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Biopharmaceuticals

Ractigen's RAG-18 Shows First Clinical Proof RNA Activation Works in DMD

Hiroshima – October 3, 2026 -- Ractigen Therapeutics presented first-in-human data showing its systemically delivered small activating RNA (saRNA), RAG-18, produced 3.5- to 5.3-fold increases in sarcolemmal utrophin expression in boys with Duchenne muscular dystrophy (DMD), marking the first clinical proof-of-mechanism for RNA activation (RNAa) in a monogenic disease. The data were disclosed in a Late-Breaking Oral Presentation at the 31st Annual Congress of the World Muscle Society (WMS 2026) in Hiroshima, Japan.

Antengene to Unveil Cos-TCE Platform Data at SITC 2026 in Phoenix

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Antengene to Unveil Cos-TCE Platform Data at SITC 2026 in Phoenix

Shanghai/Hong Kong – – October 02, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) will present preclinical results of its novel costimulatory T cell engager (Cos-TCE) platform in a Rapid Oral Abstract Presentation at the Society for Immunotherapy of Cancer Annual Meeting (SITC 2026), running November 4-8 at the Phoenix Convention Center in Arizona.

Chief Scientific Officer to present CD2-based platform data on November 6

Dr. Bing Hou, Antengene's Chief Scientific Officer, will deliver the presentation titled "A CD2-based costimulatory T cell engager platform integrating a novel CD3γε/δε-targeting antibody and steric-hindrance-based CD3 masking," filed under Abstract 15749. The session, categorized as Rapid Oral - Basic 1, is scheduled for 12:30 PM to 1:30 PM Eastern Time on November 6, corresponding to 1:30 AM to 2:30 AM Beijing time on November 7.

XtalPi Advances AI-Designed Hair Loss Drug to IND-Enabling Studies

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XtalPi Advances AI-Designed Hair Loss Drug to IND-Enabling Studies

Cambridge/Shenzhen – October 02, 2026 -- XtalPi (HKEX: 2228) has moved its proprietary hair loss drug program into IND-enabling studies, with pharmacology, safety, and chemistry, manufacturing and controls (CMC) work underway to support a future Investigational New Drug application.

Candidate matches minoxidil's efficacy at 1/100 the dose

In a DHT-induced mouse model of androgenetic alopecia, XtalPi's lead candidate achieved a hair-growth score comparable to 5% topical minoxidil while using only one-hundredth of the comparator's concentration. The company also reported preclinical signals of reduced local follicular inflammation, prompting further evaluation of low-concentration topical delivery.

NeuroSense Fights Nasdaq Delisting After Missing $35M Market Value Rule

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NeuroSense Fights Nasdaq Delisting After Missing $35M Market Value Rule

Cambridge, Mass. – – October 02, 2026 -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) received a Nasdaq Staff Determination on October 1, 2026, confirming it failed to meet the $35 million minimum market value of listed securities (MVLS) requirement by its September 29, 2026 deadline, triggering a potential delisting from The Nasdaq Capital Market.

Company to appeal delisting threat before Nasdaq Hearings Panel

NeuroSense intends to timely request a hearing before a Nasdaq Hearings Panel under Nasdaq Listing Rule 5800 Series to seek additional time to regain MVLS compliance. A timely hearing request automatically stays any suspension of trading and the filing of a Form 25-NSE with the SEC while the Panel reviews the case. The Panel has discretion to grant an exception of up to 180 days from the October 1 Staff Determination date.

FDA Approves Lilly's Jaypirca as First-Line CLL/SLL Therapy

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FDA Approves Lilly's Jaypirca as First-Line CLL/SLL Therapy

Indianapolis – October 02, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly and Company's Jaypirca (pirtobrutinib), clearing the non-covalent BTK inhibitor as a first-line treatment for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletion.

Phase 3 trial data show an 80% reduction in disease progression risk

The approval rests on the BRUIN CLL-313 trial, which randomized 282 treatment-naïve patients 1:1 to pirtobrutinib or bendamustine plus rituximab (BR) chemoimmunotherapy. At a median follow-up of 28 months, pirtobrutinib cut the risk of disease progression by 80% versus BR (HR=0.20; 95% CI, 0.11–0.37; p0.0001). Median progression-free survival was not yet reached in the pirtobrutinib arm, compared with 33.5 months for BR.

Rice-Backed Duracyte to Trial Implant That Makes Drugs Inside Body

Houston – October 02, 2026 -- Researchers at Rice University, backed by the Rice Biotech Launch Pad, have developed an implantable device that produced therapeutic monoclonal antibodies continuously for one year across multiple preclinical models, with the platform now advancing toward human trials through biotech company Duracyte.

Implant sustained antibody production for a full year in preclinical testing

The system, detailed in a study published in Science Advances titled "Once-yearly cell-based therapy for sustained and dose-tunable delivery of monoclonal antibodies," uses engineered protein producers (EPPs) enclosed in a modified biomaterial. The retrievable device also let researchers halt treatment or adjust dosing by removing or replacing the implant, addressing the foreign body response -- inflammation and scar tissue buildup -- that typically limits implanted cell therapy performance.

Saros Therapeutics Lands Second $2M NCI Award for Cancer Immunotherapy

North Chicago, Ill. – October 02, 2026 -- Saros Therapeutics has received its second Phase II award from the National Cancer Institute, worth approximately $2 million, to advance a nanoparticle-based cancer immunotherapy toward human clinical testing.

NCI funds second two-year award for nanoparticle immunotherapy

The two-year grant will support studies needed to move Saros' experimental therapy toward an Investigational New Drug (IND) application, the company said. Saros operates within Rosalind Franklin University of Medicine and Science's (RFU) Helix 51 biomedical incubator in North Chicago, Illinois, which it joined earlier this year.

Vanda Presents Three Imsidolimab Data Sets for Rare Skin Disease GPP at EADV

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Vanda Presents Three Imsidolimab Data Sets for Rare Skin Disease GPP at EADV

Washington – October 02, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is presenting three new data sets on its monoclonal antibody imsidolimab at the European Academy of Dermatology and Venereology (EADV) Annual Meeting in Vienna, Austria, running September 30 through October 3, 2026.

Vanda shows imsidolimab cuts neutrophil levels rapidly in GPP patients

Poster P1769 (Abstract AS-4323) reports a rapid reduction in neutrophils and the neutrophil percentage-to-albumin ratio following imsidolimab treatment in patients with generalized pustular psoriasis (GPP), a rare orphan skin condition.

Immunogenicity data on imsidolimab presented in separate poster

A second poster, P1784 (Abstract AS-2420), details the immunogenicity profile of imsidolimab in GPP patients.

ABK Biomedical Breaks Ground on Missouri Cancer Device Plant

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ABK Biomedical Breaks Ground on Missouri Cancer Device Plant

Ashland, Missouri – October 02, 2026 -- ABK Biomedical Inc. has launched construction of a commercial-scale manufacturing facility at Cartwright Business Park in Ashland, Missouri, designed to produce its Eye90 microspheres for liver cancer treatment. The groundbreaking, attended by Missouri Governor Mike Kehoe, follows the company's April announcement selecting Ashland for its long-term U.S. manufacturing base.

Facility targets commercial-scale output of yttrium-90 radioembolization device

The planned Good Manufacturing Practice (GMP) facility will be built for commercial-scale production of Eye90 microspheres, a clinical-stage yttrium-90 radioembolization device still under development for liver cancer treatment. The devices remain investigational and are not approved for use outside authorized clinical trials.

Rigel Pharmaceuticals Grants 35,275 RSUs to 18 New Hires

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Rigel Pharmaceuticals Grants 35,275 RSUs to 18 New Hires

South San Francisco, Calif. – October 02, 2026 -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) has granted 35,275 restricted stock units to 18 non-executive employees under its Inducement Plan.

Rigel ties new hire equity to four-year vesting schedule

The restricted stock units vest over four years, with 25% of each grant releasing annually. The Compensation Committee of Rigel's Board of Directors approved the awards as an inducement material to new employees joining the company.

Grants comply with Nasdaq Listing Rule 5635(c)(4)

Rigel issued the awards in accordance with Nasdaq Listing Rule 5635(c)(4), which permits companies to grant equity inducements to new employees outside shareholder-approved equity plans. The rule requires public disclosure of such grants, which Rigel has now made.