Pharmaceuticals & Biopharmaceuticals

Boston and Shenzhen – September 25, 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 25, 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 September 25, 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 25, 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 25, 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.

Pune, India – September 25, 2026 -- The global placenta market is set to nearly triple from USD 96.1 billion in 2025 to USD 275.18 billion by 2034, expanding at a 12.4% compound annual growth rate, according to a new analysis by Maximize Market Research.

Asia-Pacific leads global demand as Japan, South Korea and China drive placenta research

Asia-Pacific held the leading market position in 2025, backed by strong placenta research and development in Japan, South Korea and China, alongside rising production of placenta-derived products for pharmaceutical and cosmetics applications. The region's large consumer base and appetite for anti-aging and skincare solutions continue to underpin its dominant position.

Pune – September 25, 2026 -- The global bioinformatics market is projected to expand from $20.34 billion in 2025 to $64.60 billion by 2034, a 13.7% compound annual growth rate, according to new analysis from Maximize Market Research.

Genomic data volumes and NGS adoption fuel core demand

Rising volumes of genomic and biological data, driven by expanding next-generation sequencing (NGS) adoption, are pushing pharmaceutical and biotechnology companies toward advanced bioinformatics platforms, sequencing data analysis tools, and biological databases. Declining sequencing costs are drawing smaller research institutions into the market, while growing precision medicine applications are increasing demand for pharmacogenomics, biomarker analysis, and genomic diagnostics.

Vancouver – September 25, 2026 -- IM Cannabis Corp. (Nasdaq: IMCC) has closed a registered direct offering, selling 655,000 common shares at US$2.00 apiece for gross proceeds of US$1.31 million before expenses.

Norwell, Mass. – September 25, 2026 -- The National Organization for Rare Disorders (NORD) has named six companies and nonprofits as 2026 Industry Innovator honorees for delivering first-of-their-kind FDA-approved therapies to patients with rare diseases that affect a fraction of the more than 30 million Americans living with such conditions.

Six FDA approvals mark milestones across ultra-rare indications

Mighty Therapeutics was recognized for FORZINITY, the first therapy for Barth syndrome, a rare mitochondrial disease, shown to improve muscle strength and quality of life. UCB earned recognition for KYGEVVI, the first and only approved treatment for thymidine kinase 2 deficiency in patients whose symptoms began at or before age 12. Fondazione Telethon was honored for Waskyra, a gene therapy for Wiskott-Aldrich syndrome that stands as the first FDA-approved gene therapy for a primary immunodeficiency disorder and the first developed by a nonprofit.

San Diego – September 25, 2026 -- ACROBiosystems has launched CHO-Direct, a rapid high-throughput affinity validation service that delivers antibody affinity data in as little as four days from sequence submission, alongside a broader infrastructure platform called ACRO AIx aimed at AI-driven drug discovery (AIDD).

CHO-Direct compresses antibody validation timelines to four days

Using an optimized CHO cell system, CHO-Direct converts computationally generated antibody sequences into structured affinity data within days, addressing a bottleneck where AI tools generate candidate sequences faster than labs can validate them. The service leverages the protein-folding and post-translational modification environment of mammalian cells while maintaining compatibility with CHO systems already used in downstream development and manufacturing.

Boston – September 25, 2026 -- RS2 Healthcare Partners has completed an investment in KMM Group, a Hatboro, Pennsylvania-based precision contract manufacturer for the medical device industry, marking the Boston private equity firm's first new platform deal since narrowing its focus exclusively to lower middle-market healthcare investing.

RS2 names industry veteran J. Mark King as KMM's new CEO

J. Mark King, who brings more than 30 years of medical device industry experience, has been appointed President and Chief Executive Officer of KMM. King previously served as President and CEO of Tegra Medical, a medical device contract manufacturer and former RS2 portfolio company, and has also acted as an advisor to KMM prior to the deal.

"I am honored and excited to continue building on KMM's momentum," King said, citing a long working history with RS2's principals.