Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
Ideaya Biosciences Inc. bought global rights to Biocytogen Pharmaceuticals Co. Ltd.’s cancer-targeting bispecific antibody-drug conjugate (bsADC) program in a deal reaching up to $406.5 million. Announced July 31, San Francisco-based Ideaya agreed to license-in global rights to Biocytogen’s B7H3/PTK7 bispecific ADC program with topoisomerase-I (TOP1) payload to develop as either a monotherapy or combination therapy for solid tumors.
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.
Instil Bio Inc. plans re-energize the company by in-licensing the development and commercial rights to antibodies outside of China from Shanghai-based Immuneonco Biopharmaceuticals Inc. In return, Immuneonco is getting an undisclosed up-front payment and the chance for near-term payments of up to $50 million.
Radiopharm Theranostics Ltd. said it plans to list on Nasdaq by the end of 2024. The company had earlier announced plans to list in February 2023, but it delayed the listing due to market conditions.
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%.
For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.
Phase II data showing an 11.1-month improvement in overall survival for advanced ovarian cancer patients treated with the IL-12 immunotherapy IMNN-001 drove up shares of Imunon Inc. by 181% July 30. The results “could usher in the first immune-based therapy for ovarian cancer,” said Stacy Lindborg, president and CEO of the Lawrenceville, N.J.-based company.
The dealmaking continues at Boehringer Ingelheim GmbH as it plans to buy Nerio Therapeutics Inc. for $1.3 billion. The German company is bolstering its cancer programs with the Nerio acquisition, which will be added to multibillion-dollar deals cut earlier this year for cancer immunotherapies and nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) treatments.