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Roche's Breast Cancer Pill Wins Everywhere Except the One Place That Counts
Giredestrant, Roche's oral breast cancer drug, showed positive results in its phase 3 persevERA trial in first-line metastatic breast cancer, with giredestrant plus palbociclib significantly improving progression-free survival compared to the standard letrozole-palbociclib combo. The drug has also been on a winning streak elsewhere, cutting recurrence risk by 30% in early-stage disease and nearly doubling progression-free survival in second-line patients with ESR1 mutations. AstraZeneca's camizestrant, another oral SERD in late-stage development, is now a key competitor in the class.
Why it matters: This result redraws the commercial map for an entire drug class. If no oral SERD can displace standard endocrine therapy up front, the addressable market shrinks from universal to niche, and companies like AstraZeneca, Eli Lilly, and Olema need to rethink where these drugs fit.
Read more →Deals and M&A
$300M Upfront, FDA Decision in 14 Days: Alfasigma's High-Stakes Itch Drug Bet
Alfasigma paid GSK $300 million upfront (up to $690 million total) for worldwide rights to linerixibat, an oral pill for the severe, sleep-destroying itch caused by primary biliary cholangitis. The FDA's approval decision hits March 24, barely two weeks out. GSK shed the asset to focus on larger liver markets; for Alfasigma, which already owns PBC drug Ocaliva, the deal could cement its hepatology franchise overnight.
Read more →Funding and Financings
Candid Therapeutics Sneaks Onto Nasdaq With a $505M Reverse Merger
Ken Song, the CEO who sold RayzeBio to Bristol Myers Squibb for $4.1 billion, just took his next company public without an IPO. Candid Therapeutics merged with Rallybio in a deal that left Candid shareholders owning 96.3% of the combined entity. The $505 million financing round was oversubscribed, led by RA Capital and Venrock, giving the autoimmune-focused T-cell engager company cash through 2030.
Read more →Clinical and Regulatory
One Weekly Shot Instead of Seven: FDA Approves a New Dwarfism Treatment
The FDA granted accelerated approval to Ascendis Pharma's Yuviwel, the first once-weekly therapy for children with achondroplasia. In trials, kids gained an extra 1.49 cm per year of growth versus placebo, with a safety profile similar to placebo. Yuviwel now challenges BioMarin's daily-injection Voxzogo (a $927 million product), though an oral competitor from BridgeBio looms on the horizon.
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