The U.S. FDA has approved its first pharma treatment in more than 40 years for motion sickness. The green light for Nereus (tradipitant), from Vanda Pharmaceuticals Inc., was based on three clinical studies, all pivotal, including two phase III real-world trials with patients on boats and another supporting study. Nereus, an oral neurokinin-1 receptor agonist, will be available early in 2026 and is approved for preventing vomiting induced by motion. The company’s stock (NASDAQ:VNDA) had jumped 26% at midday, with shares at $8.89 each.
Corcept tumbles on relacorilant CRL in Cushing syndrome
Shares of Corcept Therapeutics Inc. (NASDAQ:CORT) were down more than 50% in morning trading after the company disclosed a complete response letter for relacorilant in patients with hypertension secondary to hypercortisolism, with the U.S. FDA requesting additional evidence of efficacy. The company intends to meet with the agency to discuss a path forward in hypercortisolism, also known as Cushing syndrome. In the meantime, focus is now on the July 2026 PDUFA date, as Corcept seeks approval for the same drug as a treatment for patients with platinum-resistant ovarian cancer.
Year marked by chaotic regulatory uncertainty in US
If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty. It was a year marked by agency firings and hirings. Resignations of key senior leaders and the loss of their institutional memory at the CDC, FDA and NIH. Reorganizations with the deletion of entire programs and offices. There were repeated threats of a global biopharma tariff ranging anywhere from 25% to 250%. Most-favored-nation pricing pressure. Private deals with individual drug companies. Funding freezes. Arbitrary cuts in NIH grant awards.
Europe year-end view: Funding stalls, Trump-related uncertainty
It’s been a year of two halves in Europe, with early optimism that the biotech sector had recovered from the post-pandemic funding drought being crushed by an investment slowdown from June onward. Venture capital raised in 2024 exceeded the 2020 total, and there were promising signs in the first six months of 2025 that this recovery would be sustained. The final tally is not yet posted, but there was a contraction in the third quarter (Q3), with $1.61 billion of VC financing raised, down from $2.06 billion in Q2, making it unlikely the 2025 total will match that of 2024.
Blossomhill advancing EGFR, CLK inhibitors with series B extension
Wife-and-husband team, J. Jean Cui and Y. Peter Li, launched Blossomhill Therapeutics Inc. in mid-2020 to focus on next-generation, macrocyclic inhibitors against oncology targets, following the couple's first stint as co-founders of Turning Point Therapeutics Inc. The San Diego-based company recently disclosed it raised an additional $84 million through an extension of its February 2024 series B, bringing Blossomhill's total raised to $257 million. The company plans to use the capital to advance its two clinical-stage candidates, epidermal growth factor receptor (EGFR) inhibitor BH-30643 and Cdc2-like kinase (CLK) inhibitor BH-30236, as well as its preclinical pipeline.
Holiday notice
BioWorld’s offices will be closed Thursday, Jan. 1. No issue will be published.
BioWorld 2025 Year in Review
BioWorld looks back at the year’s biggest news. Find all of our 2025 Year in Review articles here.
Also in the news
Cogent, Collegium, Denali, Dermata, Evogene, Hutchmed, Hyloris, Imunon, Inflarx, Mesoblast, Nido, Rosemont, Takeda, Unicycive, Verastem, Xoma
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