Merus Says FDA Grants Breakthrough Therapy Designation For Petosemtamab To Treat Head & Neck Cancer

RTTNews | 472 gün önce
Merus Says FDA Grants Breakthrough Therapy Designation For Petosemtamab To Treat Head & Neck Cancer

(RTTNews) - Oncology company Merus N.V. (MRUS) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for petosemtamab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody.

This designation follows receipt of Fast Track Designation for petosemtamab for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 (anti-PD-1) antibody announced in August 2023.

BTD is supported by data from the ongoing phase 1/2 open-label, multicenter trial evaluating petosemtamab monotherapy in patients with advanced solid tumors, including previously treated (recurrent or metastatic) HNSCC (NCT03526835).

Merus plans to provide updated efficacy, durability and safety data from this cohort in the second half of 2024.

With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner as we move toward our goal of a potential Biologics License Application (BLA) submission.

Etiketler: MRUS
read more
Asian Markets Mixed Amid Caution Trades

Asian Markets Mixed Amid Caution Trades

Asian stock markets are mixed on Friday, following the broadly positive cues from Wall Street overnight, ahead of the release of key U.S. inflation data later in the day that could impact the outlook for interest rates. Traders also digested highly anticipated earnings news from Nvidia, with the AI darling and market leader reporting second-quarter results that largely exceeded expectations.
RTTNews | 5 dakika önce
Thai Stock Market Tipped To Open In The Green

Thai Stock Market Tipped To Open In The Green

The Thai stock market on Thursday ended the two-day slide in which it had slipped almost 15 points or 1.2 percent. The Stock Exchange of Thailand now sits just above the 1,250-point plateau and it may open to the upside again on Friday.
RTTNews | 1s 11 dakika önce
Japanese Market Notably Lower

Japanese Market Notably Lower

Giving up some of the gains in the previous two sessions, the Japanese market is notably lower on Friday, despite the broadly positive cues from Wall Street overnight. The Nikkei 225 is falling well below the 42,700 level, with weakness across most sectors led by exporters and technology stocks.
RTTNews | 1s 29 dakika önce
Additional Support Predicted For Indonesia Shares

Additional Support Predicted For Indonesia Shares

The Indonesia stock market has moved higher in two consecutive trading days, gathering almost 50 points or 0.6 percent in that span. The Jakarta Composite Index now sits just above the 7,950-point plateau and it may add to its winnings on Friday.
RTTNews | 1s 41 dakika önce
Australian Market Slightly Lower

Australian Market Slightly Lower

The Australian stock market is trading slightly lower on Friday, giving up some of the gains in the previous two sessions, despite the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is staying below the 9,000 mark, with weakness in mining and financial stocks partially offset by gains in energy and technology stocks.
RTTNews | 1s 50 dakika önce
Hong Kong Shares May Stop The Bleeding On Friday

Hong Kong Shares May Stop The Bleeding On Friday

The Hong Kong stock market has finished lower in three straight sessions, tumbling almost 830 points or 3.3 percent along the way. The Hang Seng Index now rests just beneath the 25,000-point plateau although it may find traction on Friday.
RTTNews | 1s 56 dakika önce
Higher Open Called For China Stock Market

Higher Open Called For China Stock Market

The China stock market on Thursday snapped the two-day losing streak in which it had stumbled more than 80 points or 2.1 percent. The Shanghai Composite Index now sits just above the 3,840-point plateau and it's expected to see additional support on Friday.
RTTNews | 2s 11 dakika önce