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• Lipfendra (enlicitide) gained FDA approval today as the first once-daily oral PCSK9 inhibitor authorized in the US to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH).

• The PCSK9 space is currently dominated by injectable options, ​such as Amgen's Repatha (evolocumab), and Regeneron and Sanofi's Praluent (alirocumab), which are priced at between $500 and $600 per month.

• Lipfendra, meanwhile, will carry a list price of $315 a month, or around $3800 per year. (FirstWord)

• The donor-derived personalized cell therapy Tregzi received the regulatory green light to reduce the risk of chronic graft-versus-host disease (GVHD) in patients undergoing allogeneic haematopoietic stem cell transplantation (alloHSCT) for blood cancers.

• Orca Bio set out to address GVHD using three populations of cells, grown up from the blood of a matched donor for each treatment recipient.

• Haematopoietic stem and progenitor cells are infused first, to replace the diseased blood cell population. Immunosuppressive regulatory T cells (T_regs) are infused immediately afterwards, to help mitigate the risks of GVDH. Conventional T cells, delivered a few days later, speed up the reconstitution of the patient’s immune system. (Nature Reviews Drug Discovery)

• Sanofi scored FDA approval for its subcutaneous version of Sarclisa, giving the multiple myeloma treatment a potential boost in its competition with Johnson & Johnson’s powerhouse Darzalex.

• Sanofi’s new formulation, which is dubbed Sarclisa Escena, now becomes the first subcutaneous anticancer drug that can be administered manually or by an on-body injector (OBI).

• The endorsement for Sarclisa Escena applies to each of the indications for which its intravenous (IV) formulation is approved. (Fierce Pharma)

• A rare autoimmune disease affecting the kidneys has a new FDA approved treatment, a first-in-class drug whose approach of hitting two targets sets it apart from the medicines already available for treating this life-threatening condition.

• The regulatory decision covers the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

• The drug, atacicept, is the first commercial product for Brisbane, California-based Vera. This once-weekly injection will reach the market under the brand name Trutakna. (MedCity News)

• But novel approvals ticked up, from 19 in H1 2025 to 26 so far this year.

“H1/2026 heavily reflects the chaos of the first and second half of last year,” Grossman said in an email. He pointed in particular to “hostile management” by former CBER director Vinay Prasad, whom he said “was not interested in the smooth or fair management of CBER.”

• The FDA is looking to hire some 2,200 staffers—600 of whom have already been secured, Lowell Zeta, the agency’s acting chief of staff and deputy commissioner, said last month at BIO’s international convention.

• And the regulatory doors appear to be cracking open for rare disease companies that saw more stringent action under Prasad and former FDA Commissioner Marty Makary.

• Eli Lilly plans to acquire psychedelics specialist AtaiBeckley through a multibillion-dollar deal that shows big pharma’s growing endorsement of a once-dimissed, now rapidly emerging research field.

• The companies expect to close their deal before the end of September.

• If completed, the acquisition would hand Lilly a few experimental drugs that have moved into human studies. The most advanced of those, codenamed BPL-003, just entered late-stage testing as a potential therapy for hard-to-treat depression.

• BPL-003 is a version of mebufotenin — a molecular cousin to psilocybin, the psychedelic compound found in some mushroom species. A mid-sized study found that a single dose of the drug quickly reduced symptoms of treatment-resistant depression.

• AtaiBeckley’s other programs are based on compounds like MDMA and DMT. The company was formed in late 2025, when Atai Life Sciences acquired Beckley Psytech.(BioPharma Dive)

• Psychedelics stand to gain from the promising growth of Johnson & Johnson’s depression drug Spravato in the second quarter, analysts say, while also potentially posing a threat to the pharma’s neuroscience portfolio in the long run.

• Compared with the same period last year, Spravato’s Q2 revenue spiked 40% on an operational basis, bringing in $584 million worldwide, according to J&J’s second-quarter earnings report on Wednesday.

• According to an analysis from Jefferies published later in the day, J&J has designated the drug as a “key franchise,” with peak sales that could top $5 billion.

• Spravato, an esketamine-based nasal spray, was first approved in 2019 for treatment-resistant depression (TRD) and earned a label expansion in January 2025 to become the first monotherapy for the disease.

• For now, it remains the only therapy for TRD on the market, but that could soon change, as more traditional psychedelics inch closer to the market, driven by powerful clinical readouts, a more convenient use profile and the outspoken support of health officials. (BioSpace)

• That’s the long-term vision of Deep Origin, a computational drug discovery company that combines molecular physics with AI to create predictive models for clinical trials.

“What we’re after is the quality of the prediction itself. That’s the predictivity crisis, a systematic gap between what works in preclinical models and what happens in the clinic,” she said.

• But it’s a long, step-by-step journey to chase that larger goal. In the meantime, Deep Origin is tackling more bite-sized industry challenges.

“We don’t position our immediate work as ‘replacing’ clinical trials,” she said. “Right now, it’s about reducing late safety failures and animal use, and giving programs more confidence going into the clinic.”