Summary of the September Monthly Newsletter
The September Monthly Newsletter discusses continued activity across biopharma, spanning M&A, licensing, regulatory approvals and industry policy.
Eli Lilly featured prominently through its acquisition of Merida Biosciences and $3.35B collaboration with InnoCare, while Werewolf Therapeutics and Ambros Therapeutics announced a merger focused on CRPS-1.
The month also saw calls for stronger European biopharma innovation and FDA approval of Ultragenyx’s Fayuvi for MPS IIIA, alongside continued investment in emerging therapeutic platforms and rare disease treatments.
Mergers & Acquisitions
September activity highlights continued investment in innovative therapeutic platforms. Eli Lilly’s acquisition of Merida Biosciences and the Werewolf–Ambros merger reflect growing interest in precision immunology and novel approaches to pain management.
These deals underline continued efforts to strengthen pipelines through differentiated technologies, while broadening the potential range of future treatment options for patients. Overall, the activity points to continued momentum behind targeted and emerging therapeutic approaches across the sector.
Eli Lilly’s $2.9B Bet on Precision Immunology
Eli Lilly Bets $2.9B on Precision Immunology Eli Lilly is acquiring Merida Biosciences for up to $2.875B, adding a precision immunology platform designed to selectively degrade disease-causing autoantibodies rather than broadly suppress the immune system.
Merida’s lead program, MER511, is in Phase 1 for Graves’ disease and thyroid eye disease, while its pipeline also includes programs targeting allergic and other antibody-driven diseases. The deal adds another platform to Lilly’s expanding immunology pipeline and continues the pharma giant’s active 2026 M&A strategy.
Read more here.
Werewolf and Ambros Join Forces to Advance a Potential CRPS Treatment
Werewolf Therapeutics and Ambros Therapeutics Merge in $150M Biotech Deal Werewolf Therapeutics and Ambros Therapeutics are combining in an all-stock merger, alongside a $150M private placement, to advance Ambros’ Phase 3 neridronate program for Complex Regional Pain Syndrome Type 1 (CRPS-1).
The combined company will operate as Ambros Therapeutics and is expected to trade as Nasdaq: AMBX, with Phase 3 topline data anticipated in 2028.
Read more here.
Developments
In this section you will find articles on the following:
Eli Lilly Expands China Dealmaking With $3.35B InnoCare Deal
Eli Lilly has entered a strategic research collaboration and licensing agreement with China’s InnoCare Pharma covering five undisclosed drug targets. InnoCare will apply its drug discovery platform and research expertise to develop new medicines aimed at addressing critical unmet medical needs, although the companies have not disclosed the specific targets or therapeutic areas.
The agreement includes $100M in upfront and near-term payments, with InnoCare eligible for up to $3.25B in development and commercial milestones, alongside tiered single-digit royalties on annual net product sales.
The structure gives Lilly access to multiple discovery programs while limiting the upfront commitment before the targets and resulting medicines are further developed.
The deal adds another collaboration to Lilly’s active 2026 business development strategy, following a series of acquisitions, licensing agreements and research partnerships aimed at expanding its pipeline. For InnoCare, the partnership provides additional funding and a global pharma partner to advance programs emerging from its drug discovery platform.
This deal highlights the growing importance of strategic partnerships in expanding pharma pipelines and accessing external drug discovery capabilities. It also shows how large upfront commitments can be paired with substantial milestone payments, allowing companies to pursue multiple potential targets while sharing development risk.
Read more here.
Big Pharma Calls on Europe to Strengthen Biopharma Innovation
AstraZeneca, Boehringer Ingelheim, Chiesi, Ipsen, GSK, Novo Nordisk, Novartis, Roche and Sanofi have called on EU leaders to strengthen Europe’s pharmaceutical innovation environment. In an open letter, the companies said Europe is losing ground in global pharmaceutical R&D and urged policymakers to improve conditions for investment in next-generation medicines.
The companies called for faster clinical trials, stronger intellectual property protection, supportive digital policies and greater fiscal flexibility for member states to invest in innovative medicines. They highlighted data showing Europe’s share of global pharmaceutical R&D has fallen from 43% in 1990 to 31% today, while its share of commercial clinical trials has fallen to 9%.
The call comes as Europe faces increasing competition from the U.S. and China in biopharmaceutical research and clinical development. An EFPIA-commissioned analysis estimates that increasing clinical-trial activity by 50% could generate €17.9B in additional economic value and support around 82,000 jobs, alongside 158,000 additional trial places.
This case highlights growing industry concern about Europe’s competitiveness in pharmaceutical R&D and clinical trials. It also shows how policy areas including clinical-trial processes, intellectual property, reimbursement and investment conditions can influence the region’s attractiveness for life sciences development.
Read more here.
FDA Approves Ultragenyx’s Fayuvi Gene Therapy for Sanfilippo Syndrome Type A
The FDA has approved Ultragenyx’s Fayuvi (ux111) as a treatment for pediatric patients with neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. Fayuvi is the first FDA-approved treatment for MPS IIIA.
Fayuvi uses an adeno-associated virus 9 (AAV9) vector to deliver a functional copy of the SGSH gene. The treatment is administered as a one-time intravenous infusion and is intended to enable cells to produce sulfamidase, the enzyme deficient in people with MPS IIIA.
The FDA’s decision was based on data from a single-arm clinical study and comparisons with natural-history data. In the study, 17 younger or earlier-stage children showed a 23.2-point treatment effect in cognitive scores compared with natural history data. Fayuvi has a wholesale acquisition cost of $3.95 million, before discounts and rebates.
The approval follows an FDA rejection in 2025 related to manufacturing issues. Ultragenyx subsequently resubmitted the application, which received priority review. Fayuvi is the company’s second FDA-approved gene therapy following Genglycos, which was approved in August 2026.
Fayuvi’s approval adds a gene therapy option for children with MPS IIIA and follows a regulatory process that included an earlier rejection related to manufacturing and a subsequent resubmission.
Read more here.
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