Lest there’s any confusion, Lucid Diagnostics Inc. published promising results from a third study showing the benefit of its non-invasive Esoguard test for detecting esophageal cancer and precancer conditions.
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.
Immunovia AB significantly increased the accuracy of its test for the early detection of pancreatic cancer, achieving an 85% sensitivity and a specificity of 98%.
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.
Investors wanted more from ALX Oncology Holdings Inc.’s phase II study testing evorpacept (evo) combination therapy in gastric tumors, and the stock (NASDAQ:ALXO) tumbled 36% or $1.77 to close Aug. 1 at $3.04.
Macrogenics Inc., agreeing with an independent data monitoring committee, has discontinued dosing patients in the troubled phase II Tamarack study of vobramitamab duocarmazine as a second-line treatment for metastatic castration-resistant prostate cancer.
The disappointments continue for Fibrogen Inc., which is terminating work on its once-promising anti-CTGF monoclonal antibody, pamrevlumab, after reporting missed endpoints in two late-stage pancreatic cancer studies, and cutting its workforce by about 75%.
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