On September 25, Swedish pharma company Nanexa announced an exclusive global license and collaboration agreement with Novo Nordisk, leveraging Nanexa’s PharmaShell atomic layer deposition technology for up to five peptide programs. Novo Nordisk gains exclusive global rights to develop and commercialize up to five peptide programs in obesity and type 2 diabetes using PharmaShell. Nanexa receives an undisclosed upfront payment, up to €1.165B in development, regulatory and commercial milestones, plus royalties. The deal further strengthens Novo’s obesity pipeline through long-acting delivery beyond GLP-1. Source: https://www.biobucks.co/biotech-bdl-tracker-2026
On September 24, San Diego-based siRNA therapeutics company ADARx Pharmaceuticals priced an upsized IPO of 26.25 million shares at $17.00 per share (top of the $15-$17 range), raising $446.3 million—the third-largest biotech IPO of 2026. Shares began trading on Nasdaq on September 25 under ticker ADRX. ADARx’s lead asset onvuzosiran targets hereditary angioedema (HAE), with topline data from the pivotal Phase 3 STOP-HAE trial expected by late 2027. Partner AbbVie also invested approximately $89 million in a concurrent private placement, taking a 4.9% stake. The IPO underscores continued capital market enthusiasm for RNAi therapeutics in 2026. Source: https://www.globenewswire.com/news-release/2026/09/24/3368818/0/en/adarx-pharmaceuticals-announces-pricing-of-upsized-446-3-million-initial-public-offering.html
On September 25, Merck (MSD) and Eisai announced FDA approval of Welireg® (belzutifan), an oral HIF-2α inhibitor, in combination with Lenvima® (lenvatinib), for adults with advanced renal cell carcinoma (ccRCC) with a clear cell component previously treated with a PD-1 or PD-L1 inhibitor. The approval is based on the LITESPARK-005 Phase 3 study, which showed the Welireg+Lenvima combination reduced the risk of disease progression or death by 30% versus cabozantinib. This provides a new all-oral option for patients after immunotherapy failure. Source: https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/
On September 25, Mirum Pharmaceuticals and Incyte announced that the U.S. FDA approved Atebrioz™ (zilurgisertib) to reduce new heterotopic ossification (HO) volume in patients aged 12 and older with fibrodysplasia ossificans progressiva (FOP). Zilurgisertib is a once-daily oral small-molecule inhibitor of activin receptor-like kinase 2 (ALK2), directly blocking the key signaling pathway driving abnormal bone formation in soft tissue. FOP is an ultra-rare progressive genetic disorder in which soft tissue gradually ossifies, causing severe mobility impairment. The approval was based on the pivotal Phase 2 PROGRESS study. Mirum licensed worldwide rights from Incyte. Source: https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-and-Incyte-Announce-U-S–FDA-Approval-of-Atebrioz-zilurgisertib-for-Adult-and-Pediatric-Patients-with-Fibrodysplasia-Ossificans-Progressiva/default.aspx
Johnson & Johnson is in talks to sell its orthopedics business DePuy Synthes to private equity firm Apollo Global Management for approximately $20 billion. DePuy Synthes was formed from J&J’s 1998 ($3.5B) and 2012 ($21.3B) acquisitions of DePuy and Synthes, covering joint reconstruction, sports medicine, trauma, and the Velys orthopedic surgical robot.DePuy Synthes generated $9.258B in 2025, growing only 1.1% vs. 6.1% for J&J’s broader MedTech segment. Stryker overtook it as global #1 in orthopedics with ~$11.4B. Chinese centralized procurement also pressures the business. H1 2026 sales were $4.801B (+5.6%), showing recovery. J&J has not officially announced the deal; a spin-off remains an option. Source: https://news.yaozh.com/archive/49060.html
Boston Scientific announced that Arthur Butcher, EVP and Head of International MedSurg, will retire. Butcher joined in 1996, served as EVP & President of Asia Pacific from 2020-2022, and has led MedSurg & APAC Group since 2022 after over 30 years with the company. He will step down on January 1, 2027. Boston Scientific has also been recovering from a major cyberattack identified on August 25, 2026 that disrupted global operations. On September 8, the company stated the incident could materially impact Q3 and full-year results, and it expects to miss prior net sales growth and adjusted EPS guidance. This follows a July 29 guidance cut to 5%-6% organic growth due to slowing electrophysiology and Watchman momentum. Source: https://news.yaozh.com/archive/49062.html
Huadong Medicine announced that its wholly-owned subsidiary Sino-American East China has achieved positive top-line results in the China Phase III trial (HDM1002-301) of its Class 1 innovative oral small-molecule GLP-1 receptor agonist HDM1002 tablets for weight management in overweight or obese individuals. All dosage groups met all primary and key secondary endpoints at week 44; continued treatment resulted in sustained weight loss further decreasing at week 52 without a plateau; significant improvements in cardiometabolic markers, substantial reduction in liver fat content, and optimized body composition were observed; safety and tolerability were consistent with the GLP-1 class with no new signals. The company has completed Pre-NDA communication and will soon submit a marketing application in China. Research institutions indicate the biopharmaceutical industry will benefit from upcoming policies, with related companies expected to see improved performance. Source: https://finance.eastmoney.com/a/202609283885024341.html
On September 28, Leads Biolabs-B (09887) announced that its core product Velyso® (opatidijumimab, a PD-L1/4-1BB bispecific antibody) has been granted orphan drug designation by the Japanese Ministry of Health, Labour and Welfare for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is the third orphan drug designation that Velyso® has received, following those from the U.S. Food and Drug Administration and the European Commission, marking a further expansion of its global regulatory recognition into major Asian markets. Source: https://finance.eastmoney.com/a/202609283885132814.html
From September 16–18, CPHI & PMEC Shenzhen 2026 brought together pharmaceutical companies and industry professionals across APIs, excipients, finished formulations, pharmaceutical machinery, and other segments of the pharma value chain. The Drugdu.com team was on-site throughout the three-day event. We met familiar faces, connected with new companies across different sectors, talked with buyers looking for products and suppliers, and sat down with companies exploring new ways to expand their international business. After three days of conversations, one thing stood out: What matters is not simply how many people you meet at an exhibition, but what buyers and suppliers are actually looking for. Buyers Are Looking for More Than Products “Do you have suppliers for this product?” “Are there other Chinese manufacturers we can compare?” “Can we contact the manufacturer directly?” Many of our conversations with buyers started with a specific product. But finding the product is only the first step. ...
On September 16, Novartis announced the acquisition of biotechnology company Sironax for $125 million, gaining access to its proprietary blood-brain barrier (BBB) delivery platform technology. Sironax’s platform utilizes receptor-mediated transcytosis to efficiently deliver large molecule drugs (such as antibodies and gene therapies) into the central nervous system, addressing the longstanding challenge of large molecules being unable to cross the BBB. The technology platform is expected to significantly enhance Novartis’ drug development capabilities in central nervous system diseases, including Alzheimer’s disease, Parkinson’s disease, and neuro-oncology. This acquisition continues Novartis’ recent strategic investments in neuroscience and rare diseases. Blood-brain barrier delivery technology is considered a key enabling technology for next-generation CNS drug development. Source: https://tldrbio.tech/
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