Artiva Biotherapeutics Inc. raised $167 million through an upsized IPO, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other autoimmune indications. Just a few days ago, the San Diego based company had aimed to sell 8.4 million shares between $14 and $16 each, but it raised the number of shares offered to 13.92 million and lowered the price to $12 each. Shares (NASDAQ:ARTV) surged 31% to $15.64 by midday on their first day of trading July 19. AlloNK, also called AB-101, is an allogeneic, off-the-shelf, cryopreserved natural killer cell therapy designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion.
SPAC market diminished but alive despite new SEC rules
New U.S. SEC rules designed to reel back the special purpose acquisition (SPAC) market went into effect on July 1, yet only a few weeks later two such companies completed IPOs and are now targeting mergers with health care and life sciences firms, including biopharma and medical technology. In all, there have been six IPOs of SPACs looking to acquire health care companies so far in 2024, and at least five industry mergers with biopharmas have closed. While the numbers are significantly down from the heyday of 2020 and 2021, when SPAC IPOs and transactions ran rampant across sectors, they have not fallen to the non-existent status some commissioners expected would be the result of the new SEC rules.
New hope in MDD as developers push on with KORAs
Kappa opioid receptor antagonists (KORAs) have been making strides across various pipelines. Among those with prospects in the space are Cerevel Therapeutics Inc., bought by Abbvie Inc. for $8.7 billion late last year. Johnson & Johnson is among those competing in the KORA space with a candidate for adjunctive treatment of major depressive disorder, along with Neumora Therapeutics Inc., which has treatment to be used as monotherapy in the same indication.
Biosimilars to Eylea, Neupogen and Stelara among 28 US FDA approvals in June
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals. This is a significant increase from May, which had 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
Loper Bright bringing more scrutiny, uncertainty to US agencies
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority. In the wake of the Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo that unraveled Chevron deference for federal agencies, 19 senators have formed the Post-Chevron Working Group, led by Sen. Eric Schmitt (R-Mo.), to investigate the impacts of the court’s decision and to chart a path forward for oversight.
BioWorld Insider podcast: The costs of delays is updated by Tufts
New research shows the costs of delays in developing a drug candidate and in drug sales are outdated and based on anecdotal evidence, contends the Tufts University School of Medicine’s Center for the Study of Drug Development. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast this week about updating the outdated numbers and what they mean for companies and investors. Some of the report’s readers assumed average delays in sales had risen over the years to rise. “It was really quite a shock that it was a fifth of the level that we had seen often frequently referenced in the 1990 timeframe,” Getz said. The estimated cost of a day’s delay in a clinical trial, the center also found, had, counterintuitively, barely changed in the past 30 years.
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Agenus, Alnylam, Astrazeneca, Aveo, Bavarian Nordic, Bayer, Biora, Biosenic, Bridgebio, Cocrystal, Diamyd, Exscientia, Genentech, Haya, Junshi, Kiromic, Longeveron, Marinus, Paratek, Pfizer, Phathom, Pierre Fabre, Roche, Serina, Shionogi, Sumitomo, Teva, Twist, Ultragenyx, Vivoryon