Novartis AG CEO Vas Narasimhan during the company’s July 18 second-quarter earnings call said his firm was “still in the midst of completing” the buyout disclosed in February of Morphosys AG, of Munich, for €2.7 billion (then US$2.9 billion), which brought worldwide rights to pelabresib, the small-molecule BET inhibitor for myelofibrosis.
Aldeyra Therapeutics Inc. has bounced back from a complete response letter in November to produce positive phase III data for reproxalap in treating dry eye disease. The company is one of many developing treatments using diverse mechanisms of action.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.
Closely watched-for phase I data from Elevation Oncology Inc. in the Claudin 18.2 space sent shares of the Boston-based firm (NASDAQ:ELEV) down 63%, or $1.35, to close Aug. 6 at 78 cents. Elevation provided initial data from the dose-escalation portion of the ongoing experiment with antibody-drug conjugate (ADC) EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers.
In the wake of Sage Therapeutics Inc.’s recent phase II fizzle with SAGE-324 in essential tremor, Wall Street is waiting for better news in the indication, which has racked up failures across several developers. Among those finding favor lately is Praxis Precision Medicines Inc. with Nav-targeting ulixacaltamide, also known as PRAX-628, which Oppenheimer analyst Francois Brisebois said “warrants particular attention.”
Bristol Myers Squibb Co. (BMS) has terminated its $1.3 billion-plus deal for Agenus Inc.’s anti-TIGIT bispecific antibody AGEN-1777 as part of a promised belt-tightening. In May 2021, BMS paid Agenus a non-refundable $200 million up-front payment in cash for the licensing, manufacturing and commercialization agreement, then a $20 million milestone payment in December 2021 and another clinical milestone payment in January 2024 for $25 million.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
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