Streetbeat News

Regulatory

CTXR

The FDA has issued a Complete Response Letter to Citius Pharmaceuticals Inc's (NASDAQ:CTXR) Biologics License Application for denileukin diftitox (Lymphir), requiring enhanced product testing and additional controls. The FDA had no concerns about the safety and efficacy data submitted. In 2021, Citius acquired an exclusive license to develop and commercialize Lymphir in all markets except Japan and certain parts of Asia. CTXR shares are down 16% at $0.94.

Portfolio Pulse from Vandana Singh

July 31, 2023 | 1:55 pm

BAX

The FDA has reported that Baxter International Inc. has made a correction due to an increase in false upstream occlusion alarms following software upgrades in Spectrum V8 & IQ Infusion Pumps.

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:48 pm

BAX

The FDA has announced that Baxter International Inc. has issued an urgent medical device correction for its Spectrum V8 and Spectrum IQ infusion pumps with specific software versions. Baxter has received three reports of serious injury potentially associated with the device correction.

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:48 pm

NVO

Novo Nordisk's weight-loss drug, Wegovy, has launched in Germany, marking its first significant European market entry. The drug is already available in the U.S., Norway, and Denmark. Despite concerns about supply constraints, the company expects German consumers to cover the drug's expenses as public health insurance cannot cover it. The launch is seen as a positive development given Germany's adult obesity rate of 18.5%, higher than the EU average.

Portfolio Pulse from Vandana Singh

July 31, 2023 | 1:45 pm

SPY

The Chicago Purchasing Managers' Index (PMI) for July came in at 42.8, slightly below the estimated 43 but higher than the prior month's 41.5.

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:45 pm

BAYRY

REGN

Regeneron Pharmaceuticals announced two-year results from the PHOTON trial of aflibercept 8 mg, showing that fewer injections maintain vision and anatomic improvements in diabetic macular edema patients. The trial met its primary endpoint last year with aflibercept 8 mg patients achieving clinically equivalent vision gains to Eylea. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG.

Portfolio Pulse from Vandana Singh

July 31, 2023 | 1:43 pm

GNE

Genie Energy Ltd. (NYSE:GNE) announced that its subsidiary, Genie Solar, has received the notice to proceed for a 6.25-megawatt community solar farm in Lansing, New York. The project, which will include approximately 14,000 solar panels on nearly 20 acres, is expected to supply electricity to around 1,000 local homes once operational. The project is scheduled for completion in 2024, with the start of power generation contingent upon testing of the interconnection and final approval from the regional utility, New York State Electricity and Gas (NYSEG).

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:39 pm

NAVB

Navidea Biopharmaceuticals Inc (NASDAQ:NAVB) shares have dropped by 18.5% to $0.08 after the company announced that NYSE American has started delisting proceedings. The company plans to appeal the decision and if delisted, Navidea intends to quote its common stock in the over-the-counter market.

Portfolio Pulse from Henry Khederian

July 31, 2023 | 1:39 pm

YELL

MFN Partners LP has reported a 24.6% stake in Yellow Corporation as of July 20, according to a 13D filing with the SEC.

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:37 pm

SEAS

The SEC filed a complaint against SeaWorld Entertainment and James Atchison for making misleading statements about the impact of the documentary film Blackfish on the company's business. The defendants allegedly failed to disclose the 'Blackfish effect' to investors, leading to inflated stock prices. The SEC also filed a complaint against Frederick D. Jacobs for making an untrue statement before selling his SeaWorld stock. The defendants have consented to final judgments imposing a total of approximately $5.1 million in financial remedies. A Fair Fund has been established for the distribution of these funds to harmed investors.

Portfolio Pulse from Happy Mohamed

July 31, 2023 | 1:35 pm