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Viridian's Thyroid Eye Drug Just Beat Its Own FDA Deadline
The FDA approved Viridian's Lumvoa (veligrotug) for thyroid eye disease four days ahead of its June 30 deadline, making it only the second targeted biologic for a condition that can literally push your eyeballs out of their sockets. In pivotal trials, 56% of patients saw meaningful reduction in eye bulging versus just 8% on placebo. The treatment requires five infusions over 12 weeks, a noticeably lighter burden than competitor Tepezza's eight infusions over approximately 24 weeks. Shares jumped roughly 10% after hours, but analyst price targets in the mid-$30s suggest the market hasn't fully digested the news.
Why it matters: Viridian's approval transforms it from a clinical-stage company into a commercial competitor in the autoimmune space, giving thyroid eye disease patients real therapeutic choice for the first time and setting up a high-stakes market share battle with Tepezza.
Read more →Science and Discovery
For the First Time Ever, a Drug Built Muscle in Muscular Dystrophy Patients
Three patients with FSHD, a dystrophy with zero approved treatments, gained an average of 370 milliliters of lean muscle after a single IV dose of Epicrispr's EPI-321. That's unprecedented: every prior trial in this disease showed patients losing muscle, not building it. The therapy uses CRISPR to silence a toxic gene without cutting DNA. It's only three patients and six months of data, but for a field littered with failures, even a small river flowing uphill is remarkable.
Read more →Boehringer Bets $15M That the Next PD-1 Is Hiding in Your T Cells
Boehringer Ingelheim is partnering with AI-biotech Immunai to hunt for unknown immune checkpoints beyond PD-1, using a database of over 300,000 patient samples across 500 diseases. Only about 20% of cancer patients respond to current checkpoint drugs; the collaboration aims to find the molecular brakes nobody has identified yet, spanning both cancer and autoimmune disease.
Read more →A Former Tobacco-Plant Biotech Just Dosed Its First Patient With an AI-Designed Obesity Drug
iBio's IBIO-600, an AI-designed antibody that blocks muscle-wasting signals, entered a Phase 1 trial in Australia after just seven months from discovery to development candidate. The pitch: pair it with GLP-1 drugs to preserve the lean muscle mass that Ozempic and friends tend to chew through. It's early (32 patients, safety-focused), but it puts a real clinical proof point behind AI-driven drug design in the hottest market in pharma.
Read more →Deals and M&A
Biogen Spent $5.6 Billion on Apellis, Then Gutted the Lab
Barely a month after closing its Apellis acquisition, Biogen paused or killed the majority of the biotech's research programs, keeping only two approved drugs generating $689 million in annual revenue. The irony: Biogen is suspending Apellis' kidney trials while planning to use Apellis' nephrology sales team to launch a completely different kidney drug. It's the "buy the restaurant, fire the chefs" playbook that Big Pharma has been running for decades.
Read more →Big Pharma's $123 Billion Shopping Spree Is Only at Halftime
Pharma M&A has already blown past $100 billion by mid-2026, with analysts projecting the biggest dealmaking year since 2019. The fuel: over $150 billion in annual drug revenue facing patent expiration by 2028. AbbVie just dropped $10.9 billion on Apogee for next-gen eczema drugs, and GSK wrote a $10.6 billion check for Nuvalent's lung cancer portfolio. Merck still hasn't made its marquee move.
Read more →Parabilis Raised $670 Million in an IPO. It Doesn't Have a Phase 3 Trial.
Parabilis Medicines (formerly FogPharma) priced the largest biotech IPO in U.S. history at $670 million, backed by a concurrent $75 million Regeneron placement. The company's Helicon peptide platform targets "undruggable" cancer proteins inside cells. Its lead drug is still in Phase 1/2, with a registrational trial not expected until 2027. That's superstar money for a preseason rookie.
Read more →Access and Policy
Lantheus Had Perfect Clinical Data. A Broken Factory Killed Its Approval.
The FDA rejected Lantheus' cancer imaging agent LNTH-2501 despite flawless clinical data and a clean safety profile. The culprit: a third-party manufacturing facility that couldn't pass inspection. Manufacturing issues now account for roughly 74% of FDA rejection letters, and this CRL likely delays approval by 12 to 18 months. A product designed to improve supply chain access, derailed by a supply chain failure.
Read more →A Needle-Free EpiPen Alternative Exists. Good Luck Getting Your Insurance to Cover It.
CVS Caremark punted its formulary decision on Neffy, the first needle-free epinephrine nasal spray, to 2027. While the company claims 93% of commercial lives technically have "coverage," only 57% can actually get it without prior authorization hoops. The company's Q1 prescriptions tripled year-over-year, with sales reaching $17.5 million, but ARS Pharmaceuticals lost $60.6 million in the same quarter fighting for access against PBM gatekeepers.
Read more →BIO 2026's Three Big Debates: China, the Biosecure Act, and Whether AI Can Actually Cook
Biotech's biggest annual conference surfaced three strategic tensions reshaping the industry. U.S.-China decoupling is splitting companies between those who see Chinese partners as indispensable and those who see them as a liability. The Biosecure Act is already driving supply chain shifts despite enforcement timelines stretching to 2028. And AI drug discovery landed its biggest deal yet: a $2.5 billion Insilico-SK Biopharmaceuticals collaboration announced opening day.
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