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IPO
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
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THE LATEST
FDA
After sustaining a regulatory defeat in insomnia, Vanda Pharmaceuticals on Tuesday won the FDA’s approval for its atypical antipsychotic Fanapt for the treatment of manic or mixed episodes in adults with bipolar I disorder.
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
With second-generation antibody-drug conjugates, Eli Lilly, Daiichi Sankyo and others look to reduce toxicity and improve the magnitude and duration of response.
The new Cambridge, Mass.–based facility is about 460,000 square feet. Labs occupy nearly 50% of the space.
Read the latest overview of people coming and going from executive positions at biopharma companies that BioSpace covers.
FDA
Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
Under the agreement, Ipsen nabs exclusive global rights for development and commercialization of Sutro Biopharma’s STRO-003, an antibody-drug conjugate which is completing the final stages of preclinical development.
The biotech’s personalized neoantigen vaccine for colorectal cancer did not demonstrate a molecular response difference from the control arm. Gritstone blames trial protocol and plans for a Phase III study.
Roivant has chalked up a mid-stage victory for its Pfizer-partnered dual TYK2/JAK1 inhibitor, setting it up to start a Phase III trial in non-anterior non-infectious uveitis this year.
Verve Therapeutics is pausing enrollment in the Phase Ib Heart-1 study for its gene editor VERVE-101 after a patient developed grade 3 laboratory abnormalities, the company announced Tuesday.