Original reporting and analysis on the stories shaping biotech.
Insilico Medicine just dosed the first patient in the world's first Phase III trial of a drug designed entirely by AI. Rentosertib, a generative-AI-created molecule for a devastating lung disease, is now the closest any AI-designed drug has come to regulatory approval.
Bayer's sevabertinib just became the third FDA-approved HER2-directed therapy for lung cancer, posting a 71% response rate in a patient population that barely had options a few years ago. The HER2 lung cancer market is suddenly a three-way race, and the competition is heating up fast.
Samsung Biologics is dropping $1.8 billion on Swiss peptide manufacturer PolyPeptide Group in an all-cash takeover bid. The deal is a bold play to capture the exploding GLP-1 manufacturing market, and it could reshape the future of contract drug manufacturing.
MOGAD patients have never had a single FDA-approved treatment. Roche's Enspryng just got Priority Review, and the Phase III data behind it could finally change that. Decision day: January 2027.
Roche just locked up exclusive global rights to a preclinical trispecific antibody from Chinese biotech Simcere Zaiming for up to $1.53 billion. The drug has never been tested in a human, but it targets B cells in a way Roche's legacy blockbusters can't.
ARPA-H just bet $62.7 million that an AI can manage heart failure patients around the clock, prescribing drugs and ordering tests without waiting for a doctor. If it works, it could reshape how we treat the fastest-growing heart condition in America.
Two scientists who independently discovered the same brain molecule in 1998 just won the Lasker Award, often called "America's Nobel." Their work on orexin rewrote sleep medicine and spawned an entire class of insomnia drugs; now the Nobel committee may come calling.
Novartis's $12 billion RNA therapy bet just failed its biggest clinical test in a rare muscle disease, dragging down an entire sector's stocks with it. The result exposes a stubborn problem: getting RNA drugs to actually reach muscle tissue remains one of biotech's hardest unsolved challenges.
Novartis is paying $1.4 billion for Tourmaline Bio and its anti-IL-6 antibody, betting that inflammation (not just cholesterol) is the key to preventing heart attacks. The science is compelling, but the real test is still ahead.
BridgeBio's BBO-8520 is showing striking early response rates in lung cancer patients who've already failed KRAS G12C inhibitors. In a space with no approved salvage therapy, even preliminary data from this dual-mechanism drug has oncologists and Wall Street leaning in.
Pharvaris just posted Phase 3 data showing its once-daily oral pill can prevent hereditary angioedema attacks nearly as well as injectable drugs. The stock surged, analysts raised targets, and the rare disease world is paying attention.
The FDA just accepted Intellia's application for the first-ever in vivo CRISPR gene editing therapy and put it on Priority Review. If lonvo-z gets approved by its March 2027 deadline, it won't just help patients with hereditary angioedema; it'll prove we can cure genetic diseases with a single infusion.
AstraZeneca's COPD biologic tozorakimab just posted strong Phase 3 data and scored FDA Priority Review, going from a consensus forecast of basically zero to a $5 billion peak sales target. The inhaler-dominated COPD market may never look the same.
Novartis' $12 billion RNA drug acquisition just hit a wall. Del-desiran failed its Phase III trial in myotonic dystrophy type 1, torching billions in market value across the neuromuscular space and raising hard questions about the company's bet-the-farm strategy.
Every major pharma company tried to make OX40 agonists work in cancer, and every single one failed. Now Inhibrx's hexavalent approach just delivered Phase 2 results that could resurrect an entire abandoned drug class.
Roivant's inhaled lung drug just posted Phase 2 data strong enough to send the stock up 20% in a day. One analyst thinks it could be a $10 billion-a-year drug. Here's why the numbers have Wall Street losing its mind.
The FDA just approved a blood test that catches breast cancer outsmarting its own treatment, months before a scan would. Paired with AstraZeneca's new drug camizestrant, it could reshape how oncologists fight treatment resistance in real time.
Small cell lung cancer has barely budged on survival in decades. Amgen and AstraZeneca just posted a phase 3 overall survival win with a first-of-its-kind drug combo that could reshape how this brutal cancer gets treated from day one.
Novartis's $12 billion Avidity Biosciences acquisition just hit a wall: the pivotal Phase 3 trial for del-desiran in myotonic dystrophy missed its primary endpoint. Shares dropped 10%, analysts are slashing forecasts, and the biggest RNA muscle-targeting bet in biotech history is suddenly on shaky ground.
For the first time ever, a bispecific T-cell engager combined with immunotherapy has shown a survival benefit in extensive-stage small cell lung cancer. The DeLLphi-305 results could reshape the standard of care for one of oncology's most stubborn diseases.
Merck just dropped $10 billion to buy Verona Pharma and its COPD drug Ohtuvayre. With Keytruda's patents crumbling by 2028, this is Merck's biggest bet yet that respiratory drugs can fill a $30 billion hole.
Moderna just raised $2.6 billion to fund its cancer vaccine pipeline, the largest oncology bet the mRNA giant has ever made. With a landmark Phase 3 win in melanoma already in hand, the former COVID darling is going all in on a second act.
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