Arrowhead Pharmaceuticals achieved strong Phase 3 results for plozasiran, and the FDA approved Takeda and Protagonist's new polycythemia vera treatment Mimrylo. Meanwhile, AstraZeneca and Ionis suffered a late-stage trial failure for their heart disease drug eplontersen. M&A activity also picked up as Argenx bought Forte Biosciences for $2.2 billion and Teva bid for BioXcel's neuroscience assets.
Proving acute pancreatitis prevention converts plozasiran from a routine lipid reducer into a high-value preventative therapy, while an acquired priority review voucher accelerates commercial deployment.
Arrowhead Pharmaceuticals reported that its trials for plozasiran achieved median triglyceride reductions of 79% and 81% at month 12 in patients with severe hypertriglyceridemia. Presented at the European Society of Cardiology Congress in Munich, the SHASTA-3 and SHASTA-4 studies met their primary and secondary endpoints. In the highest-risk subgroup of patients with triglyceride levels above 880 mg/dL and a prior history of acute pancreatitis, the drug demonstrated a 100% reduction in events compared to placebo. Across the broader pooled population with triglycerides above 500 mg/dL, cumulative acute pancreatitis events fell by 78%. More than 90% of treated patients reached triglyceride levels below 500 mg/dL by month 12. Arrowhead plans to submit a supplemental New Drug Application to the U.S. before the end of 2026, utilizing a Priority Review Voucher purchased in August.
Plozasiran Triglyceride Reduction vs Placebo (%)
Plozasiran achieved median triglyceride reductions of 79% and 81% in phase 3.
India and Argentina Seek to Expand Pharma and Agricultural Trade
Upgrading India to Annex I status reduces regulatory approval timelines for generic drugmakers, lowering the capital required for Indian pharmaceutical expansion into Latin American markets.
India and Argentina agreed to expand market access for pharmaceutical and agricultural goods during bilateral trade talks in Buenos Aires. Bilateral trade between the two nations surpassed USD 6.5 billion in 2025, marking an annual growth rate of over 17 per cent. Under the agreement, Argentina will work to upgrade India from Annex II to Annex I within its pharmaceutical regulatory framework. Technical discussions also advanced regarding sanitary and phytosanitary measures for Indian farm exports including onions, milk products, grapes, potatoes, bananas, and pulses. Beyond trade, the countries reviewed ongoing lithium exploration projects in Catamarca by India's KABIL and explored broader cooperation across mining, energy, digital services, and space technology.
argenx Completes Acquisition of Forte Biosciences for $77 Per Share
Absorbing a clinical-stage CD122 molecule hedges revenue concentration in Vyvgart by using existing balance-sheet cash to buy a second autoimmune pipeline anchor.
Argenx completed its of Forte Biosciences at a price of 77 dollars per share in cash. The transaction closed on August 27, 2026, following a tender offer in which 19,894,879 shares were validly tendered, representing approximately 87.13 percent of Forte's outstanding common stock. Argenx funded the acquisition entirely from its cash on hand, with total consideration reported at approximately $2.2 billion. Through a subsequent , Forte became a wholly owned subsidiary of Argenx and its shares were delisted from the Market. The deal brings the antibody candidate FB102 into Argenx's immunology pipeline, adding a first-in-class anti-CD122 molecule with clinical data in vitiligo and celiac disease. Management positions the acquisition as part of the Vision 2030 strategy to expand beyond its flagship therapy Vyvgart.
FDA Approves Takeda and Protagonist Drug for Rare Blood Disorder
Mimrylo's approval proves that synthetic hepcidin mimetics can disrupt chronic phlebotomy regimes, creating a new therapeutic class that replaces invasive procedure-based care with recurring specialty biologic revenue.
The US Food and Drug Administration approved Mimrylo to treat adults with polycythemia vera. Developed by Takeda and Protagonist Therapeutics, the drug is the first approved treatment for the rare blood disorder that mimics hepcidin to regulate iron and limit red blood cell overproduction. Patients with the condition often require frequent phlebotomies to maintain hematocrit levels below 45 percent and reduce cardiovascular risks like blood clots and strokes. In the VERIFY study of 293 adults requiring frequent phlebotomies despite standard care, 76.9 percent of patients receiving Mimrylo needed no phlebotomies between weeks 20 and 32 compared to 32.9 percent on placebo. The drug was administered subcutaneously once weekly starting at 19 mg and received priority review.
VERIFY Trial Phlebotomy-Free Rate (%)
Mimrylo patients avoided phlebotomies at more than twice the placebo rate.
Adding novel gene silencers on top of established protein stabilizers yields minimal incremental clinical benefit, weakening the pricing power and commercial underwriting for combination therapies in cardiomyopathy.
AstraZeneca and Ionis Pharmaceuticals reported that their gene-silencing drug eplontersen failed to show a statistically significant reduction in cardiovascular events or death in a late-stage heart disease study. The trial, called CARDIO-TTRansform, enrolled more than 1,400 volunteers with transthyretin-mediated amyloidosis cardiomyopathy over 140 weeks. Investigators found that 29% of patients taking eplontersen experienced cardiovascular events or death, compared to 32% of those given a placebo. Most participants in the study were already taking protein stabilizers, a standard-of-care medication type. The negative results raised questions about whether combining gene silencers with stabilizers provides meaningful incremental benefits. Alnylam Pharmaceuticals shares fell as much as 5% in morning trading following the data release, while AstraZeneca and Ionis stock prices ticked down about 1% and 2%.
CARDIO-TTRansform Trial Events (%)
Eplontersen showed no significant benefit over placebo in reducing events.
Teva Acts as Stalking Horse Bidder for Bankrupt BioXcel's Neuroscience Portfolio
Using Chapter 11 to acquire late-stage sublingual film assets transfers regulatory approval risk to milestone payouts while securing a baseline valuation before open auction bidding.
Teva Pharmaceutical Industries has agreed to act as the stalking-horse bidder for BioXcel Therapeutics, offering $57.5 million upfront plus up to $67.5 million in milestones for substantially all of the bankrupt biotech's . BioXcel filed for voluntary Chapter 11 protection in the U.S. Court for the District of Delaware under case number 26-11360, listing estimated liabilities between $100 million and $500 million alongside assets valued between $10 million and $50 million. The transaction structure relies on a Section 363 auction process designed to establish a baseline while allowing higher bids, backed by a $5.7 million good-faith deposit from Teva. To fund operations through the court-supervised sale, BioXcel secured $19 million in debtor-in-possession financing from its existing secured lenders. The core assets under purchase include IGALMI sublingual film and the pending supplemental New Drug Application for BXCL501 targeting at-home treatment of agitation associated with schizophrenia or bipolar disorder, which carries an PDUFA target date of November 14, 2026. Securing the full $67.5 million in milestone payments depends on the FDA approving the candidate by that deadline, with lower thresholds scaling down if the decision is delayed to February 2027 or beyond.
FDA Seeks Public Input on Regulating Generative AI Medical Devices
Shift-planning for generative health tools toward clinician-style competency evaluations creates pre-market compliance hurdles that favor deep-pocketed platform incumbents over standalone point-solution startups.
The U.S. Food and Drug Administration has opened a public consultation on regulating medical devices powered by generative , setting an October 19, 2026 comment deadline. While the agency has authorized over 1,000 conventional AI medical devices, generative systems introduce open-ended outputs, variable responses, and reliance on third-party foundation models that current regulatory frameworks do not fully address. The discussion paper outlines a proposed two-axis risk framework evaluating software function and the severity of potential harm from incorrect outputs, ranging from informational support to autonomous action. To address these challenges, the is exploring a competency-based evaluation model inspired by human clinician credentialing, incorporating non-clinical benchmarking and clinical confirmation studies before market entry. The consultation does not establish binding policy or immediate new evidence requirements, but serves to gather stakeholder feedback on how to oversee technologies capable of producing hallucinations or variable clinical recommendations.
Strong late-stage trial wins and active M&A contrast sharply with major clinical setbacks in cardiac gene silencing. The key open question is whether regulators will rapidly adapt to novel generative AI medical device frameworks while trial risks persist.
This, every morning.
SuMarket writes Healthcare and Pharmaceutical Sector every morning, along with every other section of the market and the companies and topics you follow. Free to read.