Nona Biosciences Inc. scored a deal with Pfizer Inc. related to the former’s mesothelin-targeted antibody-drug conjugate (ADC), HBM-9033. The global clinical development and commercialization pact brings Cambridge, Mass.-based Nona as much as $53 million in up-front and near-term cash from Pfizer, of New York, along with up to $1.05 billion in milestone-related payments as the ADC moves along. Terms also include tiered royalties ranging from high single digits to high teens. Nona’s parent company is Shanghai-based HBM Holdings Ltd.
US Worldmeds nabs FDA nod for oral maintenance therapy for high-risk neuroblastoma
Following the recommendation of its Oncology Drugs Advisory Committee (ODAC), the U.S. FDA approved U.S. Worldmeds LLC’s eflornithine 192-mg tablets for use as a maintenance therapy in patients with high-risk neuroblastoma. Branded Iwilfin, the specific, irreversible inhibitor of ornithine decarboxylase previously known as DFMO, is expected to be available in the coming weeks. More than half of the 700 to 800 yearly cases of neuroblastoma are classified as high-risk, due to the prevalence of relapse after remission. Nearly one-third of high-risk patients relapse within two years following immunotherapy, and most die within five years. The drug’s approval is noteworthy both for the urgent need to improve those survival numbers as well as the fact that a single external-controlled trial provided sufficient evidence to convince regulators.
Top Trends of 2023: Asia biotech ecosystems roaring back
If the COVID-19 pandemic shocked countries to build self-reliance in biomedical ecosystems, the re-opening of borders in 2023 kickstarted international collaborations to grow major biohubs in Asia. Countries in the Asia Pacific (APAC) region – including Singapore, China, Japan, Korea and Australia – increasingly drew overseas investors and collaborators, helping each country grow national biotech capabilities and expertise.
Biopharma stocks again on the upswing after rollercoaster year
The BioWorld Biopharmaceutical Index (BBI) made an upward turn to end November with a 4.37% increase for the year. It has been a dynamic year for BBI, which reached a low point at the end of February (down 3.65%) and peaked at the end of August (up 7.87%). In October, BBI ended the month up 0.98% and outperformed both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA). BBI remains higher than the NBI, which is down 8.05% as of the November close, but has fallen below the DJIA, which ended November up 8.46% for the year.
Biopharma deals and M&A remain on track to outpace 2022
Biopharma deals totaled $18.97 billion in November, marking a notable decrease from October’s historic value of $44.91 billion. Even still, through the first 11 months of 2023 cumulative deal value reached $194.26 billion, an 18.65% gain over the $163.73 billion recorded in the same period in 2022. On a monthly average, biopharma deals were valued at $17.66 billion this year, exceeding the 2022 monthly average of $14.88 billion.
BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.
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