Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the serious gastric emptying condition for which there has been no new treatment in 40 years. The complete response letter (CRL) issued on the Sept. 18 PDUFA date for the neurokinin-1 receptor antagonist, which Vanda licensed from Eli Lilly and Co. in 2012, requested additional studies that the company said are not in line with the advice of experts in the field.
After disclosing data from the phase II Herald study, Aligos Therapeutics Inc. may sign a partner to help advance ALG-055009, a thyroid hormone receptor (THR) beta agonist, in subjects with metabolic dysfunction-associated steatohepatitis (MASH, formerly nonalcoholic steatohepatitis, or NASH).
Wall Street apparently wanted more from Prelude Therapeutics Inc.’s phase I data with SMARCA2 enzyme degrader PRT-3789 in cancer, which rolled out Sept. 13 during the recent European Society of Medical Oncology Congress in Barcelona, but hopes are still high for other prospects in the class pushed forward by various developers.
Investors reading into the U.S. FDA’s decision to skip an advisory committee meeting to discuss the NDA for Applied Therapeutics Inc.’s govorestat, seeking approval as the first therapy for treating classic galactosemia, clearly saw reasons for optimism, as shares of Applied (NASDAQ:APLT) jumped 69% to close Sept. 18 at $7.85.
Rakovina Therapeutics Inc. and Variational AI Inc. have entered into a research collaboration to identify and develop novel small-molecule therapies against DNA damage response (DDR) targets for the treatment of cancer.
Researchers from Circle Pharma Inc. have presented preclinical data for CID-078, a novel orally bioavailable cyclin A/B Rxl macrocycle being developed for the treatment of patients with lung cancer. CID-078 was developed as a macrocycle that binds to the hydrophobic patch of cyclins A and B and blocks RxL-dependent interactions of proteins, such as that of E2F1 with cyclin A-CDK2 and Myt1 with cyclin B-CDK1.
Scattered investor qualms about Nuvalent Inc.’s largely upbeat data during the European Society for Medical Oncology (ESMO) meeting in Barcelona didn’t stop the firm from pricing an upsized $500 million public offering. The Cambridge, Mass.-based firm is selling 5 million shares of class A common stock at $100 each. The offering is expected to close on Sept. 18, with underwriters holding a 30-day option to purchase up to 750,000 more shares.
Immuneering Corp. CEO Benjamin Zeskind said he is “pleased with enrollment across the full trial” that’s ongoing with IMM-1-104 in cancer, and 30 subjects are due per arm in five arms that the phase IIa experiment includes.
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
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