Streetbeat News

Regulatory

MRK

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of Merck's Winrevair (Sotatercept) for use in combination with other therapies for pulmonary arterial hypertension (PAH) in adult patients. The European Commission's decision is expected in Q3.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 11:02 am

APLS

Apellis Pharmaceuticals announced that it plans to seek re-examination following a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding its drug Pegcetacoplan for the treatment of geographic atrophy in the EU.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 11:01 am

MRNA

VGK

Moderna's mResvia received a positive opinion from the CHMP for the prevention of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus in adults aged 60 and older.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:58 am

RCKT

Trading in RCKT was halted at 6:56:37 a.m. ET due to pending news.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:56 am

RCKTW

Trading in RCKTW has been halted as of 6:56:37 a.m. ET pending news. Investors should stay tuned for further updates.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:56 am

JNJ

VGK

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Janssen's Eurneffy (Epinephrine), the first emergency treatment for allergic reactions administered as a nasal spray.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:55 am

TSLA

A 550-pound World War 2-era bomb has been found near Tesla's Gigafactory in Berlin, leading to a planned detonation and temporary production stop. The factory is under scrutiny due to environmental protests against its expansion plans.

Portfolio Pulse from Anan Ashraf

June 28, 2024 | 10:48 am

SPRY

ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the marketing authorization application for EURneffy, an adrenaline nasal spray. The CHMP recommended market authorization in the EU for the emergency treatment of allergic reactions (anaphylaxis). The formal marketing authorization process by the European Commission is expected to occur in Q3 2024.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:31 am

PTCT

PTC Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the renewal of the conditional marketing authorization for Translarna (Ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). This follows a previous negative opinion by the European Commission, which was returned for re-review.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2024 | 10:06 am

BTDR

META

Meta Platforms Inc. (NASDAQ:META) has warned the Australian government that it may block news content on its platform if required to pay licensing fees. This follows similar actions in Canada and comes amid increased scrutiny from the Australian government. The decision could impact Australian media companies and broadcasters.

Portfolio Pulse from Benzinga Neuro

June 28, 2024 | 8:34 am