Dover, Del. – September 24, 2026 -- Clywedog Therapeutics, Inc. reported that its investigational menin inhibitor balomenib produced a placebo-adjusted mean HbA1c reduction of 0.77% at Week 12 (p0.01) and 0.70% at Week 16 (p0.05) in a Phase 1b trial, effects recorded three months after the drug's final dose following just three weeks of treatment.
Tokyo – September 24, 2026 -- Astellas Pharma Inc. (TSE: 4503) has dosed the first patient in a Phase 3 study evaluating setidegrasib, an investigational KRAS G12D-targeted protein degrader, against docetaxel in previously treated non-small cell lung cancer (NSCLC) patients carrying the KRAS G12D mutation.
The randomized, open-label study will enroll approximately 356 patients across multiple countries whose locally advanced or metastatic NSCLC has progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. Dual primary endpoints are progression-free survival, assessed by blinded independent central review, and overall survival.
San Diego – September 24, 2026 -- Viking Therapeutics plans to raise $400 million through simultaneous public offerings of $200 million in common stock and $200 million in convertible senior notes due 2032, with proceeds earmarked for its obesity drug pipeline.
The biopharmaceutical company intends to grant underwriters a 30-day option to purchase an additional $30 million in common stock and a separate 30-day option for up to $30 million more in notes to cover over-allotments. Completion of one offering is not contingent on the other, giving Viking flexibility if market conditions shift. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC are serving as joint book-running managers for both transactions.
Toronto – September 23, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has hit its 110-patient enrollment target for the pivotal Phase III MAVERIC trial ahead of its end-of-September guidance, and will now expand recruitment to as many as 150 patients.
A blinded review of patients randomized 1:1 to CardiolRxTM or placebo found a lower-than-anticipated rate of pericarditis recurrence, according to Cardiol. The MAVERIC Steering Committee recommended the enrollment increase to capture enough clinical events for a statistically robust efficacy read.
President and CEO David Elsley said the company is not aware of any change in routine clinical practice that would explain the reduced recurrence rate, calling the finding encouraging.
Boulder, Colorado – September 22, 2026 -- Edgewise Therapeutics (Nasdaq: EWTX) disclosed preclinical data showing its lead cardiac drug candidate EDG-7500 improves heart relaxation while preserving systolic function, a mechanism the company says addresses a core driver of hypertrophic cardiomyopathy (HCM) that current therapies do not fully target.
The company's Chief Scientific Officer, Alan Russell, said Edgewise screened more than 7,000 pharmacologically diverse compounds targeting the Regulatory Light Chain (RLC) before selecting molecules exhibiting positive lusitropic properties without compromising systolic performance. "EDG-7500's diastolic-biased profile has the potential to address a central pathologic driver of both symptomatic obstructive and nonobstructive HCM," Russell said.
Uppsala, Sweden – September 22, 2026 -- Beactica Therapeutics AB has initiated IND-enabling studies for BEA-17, a first-in-class oral degrader targeting the epigenetic regulators LSD1 and CoREST, moving the glioblastoma therapy toward first-in-human trials.
Glioblastoma remains the most common and aggressive primary brain tumour, with a median overall survival of approximately 15 months. Standard of care has stayed essentially unchanged for more than 20 years, and immunotherapies successful against other cancers have consistently failed against GBM's immunosuppressive tumour microenvironment.
Boston – September 21, 2026 -- Cellular Intelligence, a Boston-based AI company building a universal foundation model of cell signaling, has appointed Turing Award laureate Yann LeCun, Moderna co-founder Robert "Bob" Langer, BioInnovation Institute CEO Jens Nielsen and Helmholtz Munich computational health director Fabian Theis to its Scientific Advisory Board. Langer also joins the company's Board of Directors as an observer.
Shanghai – September 20, 2026 -- Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK) reported that its oral FGFR2/3 inhibitor lavengratinib achieved a mean increase of 2.4 cm/year in annualized height velocity among children with achondroplasia in the lowest-dose cohort of a Phase II trial, with a 100% responder rate.
All seven participants aged 6 to 12 in cohort 1 of the ABSK061-202 study received lavengratinib at 0.064 mg/kg once daily for 27 weeks. Responders were defined as achieving at least a 25% improvement in annualized height velocity from baseline, a threshold every participant in the cohort met.
Shanghai – September 19, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has out-licensed its proprietary WuXiTecan-2 payload-linker technology platform to Ona Therapeutics under an exclusive global agreement targeting a single antibody-drug conjugate (ADC) candidate.
The agreement grants Ona Therapeutics exclusive global rights to develop an ADC candidate using WuXi XDC's WuXiTecan-2 platform. The total potential deal value comprises an upfront payment plus development, regulatory and sales milestone payments, with WuXi XDC also eligible for tiered royalties on net sales once the resulting product reaches commercialization. WuXi XDC will additionally provide chemistry, manufacturing and controls (CMC) development and manufacturing support through its integrated ADC CRDMO platform.
Tel Aviv, Israel – September 18, 2026 -- Lutris Pharma will present updated phase 2 clinical data for its topical B-Raf inhibitor LUT014 at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, running September 30 through October 3.
The randomized, double-blind, placebo-controlled trial results will be delivered in an oral presentation titled 'Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-Raf Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.' The session, Free Communication 6: Pruritus/Adverse Drug Reactions, is set for Friday, October 2, 2026, from 11:25 to 11:35 am CET in Hall N. Anisha Patel, MD, professor of Dermatology at The University of Texas MD Anderson Cancer Center in Houston, will present the data under Abstract ID AS-1328.