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• J&J’s Tecvayli was approved as part of a combination regimen with its Genmab-partnered Darzalex Faspro as a second-line therapy for relapsed or refractory multiple myeloma, just 55 days after it was filed with the FDA.

• The rapid approval—the third under the FDA’s recently-introduced Commissioner's National Priority Voucher (CNPV) program—moves BCMAxCD3 bispecific T-cell engager Tecvayli (teclistamab) up the treatment pathway from its previous use as a fifth-line or later therapy for the blood cancer.

• It will now be an option for patients previously treated with a regimen including a proteasome inhibitor and an immunomodulatory agent. (PharmaPhorum)

• The FDA has approved Sotyktu (deucravacitinib) as a treatment for adults with active psoriatic arthritis.

• It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication.

• The approval comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.

• With the new FDA nod in hand for Sotyktu, BMS can reach more patients with the oral medicine, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion. (FiercePharma)

• It also represents a significant narrowing of the potential use that Trump administration officials had suggested for the little-known form of the vitamin folate.

• FDA commissioner Marty Makary had suggested then that “hundreds of thousands” of children would benefit from the drug, and Health Secretary Robert F. Kennedy Jr. called it an “exciting therapy that may benefit large numbers of children who suffer from autism.”

• A study published in The Lancet this month found a 71% increase in prescriptions after the White House briefing.

• Leucovorin is an existing drug that has traditionally been used alongside chemotherapy treatment.

“This action may benefit some individuals with FOLR1- related cerebral folate transport deficiency who have developmental delays with autistic features,” Makary said in a statement. (Axios)

• Vertex reported a phase 3 win for its kidney disease prospect povetacicept, meeting analyst expectations and firing the starting gun on a race to the FDA that could result in an accelerated approval in November.

• The data come from a prespecified Week 36 interim analysis of a trial comparing povetacicept, a dual inhibitor of the BAFF and APRIL cytokines, to placebo in immunoglobulin A nephropathy (IgAN).

• Vertex posted a 49.8% reduction in the urine protein to creatinine ratio (UPCR) compared to placebo, achieving the trial’s primary endpoint and generating evidence that povetacicept improves kidney function. (Fierce Biotech)

• Vima Therapeutics announced it has raised $100 million in the hopes of bringing to market a new oral therapy that might help people with certain neurological disorders regain control of movement.

• The company was hatched by biotechnology investor Atlas Venture more than three years ago. It has since advanced a combination drug called VIM0423 to the precipice of mid-stage studies in Parkinson’s disease and dystonia. Both trials are expected to read out in 2027.

• Vima estimates that about 160,000 people in the US have isolated dystonia, a chronic and disabling neurological condition that causes involuntary muscle contractions that can worsen as a person moves.

• For a larger share, dystonia is a symptom of other brain diseases, among them Parkinson’s. (BioPharma Dive)

• BioNTech founders Ugur Sahin and Özlem Türeci, who oversaw the development of a COVID-19 vaccine that would help the world move out of the pandemic, are leaving the famed mRNA biotech to form a new one.

• The move comes as BioNTech shifts to being a multiproduct commercial biotech, allowing Sahin and Türeci to transition back into research on next-generation mRNA therapeutics.

“For us, this is the right time to prepare to hand over the baton,” Sahin said in a statement.

“At the same time, Özlem and I are ready to become pioneers once again. Our vision has always been to translate our science into meaningful advances for patients, and we see extraordinary opportunities to unlock the next generation of transformative innovations.”

• The new, unnamed company will take technology from BioNTech with a goal of developing next-generation mRNA therapeutics. This will be the third biotech founded by Sahin and Türeci, after Ganymed Pharmaceuticals in 2001 and BioNTech in 2008. (BioSpace)

• These molecules, known as long non-coding RNAs, are important for controlling how genes are regulated.

• Long non-coding RNAs outnumber the more well-studied protein-coding genes nearly two-to-one, yet there’s been comparatively little research on them.

• That discrepancy has always bothered Khan; now he has shown that three lncRNAs previously known to control immune system genes can reduce inflammation when administered to human cells and in mice.

• But the other mysterious parts of the genome, sometimes dubbed “genomic dark matter,” are rich in their own ways.

• Scientists have identified roughly 36,000 lncRNAs amid that dark matter and over the past decade have slowly begun to understand what these many thousands of molecules do. (Endpoints)