Pharmaceuticals & Biopharmaceuticals

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.

Stockholm – October 05, 2026 -- Moberg Pharma AB (OMX: MOB) reported that its topical onychomycosis treatment MOB-015 achieved mycological cure in 74.3% of evaluable Phase 3 patients regardless of baseline antifungal susceptibility, according to new peer-reviewed data published in the Journal of Fungi.

Researchers screened 506 dermatophyte isolates for terbinafine resistance markers

The analyses draw on the company's completed North American Phase 3 trial of MOB-015, a once-daily treatment applied for 48 weeks. The work was conducted with Professor Mahmoud Ghannoum at Case Western Reserve University in Cleveland, Ohio, examining in vitro terbinafine susceptibility across the full isolate population.

Taipei – October 05, 2026 -- AnnJi Pharmaceutical Co., Ltd. (TPEx: 7754) is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial for AJ201, an oral small molecule targeting spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's disease, a rare inherited neuromuscular disorder with no FDA-approved treatment.

AJ201 becomes the only investigational SBMA therapy in Phase 3 development worldwide

AnnJi submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now move to activate U.S. trial sites. The global, multicenter, randomized, double-blind, placebo-controlled ROMA-KD study is designed to evaluate efficacy and safety in ambulatory patients with symptomatic SBMA, with approximately 200 patients expected to enroll worldwide and the United States serving as a key region.

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.

Hiroshima – October 03, 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.

Shanghai/Hong Kong – – October 03, 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.

Cambridge/Shenzhen – October 03, 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.

Cambridge, Mass. – – October 03, 2026 -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) received a Nasdaq Staff Determination on October 03, 2026, confirming it failed to meet the $35 million minimum market value of listed securities (MVLS) requirement by its October 03, 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.

Indianapolis – October 03, 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.