IntellaTurn, LLC

• The agency also issued a draft guidance to clarify the circumstances under which developers can rely on one rigorous, adequate, and well-controlled clinical trial, along with confirmatory evidence, to support drug approvals.

• The program includes a series of measures designed to speed up drug development from the IND stage to late-stage clinical trials.

• The deadline for submitting public comments is 22 July.

• AbbVie is making its biggest acquisition in years in a bid to expand its portfolio of autoimmune disease drugs, announcing plans to buy Apogee Therapeutics for nearly $11 billion.

  The pharmaceutical giant will pay $135.11 per share for Apogee, a roughly 49% premium to the biotechnology company’s closing price on Friday. The acquisition should close in the third quarter of 2026, pending approvals from shareholders and regulatory agencies.

• The purchase is AbbVie’s largest since taking over Botox maker Allergan in a $63 billion deal in 2019. It also surpasses the company’s big-ticket buyouts of ImmunoGen and Cerevel Therapeutics in 2023, two deals AbbVie used to add medicines for cancer and neurological diseases.

• For the biotechnology sector, the buyout adds to a particularly active year for company purchases.

• So far, 32 deals have been struck with at least $50 million in guaranteed upfront payments.

  • Around two thirds of those deals have been worth at least $1 billion and six have eclipsed $5 billion. Both totals are on pace to surpass what’s been seen in every year since at least 2020. (BioPharma Dive)

• Four months after rejecting Regenxbio's gene therapy for mucopolysaccharidosis II (MPS II), the FDA appears to have had a change of heart, agreeing that existing clinical data may support an accelerated approval filing. Company shares jumped about 20% on the news.

• The biotech said Monday that regulators no longer require additional studies, new patient enrollment or the untreated control arm that had been proposed in a February complete response letter (CRL) for Navsunli.

• Instead, the FDA advised the company to request a Type A meeting to review existing longer-term biomarker and clinical data from the CAMPSIITE study, and to resubmit its BLA after that discussion.

• Regenxbio expects that meeting to take place in July and afterwards plans to resubmit its BLA in the third quarter.

• The FDA's new stance marks its latest regulatory reversal involving therapies for serious diseases with limited treatment options.

  • In recent weeks, it has also reversed course on Replimune's twice-rejected melanoma therapy and uniQure's gene therapy for Huntington's disease after previously demanding additional studies. (FirstWord)

• Denali Therapeutics has sold a priority review voucher for $195 million, marking a rise in value for the coveted regulatory fast passes.

• Denali snagged the ticket from the approval of rare disease drug Avlayah in March 2026. The drug was cleared by the FDA for use in patients with Hunter syndrome. The buyer was not disclosed in Denali’s announcement.

• The biotech intends to use the proceeds from the sale to support a pipeline of assets generated using its TransportVehicle technology, which aids the passage of drugs across the blood-brain barrier. Denali is developing therapies for lysosomal storage disorders and neurodegenerative diseases.

• The FDA awards priority review vouchers (PRVs) upon approval of a drug that has been granted a rare pediatric disease tag. Companies can either use them for a speedy approval of another drug or sell them, generating non-dilutive capital. (BioSpace)

• The biotech’s LSD recipe, known as DT120 ODT, scored wins on all primary and key secondary endpoints of the 149-patient Emerge trial, Definium announced, marking a reduction in depression symptoms not hit by competing medicines.

“It's really of a magnitude, of a rapidity, and of a durability that we've never before seen in a phase 3 study,” Barrow added.

Definium was formerly known as Mind Medicine or MindMed before rebranding in January.

• Compass Pathways was chosen for a voucher, along with the Usona Institute—where Barrow previously worked—and Transcend Therapeutics. Definium was not granted a voucher.

“We certainly believe there's a lot of momentum behind us and the field more broadly,” Barrow said. The company has moved quickly over the past five years to launch its suite of phase 3 studies for DT120, he said.

• The FDA has been evaluating a blood test called Galleri (pronounced like "gallery") as a breakthrough device that can detect many different types of cancer in one test.

• FDA could approve it later this year, clearing the way for such testing to become broadly available.

• By comparison, the Galleri test can detect small amounts of DNA or other cancer markers for up to 50 cancers in a single vial of blood.

• Galleri and another test called Cancerguard by Exact Sciences are both multi-cancer early detection tests that already can be ordered in the US under a special FDA designation.

• A more rigorous FDA approval process will be necessary for the tests to be covered by Medicare and other insurance.

"It's a real fundamental shift in how we think about cancer screening," says Megan Hall, vice president of medical affairs for Grail, a research company founded to bring Galleri to market.