Shares of Omeros Corp. (NASDAQ:OMER) were trading at $9.83, up $5.73, or 139%, on word from the company and Novo Nordisk A/S that they have signed a definitive asset purchase and license agreement for zaltenibart (formerly OMS-906) to treat rare blood and kidney disorders. Bagsvaerd, Denmark-based Novo gets global rights to develop and commercialize the compound in all indications. Omeros, of Seattle, is eligible for $340 million in up-front and near-term milestone payments, and as much as $2.1 billion if development and commercial goals are met, plus tiered royalties. Zaltenibart is an antibody designed to inhibit MASP-3, and Omeros has chalked positive phase II data in paroxysmal nocturnal hemoglobinuria (PNH).

Tubulis smashes series C European record with $356M raised

Antibody-drug conjugate (ADC) specialist Tubulis GmbH has raised a hefty €308 million (US$356 million) series C to expand clinical development of TUB-040, positioning its lead program for use in additional indications and as an earlier line of therapy. The closing of the round was announced days before the company presents the first clinical data from the phase I/II study of TUB-040 in platinum-resistant ovarian cancer at the European Society of Medical Oncology meeting in Berlin on Oct. 19. What appears to be the largest series C ever raised by a European biotech will enable Tubulis to validate its approach of designing all the elements of its ADCs in-house, with the aim of conferring superior biophysical properties and allowing for greater drug-to-antibody ratios.

Pelage’s regenerative approach to hair loss draws $120M in series B

Touting a science-driven, regenerative medicine-based treatment for hair loss “designed for the 21st century,” Pelage Pharmaceuticals Inc. drew a solid group of investors to the table in an oversubscribed $120 million series B round to fund an upcoming phase III program for PP-405, a topical small molecule targeting hair follicle stem cells. “What was really exciting to us it that it literally came together in three weeks,” from initiation to fulfilling the round, according to CEO Daniel Gil. “There was really strong interest, which was very gratifying. I think it speaks to truly bringing innovation to this space,” which hasn’t seen a new U.S. FDA-approved treatment option in nearly three decades.

BioFuture 2025: The challenge of accurate drug pricing

Government and market demands on companies and their pricing strategies have shifted dramatically in the past 10 years and the pricing landscape continues to change, creating uncertain ground beneath developers’ feet. At the BioFuture conference in New York, a panel discussed how big and small companies go about their pricing strategies and build educated guesses into how that strategy might work out in the market. Setting a price for a drug launch is a particularly tough task, according to Neal Masia, the CEO of Entityrisk Inc., because “companies are super aware, if they do anything wrong, they’re toast.” The BioFuture 2025 conference concludes today, Wednesday, Oct. 15.

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15. “As many know, there has been a huge reduction in force at the FDA earlier this year, which was part of sweeping reorganization that impacted the U.S. Department of Health and Human Services (HHS),” panel moderator Kelly Cho, senior managing associate at Sidley Austin LLP, said in opening remarks. With talks of a second wave of layoffs following the U.S. government shutdown Oct. 1, the changes go just beyond “huge” or “sweeping,” Chung Sang-mok, president of Biostar Group, commented: “I would label them as radical, meaning that these are changes that have never occurred before.” Simultaneously, “we are hearing that China will outpace the U.S. in [new drug R&D] and the life sciences,” Cho said. 

White House continues to churn out EOs

While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration in still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens and market competition. Several of the other EOs the president has issued are broad in scope and may indirectly or peripherally impact the life science industries, including ones pertaining to trade agreements and general tariffs that could be applied to some medical devices, supplies and even the manufacturing equipment and products drug and device makers rely on.

Also in the news

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