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Regulatory

KMDA

Kamada Ltd. has expanded its US plasma operations by opening a new plasma collection center in Houston, TX, and plans to submit for FDA approval. The center is expected to significantly increase Kamada's plasma collection capacity and contribute to its revenue growth.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:19 am

BABA

LI

NVDA

PGJ

Alibaba's cloud computing unit partners with Nvidia to enhance autonomous driving for Chinese automakers amid U.S. semiconductor sanctions. The collaboration integrates Alibaba's language models with Nvidia's platforms, showcasing advancements at the Apsara Conference.

Portfolio Pulse from Anusuya Lahiri

September 23, 2024 | 11:08 am

QURE

uniQure's AMT-191, a gene therapy for Fabry disease, has received Orphan Drug Designation from the FDA. This status supports uniQure's ongoing Phase I/IIa trial and offers incentives like tax credits and market exclusivity upon approval.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:07 am

SPY

Minneapolis Fed President Kashkari stated that the risks have shifted towards a weakening labor market and higher unemployment. He supported the 50 basis points rate cut, citing progress on inflation and a softening labor market.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:04 am

IVVD

Invivyd, Inc. (NASDAQ:IVVD) shared new data on the neutralization activity of its drug pemivibart against various COVID-19 variants. The data shows stable neutralization results across a range of variants, with no significant mutational changes in the drug's binding site since the Omicron variant. Invivyd collaborates with LabCorp's Monogram Biosciences for virology assessments, ensuring the drug's efficacy against evolving SARS-CoV-2 variants.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:03 am

ALKS

Alkermes plans to present clinical data from its Phase 1B study of ALKS 2680, targeting narcolepsy type 2 and idiopathic hypersomnia, at the European Sleep Research Society Congress in 2024.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:02 am

BDTX

Black Diamond Therapeutics reported promising Phase 2 results for BDTX-1535 in treating EGFR-mutant non-small cell lung cancer, showing a 42% response rate and good tolerability. The company aims for FDA approval and plans to release more data in 2025.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 11:01 am

TPX

Tempur Sealy International is progressing with its acquisition of Mattress Firm, despite FTC challenges. Court hearings are set for November 2024. Tempur Sealy plans to divest 73 Mattress Firm locations and its Sleep Outfitters subsidiary to Mattress Warehouse, contingent on the acquisition's completion.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 10:58 am

AZN

AstraZeneca's Fasenra has been recommended for approval in the EU as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis. The recommendation is based on the MANDARA Phase III trial results.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 10:49 am

XOMA

ZVRA

XOMA Royalty announced that Zevra Therapeutics has received FDA approval for MIPLYFFA. XOMA is entitled to receive mid-single digit royalties on MIPLYFFA sales and up to $52.6 million in milestone payments.

Portfolio Pulse from Benzinga Newsdesk

September 23, 2024 | 10:34 am