Drug Development

Lilly's Foundayo Cuts Cardiovascular Death Risk 53% in ACHIEVE-4 Trial

Indianapolis – – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its oral GLP-1 therapy Foundayo (orforglipron) reduced cardiovascular death risk by 53% and all-cause death risk by 57% compared with insulin glargine in the Phase 3 ACHIEVE-4 trial, the largest and longest study of the medicine in type 2 diabetes to date.

Foundayo meets non-inferiority bar on major cardiovascular events

Among 2,749 participants randomized across 16 countries including the U.S., Germany, India, Brazil and South Korea, Foundayo showed a 16% lower risk of MACE-4 (cardiovascular death, heart attack, stroke or hospitalization for unstable angina) versus insulin glargine, with a hazard ratio of 0.84 (95.0% CI: 0.59 to 1.20), meeting the prespecified non-inferiority threshold. The risk of MACE-3 (cardiovascular death, heart attack or stroke) was 23% lower (hazard ratio: 0.77; 95.0% CI: 0.52 to 1.13).

Clarenta Group Acquires Majority Stake in Paris-Based L2D

London – September 30, 2026 -- Clarenta Group has taken a majority stake in Leads To Development (L2D), a Paris-based preclinical and regulatory consultancy, expanding its reach into early-stage drug development ahead of first-in-human trials.

Clarenta adds non-clinical and manufacturing expertise to its clinical development platform

L2D specializes in defining development pathways, assessing preclinical evidence, troubleshooting manufacturing processes, and building regulatory strategies for biotech and pharmaceutical sponsors. The addition connects this early-stage scientific work directly to Clarenta's existing Early Phase Unit and clinical consulting capabilities.

Acurx Enrolls First Patient in PATHFINDER Trial for Recurrent C. diff

Staten Island, N.Y. – September 29, 2026 -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) has enrolled the first patient in its PATHFINDER clinical trial evaluating ibezapolstat in patients with multiply-recurrent Clostridioides difficile infection (rCDI), a condition affecting up to 40% of patients treated with vancomycin after multiple prior episodes.

Fully funded pilot trial targets approximately 20 patients with severe recurrence history

The Phase 2 PATHFINDER study is a multicenter, open-label, single-arm trial enrolling patients who have experienced at least three CDI episodes within the past 12 months. Participants receive ibezapolstat for 14 days, with assessments for Clinical Cure at Day 16, Sustained Clinical Cure at Day 42, and recurrence rates tracked through Week 24.

Hengrui Licenses Oral GLP-1/GIP Drug to Novo in $2.6B Deal

Shanghai – – September 29, 2026 -- Hengrui Pharma has licensed its investigational obesity and diabetes drug HRS-1596 to Novo Nordisk in a deal worth up to 2.6 billion US dollars, including a 300 million dollar upfront payment.

Novo secures global rights excluding Greater China

Under the agreement, Novo obtains exclusive rights to develop, manufacture and commercialise HRS-1596 worldwide, excluding the Chinese mainland, Hong Kong SAR, Macao SAR and Taiwan Region. Hengrui Pharma retains eligibility for royalties on net sales of the drug within Novo's licensed territory, on top of the milestone-based payments tied to development, regulatory and commercial targets.

Ascletis' Oral ASC50 Cuts Psoriasis Severity 48.9% in Phase I Trial

Hong Kong – – September 28, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) reported a 48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) scores from a 28-day U.S. proof-of-concept trial of ASC50, an oral small molecule IL-17A inhibitor positioned as a needle-free alternative to injectable antibody therapies for plaque psoriasis.

Once-daily 200 mg dosing matched published efficacy benchmarks for injectable IL-17A antibody secukinumab

The randomized, double-blind, placebo-controlled Phase I study (NCT07024602) enrolled mild-to-moderate plaque psoriasis patients who received once-daily 200 mg oral ASC50 for 28 days. Ascletis said the PASI reduction was comparable to published secukinumab data, though the comparison was not conducted head-to-head.

Viking Therapeutics Closes Upsized $575M Stock and Convertible Note Offering

San Diego – September 28, 2026 -- Viking Therapeutics, Inc. (Nasdaq: VKTX) has closed concurrent upsized public offerings totaling approximately $575.0 million in gross proceeds, funding to accelerate its late-stage obesity drug pipeline.

Viking raises $575 million through combined stock and convertible note sale

The clinical-stage biopharmaceutical company sold 9,035,714 shares of common stock at $35.00 per share, alongside $258.75 million in aggregate principal amount of 2.00% convertible senior notes due 2032. Both tranches were upsized after underwriters fully exercised their options, adding 1,178,571 shares to the equity offering and $33.75 million to the note offering.

IDEAYA Biosciences Promotes Michael White to President, R&D

South San Francisco, Calif. – September 28, 2026 -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA) promoted Dr. Michael White from Chief Scientific Officer to President, Research and Development, effective September 28, 2026.

White expands authority over IDEAYA's oncology pipeline after five years as CSO

Dr. White has served as Chief Scientific Officer at IDEAYA since 2021, overseeing research into synthetic lethality and antibody-drug conjugate (ADC) programs targeting solid tumors. The precision medicine oncology company's pipeline spans multiple indications, including uveal melanoma, pancreatic cancer, small cell lung cancer, non-small cell lung cancer, colorectal cancer and breast cancer.

SOLA Japan Wins ¥6B AMED Grant for ALS Gene Therapy SOL-257

Tokyo – September 28, 2026 -- SOLA Biosciences Japan GK has secured a grant of approximately 6 billion yen over five years from Japan's Agency for Medical Research and Development (AMED) to advance SOL-257, a gene therapy candidate targeting the TDP-43 protein implicated in amyotrophic lateral sclerosis (ALS). The award, granted under AMED's Strengthening Program for Pharmaceutical Startup Ecosystem, was announced June 5, 2026, and positions SOLA Japan as the company's central development hub for the program.

AMED grant targets a pathology present in 97% of ALS cases

SOL-257 is designed to restore the structure and function of misfolded TDP-43, a protein that becomes mislocalized and aggregated in motor neurons in roughly 97% of ALS cases, according to SOLA. The company describes SOL-257 as a potentially first-in-class, disease-modifying gene therapy built on its proprietary JUMP70 platform.

Sanyou Bio, NovoCodex Partner to Co-Develop Dual-Payload ADCs

Shanghai – September 24, 2026 -- Sanyou Biopharmaceuticals Co., Ltd. and NovoCodex Biopharmaceuticals Co., Ltd. have signed a strategic collaboration agreement to jointly develop next-generation antibody-drug conjugates (ADCs), combining Sanyou Bio's AI-driven antibody discovery platforms with NovoCodex's clinically validated site-specific conjugation technology.

NovoCodex brings a clinically validated conjugation platform to the partnership

NovoCodex's proprietary NovoCodeTM platform incorporates unnatural amino acids into antibodies to achieve defined, controllable conjugation sites, producing homogeneous ADC products rather than the heterogeneous mixtures typical of traditional random conjugation. The technology has been validated in the pivotal Phase III trial of ARX788 and supported ARX305 in showing a favorable safety window and durable antitumor activity in advanced renal cancer patients with high CD70 expression.

Atossa CEO Quay to Join Harvard Panel on Aging Drug Development

Seattle – September 24, 2026 -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced that President and CEO Steven Quay, M.D., Ph.D., will serve as a panelist at the 13th Aging Research and Drug Discovery Meeting (ARDD 2026), scheduled for October 1-3, 2026, at the David Rubenstein Treehouse at Harvard University in Boston.

Quay joins regulatory and academic leaders to discuss clinical pathways for aging-related diseases

The panel, titled "Clinical Trials in Diseases of Aging: From Evidence to New Therapeutics and Regulatory Pathways," is set for Thursday, October 1, 2026, from 11:20 a.m. to 12:00 p.m. ET. The session will be moderated by Sebastien Thuault, Editor at Nature Medicine, and will include Jill Lee, Director of Regulatory Policy & Intelligence at Novo Nordisk; Calum MacRae, Professor at Mass General Brigham; and Steve Horvath, Professor at UCLA.