🏳️‍🌈We’ve released our fifth annual report highlighting LGBTQ+ leaders who are working on inclusion in the drug development industry. Kyle LaHucik spoke with six honorees who come from various parts of the life sciences industry, including an HR leader, a chief medical officer, an analyst and a lawyer. 

The honorees discussed trends around inclusion and shared their individual experiences. Some of them said they’re seeing the impact of pushback against diversity, equity and inclusion programs. Roughly a quarter of respondents to a recent Endpoints Signal survey reported a decrease in DEI initiatives at their organization. But Evan Seigerman, an analyst at BMO Capital Markets and honoree, remains hopeful despite the current climate. He told Kyle that it’s important to remember that there’s been “a positive change on Wall Street in my 13-plus years doing this,” where companies are “truly ensuring not only tolerance, but true welcoming of LGBTQ folks.”

You can read more here about this year’s honorees and their push for progress. You can also replay our virtual event here, where Kyle led a conversation on the state of LGBTQ+ inclusion in biopharma, and spoke with Koppa chief economist M. V. Lee Badgett about the economics of LGBTQ+ inclusion.

🖥️The Danish pharma company allegedly had some of its most valuable IP stolen by hackers this week, including the manufacturing processes behind Wegovy and Ozempic and several AI models. A hacking collective called FulcrumSec claims to have stolen AI models, and is now trying to sell the information to other bidders after Novo refused to pay $25 million to stop it from posting the data online, Reuters has reported.

Novo itself is dancing around the hack in public comments, only acknowledging an "IT security incident" on Thursday. The company has remained largely mum about what may have been swiped or its potential value. A Novo spokesperson declined to give Endpoints News detailed answers to questions about the accuracy of the claims. Read more from Elizabeth Cairns here.

🧠The FDA will allow uniQure to seek accelerated approval for its Huntington’s disease gene therapy after all. Former FDA leaders Marty Makary and Vinay Prasad had objected to the move earlier this year, in a reversal from previous guidance uniQure received. But now, rather than conduct a placebo-controlled study that likely would have required a 12-hour sham brain surgery, uniQure can use long-term data from a mid-stage trial as the basis for approval.
 

This week’s update represents an apparent rebuke to Makary and Prasad. The two often requested more stringent examinations of drugs under review — impacting rare disease treatments. But Prasad departed the FDA at the end of April, and Makary followed him out the door a few weeks later. Previous FDA leadership had sometimes lowered the bar for approvals where large, placebo-controlled trials were not readily doable. Under Acting Commissioner Kyle Diamantas, who previously ran the agency’s food division, industry analysts view the uniQure update as officials signaling that the new approach is the same as the old.

The design of a confirmatory trial remains the biggest unanswered question. In a press release, uniQure said the FDA is considering letting the company use a control arm with standard-of-care therapy instead of a sham procedure, but that no final decision has been made. Read more from Max Gelman here.

🤝 AbCellera has lined up a preclinical collaboration with Jazz Pharmaceuticals to take T cell engagers into gastrointestinal cancers and other solid tumors. The tie-up starts with $56 million upfront and two unnamed targets already selected, Kyle LaHucik wrote. Within the next year, the duo could expand to a third target, which would trigger another $28 million for AbCellera. 

If the companies like what they see from that first round of experimental medicines, they could add another two programs for $56 million upfront. Each program comes with up to $792 million in milestones. That’s about $4.1 billion in total, if all five programs produce an approved medicine. You can read more about the deal here.