Streetbeat News

Regulatory

VIRI

Virios Therapeutics has received guidance from the FDA on the requirements for progressing its IMC-2 treatment, a combination of Valacyclovir and Celecoxib, for symptoms associated with Long COVID illness, including fatigue and orthostatic intolerance.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:09 pm

PPTA

Perpetua Resources Corp. is progressing with the Stibnite Gold Project, aiming to supply the U.S. with antimony and establish a major gold mine. The company is advancing through the NEPA process and preparing for construction. Andrew Cole's appointment to the Board of Directors is expected to enhance operational expertise.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:07 pm

SNDX

Syndax Pharmaceuticals announced recent updates and anticipated milestones for 2024, including the potential launch of two products in the U.S. The company also completed a $230M follow-on offering in December, which they believe extends their financial runway through 2026. They are currently working with the FDA on regulatory submissions.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:05 pm

BMY

The European Medicines Agency (EMA) has validated Bristol Myers Squibb's application for repotrectinib, a treatment for locally advanced or metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors. This validation indicates that the application is complete and the EMA will now begin its formal review process. Repotrectinib is a targeted therapy designed to inhibit cancer growth in patients with specific genetic alterations, and its validation by the EMA is a crucial step towards potential approval and commercial availability in Europe.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:01 pm

BMY

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application for repotrectinib, a next-generation tyrosine kinase inhibitor. If approved, repotrectinib could become a leading treatment for ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors in the EU.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:01 pm

IQV

IQVIA Holdings, Inc.'s planned acquisition of DeepIntent, a healthcare advertising firm, has been blocked by a U.S. court following a Federal Trade Commission (FTC) order due to concerns over potential harm to competition. The FTC argued that the merger could lead to higher consumer prices and negative effects on patients. Despite IQVIA's disappointment and disagreement with the FTC's stance, the company is considering its options after the court's decision. DeepIntent's CEO stated the company would remain independent if the merger was blocked. The financial details of the deal were not disclosed.

Portfolio Pulse from Nabaparna Bhattacharya

January 02, 2024 | 11:55 am

NRXP

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) has announced its plans to comply with Nasdaq's minimum bid price and Market Value of Listed Securities (MVLS) requirements. The company previously received two deficiency notices from Nasdaq for not maintaining a minimum $1 bid price and an MVLS of $50 million. NRx Pharmaceuticals intends to present a full compliance plan to Nasdaq by January 4, 2024, which will be based on achieving clinical milestones.

Portfolio Pulse from Charles Gross

January 02, 2024 | 11:55 am

AGR

PNM

Avangrid Inc (AGR) has terminated its merger agreement with PNM Resources (PNM) due to the failure to receive all final regulatory approvals by December 31, 2023. The merger, which has been in progress since 2020, was expected to bring over $300 million in benefits to PNM's consumers and communities. Despite obtaining necessary approvals, except from the New Mexico Public Regulation Commission, the merger's future remained uncertain. Avangrid will now focus on its growth opportunities, including over $9 billion in incremental capital projects. Avangrid reaffirmed its 2023 EPS guidance, while PNM Resources will provide a financial update on February 6, 2024. PNM shares dropped 3.87% in premarket trading.

Portfolio Pulse from Shivani Kumaresan

January 02, 2024 | 11:31 am

LBPH

Longboard Pharmaceuticals, Inc. (NASDAQ:LBPH) is set to host a conference call to discuss the topline data from the PACIFIC Study, a Phase 1b/2a clinical trial for bexicaserin in participants with Developmental and Epileptic Encephalopathies (DEEs). The call is scheduled for January 2, at 8:30 AM ET. Bexicaserin is a novel 5-HT2C receptor superagonist with potential therapeutic benefits and no observed impact on other receptor subtypes.

Portfolio Pulse from Charles Gross

January 02, 2024 | 10:59 am

AZN

SNY

China has approved Beyfortus (Nirsevimab), a long-acting monoclonal antibody developed by AstraZeneca and Sanofi, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection in neonates and infants. The treatment is expected to be available for the 2024-2025 RSV season.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 8:29 am