Clinical Development

Rockville, Md. – October 13, 2026 -- REGENXBIO Inc. (Nasdaq: RGNX) will host a three-hour investor event on October 13, 2026 to review its wet age-related macular degeneration (wet AMD) gene therapy program, with topline pivotal data anticipated in the fourth quarter of 2026.

Event runs 1:00 p.m. to 4:00 p.m. ET in New York and online

The session will be held in person in New York and streamed by webcast. It will cover the clinical program for surabgene lomparvovec (sura-vec, ABBV-RGX-314), which REGENXBIO is developing in collaboration with AbbVie.

Management and five retina specialists to address commercial readiness

REGENXBIO management and retina specialists will discuss the treatment landscape, unmet need, the ATMOSPHERE and ASCENT pivotal trials, and the commercial readiness of sura-vec in wet AMD.

Five key opinion leaders are scheduled to appear:

Seoul – October 13, 2026 -- Parkinson's patients taking the investigational drug solengepras gained an average of 36 more minutes of "good" movement time per day than those on their regular medication alone, and the drug will now be submitted to the U.S. Food and Drug Administration for approval.

ARISE trial results presented at the MDS International Congress

The data from the ARISE clinical trial were presented at the International Congress of Parkinson's Disease and Movement Disorders. Patients, who can have difficulty moving, also reported improvements in measures of daily living, according to the source.

Patient-reported outcomes were positive across all measured areas of daily living. Drooling and saliva control showed the most significant self-reported change, while improved daytime sleepiness was also recorded.

Beijing – October 13, 2026 -- T-MAXIMUM PHARMACEUTICAL has received FDA clearance to start a Phase 2 study of MT027, its B7-H3-targeted allogeneic CAR-T therapy, in patients with brain metastases from lung and breast cancer. It is the second Phase 2 program for the asset to clear the agency.

MT027 now has two FDA-cleared Phase 2 programs in intracranial solid tumors

The FDA previously cleared a Phase 2 study of MT027 in recurrent glioblastoma. The therapy holds Orphan Drug Designation and Fast Track Designation. The two programs give T-MAXIMUM a dual-indication portfolio covering both primary and metastatic intracranial solid tumors.

Sydney – October 13, 2026 -- The Safety Review Committee (SRC) for Racura Oncology's HARNESS-1 trial has cleared lead drug RC220 to escalate to 100 mg/m2, after finding no dose-limiting toxicities in either Cohort 1 patient. The Phase 1a/b study combines RC220 with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

Both Cohort 1 patients received RC220 at 50 mg/m2 by intravenous infusion alongside osimertinib at 80 mg daily. The second patient has received three RC220 doses, given 21 days apart, with no dose-limiting toxicities or treatment-related safety concerns.

Taipei, Shanghai and San Francisco – October 05, 2026 -- HanchorBio, Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared the investigational new drug application for HCB303, clearing the path for the company's second trispecific immunotherapy to enter human testing.

FDA clearance unlocks Phase 1 trial for advanced solid tumors

The clearance allows HanchorBio to launch a Phase 1 first-in-human, dose-escalation, multi-regional study (HCB303-ONC-101) in patients with advanced, relapsed or refractory solid tumors who have exhausted standard treatment options. The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers and preliminary antitumor activity. The decision follows pre-IND feedback HanchorBio received from the FDA in August 2026.

Taipei – October 05, 2026 -- Energenesis Biomedical Co., Ltd. (TWSE: 6657) has signed a Memorandum of Understanding with South Korea's Yoo Young Pharm. Co., Ltd. (YYP) to pursue development, registration, and commercialization of its diabetic foot ulcer drug candidate ENERGI-F703DFU in the Korean market.

MOU sets framework for Korea rights on ENERGI-F703DFU

Under the agreement, YYP would gain rights to develop, register, and commercialize ENERGI-F703DFU in Korea, leveraging Energenesis' clinical data package, including Phase III trial results, alongside YYP's regional commercial and clinical network. The MOU establishes a framework for continued negotiations; terms of a definitive agreement remain subject to further discussion between the two companies.

Tokyo – October 05, 2026 -- Celaid Therapeutics Inc. has completed the second close of its Series B financing round, raising JPY 400 million (approximately USD 2.6 million) with new backing from Shionogi & Co., Ltd. and Teikoku Ventures, Inc.

Shionogi and Teikoku Ventures enter as new strategic investors

The two pharmaceutical-linked investors cited the development progress and therapeutic potential of CLD-001, Celaid's lead hematopoietic stem cell (HSC) therapy candidate, as the basis for their investment. Teikoku Ventures operates as the corporate venture capital arm of the TEIKOKU SEIYAKU Group.

AMED advances Celaid to Stage 3 funding under startup ecosystem program

Celaid also passed the second stage-gate review of AMED's "Strengthening Program for Pharmaceutical Startup Ecosystem,

Melbourne – October 05, 2026 -- CSL and Alentis Therapeutics have signed an exclusive global collaboration to develop and commercialize lixudebart, a potential first-in-class therapy targeting claudin-1 for rare kidney and liver diseases, with CSL paying Alentis US$355 million upfront and up to US$1.2 billion in commercial milestones.

CSL pays $355 million upfront, commits $1.2 billion in milestone payments

Under the agreement, CSL will fully fund the ongoing Phase 2 RENAL trial, the planned Phase 3 trial in ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN), and Phase 2 trials in focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC). Once commercialized, global profits will be split 55 percent to CSL and 45 percent to Alentis.

Paramus, N.J. – October 01, 2026 -- NS Pharma, Inc. reported 5-year efficacy and safety data showing its investigational therapy brogidirsen maintained or improved motor function in Duchenne muscular dystrophy (DMD) patients amenable to exon 44 skipping, with zero treatment discontinuations across the study period.

Six-participant trial records no serious adverse events over five years

The data, presented by Japan's National Center of Neurology and Psychiatry (NCNP) at the 31st annual International Congress of the World Muscle Society in Hiroshima, Japan, covered an open-label extension of an investigator-initiated clinical trial. All six participants received weekly intravenous dosing of brogidirsen (NS-089/NCNP-02), an antisense oligonucleotide co-discovered by Nippon Shinyaku and NCNP. After five years of administration, no serious or severe adverse events, anaphylaxis, or discontinuations tied to long-term dosing were recorded.

Groton, Conn. – September 30, 2026 -- Astrocyte Pharmaceuticals Inc. has closed a $9.5 million Series B financing round to advance Phase 2 development of AST-004, its cerebroprotective therapy for concussion, traumatic brain injury (TBI) and stroke. The round brings total capital raised by the clinical-stage biotech, including grants, to $40 million.

DeepWork Capital leads financing with four new investors joining the round

The Series B was led by DeepWork Capital, with continued backing from existing investors and new participation from MintPharma Capital, Waterstar Capital, Dynagrow Capital and Angel Star Ventures. Jackson Streeter, M.D., Venture Partner at DeepWork Capital, said the firm has been impressed by the consistency of Astrocyte's science and the progress of its clinical programs.