“Home-run” efficacy and what Cowen analyst Tyler Van Buren called “pristine” safety in the phase II Alpha3 study with CAR T therapy cemacabtagene ansegedleucel (cema-cel) sent shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) skyward to a $4.46 high, up nearly 64%, on April 13. Shares eventually closed at $3.06, up 34 cents.
“Unprecedented,” “remarkable” and “transformative” were just a few of the descriptives tossed out by Wall Street analysts in response to Revolution Medicines Inc.’s phase III readout, showing RAS inhibitor daraxonrasib hit its overall survival and progression-free survival endpoints in previously treated patients with metastatic pancreatic ductal adenocarcinoma, setting up the company for potential regulatory filings this year and triggering another round of M&A speculation.
Gluetacs Therapeutics (Shanghai) Co. Ltd. has discovered new proteolysis targeting chimera (PROTAC) compounds comprising a cereblon (CRBN)-binding moiety coupled to a SWI/SNF-related matrix-associated actin-dependent regulator of chromatin subfamily A member 2 (SMARCA2) and SMARCA4-targeting moiety. They are designed for use in the treatment of cancer, transplant rejection, infections, diabetes, autoimmune, neurological, inflammatory and cardiovascular disorders, among others.
Dovetree Medicines Unus Inc. has divulged new cellular tumor antigen p53 (TP53) (Y220C mutant) stabilizers potentially useful for the treatment of cancer.
Solve Therapeutics Inc. has disclosed new antibody-drug conjugates (ADCs) comprising antibody or antigen binding fragments targeting trophoblast glycoprotein (TPBG; 5T4) linked to a cytotoxic drug and therefore potentially useful for the treatment of cancer.
Researchers from Sun Yat-sen University and collaborators reported the preclinical efficacy of SGI-7079, an AXL inhibitor, in models of retinoblastoma.
Retinoid X receptor γ (RXRγ) is a key nuclear receptor that sustains androgen receptor (AR) signaling. In castration-resistant prostate cancer (CRPC), RXRγ contributes to disease progression by maintaining adaptive transcriptional networks that promote therapy resistance and tumor cell survival.
Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
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