Solt DB

One quarter through the "century of biology," we're great at building startups deemed successful by the vanity metrics of success, but terrible at building commercially successful businesses. Why does the storytelling and perception of synthetic biology companies often deviate from the realities of the underlying?businesses? https://lnkd.in/e_FGGRY6

Drug development is a three-legged stool. A slew of emerging technology platforms combine experimental and computational data to de-risk drug discovery. That includes Dynamo from Relay Therapeutics, Recursion OS from Recursion , and cell engineering services from Ginkgo Bioworks, Inc. , among others. Yet, amid all the hype, investors appear to be forgetting the simple reality of successful drug development: discovered molecules must become developed molecules must become commercialized molecules. Execution in one area doesn't guarantee success in another – and few companies succeed at all three. The most important is commercial execution, for which AI drug discovery expertise offers no help at all. Relay Therapeutics has demonstrated it excels at drug discovery. The FGFR2 inhibitor lirafugratinib earned FDA Breakthrough Therapy designation – the first AI-discovered molecule to do so – by doubling response rates in bile duct cancer. Meanwhile, the company's scientists solved the first full-length structure of the PI3K-alpha protein (one of the most important in human biology) and discovered a novel allosteric pocket, leading to RLY-2608 as the first pan-mutant PI3K-alpha inhibitor. The company is also proficient in drug development. Its four clinical-stage assets were or are being evaluated in programs designed to enroll 1,701 patients total, according to data published by the National Institutes of Health (NIH). It has already dosed over 800 patients within its two leading programs. By contrast, fellow supercomputer-wielder Recursion Pharmaceuticals expects to enroll 622 patients when evaluating its first seven assets.?

Another peek behind our paywall for equities research. This research note discusses the pivotal study design of ReDiscover-2 from Relay Therapeutics , which will pit RLY-2608 plus fulvestrant against Truqap plus fulvestrant in second-line HR+/HER2- breast cancer. ?? Truqap from AstraZeneca has become the standard of care in this setting, notching full-year 2024 revenue of $430 million. Not a bad haul for its first full year on the market. Its overnight success has knocked Piqray from Novartis off its blockbuster trajectory. ?? Commercial success when targeting PI3K-alpha mutations in breast cancer is driven by efficacy and low rates of grade 3 hyperglycemia. Both Truqap (2%) and RLY-2608 (3%) check that box. Non-selective PI3K inhibitors such as Piqray (29%) are more difficult for oncologists to manage. ?? The ReDiscover-2 study design favors a positive outcome and at least one approval for RLY-2608. Co-primary endpoints will be median progression free survival (mPFS) in kinase mutations and mPFS overall. Truqap notched 5.5 months overall in its pivotal study, while RLY-2608 delivered 11.4 months overall and 11.4 months in kinase mutations. However, a larger study could lift mPFS in kinase mutations near 18.4 months. ?? If RLY-2608 earns a kinase-specific approval, then it's a $1.5 billion opportunity with no competition. If RLY-2608 secures a broader approval, then it's a $3 billion opportunity. https://lnkd.in/eDA-w_up

We donate 6% of all membership revenue to public benefit projects, including decarbonization efforts through Stripe Climate. Check out some of the new projects for 2025! https://lnkd.in/e2h4NWVX

A peek behind our paywall! Fresh off a licensing deal for NDA-ready lirafugratinib, there are subtle hints Relay Therapeutics $RLAY isn't done monetizing its R&D engine. Maybe the hints aren't so subtle if investors look at 2025 guidance.

Americans are rightly pissed off at the broken American healthcare system. Earlier this year, we compiled the first-ever database of global blockbuster drug products. Although Americans represent 4% of the world population, they generate 60% of global blockbuster sales.

Arrowhead Pharma recently submitted its first-ever BLA. The asset, plozasiran, is an siRNA molecule that inhibits ApoC3 expression in liver cells to reduce triglycerides. The RNAi therapeutic has earned FDA Breakthrough Therapy designation and is expected to earn approval in a rare metabolic disorder in 1H 2025. Approvals in broader indications could follow.

In 2024, Novartis' Pluvicto will become the first blockbuster radiopharmaceutical. The field has grown so quickly it's impacted global supply chains for radiomolecules. Seriously. But how do they work? Solt DB Database Builder Luca Stenger drops some knowledge in this illustration.

Today, over 94% of all cotton, soybean, and corn grown in the United States harbors improved genetic traits. That's up from 61%, 54%, and 25% respectively in 2000. The impressive adoption curve was powered by the emergence of stacked traits, which combine insecticide and herbicide benefits into one seed. Read more and view interactive data visualizations: https://lnkd.in/et4Mk4T3

If you paid **ANY** U.S. income taxes from 2014 to 2023, then you had a higher tax rate than Pfizer. In fact, the U.S. government gave Pfizer tax breaks of $17 billion in that decade. The world's formerly-largest drug developer generated earnings before income taxes (EBIT) of $138 billion in that span. It spent $124 billion on dividends and share buybacks vs. $89.5 billion on R&D expenses.