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The FDA approved Revolution Medicines' Rasonque for patients with metastatic pancreatic adenocarcinoma who have received one prior treatment and are not eligible for multiagent therapy. The drug, formerly daraxonrasib, nearly doubled median survival compared to chemotherapy in a Phase 3 trial. It targets RAS mutations via a novel molecular glue mechanism. The list price for a 30-day supply is $39,800, and analysts predict peak annual sales of $11.5 billion. The approval was expedited using a special voucher, and European regulators are conducting a phased review.
The U.S. FDA approved Revolution Medicines' pancreatic cancer drug Rasonque (daraxonrasib) on Wednesday for patients with metastatic pancreatic ductal adenocarcinoma who have received one prior treatment. In clinical trials, the drug nearly doubled median patient survival and has been hailed as a 'game-changing' therapy by oncologists and Wall Street analysts. Rasonque targets RAS mutations through a 'molecular glue' mechanism and is projected to reach peak annual sales of $11.5 billion.
Spyre Therapeutics announced results from a Phase 2 trial of SPY072 in rheumatoid arthritis, where the drug failed to meet the company's predefined development threshold, prompting a shift to other autoimmune indications. Shares dropped 13% in response, with a market value loss exceeding $1 billion.
Biohaven has entered into a strategic agreement with SK Biopharmaceuticals to sell the global rights to its Kv7 ion channel technology and lead asset opakalim (for focal epilepsy) for a total transaction value of up to $795 million. The deal includes a $350 million upfront payment, an additional $50 million in 2025, and up to $150 million in development and regulatory milestone payments, while SK will assume potential obligations to Knopp Biosciences. Biohaven retains royalties on future sales and plans to focus on other pipeline programs.
Today's industry news roundup: Eli Lilly's Zepbound study shows reduced medical costs for obese or overweight adults over 55; Akeso and Summit's ivonescimab shows survival benefit in a Phase III trial for advanced biliary tract cancer in China; McKesson acquires Precision Medicine Group for $2.25 billion; Haisco licenses immunology drug to newly formed Sentivera; Johnson & Johnson's Imaavy receives FDA approval for warm autoimmune hemolytic anemia; Bausch + Lomb advances dry eye drug into Phase III trials.
The FDA has expanded approval of Jazz Pharmaceuticals' Ziihera for frontline use in HER2-positive gastrointestinal cancers, a setting where it reduced progression or death risk by 35% versus Herceptin and chemo in a Phase 3 trial. RBC analyst Leonid Timashev sees a market opportunity north of $1.5 billion with relatively quick uptake, while Stifel's Annabel Samimy notes roughly 12,000 eligible U.S. patients, far more than the 1,500 with biliary tract cancer. The broad label includes lower HER2 expression and tumors in the esophagus and gastroesophageal junction. Jazz acquired most rights from Zymeworks in 2022; Zymeworks earned a $250 million payment for the approval and stands to receive up to $1.3 billion in milestones plus royalties. Ziihera's revenue could climb further if breast cancer trials, with initial data expected in late 2027, are successful.
The U.S. FDA approved Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) in combination with chemotherapy (with or without immunotherapy Tevimbra) for first-line treatment of HER2-positive gastrointestinal cancers on Tuesday. The drug had previously received accelerated approval for advanced biliary tract cancer, generating $24.8 million in related revenue in 2025. Analysts estimate the market opportunity for the new indication exceeds $1.5 billion, and the FDA imposed no excessive safety restrictions. Jazz and partner Zymeworks will share milestone payments, with Zymeworks having already received $250 million, plus $1.3 billion in future milestones and royalties.
The Elecsys pTau217 blood test, developed jointly by Roche and Eli Lilly, has received U.S. FDA approval to aid in the assessment of Alzheimer's disease. The test targets individuals aged 55 and older showing signs of cognitive decline and helps clinicians evaluate the likelihood of amyloid pathology. Both Labcorp and Quest Diagnostics have announced plans to offer this test.
The latest MassBio industry report indicates that in the first half of 2026, Massachusetts biotech companies secured nearly $3.5 billion in venture capital, up 25% year-over-year, with eight Boston-area biotech companies completing IPOs. However, funding is concentrating in more mature companies, with the average seed round amount dropping to $4.65 million, while the average Series A round approaches $80 million, leaving early-stage startups facing financing difficulties. The report also includes a first-ever "China Watch" section, showing that China's drug pipeline grew 36.2% year-over-year, surpassing Europe for the first time.