PTC Therapeutics Inc. rolled out data from the phase II Pivot-HD trial in stage 2 and stage 3 Huntingdon’s disease with PTC-518. The drug, an oral, centrally as well as peripherally distributed huntingtin (HTT) pre-mRNA splicing modifier, met Pivot-HD’s primary endpoint of reduction in HTT protein levels at week 12 with favorable safety and tolerability. Shares of PTC (NASDAQ:PTCT) were trading at $40.98, down $8.97, or 17%.

Aggressive tone but few changes in US 301 trade report

Falling in line with President Donald Trump’s trade policies, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property (IP) rights or that otherwise discriminate against products from foreign companies. Yet it continued to identify the regulars to the Priority Watch and Watch Lists with few changes, despite years of the biopharma and med-tech industries pointing out IP and access problems they face in other countries. The only differences on the lists this year are Mexico being moved from the Watch List to the Priority Watch List and Turkmenistan working its way off the lists altogether.

Australia follows Canadian lead; Labor win a sharp rebuke to Trump

Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research. The landslide victory for the Labor party was a strong rebuke to U.S. President Donald Trump’s administration, as the opposition Liberal party, which is more akin to the U.S. Republican party, touted similar policies on immigration with the campaign slogan, “Make Australia Great Again.”

Wegovy’s oral GLP-1 chases approval in obesity

The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. The company said the FDA will make a decision on the NDA sometime in the fourth quarter of 2024. The injectable formulation of Wegovy is already approved for those 12 and older with obesity. There are 58 oral GLIP-1s in active development, with 16 of them in obesity, according to Cortellis. Only non-insulin-dependent diabetes has more, with 17 oral GLP-1s in development.

Immutep’s efti shows strong survival data in head and neck cancer 

Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1.

Also in the news

Alk-Abello, Amgen, AN2, ARS, Astrazeneca, Bavarian Nordic, Cassava, Cidara, Crown, Cytokinetics, Foghorn, Genmab, Indivior, Innocare, Marvel, Neuren, Next, Nxera, Pliant, Stately, Synhale, Transcode, Vaxcyte