Biopharmaceuticals

Cambridge, Mass. – September 25, 2026 -- Zifo has been named runner-up in the 2026 CDISC AI Innovation Challenge for TLFGenix, its AI-driven pipeline for generating clinical trial tables, figures, and listings, marking the company's second consecutive year of recognition in the competition.

Zifo's TLFGenix converts statistical analysis plans into traceable clinical outputs

TLFGenix was recognized under Use Case 3: AI-Driven Tables, Figures, and Listings Generation, one of three use cases in the global competition. The system uses six specialized agents to digitize Statistical Analysis Plans into a structured logical model, profile ADaM datasets, generate an ARS-aligned analysis specification, produce R driver scripts, execute them in a network-isolated sandbox, and check schema and output consistency. Statisticians approve the analysis specification before code generation and sign off on each individual output.

Uppsala – September 25, 2026 -- Nanexa AB has signed a global exclusive license and collaboration agreement with Novo Nordisk worth up to EUR 1.165 billion, granting the Danish pharmaceutical giant rights to the Swedish company's PharmaShell atomic layer deposition (ALD) drug delivery platform for peptide-based treatments in obesity, type 2 diabetes and other cardiometabolic diseases.

Novo Nordisk gains rights to up to five development programs under the deal

The agreement covers formulations targeting monthly and quarterly administration frequencies, reducing dosing burden for chronic metabolic and cardiovascular disease patients. Novo Nordisk will lead global development and commercialization across all programs, while Nanexa retains eligibility for milestone-based payments tied to development, regulatory and sales achievements.

Shanghai – September 25, 2026 -- Nutshell Therapeutics (Shanghai) Co., Ltd. has received FDA clearance of its Investigational New Drug (IND) application for NTS231, a covalent allosteric molecular glue degrader targeting NRF2, allowing the company to begin clinical development in the United States. NTS231 is the first NRF2 degrader originating from China and only the second such molecule worldwide to reach clinical-stage development.

Raritan, N.J. – September 25, 2026 -- Half of patients with early-line relapsed or refractory multiple myeloma treated with a single infusion of Johnson & Johnson's CARVYKTI® (ciltacabtagene autoleucel) remained alive and progression-free for at least five years without maintenance therapy, according to new long-term data from the Phase 2 CARTITUDE-2 study.

Half of patients reach five-year progression-free survival without maintenance

In the initial subgroup of cohort A (N=20), 10 of 20 patients treated with a single CARVYKTI® infusion remained progression-free at a median follow-up of 60.7 months. Median progression-free survival reached 60.5 months, and the results were presented at the International Myeloma Society Annual Meeting (Abstract #PA-288). Cohort A enrolled patients who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.

Copenhagen – September 25, 2026 -- H. Lundbeck A/S will relocate its US headquarters from Deerfield, Illinois, to Greater Boston, Massachusetts, establishing a global innovation hub in the region over the next year.

Lundbeck ties the move to the next phase of its Focused Innovator strategy

The Danish biopharmaceutical company said the relocation supports plans to scale its growing neuroscience portfolio, expand innovation opportunities and build out digital and AI capabilities. Charl van Zyl, President and CEO of Lundbeck, said the US has been a key driver of the company's commercial progress over the past three years, during which Lundbeck delivered growth, transformed its pipeline and applied disciplined capital allocation.

Stockholm – September 25, 2026 -- SciBase Holding AB's SEK 57.5 million rights issue is now fully covered after Bergs Securities AB confirmed a binding guarantee commitment of approximately SEK 24.2 million, equal to 42 percent of the offering.

Guarantee commitment converts letter of intent into binding coverage

Bergs Securities fulfilled on September 25, 2026, a guarantee intention it first announced on September 3, 2026, by delivering a formal guarantee confirmation to SciBase. The firm has backed the commitment with sub-guarantee agreements from a consortium of investors covering the full guaranteed amount.

Boston and Shenzhen – September 24, 2026 -- XtalPi Holdings Limited (HKEX: 2228) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for KQTD-126, a potential first-in-class gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor targeting chronic intestinal pain in irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

KQTD-126 marks XtalPi's first proprietary pipeline candidate to reach IND stage

The submission represents the inaugural IND filing from XtalPi's internally developed pipeline, which the company disclosed in its recent interim results. It confirms the company's transition from a discovery-services provider to a clinical-stage drug developer built on AI and robotics.

Rockville, Md. – September 24, 2026 -- REGENXBIO Inc. (Nasdaq: RGNX) reported that 60% of Dose Level 3 participants with three-year follow-up data in its Phase II ALTITUDE study achieved a greater-than-2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) after a single in-office treatment with investigational gene therapy sura-vec, with no vision-threatening events recorded among responders.

Three-year data confirm durable DRSS improvement without repeat injections

In long-term follow-up as of August 17, 2026, six of ten Dose Level 3 participants with non-proliferative diabetic retinopathy (NPDR) who reached the three-year visit sustained a greater-than-2-step DRSS improvement without additional diabetic retinopathy treatment. The suprachoroidal delivery used Dose Level 3 (1.0x10^12 GC/eye) combined with short-course prophylactic topical steroids.

Pune – September 24, 2026 -- The global autoimmune treatment market reached USD 176.6 billion in 2025 and is forecast to expand at a 6.9% CAGR through 2034, hitting USD 321.95 billion, according to a new analysis from Maximize Market Research.

North America dominates the market on strong pharmaceutical R&D infrastructure

North America held the largest share of the market in 2025, driven by high disease prevalence, advanced healthcare infrastructure, established specialist care and elevated healthcare spending. The United States anchors regional growth, backed by leading pharmaceutical and biotechnology firms, advanced diagnostic capacity, and rising adoption of biologics, immunosuppressants, monoclonal antibodies and targeted therapies. Canada and Mexico are contributing through improving healthcare access and disease awareness.

Pune, India – September 24, 2026 -- The global multiple sclerosis treatment market reached USD 26.76 billion in 2025 and is forecast to climb to USD 44.45 billion by 2034, expanding at a 5.8% CAGR, according to a new report from Maximize Market Research.

Disease-modifying therapies and biologics drive current market expansion

Rising MS prevalence, improved diagnostic capabilities, and growing adoption of immunomodulators, immunosuppressants, interferons, oral disease-modifying therapies (DMTs), and monoclonal antibodies are fueling demand across relapsing-remitting (RRMS), primary progressive (PPMS), secondary progressive (SPMS), and clinically isolated syndrome (CIS) patient segments. High-efficacy biologics and oral treatment options are increasingly displacing older therapy classes as patients and physicians prioritize convenience and disease-progression control.