Finance

Like old times. Oruka Therapeutics brings back the 'wall-crossed' PIPE

From my colleague Adam Feuerstein: Oruka Therapeutics raised $180 million at $15 per share from a mob of biotech hedge funds — 13 were listed in the company's press release alone. 

The deal was structured as a "wall-crossed" PIPE, which means all the buyers were given an advance look at new, first-in-human data for ORKA-001, Orka's long-acting IL-23 antibody, showing an approximate 100 day half-life. The blood-exposure data support the potential for once-yearly maintenance dosing in psoriasis, the company said in its announcement this morning. Currently approved antibody treatments must be injected as infrequently as four times per year. 

Orka is conducting a mid-stage study of ORKA-001 in patients with psoriasis. Initial results are expected in the second half of 2026.

regulation

Does the FDA have the resources to crack down on pharma ads?

The Food and Drug Administration yesterday published about 100 letters that it sent to pharma companies and health care providers, ordering them to stop or alter what it described as misleading ads or other promotions. But experts questioned whether the agency has the resources to actually enforce its warnings since it laid off many of the experienced staff who would lead the effort.

The letters are a mixture of warning letters and “untitled” letters. Warning letters tend to be for more serious violations and require more action from companies. The almost 70 warning letters mainly target telehealth companies selling compounded versions of FDA-approved brand drugs, particularly GLP-1s.

But the FDA also sent warning letters to Eli Lilly and Novo Nordisk, saying that the companies did not adequately present risk information about their GLP-1s during a television special hosted by Oprah Winfrey. In comments to STAT, the companies noted that the program was not an ad and it was independently produced and broadcast by ABC.

Read more from STAT's Lizzy Lawrence and Ed Silverman.

CHRONIC DISEASE

Roivant, Priovant skin drug succeeds in late-stage clinical trial 

The biotech firm Roivant and its spinout Priovant said this morning that their immune-modifying drug brepocitinib outperformed a placebo in treating dermatomyositis, a skin condition that affects about 50,000 Americans.

The companies plan to file the drug for approval with the Food and Drug Administration in the first half of next year.

Dermatomyositis is an inflammatory condition marked by debilitating muscle weakness and skin lesions that can make it difficult to climb stairs or get dressed.

Read more from STAT's Matt Herper.