Clinical Development

XellSmart's Parkinson's Cell Therapy Completes Phase II Enrollment

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XellSmart's Parkinson's Cell Therapy Completes Phase II Enrollment

Seoul – October 18, 2026 -- XellSmart's off-the-shelf Parkinson's cell therapy XS411 improved OFF-state motor scores by an average of more than 30 points at six months in all nine Phase I participants, and its 30-patient Phase II trial in China has completed enrollment.

The data were presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS). The company says the results showed no dose-limiting toxicities, serious adverse events or adverse events related to XS411.

Phase I data show motor and imaging gains in nine patients

The single-arm, open-label trial used a 3+3 dose-escalation design across three cohorts. Participants had moderate-to-advanced disease, a mean duration of about 10 years, end-of-dose wearing-off and OFF-state Hoehn-Yahr stages of 3 to 4. Cells were transplanted into the bilateral posterior putamen.

Myosin Therapeutics to Pitch MT-125 at BioFuture 2026 in New York

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Myosin Therapeutics to Pitch MT-125 at BioFuture 2026 in New York

Jupiter, Florida – October 16, 2026 -- Myosin Therapeutics will present its first-in-class cancer candidate MT-125 at BioFuture 2026 in New York City on October 27–28, seeking investors and pharmaceutical partners to fund an extension into two additional treatment-resistant cancers.

CEO Courtney Miller joins oncology panel on October 27

Chief Executive Officer Courtney Miller, PhD, will speak on the panel "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics." The session covers next-generation cell therapies, AI-enabled cancer drug discovery, precision medicines and advanced therapeutic platforms. Participating CEOs will introduce their companies, followed by a moderated round-robin discussion.

Chief Medical Officer Karen Smith, MD, PhD, MBA, LLM, will join Miller for investor and strategic partner meetings throughout the conference.

TORL BioTherapeutics Names New CFO and CMO Ahead of Late-Stage Push

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TORL BioTherapeutics Names New CFO and CMO Ahead of Late-Stage Push

Los Angeles – October 16, 2026 -- TORL BioTherapeutics has appointed Sandip Kapadia as Chief Financial Officer, a executive who has raised more than $2 billion in public capital for emerging biotechnology companies, and Eric Sievers, M.D., as Chief Medical Officer, completing a year-long expansion of its leadership team.

TORL prepares lead antibody-drug conjugate for late-stage development

The clinical-stage oncology company is advancing its antibody-based portfolio toward late-stage development and potential commercialization. Its lead asset, ixotatug vedotin (Ixo-V), is being evaluated in platinum-resistant ovarian cancer and other cancers that express CLDN6, including germ cell tumors, and in various combinations. Ixo-V has FDA Fast Track designation.

TORL describes Ixo-V as the first and only antibody-drug conjugate (ADC) that selectively targets Claudin 6 (CLDN6) using a proven monomethyl auristatin E (MMAE) linker-payload construct.

Vanda's VQW-765 Fails Phase III Social Anxiety Trial; Program on Hold

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Vanda's VQW-765 Fails Phase III Social Anxiety Trial; Program on Hold

Washington – October 15, 2026 -- Vanda Pharmaceuticals (Nasdaq: VNDA) has put its VQW-765 program on hold after the Phase III Study 3201 in adults with social anxiety disorder missed its primary endpoint, and the company said the data did not confirm earlier Phase II findings.

Phase III trial misses primary and key secondary endpoints

Study 3201 (NCT07221578) tested VQW-765 as an on-demand treatment for acute anxiety. Female participants who received the drug showed no statistically significant difference in distress from those who received placebo during the performance phase of the Trier Social Stress Test (TSST). The primary endpoint was measured on the Subjective Units of Distress Scale (SUDS), a 0-to-100 self-rating of nervousness.

The study also missed its key secondary endpoint, SUDS during the TSST performance phase in the full male and female population.

Carnyx's CNYX-005 Adds 1.5-2 Hours of Sleep in Aged Rat Study

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Carnyx's CNYX-005 Adds 1.5-2 Hours of Sleep in Aged Rat Study

Indianapolis – October 14, 2026 -- Carnyx Therapeutics Ltd. unveiled CNYX-005, an oral sleep candidate that increased total sleep time by roughly 1.5 to 2 hours in aged rats versus a control arm, as the preclinical-stage company moves toward clinical development.

The increase was driven primarily by more non-rapid eye movement (NREM) sleep. Researchers measured sleep architecture using continuous electroencephalography (EEG) monitoring.

Carnyx hires Chris Brearley, M.D., as Chief Medical Officer ahead of clinical entry

Brearley brings more than 30 years of experience in translational medicine, clinical pharmacology and early-stage drug development. His prior roles include senior positions at Pfizer, Amgen and Serono. He has designed and overseen first-in-human and early-stage clinical studies, the stage CNYX-005 now approaches.

Brearley said he aims to translate the findings into a rigorous clinical development program.

Telix Brings 20 Abstracts, 12 Oral Slots to EANM Vienna

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Telix Brings 20 Abstracts, 12 Oral Slots to EANM Vienna

Melbourne – October 14, 2026 -- Telix Pharmaceuticals will present 20 company-related abstracts at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna on October 17-21, 2026. Twelve of them were selected for top-rated oral presentations, with the rest running as ePosters.

Three pivotal therapeutic programs lead the oral lineup

The Phase 3 IPAX BrIGHT trial of TLX101-Tx (iodofalan-131I) in recurrent glioblastoma will be presented on October 19 by Nelleke Tolboom of UMC Utrecht. The study tests the therapy with or without lomustine against lomustine alone at first recurrence. The same morning session includes the IODO-RISE study of TLX101-Tx in recurrent high-grade glioma.

Paradigm Therapeutics Named Prix Galien Finalist for Second Year

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Paradigm Therapeutics Named Prix Galien Finalist for Second Year

Mount Pleasant, S.C. – October 14, 2026 -- Paradigm Therapeutics, Inc. has been named a finalist for the 2026 Prix Galien USA "Best Start-Up" Award, its second consecutive nomination after being a nominee in 2025.

The clinical-stage biopharmaceutical company is developing SD-101 (ZorblesiaTM), a topical cream for wounds and lesions across the entire skin surface in patients with Epidermolysis Bullosa (EB). The Galien Foundation manages the awards, which will be presented on October 14, 2026, at the American Museum of Natural History in New York City.

Inhibrx Sets Four Oncology Data Presentations Across Three Meetings

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Inhibrx Sets Four Oncology Data Presentations Across Three Meetings

San Diego – – October 14, 2026 -- Inhibrx Biosciences (Nasdaq: INBX) will present phase 2 data on both clinical-stage candidates in its pipeline in four sessions at three oncology conferences between Oct. 25 and Nov. 20, 2026.

Ordastobart phase 2 primary analysis goes to ESMO on Oct. 25

The first session is an oral presentation at the European Society for Medical Oncology (ESMO) Congress in Madrid on Sunday, Oct. 25, from 8:30 to 10:00 AM CET. Lead author Jong Chul Park will present the phase 2 primary analysis of HexAgon-HN, a phase 2/3 study of the hexavalent OX40 agonist ordastobart (INBRX-106) combined with pembrolizumab. The trial covers first-line treatment of PD-L1-high recurrent/metastatic head and neck squamous cell carcinoma.

Akiram's AKIR001 Shows No Dose-Limiting Toxicity in 8 Patients

Uppsala – October 13, 2026 -- Akiram Therapeutics reported no dose-limiting toxicities among the eight patients treated so far with its lead radiopharmaceutical candidate 177Lu-AKIR001 in a Phase I trial, with treatment-related adverse events limited to grade 1-2.

The Swedish clinical-stage biotech will present the first clinical data at the EANM 2026 Congress in Vienna, October 17-21. The abstract was selected as a Top Rated Oral Presentation (TROP).

Sustained tumor retention supports continued dose escalation

The first-in-human study is evaluating 177Lu-AKIR001 in patients with irresectable or metastatic CD44v6-positive solid tumors who have no remaining standard treatment options. At data cut-off, eight patients had been treated, and four of them received repeat treatment after the first administration.

ArkBio Wins FDA Clearance for Phase II Flu Prevention Trial of AK0406

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ArkBio Wins FDA Clearance for Phase II Flu Prevention Trial of AK0406

Shanghai – October 13, 2026 -- Shanghai Ark Biopharmaceutical (ArkBio) has received U.S. Food and Drug Administration clearance of its investigational new drug application for AK0406, allowing a phase II trial of the long-acting antiviral drug-Fc conjugate for influenza prevention in the general U.S. population.

CDC data shows 24,000 U.S. flu deaths despite vaccines

The U.S. Centers for Disease Control and Prevention reports that the 2025–2026 influenza season caused at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States. ArkBio says shifting circulating viruses and variable immune response limit vaccine protection, particularly among older adults and immunocompromised people.