An uncommon route to the public markets – direct listing – paid off for Turn Therapeutics Inc., with shares (NASDAQ:TTRX) closing Oct. 9 at $9.20, up $2.20, or 31%, having risen as high as $26.50 in its second day of trading. The firm is advancing late-stage clinical programs in eczema and onychomycosis. Also in the works are global health initiatives in thermostable vaccine delivery designed to serve underserved areas.
More than a decade after the last idiopathic pulmonary fibrosis (IPF) treatment gained U.S. FDA approval, Boehringer Ingelheim GmbH’s Jascayd (nerandomilast) is set to hit the market following the agency’s green light on Oct. 7. While expected to offer a modest benefit over existing therapies, Jascayd, an orally administered preferential inhibitor of phosphodiesterase 4B with breakthrough therapy status, is viewed by analysts as the first of several potential advancements in the IPF space over the next few years.
In a deal that could top $2 billion, China-based Innocare Pharma Ltd. licensed the exclusive worldwide development and commercialization rights to the BTK inhibitor orelabrutinib to Zenas Biopharma Inc. for multiple sclerosis and other indications aside from oncology.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide.
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
Arcus Biosciences Inc. has announced five new research programs for autoimmune and inflammatory diseases, and is targeting initiation of the first clinical studies next year.
Impaired fracture healing is a clinical management challenge. Fracture healing can be impaired due to several factors, such as aging, chronic inflammation or metabolic abnormalities. Osteoclasts play a crucial role in bone tissue reconstruction, but their abnormal activation can lead to impaired fracture healing. In a recent publication in Frontiers in Immunology, researchers from Naval Military Medical University and collaborators searched for crucial regulatory genes in the process of bone fracture healing.
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
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