Zenocutuzumab

Starting January 1, 2025, Independence Blue Cross updates specialty drugs requiring precertification for certain plans. Includes FDA-approved drugs like Ahzantive, Bkemv, and pending approval drugs. Updates also reflect brand name changes for previously added drugs.

In December 2024, FDA approved several treatments including zenocutuzumab for NRG1+ NSCLC and pancreatic cancer, cosibelimab for CSCC, and combinations for BRAF V600E+ mCRC. Fast track and breakthrough designations were granted for treatments in MDS, cervical cancer, NSCLC, and SCLC. Priority reviews were given for taletrectinib in ROS1+ NSCLC and remestemcel-L for pediatric acute GVHD.

In 2024, the FDA approved over 60 oncology therapies, including 11 first-in-class drugs. Highlights include Revumenib and Zolbetuximab for leukemia and gastric cancer, respectively, and new treatments targeting HER2, PD-L1, and ALK with improved efficacy and reduced toxicity. The approvals also featured novel strategies like bispecific antibodies and CAR T-cell therapies, alongside new indications for existing drugs.

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

Merus (NASDAQ:MRUS) received a 'Buy' consensus rating from fourteen brokerages, with a $85.64 average price target. Analysts from Goldman Sachs, UBS Group, HC Wainwright, Citigroup, and Guggenheim issued buy ratings, with price targets ranging from $72.00 to $109.00. Institutional investors increased stakes, owning 96.14% of the stock. Merus reported ($0.95) EPS for Q3, missing estimates, with $11.77M revenue, exceeding expectations. The company focuses on developing antibody therapeutics for cancer treatment.

FDA approved treatments in December 2024 include durvalumab for small cell lung cancer, zenocutuzumab for NRG1+ NSCLC and pancreatic adenocarcinoma, cosibelimab for cutaneous squamous cell carcinoma, ensartinib for ALK+ NSCLC, encorafenib plus cetuximab for BRAF V600E+ metastatic colorectal cancer, tislelizumab plus chemo for PD-L1+ gastric/GEJ cancer, and subcutaneous nivolumab for advanced solid tumors.

MSKCC advanced cancer treatments in 2024 include new surgical techniques, vaccines, drugs enhancing radiation, and diagnostic tools. The FDA approved 11 drugs based on MSK's pivotal clinical trials, covering new uses for existing drugs, effective drug combinations, engineered cell therapies, and novel targeted therapies. Key developments include a KRAS vaccine for pancreatic and colorectal cancer, combination drug-radiation treatment for basal cell carcinoma, noninvasive E-nose for lung cancer detection, improved transplant success with partially matched donors, exercise impact on prostate cancer biomarkers, new imaging for lung and prostate cancers, TIL therapy for non-small cell lung cancer, robotic neurosurgery for spinal tumors, avoiding surgery for HPV throat cancer with innovative radiation, imlunestrant for ER+, HER2- advanced breast cancer, mRNA vaccine for pancreatic cancer, and immunotherapy for rectal cancer. FDA approvals included tepotinib for METex14 lung cancer, CAR T treatment for mantle cell lymphoma, selpercatinib for RET-linked thyroid cancer, repotrectinib for NTRK fusion cancers, adagrasib with cetuximab for KRAS-G12C colorectal cancer, afamitresgene autoleucel for synovial sarcoma, vorasidenib for IDH glioma, inavolisib with fulvestrant and palbociclib for breast cancer, revumenib for KMT2A leukemia, zanidatamab for HER2 biliary tract cancer, and zenocutuzumab for NRG1 fusion pancreatic and lung cancers.

Merus announced the FDA extended the PDUFA goal date for zenocutuzumab's BLA to February 4, 2025, to review additional CMC information, without requesting further clinical data. Shares dropped 4.4% pre-market. Merus seeks a commercial partner for Zeno.

Zenocutuzumab approved for NRG1+ NSCLC and PDAC; sacituzumab tirumotecan granted breakthrough status for EGFR+ NSCLC; durvalumab approved for limited-stage SCLC; sonodynamic therapy shows improved OS and PFS in recurrent glioblastoma; systemic therapy choice impacts brain metastases outcomes.

Jim Cramer discusses Merus N.V. (MRUS) under his lightning rounds spotlight, noting its speculative nature despite FDA approval for cancer therapy Bizengri. Cramer cautions against market complacency and overly optimistic expectations for Federal Reserve rate cuts, highlighting the potential for disappointment. MRUS ranks 3rd on the list, with AI stocks seen as more promising for higher returns.