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Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.

A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.

While expected and seen as largely incremental, Jefferies analyst Peter Welford in a Tuesday note to investors said the detailed data for three early-stage assets support moving them into Phase IIb studies and creates a “foothold” for AstraZeneca in the weight loss space.

Coming off of a strong third quarter, Vertex Pharmaceuticals is nearing several important milestones, including the potential approvals of vanzacaftor triple in cystic fibrosis and the non-opioid therapy suzetrigine in pain—both slated for January 2025.

In a deal worth up to $285 million initially for the lead program, Novo Nordisk will gain access to Ascendis’ TransCon technology platform in an effort to find novel GLP-1 candidates with reduced dosing frequency.

Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year.

Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, myasthenia gravis and other conditions traced to misdirected immune response.

The Big Pharma companies made a last-ditch effort asking a U.S. appeals court to reconsider their lawsuits against the Inflation Reduction Act’s Medicare drug price negotiations, which they contend infringe on their constitutional rights.

Jefferies analyst Roger Song in an investor note said that Viking Therapeutics’ readout for its investigational therapy VK2735 exceeded expectations, with “class-leading” weight loss. Patients on 100-miligram doses of the pill lost 8.2% of their body weight after 28 days.

The FDA is set to decide on four promising therapies in the next two weeks, including a CAR T for acute lymphoblastic leukemia.

This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets.

While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level.

• The capacity expansion in Bubendorf reached another important milestone with the inspection of Building K. The announced start-up is proceeding according to plan. • In Vista, CA, Bachem acquired a property adjacent to its existing facility. The acquisition will enable a future capacity expansion at the Vista site, thereby strengthening Bachem’s presence in the US market.

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◆ VIAL-INHBE is a novel, GalNAc-conjugated INHBE (Activin E) siRNA for the treatment of obesity and other cardiometabolic indications with a projected Q6M dosing intervall ◆ VIAL-INHBE DIO mouse model data demonstrated compelling fat-selective weight-loss and lean mass preservation ◆ Combination therapy with a low-dose GLP-1 resulted in synergistic weight loss and lean mass preservation that was maintained off-GLP-1 treatment ◆ A Phase 1 open-label study in Australia is initiating to evaluate safety, pharmacokinetics, and pharmacodynamic responses ◆ Interim subcutaneous safety and pharmacokinetic data are expected in H1 2026