Blackstone Labs LLC

Johnson & Johnson and Protagonist Therapeutics are pitting their once-daily psoriasis pill against drugs like Bristol Myers Squibb’s Sotyktu in a bid to compete in the crowded market. The duo reported Wednesday that their experimental oral IL-23 receptor blocker beat Sotyktu in two Phase 3 studies. The results showed that icotrokinra helped a greater proportion of psoriasis patients achieve clear or almost clear skin at 16 and 24 weeks — and with fewer side effects. The detailed data are set to be shared on Thursday at the European Academy of Dermatology and Venereology’s annual meeting in Paris, and they build on previously reported topline results. While the results compare two pills, J&J and Protagonist are also starting another Phase 3 trial pitting icotrokinra against J&J’s Stelara, an injectable medication. The companies, which plan to study icotrokinra in other immune diseases, believe it can become a multibillion-dollar product. The ICONIC-ADVANCE 1 and 2 studies each included over 700 participants who received either icotrokinra, placebo or Sotyktu. Icotrokinra met the primary endpoints, which compared it to placebo at 16 weeks on two psoriasis disease activity measures. Based on a measure called the Investigator’s Global Assessment scale, 68% or 70% of patients achieved almost clear or clear skin compared to 50% or 54% of participants on Sotyktu at 16 weeks, with similar results at 24 weeks. And on another measure called the Psoriasis Area and Severity Index, 55% or 57% of participants on icotrokinra saw an improvement of 90% or better compared to 30% or 34% of participants on Sotyktu. That difference was likewise maintained to 24 weeks. J&J and Protagonist started working together in 2017 in a deal that ultimately led to the discovery and development of icotrokinra. Oruka Therapeutics reported healthy volunteer results on Wednesday, noting that its findings could translate to once-yearly dosing of ORKA-001, its long-acting IL-23 antibody. Oruka also announced on Wednesday that it raised a $180 million private placement from Viking Global Investors, Affinity Healthcare Fund, Blackstone and others. Oruka’s study enrolled 24 healthy adults and tested three different doses. It showed that ORKA-001 had a half-life of approximately 100 days, which is greater than three times that of AbbVie’s Skyrizi, according to the company. That half-life “increases likelihood of once-per-year dosing,” Oruka said. The biotech is currently running a Phase 2a study of ORKA-001 in moderate-to-severe psoriasis patients, with initial data expected in the latter half of 2026. It also plans to start a Phase 2b study in the first half of next year before the completion of that Phase 2a study. Oruka said it expects the PIPE financing to fund it for at least one year following its data readouts in 2027. Its stock $ORKA was up about 10% on Wednesday morning.

The deal is expected to close by the fourth quarter of 2025. With a buyout of scPharmaceuticals worth up to $360 million, MannKind is looking to dive into the large and growing field of cardiometabolic treatments.Endocrine and orphan lung disease-focused MannKind will shell out $5.35 per share—plus a contingent value right (CVR) of $1.00 per share—to buy scPharmaceuticals and Furoscix, the latter company's on-body infuser that delivers furosemide.The total deal value of $360 million represents a 31% premium to scPharmaceuticals’ Aug. 22 closing price, according to a Monday press release.With the deal, MannKind will add scPharmaceuticals’ Furoscix to its lineup of marketed products. The 2022-approved drug is an on-body infuser that delivers generic furosemide as a self-administered, subcutaneous loop diuretic to help relieve the fluid retention and swelling that accompany heart failure and other conditions.In March, Furoscix tacked on a new indication, allowing its use to treat edema in patients with chronic kidney disease (CKD).Over the first half of this year, scPharmaceuticals pulled in sales growth of 96% from the same period last year, generating $27.8 million. MannKind expects its own established strengths in the endocrinology department to help boost Furoscix’s market opportunity in CKD, and it plans to continue utilizing the “talented team” at scPharmaceuticals to continue fostering the drug's growth.MannKind currently markets inhalation powder Afrezza for type 1 and 2 diabetes, plus an all-in-one insulin delivery patch V-Go as well as United Therapeutics-partnered pulmonary arterial hypertension (PAH) treatment Tyvaso DPI. With Furoscix in the mix, the company expects its annual sales will grow beyond $370 million.The company amended a strategic financing agreement with Blackstone to add $175 million in additional funding to support the acquisition. ScPharmaceuticals’ shares surged more than 14.90% on Monday morning to $5.58, while MannKind’s dipped by 5.35% to $3.89. 

Plus, news about Vaxxas, Mid-Atlantic BioTherapeutics, Incyclix Bio and Invivyd: 🫀 MannKind to buy scPharmaceuticals: The Connecticut biopharma is paying $5.35 per share upfront in cash, plus a potential milestone payment of up to $1.00 per share. The deal gives scPharmaceuticals an equity value of $303 million upfront or $360 million total if the CVR is achieved. The FDA in 2022 approved scPharmaceuticals’ drug-device product Furoscix for certain types of heart failure. MannKind said it would have to pay about $81 million to get out of a credit facility that scPharmaceuticals had inked with Perceptive Advisors . Blackstone is helping fund the acquisition as part of an amendment to a financing agreement earlier this month. MannKind’s stock $SCPH was down about 5% on Monday morning. — Kyle LaHucik 🔬There’s a new RNA medicines biotech: Arnatar Therapeutics, a San Diego biotech founded by former Ionis leaders, launched Monday with a pipeline of RNA medicines for cardio metabolic, liver, kidney and CNS diseases. The company unveiled a $52 million Series A, though it said the round closed last year. Its candidates include Phase 1-stage ART101 for hypertension and ART4, an antisense oligonucleotide for Alagille syndrome that’s been granted orphan and rare pediatric disease designations. — Kyle LaHucik 🩹 Vaxxas raises about $58M for its needle-free vaccine tech: The biotech secured about 90 million Australian dollars to boost production of its high-density microarray patch for “market readiness.” The needle-free vaccine technology has so far been administered to over 750 participants in clinical trials and has shown robust immune response, according to Vaxxas. The funding marks one of this year’s largest financings for a private biotech in Australia. — Alexis Kramer 💰 Mid-Atlantic BioTherapeutics to get up to $50M: Legend Innovation Life Science Fund said Saturday that its planned investment will support Mid-Atlantic’s development of new “anti-aging” drugs for neurological diseases and cancer. Mid-Atlantic should expect the first funding tranche in the third quarter of this year before it begins a Phase 3 trial for its viral encephalitis drug in 2026. — Alexis Kramer 💸 Incyclix Bio extends Series B with $11.3M: The company is working on a CDK2 inhibitor that’s headed to a Phase 1/2 trial, with the help of the new funding. The extension’s investors include Eshelman Ventures, Eli Lilly, Pharmacosmos and Cape Fear BioCapital. — Jaimy Lee 🏷️ Invivyd ended up raising $57.5 million in its public offering, up from the $50 million it sought. — Jaimy Lee