Septerna Inc.’s stock plunged as much as 68% throughout the day Feb. 18 on news that the company was stopping a phase I trial of SEP-786 in healthy volunteers following two severe events of elevated unconjugated bilirubin in the highest dose cohort of the multiple ascending-dose portion of the study.
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
While first-generation glucagon-like peptide-1 receptor agonists have clearly taken the obesity market by storm, generating billions of dollars for Novo Nordisk A/S and Eli Lilly and Co., several other companies are developing follow-on products that could clean up the tolerability and adherence issues of Wegovy (semaglutide) and Zepbound (tirzepatide).
The fast pace in which the Trump administration has rolled out changes to how government and businesses operate – a disruptive effort that appears to be creating a new world order – has caught the attention of biopharma industry leaders who spoke Tuesday at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York.
Cognition Therapeutics Inc. evolved from the work of a neuroscientist and a chemist working in the San Francisco Bay area, seeking out targets to block the effects of Alzheimer’s disease. Since the company’s 2007 inception, it has received close to $200 million in U.S. NIH grant funding. Investors often tell CEO Lisa Ricciardi, who joined the company in 2020: “’That’s because you have a relationship with the FDA.’ Well, no. It’s because it’s competitive” and the company’s research has met the muster. “You have to apply two or three times. … It’s with rigor that these results are generated and that we’re able to get more funding.”
Raising money to advance promising science is a constant struggle, bringing biopharma executive leadership together to learn about investment strategies in the opening session at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York. “We’re bottoms-up investors. If we like the technology, we like the product, we think it’s going to work, we want to find a way to invest,” said Chris Garabedian, chairman and CEO of Xontogeny.
BioWorld’s three-part analysis of M&As sought to discover successful transactions and to understand the trend of multibillion-dollar deals that have become commonplace in the last decade. Instead, more than 80% of the acquisitions explored simply indicate that buyers are paying too much, suggesting that transactions meant to restore pipelines and revenues with innovative and marketed products are sometimes akin to high-stakes gambling. In part three, the final part of this series, we examine four more disappointments in which the return on investment (ROI) remains well behind the price paid in acquiring the company.
Due diligence plays a significant role in M&A transactions, but the eventual return on investments don’t always add up to the purchase price. While some companies such as Abbvie Inc. and Bristol Myers Squibb Co. – as shown in part one of this three-part series – have succeeded in acquiring products able to surpass M&A sticker prices, the vast majority of deals analyzed by BioWorld showed that most buyers remain significantly in the red.
