Allogene Therapeutics Inc. officials took many questions but had few answers during a conference call regarding the FDA’s clinical hold after the report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the phase I/II Alpha2 study.
It looks like Shanghai Miracogen Inc.’s antibody-drug conjugate (ADC) partnership with Synaffix BV is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered a U.S. phase I/II trial to treat solid tumors.
A lack of toxicity and the shrinking of tumors were at the heart of new interim data produced from a two-stage phase II study by Relay Therapeutics Inc. The company reported that the oral small molecule RLY-4008, designed to elicit responses across a broad spectrum of resistance mutations and in multiple tumor types, selectively inhibited fibroblast growth factor receptor (FGFR) 2 in ways that are not limited by off-target toxicities of hyperphosphatemia (FGFR1) and diarrhea (FGFR4).
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
Data from two phase I studies from Prelude Therapeutics Inc. helped open the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics on Oct. 7 but tugged the company’s stock sharply downward.
With its topical gel for primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older, Brickell Biotech Inc. is gearing up to challenge Journey Medical Corp.’s Qbrexza (glycopyrronium), an anticholinergic agent contained in a single-use, pre-moistened, medicated cloth.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Brickell, Bristol Myers, Celltrion, Denali, G1, Genetx, Inhalon, Jounce, Minervax, Timber, Ultragenyx.
The start of a phase Ib/II trial with nanatinostat by Viracta Therapeutics Inc. has brought new attention to the burgeoning field of synthetic lethality, where a number of players are piquing the interest of Wall Street.
Privately held Retrotope Inc., the only company currently in the clinic studying the ultra-rare and fatal neurological disorder infantile neuroaxonal dystrophy, has new data it hopes to present to the FDA early next year.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Apexigen, Cassava, Covicept, Dialectic, Elicio, Entera, Legacy, Panther, Pharmather, Precirix, Takeda, Vaxart.
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