Biopharmaceuticals

Delray Beach, Fla. – October 05, 2026 -- The global AI in Protein Engineering market will climb to USD 3.82 billion by 2031 from USD 1.44 billion in 2026, a 21.6% compound annual growth rate, according to a new forecast from MarketsandMarkets.

North America holds 48.6% market share as software platforms dominate spending

North America led the market with a 48.6% share in 2025. Software and platforms accounted for 75.4% of revenue the same year, as pharmaceutical and biotech firms prioritized AI-driven design tools over services. Within protein types, miniproteins are set to post the fastest growth at 23.7% CAGR through 2031.

New York – October 05, 2026 -- A new multisector coalition launched the 30x30x50 Brain Challenge, pledging to cut stroke incidence by 30 percent and increase primary-care cognitive screening by 50 percent across 30 global cities by 2031.

Atria-coordinated coalition unites pharma, tech and the UN behind brain health delivery

The International Brain Health Coalition (IBC), coordinated by the Atria Research and Global Health Institute (ARGHI), brings together patients, multilateral institutions including the United Nations, and organizations spanning medicine, technology, and finance. Collaborators include Eli Lilly and Company, Bristol Myers Squibb, Microsoft, the Royal Bank of Canada, the American Heart Association, UN Women, Western University, and the AI-Mind Institute in Norway.

San Carlos, Calif. – October 05, 2026 -- A non-invasive urine test can now predict whether bladder cancer patients will respond to immunotherapy before treatment even begins, according to a Stanford-led study published in Nature Medicine and announced by Resero Bio.

Study analyzed 683 urine samples to validate cell-free RNA platform

Researchers from Stanford Cancer Institute and the VA Palo Alto Health Care System used uRARE-seq, Resero Bio's proprietary targeted cfRNA sequencing method, to analyze 683 urine samples from bladder cancer patients and controls. The platform distinguished low-grade from high-grade tumors and non-muscle invasive from muscle-invasive disease, determinations that currently require tissue biopsy or surgical resection.

Bridgewater, N.J. – – October 05, 2026 -- Insmed Incorporated (Nasdaq: INSM) announced that Chief Financial Officer Sara Bonstein will step down on October 30, 2026, after nearly seven years in the role, during which the company raised more than $4.2 billion in capital.

Bonstein exits after helping raise $4.2 billion for Insmed

Bonstein will remain CFO through the company's third-quarter 2026 earnings report and will participate in the earnings call on October 29, 2026, before departing the following day. Insmed has launched a search with an executive search firm to identify her successor. The company stated the transition is unrelated to any disagreement over accounting practices, financial statements, internal controls, or operations.

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.

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 04, 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 4, 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.