Streetbeat News

Regulatory

MRK

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Merck's Keytruda in combination with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 12:43 pm

OCGN

Ocugen has announced the first patient dosing in its Phase 1/2 clinical trial for OCU410ST, a modifier gene therapy for Stargardt disease, which directly affects the retina. This marks a significant step in the company's research and development efforts.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 12:37 pm

GLD

IEUR

SPY

UUP

US stock markets closed lower on November 10th due to rising Treasury yields and comments from Federal Reserve Chair Jerome Powell about the need to bring inflation back to its target. S&P 500 and Nasdaq broke their winning streaks, with all S&P sectors finishing lower. Asian and European markets also closed lower, with commodities trading mixed. US futures were down.

Portfolio Pulse from Akanksha Bakshi

November 10, 2023 | 12:33 pm

PCRX

Pacira Pharmaceuticals has announced that the FDA has approved the expanded label of its product, EXPAREL, to include two additional nerve block indications. This will significantly extend its reach within more than 3 million lower extremity procedures.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 12:33 pm

LYEL

Lyell Immunopharma, Inc. (NASDAQ:LYEL) shares are trading higher after the company announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to LYL845 for the treatment of patients with stage IIB-IV melanoma. LYL845 is currently being investigated in a Phase 1 clinical trial. Initial data from the trial are expected in 2024.

Portfolio Pulse from Nabaparna Bhattacharya

November 10, 2023 | 12:30 pm

AZN

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AstraZeneca's Omjjara for the treatment of Myelofibrosis. The article does not mention GSK or VGK.

Portfolio Pulse from Charles Gross

November 10, 2023 | 12:21 pm

MAIA

The FDA has granted Orphan Drug Designation to MAIA Biotechnology's lead asset THIO, a cancer telomere-targeting agent, for the treatment of Glioblastoma.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 12:03 pm

INAB

IN8bio, Inc. (NASDAQ:INAB) will present two posters at the Society for Neuro-Oncology (SNO) 28th Annual Meeting, highlighting the potential of its DeltEx Drug Resistant Immunotherapy (DRI) to treat patients with newly diagnosed glioblastoma multiforme (GBM). The posters will detail the study design for INB-400, the company-sponsored Phase 2 trial, and provide updated clinical data from the Phase 1 INB-200 trial.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 12:02 pm

NXU

Nxu has announced that it has received the SEC effectiveness on Form S-3 Shelf Registration Statement for $75M in primary capital.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 11:32 am

TSM

Semiconductor Manufacturing International Co. (SMIC), China's largest chipmaker, reported an 80% drop in Q3 profits due to weak global demand. The company's Q3 revenue was $1.62 billion, a 15% decrease YoY. SMIC has been struggling with US sanctions limiting China's chipmaking technology and exports. Despite the downturn, SMIC expects a 1-3% revenue increase in Q4.

Portfolio Pulse from Benzinga Neuro

November 10, 2023 | 11:31 am