💊The study looked at giredestrant as a frontline therapy in combination with Pfizer’s Ibrance for certain breast cancer patients. Roche said there was a numerical improvement in progression-free survival in the giredestrant arm versus a control group. But the difference wasn’t statistically significant.

Roche continues to make the case for giredestrant. The selective estrogen receptor degrader, or SERD, is currently awaiting US approval based on a successful Phase 3 trial called evERA in advanced breast cancer. And Roche is planning to submit data from a separate Phase 3 trial in early-stage breast cancer in the coming weeks. That trial, dubbed lidERA, “is actually the primary driver of giredestrant’s potential,” according to a Roche spokesperson. 

The spokesperson said that “the commercial opportunity for giredestrant remains substantial,” noting that lidERA was the first Phase 3 trial of a SERD to demonstrate a significant benefit in the adjuvant setting.

But Jefferies analysts called the update a “meaningful setback.” They said the news “pulls the rug from” giredestrant’s multibillion-dollar sales case. Endpoints senior biopharma journalist Elizabeth Cairns breaks down the implications here. 

👋Uğur Şahin and Özlem Türeci are set to leave BioNTech by the end of the year and set up a new company dedicated to next-generation mRNA innovations. BioNTech said it would contribute certain rights and mRNA technologies to the new, unnamed company “on an arm’s length basis” in exchange for a minority stake and possible milestones and royalties.

It remains to be seen exactly what the new biotech will work on. Şahin told investors on a call that the mRNA space “is rapidly advancing and we are seeing a lot of innovation happening, particularly in combination with AI. And we together felt really the need to address that.” Aside from the part-ownership by BioNTech, the new entity will have distinct resources, operations and funding options.

Meanwhile, BioNTech will narrow its focus to its late-stage pipeline and begin the search for a new CEO and medical chief. CFO Ramón Zapata-Gomez said on the call that BioNTech was looking for “leaders with strong experience in late-stage development and commercial execution, which reflects BioNTech’s next phase of growth.”

A legacy at BioNTech: Şahin and Türeci founded the company in 2008 with Christoph Huber, initially focusing on cancer. But everything changed when the biotech used its mRNA expertise to develop a shot for Covid-19 in collaboration with Pfizer. In recent years, BioNTech has worked hard to diversify away from the Covid vaccine, which remains its only marketed product. 

📈Eli Lilly’s recent success in weight loss has hauled it to new heights. CEO David Ricks wants to keep it there. 

Under Ricks’ leadership, Lilly recently touched a trillion-dollar valuation. To keep the momentum, Ricks needs to build out a pipeline that’s so broad and so forward-looking that it defies the gravitational pull of blockbuster patent expiries, Endpoints’ Andrew Dunn writes. Ricks calls it achieving “exit velocity.”

To do that, Lilly has undertaken a range of unusual tactics. While it continues to build out its weight loss franchise with additional assets, it’s also partnering with Nvidia on a new AI-powered discovery lab, constructing an industry-leading supercomputer, offering an AI model-for-data swap to biotechs, leaning heavily into direct-to-patient sales, and partnering with the VC firm a16z on a new biotech fund.

Ricks brings an obsession with speed to Lilly, and with it, lots of deals. Ricks said at JPM that the business development team averaged a deal every nine days in 2025, totaling 39 for the year. And the company has kept up its frenetic pace since then. Read more here from Andrew’s deep dive into how Lilly plans to stay on top. 

🥊This week, Hims and Novo ended their feud. Hims will stop advertising compounded GLP-1s and prescribe them only on a “limited scale.” Instead, it will offer Novo’s brand-name treatments at discounted cash prices. Novo dropped its lawsuit against the telehealth company in return.

While Novo won the dispute, Hims and its peers are impacting the broader US system for selling drugs. Compounded GLP-1s supercharged Hims’ growth over the past couple of years. And pressure from compounders, along with political pressure, has prompted pharma companies to lower their drug prices. When Novo launched its Wegovy pill in January, it immediately offered patients a cash price starting at $149 a month, allowing telehealth partners like Ro and Weight Watchers to offer it at the same price. By early February, more than 170,000 people were on the Wegovy pill, and most were paying cash, Novo officials said.

Hims could still face challenges as it shifts its focus to brand-name GLP-1 treatments. It could lose patients to companies that continue to offer compounded versions, or suffer smaller margins. And there’s still the question of what the FDA’s next steps are: FDA Commissioner Marty Makary had promised a crackdown on GLP-1 compounding, naming Hims explicitly. You can read more here from Shelby Livingston and Ngai Yeung, or tune in to our Post-Hoc Live session for further analysis. 

🧪The readout paves the way for Vertex to complete an accelerated approval filing by the end of the month. The interim data come from the ongoing RAINIER trial, studying povetacicept for a disease called immunoglobulin A nephropathy, or IgAN. Vertex said the drug reduced the urine protein-to-creatinine ratio — an early indicator of IgAN — by 52% from baseline after 36 weeks. 

Povetacicept plays a key part in Vertex’s strategy. The company picked up the drug in its $4.9 billion buyout of Alpine Immune Sciences in 2024, and CEO Reshma Kewalramani this week described kidney-related diseases as “Vertex’s fourth franchise alongside cystic fibrosis, hematology and acute pain.”

If approved, the drug could enter a competitive market. But Vertex chief commercial officer Duncan McKechnie described the drug’s dosing regimen — a monthly, at-home auto-injector — as a potential key advantage in winning over physicians. Andrew Dunn breaks down the readout here.