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BridgeBio’s dwarfism pill delivers standout Phase 3 data & the first approval of an immune checkpoint inhibitor in ovarian cancer

AuthorAuthor

Joachim Eeckhout & Eduardo Longoria
February 13, 2026

 

Good morning!

Massachusetts-based Surge Therapeutics just dosed the final patient in its phase 1 trial of SRG-514, a breast cancer therapy designed to be injected directly into the tumor site during surgery. The drug is a reformulated version of ketorolac, a commonly used anti-inflammatory pain medicine typically given after surgery. Surge delivers it directly into the surgical cavity at the time of resection, aiming to eliminate residual cancer cells before they seed recurrence. A pivotal phase 3 study is planned for this summer.

Why it matters: About 9 million cancer patients undergo tumor resection each year, and roughly 40% will recur within five years, with most cancer deaths stemming from recurrence or metastasis. Surge is betting the operating room is oncology’s most overlooked intervention point.

Bottom line: If it works, cancer surgery could become both a removal and a relapse prevention process.

—Joachim E.

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SNAPSHOT

BridgeBio’s dwarfism pill delivers standout Phase 3 data and measures up in the rivalry with BioMarin and Ascendis

BridgeBio’s oral drug infigratinib met its Phase 3 goal in children with achondroplasia, the most common form of dwarfism, boosting annual growth rates by 1.74 to 2.1 cm over placebo and positioning the company to seek approval later this year.

Why it matters: The results set up a high-stakes showdown with BioMarin’s Voxzogo and Ascendis’ pending therapy and could shift patients toward a more convenient oral option. Enthusiasm about the results sent BridgeBio’s shares rocketing up by over 15% premarket.

Backstory: Achondroplasia affects roughly 1 in 15,000 to 40,000 newborns. The FDA has approved only one treatment: BioMarin’s daily injectable Voxzogo, which generated $654 million in the first nine months of last year. Ascendis’ once-weekly TransCon CNP is under FDA review.

Big picture: The dwarfism market is evolving from a single-product space into a competitive field. BridgeBio, buoyed by multiple recent clinical wins and a 140% stock surge over the past year, is betting that efficacy and convenience can unlock significant share in a de-risked, high-value market. This bet is backed up by physicians suggesting that even comparable efficacy to injectables could prompt up to half of patients to switch to an oral therapy.

Zoom in: ~110 children enrolled in the one-year study and not a single one left the study early due to side effects. The trial showed impressive results that topped Voxzogo’s 1.57 cm growth and rivaled Ascendis’ reported results. Annualized height velocity improved by 1.74–2.1 cm vs. placebo and bodes well for the drug’s targeting of FGFR3, a protein that suppresses bone growth. No serious adverse events were tied to treatment; only three mild, transient phosphate elevations were reported.

What’s next: BridgeBio plans regulatory meetings and potential marketing filings in the second half of 2026, while accelerating development in hypochondroplasia, another type of dwarfism. An FDA decision on Ascendis’ drug could come by month’s end.

SNIPPETS

What’s happening in biotech today?

🔓 Checkpoint unlocked: The FDA has approved Merck’s Keytruda as a second- or third-line treatment for patients with PD-L1-positive, platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal carcinoma, marking the blockbuster drug’s first approval in ovarian cancer and making it the first immune checkpoint inhibitor cleared for this indication. Keytruda, used with paclitaxel chemotherapy and with or without Roche’s Avastin, demonstrated in a phase 3 trial a 28% reduction in disease progression or death and a 24% reduction in death compared to placebo, with median overall survival of 18.2 months versus 14.0 months. While benefits were greater in PD-L1-negative patients in subgroup analysis, the approval applies only to PD-L1-positive tumors.

✂️ Staff cuts: Seres Therapeutics is laying off 30% of its workforce and pausing further investment in its phase 2 trial of SER-155, a microbiome therapy aimed at preventing bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplant, as part of a new strategic shift to conserve cash. Although the company had advanced the trial to final protocol submission and drug manufacturing, it will now prioritize earlier-stage programs such as SER-603 for inflammatory and immune diseases while seeking funding or partnerships to resume SER-155 development. Despite prior layoffs and runway extension efforts, Seres expects its cash to last only through the third quarter of 2026, as it continues exploring collaborations and awaits limited clinical data from a small SER-155 study in immune-related enterocolitis.

🔄 CEO shuffle: Belén Garijo, outgoing CEO of Merck, will become CEO of Sanofi following its 29 April annual general meeting after the French drugmaker’s board declined to renew Paul Hudson’s contract, leading to his departure on 17 February after six years in the role. Hudson had sought to strengthen Sanofi’s pipeline and find a successor to blockbuster Dupixent, but despite advancing 82 clinical-stage projects and pursuing a $9 billion acquisition of Blueprint Medicines, the company faced late-stage setbacks and lingering doubts about future growth. Garijo, who has led Merck since 2021, will be succeeded there by Kai Beckmann, as Sanofi continues focusing on innovative medicines, immunology, mRNA partnerships, and plans to separate its consumer health unit.

💰 Capital quest: Europe’s life sciences sector faces a widening financing gap despite strong scientific output, capturing only 7% of global biotech venture capital and seeing nearly all recent EU biotech IPOs list outside Europe. In response, the newly formed European Life Sciences Coalition (ELSC), backed by Invest Europe and comprising major investors, research institutes and legal advisers managing over €24 billion in assets, aims to reform structural barriers that limit long-term capital formation and company scaling. The group plans to engage EU policymakers on capital market integration, regulatory bottlenecks and initiatives such as a biotech-focused fund-of-funds and a Nasdaq-style European exchange, arguing that without deeper capital pools and more unified markets, Europe risks losing companies, innovation and patient access to the U.S.

🇲🇽 Mexican mRNA: Mexico has signed a five-year agreement with Moderna to expand access to mRNA vaccines for respiratory diseases as part of its “Plan Mexico” strategy to boost local production and health security. Under the deal, Moderna will supply its respiratory vaccine portfolio and transfer technology for its Covid-19 vaccine, mRNA-1273 (Spikevax), to Mexican pharmaceutical company Liomont, enabling domestic manufacturing. The partnership contrasts with recent US setbacks for Moderna, including the FDA’s refusal to review its new mRNA flu vaccine and federal funding cuts to mRNA research. Mexico has already ordered up to 10 million updated Covid-19 doses, while other pharma companies are also increasing investments in the country.

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