Drug Development

LONDON – – October 07, 2026 -- OncoBayes has completed preclinical work on OB-001, an oral drug candidate designed to overcome antibody-drug conjugate (ADC) resistance and boost brain penetration of tyrosine kinase inhibitors (TKIs), the privately held clinical-stage pharmaceutical company announced.

OB-001 raises osimertinib brain exposure by nearly 400% in mouse studies

In perfused-brain mouse models, pretreatment with OB-001 increased brain exposure of osimertinib by almost 400%, while plasma exposure remained broadly unchanged. The data, presented at AACR 2026, covered four gold-standard kinase inhibitors and showed systemic drug levels were largely unaffected by the efflux-pump inhibition.

Burlingame, Calif. – October 06, 2026 -- Enliven Therapeutics, Inc. (Nasdaq: ELVN) has reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, a pivotal Phase 3 trial testing relcobatinib against standard second-generation therapies in previously treated chronic myeloid leukemia (CML). The company remains on track to initiate the trial before year-end 2026.

FDA clears path for 450-patient head-to-head comparison

ENABLE-2 is designed to enroll approximately 450 adults with CML who have already received one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib at 80 mg once daily or an investigator-selected second-generation TKI -- dasatinib, nilotinib, or bosutinib. The primary endpoint is major molecular response (MMR) at Week 24, with MMR at Week 96 as a key secondary measure.

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.

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.

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.

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.

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.

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.

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.

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.