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Regulatory

HGEN

Humanigen (OTC:HGEN) has filed for bankruptcy following the FDA's rejection of its COVID-19 drug, lenzilumab. The company reported $44.1 million in unsecured debts against assets of $521,000. The FDA's decision, legal challenges, and studies questioning the drug's efficacy have led to a financial crisis for Humanigen, resulting in its delisting from Nasdaq in October 2023. The stock has lost almost all value from its previous $20 trading range.

Portfolio Pulse from Vandana Singh

January 05, 2024 | 3:55 pm

SANA

Sana Biotechnology, Inc. (NASDAQ:SANA) shares rose after the FDA cleared its IND application for SC262, a study for patients with relapsed or refractory B-cell malignancies. This clearance follows a previous FDA clearance for SC291 for lupus nephritis and related conditions. The company anticipates presenting data from multiple studies, including SC262, later in the year. SANA's stock price increased by 2.24% to $5.01.

Portfolio Pulse from Nabaparna Bhattacharya

January 05, 2024 | 3:54 pm

NVO

A U.S. study found that Novo Nordisk's drugs Ozempic and Wegovy do not increase the risk of suicidal thoughts. Contrary to prior concerns, the study showed a lower incidence of such thoughts among users compared to other treatments. The study, funded by the U.S. National Institutes of Health and published in 'Nature,' analyzed data from over 1.8 million patients. Semaglutide, the active ingredient in both drugs, was linked to a significantly lower risk of suicidal ideations. Novo Nordisk's stock (NVO) was down 0.60% at $106.99 on the last check Friday.

Portfolio Pulse from Vandana Singh

January 05, 2024 | 3:41 pm

AZN

GRCL

AstraZeneca (NASDAQ:AZN) is set to acquire Gracell Biotechnologies Inc. (NASDAQ:GRCL) for up to $1.2 billion, an 86% premium over its pre-announcement share price. The deal offers hope for cash-strapped Chinese biotechs, as Gracell's shares surged 60.3% post-announcement. Gracell, which focuses on CAR-T cell therapy for cancer treatment, has been operating at a loss with its most advanced product still in phase 1 trials. The acquisition by AstraZeneca will bolster its cell therapy capabilities, taking over Gracell's technology and trials. However, the sector faces uncertainty due to an FDA investigation into potential risks associated with CAR-T therapies.

Portfolio Pulse from The Bamboo Works

January 05, 2024 | 3:26 pm

GOOG

GOOGL

A Reddit user used Stability AI's Stable Diffusion to create a realistic image of a non-existent woman with a fake passport, raising concerns about AI's potential to forge identities. The incident reflects growing issues with AI misuse, as seen with Scarlett Johansson's lawsuit and fake images in a New Jersey high school. Google has developed a tool to detect AI-generated photos, aiming to mitigate such risks.

Portfolio Pulse from Rounak Jain

January 05, 2024 | 3:18 pm

SLGC

Trading for SLGC was halted and then resumed at 10:10 AM ET, with an update on news and resumption times.

Portfolio Pulse from Benzinga Newsdesk

January 05, 2024 | 3:10 pm

VRNOF

A Montgomery County Circuit Court Judge in Alabama has issued a restraining order preventing the Alabama Medical Cannabis Commission (AMCC) from issuing medical marijuana facility licenses. The decision follows a complaint by several plaintiff companies alleging that the AMCC violated Alabama law with a faulty voting process. The judge believes the plaintiffs will likely prove the AMCC's wrongdoing. Previously, the AMCC awarded 20 medical cannabis licenses and five integrated facility licenses. The legal battle over the licensing process has been ongoing, with previous attempts to issue licenses in June and August failing due to legal challenges involving companies like Medella LLC and Verano Holdings Corp.

Portfolio Pulse from Jelena Martinovic

January 05, 2024 | 3:01 pm

NVS

Novartis has received FDA approval for its new radioligand therapy (RLT) manufacturing facility in Indianapolis, which is now the largest and most advanced of its kind. The facility will increase RLT production capacity to 250,000 doses in 2024, ensuring an unconstrained supply of Pluvicto and Lutathera for current and future demand. Novartis has also doubled weekly production of Pluvicto, allowing treatment within two weeks of diagnosis. The company is expanding its global RLT manufacturing network, including new facilities in Japan and China, and aims to improve patient access by adding more treatment sites.

Portfolio Pulse from Benzinga Newsdesk

January 05, 2024 | 2:31 pm

NTRB

Nutriband Inc. has signed a commercial development and clinical supply agreement with Kindeva Drug Delivery for Aversa Fentanyl, an abuse-deterrent fentanyl patch. This agreement will enable Kindeva to develop the manufacturing process and produce clinical supplies for FDA-required studies. Aversa Fentanyl, which combines Nutriband's proprietary technology with Kindeva's FDA-approved patch system, has a potential market of $80M - $200M in annual US sales. The technology aims to improve safety while ensuring access for patients in need.

Portfolio Pulse from Benzinga Newsdesk

January 05, 2024 | 2:21 pm

NVO

A recent NIH-funded analysis revealed that patients treated with Semaglutide, a medication for obesity or type 2 diabetes, had a significantly lower risk of suicidal ideation, ranging from 49% to 73%, compared to those given other medications. This finding could have implications for the prescription practices for these conditions.

Portfolio Pulse from Benzinga Newsdesk

January 05, 2024 | 2:06 pm