R&D/Clinical Trials

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.

Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical treatment for chronic low back pain associated with degenerative disc disease.

Following the discontinuation of ALLO-647 due to a treatment-related death, Allogene will move forward with a streamlined outpatient regimen aimed at accelerating enrollment and regulatory review in the Phase II ALPHA3 trial (NCT06500273).

Gene Mack, CEO, GAIN Therapeutics, outlines how early trial results for GT-02287 are shaping the company’s strategy for advancing a potential new treatment for Parkinson’s disease.

Gene Mack, CEO, GAIN Therapeutics, shares how growing clinician confidence and strong early experiences helped accelerate enrollment in the company’s Phase Ib Parkinson’s disease trial.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how positive Phase III results for Emrelis may position AbbVie as a key player in MET-high non-small cell lung cancer, expanding its presence in precision oncology and antibody-drug conjugates.

Gen Li discusses how competition and other factors can impact existing issues with clinical trial design.

Planning and recruitment issues can compound during this critical phase of the drug development process.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, highlights Emrelis’ potential to broaden its clinical impact by expanding into other solid tumors with high c-MET overexpression, beyond its current focus on non-small cell lung cancer.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Emrelis marks a pivotal moment for ADC therapies in oncology, reflecting the FDA’s growing confidence in their safety and efficacy and accelerating the shift toward precision medicine in cancer treatment.

The MC4R agonist targets rare genetic and hypothalamic obesity, with potential as a combination or maintenance therapy for general obesity alongside GLP-1 agents.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, discusses how Emrelis fits into the current antibody-drug conjugate landscape and what distinguishes its approach in biomarker-driven oncology.

Corina Dutcus, SVP, oncology global clinical development lead at Eisai, discusses the potential of the E7386 and lenvatinib combination to address unmet needs in second-line treatment for endometrial carcinoma patients.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, explains how E7386 and lenvatinib work together to target advanced endometrial carcinoma through dual mechanisms of action and WNT pathway modulation.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, highlights how long-term LEAP-002 data provides critical reassurance around Lenvima’s durability and safety in treating unresectable hepatocellular carcinoma.

Preclinical study shows oral PL7737 agonist outperforms tirzepatide alone in rodent models, supporting Palatin’s plans for clinical trials targeting both general and rare forms of obesity.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, highlights how consistent survival data from the LEAP-002 study reaffirms lenvatinib’s value in first-line treatment of unresectable hepatocellular carcinoma.

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed that the doravirine/islatravir combination was non-inferior to both baseline antiretroviral therapy and to bictegravir/emtricitabine/tenofovir alafenamide in treating HIV.

The traditional approach to trial management relies on a mix of solutions that often become siloed and difficult to integrate.

The supplemental New Drug Application is supported by Phase III data, which showed Caplyta significantly prolonged time to relapse compared to placebo and reduced the risk of relapse by 63% in patients with schizophrenia.

The delivery method showed promise in preventing the illness.

The Phase II THULITE trial will analyze the safety and efficacy of BI 1815368, an investigational oral therapy designed to reduce fluid leakage in the retina and ease the treatment burden for patients with diabetic macular edema.

Results from the Phase III VEGA-3 trial show that a significantly higher number of patients with presbyopia who received MR-141 achieved a ≥3-line gain in binocular near visual acuity without compromising distance vision compared to placebo.

Results from the Phase III Vivacity-MG3 trial show that Imaavy provides more consistent disease control than other approved FcRn blockers in adults with generalized myasthenia gravis.

Pedro Valencia, VP, asset strategy, leadership, oncology, AbbVie, outlines how the company is accelerating development across lung, gastrointestinal, and ovarian cancers following ASCO 2025, with a focus on advancing antibody drug conjugates and expanding late-stage studies.