News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) sent Astrazeneca plc’s shares (LON:AZN) down by 9.49% on the morning of July 9. There was a similar impact on shares in Astrazeneca’s partner, Ionis Pharmaceuticals Inc., after it was announced the 1,432-patient study had not met the composite endpoint of reducing cardiovascular mortality and recurrent CV events. The company’s shares (NASDQ:IONS) fell by more than 19% in premarket trading. The failure of the phase III Cardio-TTRransform trial was despite “large and sustained reductions” in transthyretin levels that were consistent with Wainua’s gene silencing effect of blocking production of faulty TTR protein in the liver.

Forte, First Tracks soar on FB-102 vitiligo data; celiac readouts next

Encouraging phase I data this week of new treatments for the chronic autoimmune disorder vitiligo, which alters skin pigment by destroying melanocytes, drove excitement in the space. The latest to roll out data, Forte Biosciences Inc., disclosed a statistically significant benefit of anti-CD122 monoclonal antibody FB-102, achieving a 29.6% mean improvement on the Facial Vitiligo Area Scoring Index (F-VASI) from baseline at week 24 in a phase Ib trial. Responses were seen early, by day 64. While there is one approved drug for vitiligo, Incyte Corp.’s JAK inhibitor Opzelura (ruxolitinib cream 1.5%), Forte’s phase Ib data offers a positive readthrough to its phase II program in celiac disease, an autoimmune disorder tied to eating gluten for which there are no approved therapeutics. Forte received fast track designation from the U.S. FDA in May for the indication and expects top-line results later this year. Shares (NASDAQ:FBRX) soared 43%, or $8.90, to $29.48 in early trading July 9, while competitor First Tracks Biotherapeutics Inc. (NASDAQ:TRAX), which has CD122 antagonist and celiac prospect ANB-033, climbed 42%, or $8.68, to $29.45 by midday. Earlier this week, Teva Pharmaceutical Industries Ltd. said it would advance its vitiligo prospect, IL-15 inhibitor TEV-‘408, into a phase IIb study for vitiligo based on positive phase Ib data.

AI co-scientist performs biomedical research ‘at expert level’ in less time

While biomedical resources in the form of specialized tools, hundreds of thousands of published papers and huge repositories of ‘omics, health records and other data, are growing exponentially, discovery is getting slower and more expensive. That is the perspective from which scientists at Stanford University approached the development of their artificial intelligence (AI) research assistant Biomni. A preprint describing Biomni was posted on the Biorxiv server in June 2025. In the peer-reviewed version published in Science, July 9, 2026, the researchers describe validating the outputs of the system in a wet lab and on real datasets.

COVID-19 injuries, posting of CRLs on HHS’ 2027 rulemaking agenda

What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs. Topping the HHS fiscal 2027 agenda is a proposed rule-in-the-making that would add injuries from COVID-19 countermeasures to the government’s Countermeasures Injury Compensation Program. The concern is that HHS may add injuries with little scientific basis. Another proposed rule still in early stages would formalize a practice former FDA Commissioner Marty Makary started last year to make complete response letters (CRLs) public.

Newco news: Integrant targets cartilage repair with AI-biologics platform

For decades, treatment options for osteoarthritis have followed a familiar path: As cartilage deteriorates and pain worsens, conservative therapies eventually give way to joint replacement surgery. Australian regenerative medicine company Integrant Pty Ltd. wants to change that trajectory. Rather than replacing damaged joints, the company is building a platform designed to regenerate cartilage and preserve joint function by combining biologics, medical devices and artificial intelligence. After completing a AU$10 million (US$6.9 million) series A round, Integrant is preparing a pre-IPO capital raise ahead of a planned Nasdaq listing later this year. Proceeds are expected to support the company’s first midstage biologics program and international expansion.

FENS 2026: Next-gen biologics take on brain disease

Whether by fine-tuning neurotransmitter signaling or silencing disease-associated genes, emerging biologic therapies are reshaping neuroscience drug development, according to presentations at the FENS Forum 2026.

Science fiction realized: BCI tech is here

After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care, what’s driving investor interest and the challenges ahead.

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