SNAPSHOT

Novartis is spending $2 billion upfront to reclaim an edge in breast cancer treatments

Novartis is paying $2 billion upfront, plus up to $1 billion in milestones, to acquire Synnovation Therapeutics’ subsidiary Pikavation and its lead pan-mutant-selective PI3Kα inhibitor, SNV4818, in a bid to strengthen its position in breast cancer.

Why it matters: The deal shows how urgently Novartis wants to defend its breast cancer business as Roche, Eli Lilly and others push newer PI3Kα drugs that may be safer and easier for patients to tolerate. Better tolerability could make these drugs more competitive in combination treatment regimens.

Backstory: Novartis already markets Piqray, a PI3Kα inhibitor, in breast cancer. But Piqray and Roche’s Itovebi both hit mutant and wild-type PI3Kα. That matters because blocking wild-type PI3Kα is linked to severe hyperglycemia, making safety a key weakness of current drugs.

Big picture: Researchers have increasingly viewed mutant selectivity as the path to better drugs. Novartis helped establish this treatment class, but the competitive landscape is shifting fast. Roche has gained momentum through label expansion and new data, while Lilly, Relay Therapeutics and others are pushing mutant-selective PI3Kα inhibitors deeper into late-stage development.

Zoom in: Synnovation launched a phase 1/2 trial of SNV4818 about a year ago in breast cancer and other solid tumors, testing it alone and with AstraZeneca’s Faslodex and Pfizer’s Ibrance. The goal is to assess safety, tolerability, efficacy and dose selection. Novartis said the asset fits naturally with CDK inhibitors and endocrine therapy. That matters because an earlier phase 1b study of Piqray with Novartis’ Kisqali and Faslodex ran into toxicity, with 10 of 18 patients needing at least one dose reduction.

What’s next: Novartis expects to close the deal by mid-2026, then will likely work to accelerate development and position SNV4818 in combination regimens central to breast cancer treatment.

SNIPPETS

What’s happening in biotech today?

🧬 Protein fix: Congruence Therapeutics has raised $39.5 million in a financing round co-led by Dimension and OrbiMed to advance its small molecule corrector pipeline into clinical development. The funding will primarily support a Phase I/Ib trial of CGX-926, targeting MC4R-deficient genetic obesity in both healthy participants and patients. Additional efforts include completing IND-enabling studies for candidates addressing GBA1-driven Parkinson’s disease and Alpha-1 antitrypsin deficiency, with plans to file CTA/IND applications by early 2027. The company also continues to expand research collaborations and leverage its Revenir platform, which uses computational analysis of protein dynamics to guide drug discovery.

💰 Big funding: Alphabet’s life sciences subsidiary Verily has secured $300 million in funding, led by Series X Capital with participation from Alphabet and new investors including UCHealth and the University of Colorado Anschutz, as it transitions into an independent company renamed Verily Health. Alphabet will retain a minority stake but no longer hold control. The investment will support the expansion of its AI-driven precision health platform, including Verily Pre and the consumer app Verily Me, as well as the development of new AI agents. The company continues to deepen partnerships and focus on scalable AI solutions for clinical care, research, and public health after strategically narrowing its business scope.

✅ FDA approval: The FDA has approved Rhythm Pharmaceuticals’ Imcivree for acquired hypothalamic obesity, a rare condition caused by brain injury, expanding the drug’s use beyond previously approved genetic obesity disorders. The once-daily injection demonstrated significant efficacy in trials, helping patients lose about 18 percentage points more body weight than placebo, and became the first treatment available for this condition. The decision strengthens Rhythm’s commercial outlook, with analysts estimating a market opportunity exceeding $1 billion, though the company expects a gradual launch. Despite past regulatory delays and ongoing financial losses, the approval positions Imcivree as a differentiated therapy targeting the MC4R pathway.

❌ License drop: Gilead Sciences has declined to exercise its option to license Assembly Biosciences’ phase 1-stage hepatitis B candidate ABI-4334, returning full control of the capsid assembly modulator to Assembly. The decision follows a 2023 agreement in which Gilead paid $100 million for opt-in rights to Assembly’s pipeline, though it previously licensed two herpes programs under the deal. Assembly will now seek a new partner for ABI-4334, while the move reduces potential milestone payments from the original agreement. Gilead continues to pursue other HBV efforts, including a separate partnership with Hookipa Pharma, and markets its existing HBV drug Vemlidy.

SPEED READ

More news

• Genentech discontinued its RIPK1 inhibitor flizasertib after interim phase 2 data showed it was unlikely to improve post-surgical acute kidney injury outcomes, highlighting ongoing challenges in the drug class.

• Pfizer discontinued its early-stage CD228-targeting ADC PF-08046031, acquired via Seagen, for business reasons, continuing a broader post-acquisition pipeline pruning despite no safety concerns.

• Roche halted development of its myostatin-targeting antibody emugrobart after mid-stage trials showed inconsistent improvements in muscle function, weakening its prospects in spinal muscular atrophy and related disorders.

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