Issue #84·

A pig kidney kept a man alive for 271 days. Now the FDA wants more.

A gene-edited pig kidney just set a durability record that could reshape transplant medicine for 90,000 Americans on the waitlist. Meanwhile, pharma is pouring hundreds of billions into U.S. factories, UCB dropped $2 billion on a company that didn't exist two years ago, and an algorithm went shopping for a cancer drug.

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The Pig Kidney That Worked for Nine Months

Tim Andrews lived 271 days on a gene-edited pig kidney, the longest a xenotransplant has ever kept a human off dialysis. The kidney, engineered by eGenesis with 69 CRISPR modifications, was eventually removed after chronic rejection set in, but not before proving that cross-species organs can sustain a person for months. The FDA has now cleared an expanded Phase 1/2/3 trial for 33 patients with end-stage kidney disease. With 90,000 people on the U.S. kidney waitlist and only 28,000 transplants performed last year, the stakes could not be higher.

Why it matters: This is the strongest clinical evidence yet that xenotransplantation can work in living humans, and the FDA's trial expansion signals regulators see a viable path forward for a technology that could fundamentally close the organ shortage gap.

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Deals and Strategy

UCB Paid $2 Billion for a Company That Didn't Exist Two Years Ago

UCB is paying $2 billion upfront for Candid Therapeutics, a biotech formed in 2024 that has never sold a product. The crown jewel is cizutamig, a T-cell engager that sends immune cells after the plasma cells producing disease-causing antibodies in autoimmune conditions like lupus. It's been tested in about 80 patients so far. UCB is betting that "immune reset" can replace chronic therapy for millions of autoimmune patients.

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The $2 Stock That Just Sold for $1.1 Billion

Esperion once traded above $115. It was languishing under $2 when healthcare PE firm ARCHIMED swooped in with an all-cash take-private at $3.16 per share. The twist: Esperion's cholesterol drug bempedoic acid actually reduces heart attacks by 13%, U.S. net product revenue grew 48% in 2024, and the market just didn't care. ARCHIMED sees a mansion where Wall Street saw a teardown.

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Novartis Is Firing Scientists While Posting $13 Billion Quarters

Novartis cut research staff despite Q1 revenue of $13.1 billion, with top drugs growing 55% to 79%. The reason: a deliberate shift toward sourcing innovation externally through licensing and acquisitions, rather than running sprawling internal discovery. It's a model Big Pharma is converging on, and it means more deal flow for clinical-stage biotechs with the right assets.

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Clinical and Regulatory

A Cancer Vaccine Built From Your Own Tumor DNA Just Finished Enrollment

Moderna and Merck completed enrollment in their pivotal Phase III trial for a personalized mRNA cancer vaccine in melanoma. Each dose is custom-built from a patient's tumor DNA, targeting up to 34 unique mutations. Phase IIb data showed a 49% reduction in recurrence at five years when added to Keytruda. Interim Phase III data are expected later in 2026.

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Pfizer's Two-in-One Cancer Drug Is Headed for a Keytruda Showdown

Pfizer advanced a bispecific antibody that blocks both PD-1 and VEGF into Phase III trials across lung and colorectal cancers, directly challenging Keytruda-based regimens. Early data showed response rates up to 69% in lung cancer. Pfizer paid $1.25 billion to license the drug from 3SBio, and the trials will enroll over 2,300 patients total.

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Starving Tumors: Faeth's Metabolic Therapy Posts 80% Response Rate

Faeth Therapeutics reported an 80% response rate in endometrial cancer with Piktor, a combo that shuts down the PI3K/mTOR pathway at three points simultaneously. The wildest part: they're also prescribing an insulin-suppressing diet to cut off the tumor's fuel supply. Small numbers (10 patients), but progression-free survival hit roughly 11 months versus three to four for chemo alone.

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Industry Shifts

Pharma's $290 Billion Bet on American Soil

Biopharma companies have pledged over $350 billion toward U.S. manufacturing in just six months, driven by threatened tariffs of 100% or more on imported drugs. Merck leads at $70 billion, followed by J&J ($55B), Roche ($50B), and AstraZeneca ($50B). The catch: these are pledges, not finished factories. Most take five to ten years to build, and the talent to staff them doesn't yet exist.

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BMS Hands 30,000 Employees an AI Copilot

Bristol Myers Squibb is deploying Anthropic's Claude AI across its entire global operation, from drug discovery to the sales force. The goal isn't a chatbot; it's an intelligence layer that drafts regulatory documents, traces manufacturing problems, and connects decades of siloed data. With billions in revenue at risk from patent cliffs by 2030, BMS is treating AI as a survival tool.

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An Algorithm Went Shopping and Bought a Cancer Drug

Pathos AI used its Foundry platform to scan thousands of clinical datasets, flag a promising Belgian cancer drug called DO-2, and acquire the company behind it. Early Phase 1 data showed a 100% response rate in MET-driven lung cancer patients (10 of 10) with dramatically lower side effects than existing drugs. It's one of the first clinical-stage deals sourced entirely by AI.

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