On Wednesday, the FDA approved Merus N.V.'s (NASDAQ:MRUS) Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.

Bizengri is Merus's first approved medicine and is based on the proprietary Biclonics technology platform.

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These indications are approved under accelerated approval based on the overall response rate (ORR) and duration of response (DOR).

Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Bizengri 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.

Bizengri's approval is based on data from the eNRGy trial. In patients with NRG1+ pancreatic adenocarcinoma (n=30), Bizengri demonstrated an ORR of 40%.

DOR in NRG1+ pancreatic adenocarcinoma ranged from 3.7 months to 16.6 months. In the same trial, patients with NRG1+ NSCLC (n=64) treated with Bizengri demonstrated an ORR of 33%. The median DOR in NRG1+ NSCLC was 7.4 months.

b writes, "Investor focus remains on petosemtamab, with the next key catalyst for the company being updated data for petosemtamab in previously treated head and neck squamous cell carcinoma (HNSCC) at ESMO Asia on December 7."

The analyst assumes Bizengri will be priced at roughly $30,000 per treatment and estimates combined peak U.S. sales in NRG1 fusion NSCLC and PDAC attributable to Merus (based on an estimated 8% royalty rate) of roughly $16.5 million.

Price Action: MRUS stock is down 3.70% at $43.80 at the last check on Thursday.

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