidil while using only one-hundredth of the comparator's concentration. The company also reported preclinical signals of reduced local follicular inflammation, prompting further evaluation of low-concentration topical delivery.

Saros Therapeutics Lands Second $2M NCI Award for Cancer Immunotherapy

North Chicago, Ill. – October 02, 2026 -- Saros Therapeutics has received its second Phase II award from the National Cancer Institute, worth approximately $2 million, to advance a nanoparticle-based cancer immunotherapy toward human clinical testing.

NCI funds second two-year award for nanoparticle immunotherapy

The two-year grant will support studies needed to move Saros' experimental therapy toward an Investigational New Drug (IND) application, the company said. Saros operates within Rosalind Franklin University of Medicine and Science's (RFU) Helix 51 biomedical incubator in North Chicago, Illinois, which it joined earlier this year.

Ascletis' ASC36_35FDC Shows Stronger Weight Loss Than Rival Combos in Preclinical Data

Image
Ascletis' ASC36_35FDC Shows Stronger Weight Loss Than Rival Combos in Preclinical Data

Hong Kong – – October 02, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) presented preclinical data showing its ASC36_35FDC injectable combination drove a 24.8% body-weight reduction in a diet-induced obesity rat model on Day 14, outperforming two competitor co-formulations tested under identical dosing conditions.

The data were unveiled in a short oral discussion at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting, held September 28–October 2, 2026, in Milan, Italy.

Novartis Pays Abogen $575M Upfront for mRNA T-Cell Engager Rights

Suzhou – October 02, 2026 -- Novartis has agreed to pay Abogen Biosciences an upfront fee of USD 575 million to secure worldwide rights to ABO2203, an mRNA-encoded CD19xCD3 T-cell engager for autoimmune diseases, with total deal value reaching up to approximately USD 7.2 billion if all milestones and options are exercised.

Novartis secures exclusive worldwide license to Abogen's lead autoimmune asset ABO2203

The licensing and option agreement grants Novartis an exclusive global license to ABO2203, which Abogen describes as the first mRNA-encoded T-cell engager to enter clinical evaluation for autoimmune diseases. The molecule uses mRNA to direct endogenous production of T-cell engagers in vivo, targeting B-cell depletion through a mechanism the companies say differs from traditional recombinant T-cell engagers.

Hansoh's Olatorepatide Shows 19.3% Weight Loss at Week 48 in Phase III Trial

Milan – October 02, 2026 -- Hansoh Pharma's dual-biased GLP-1/GIP receptor agonist Olatorepatide (HS-20094) achieved a mean weight loss of 19.3% at Week 48 in the 15 mg dose group of a Phase III Chinese trial, with no plateau observed in the weight-loss curve.

The data, presented as a Late-breaking Abstract oral presentation at the European Association for the Study of Diabetes (EASD) Annual Meeting running September 28 to October 2, 2026 in Milan, come from the LIGHTEN study, a multicenter, randomized, double-blind, placebo-controlled trial enrolling 604 Chinese adults with overweight or obesity.

Trial enrolled 604 participants across four dose arms over 48 weeks

Participants with a BMI of 28 kg/m2 or above, or 24-28 kg/m2 with a weight-related comorbidity, were randomized 1:1:1:1 to once-weekly subcutaneous Olatorepatide at 5mg, 10mg or 15mg, or placebo. A total of 90.1% completed the full 48-week treatment period.

Lutris Pharma's LUT014 Gel Hits 71.8% Success Rate in Phase 2 Rash Trial

Image
Lutris Pharma's LUT014 Gel Hits 71.8% Success Rate in Phase 2 Rash Trial

Tel Aviv, Israel – October 01, 2026 -- Lutris Pharma reported that its topical B-Raf inhibitor LUT014 achieved Treatment Success in 71.8% of patients with EGFR inhibitor-induced acneiform rash, compared with 38.5% on placebo (p=0.003), in updated Phase 2 data presented at the 35th EADV Congress in Vienna.

LUT014 0.1% gel cuts clinician-assessed rash severity and patient symptom burden

Among the composite endpoint's components, 56.4% of patients on LUT014 0.1% achieved at least a one-grade improvement on the CTCAE v5.0 acneiform rash scale versus 15.4% on placebo (p=0.0002). Using the FACT-EGFRI-18 patient-reported symptom score, 53.8% of treated patients reported at least a five-point improvement versus 28.2% on placebo (p=0.021).