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Regulatory

PRTK

Paratek Pharmaceuticals has announced a modification to its Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA). The modification provides new development milestones for the next procurement of NUZYRA, a treatment for pulmonary anthrax. The next procurement will be split into two equal parts based on the achievement of specific development milestones. The first procurement will be triggered by positive data from a dose-ranging efficacy study in 2024. The second procurement will be triggered by positive data from two studies in 2024. The final procurement will be triggered by Paratek's receipt of sNDA approval from the FDA for the treatment of inhalation anthrax.

Portfolio Pulse from Happy Mohamed

July 10, 2023 | 12:04 pm

CNTB

Connect Biopharma has presented additional data from its atopic dermatitis trial in China at the 2023 World Congress of Dermatology. The data, from four poster presentations, detailed the achievement of primary and secondary endpoints, improvements in investigator-rated outcomes, and improvements in patient reported outcomes from the initial 16-week treatment period with rademikibart (formerly known as CBP-201) in patients with moderate-to-severe atopic dermatitis in the pivotal CN002 trial.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 12:04 pm

BTCUSD

META

TSLA

Major stories from the weekend include Elon Musk's test drive of Tesla's Cybertruck, the potential introduction of a gold-backed currency by BRICS countries, and warnings of a potential recession by U.S. Treasury Secretary Janet Yellen. Additionally, Bitcoin is expected to face a significant test in 2023, and Twitter is struggling to prove that Meta Platform Inc stole trade secrets.

Portfolio Pulse from Benzinga Newsbot

July 10, 2023 | 12:03 pm

MAIA

Maia Biotechnology has announced preliminary survival data from the Part A safety lead-in of its ongoing THIO-101 Phase 2 trial. The trial is evaluating THIO in sequential combination with Cemiplimab in advanced non-small cell lung cancer. The first two patients dosed with THIO have shown no documented progression for 12.2 and 11.5 months, and no new anti-cancer treatment 10.2 and 8.5 months after concluding treatment with THIO.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 12:02 pm

CNTA

Centessa Pharmaceuticals has announced the dosing of the first subject in its registrational PRESent-2 study, which is evaluating SerpinPC for the treatment of Hemophilia B without inhibitors.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 12:01 pm

ZVSA

ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA) has announced the publication of an article in the peer-reviewed journal Circulation. The article demonstrates the role of inflammasome NLRP3 activation in hypertrophic heart disease induced by mechanical stress. ZyVersa is a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 11:42 am

FXI

China's Central Bank has extended policies to support the stable and healthy development of real estate markets until the end of 2024. This encourages financial institutions and real estate enterprises to negotiate independently.

Portfolio Pulse from Charles Gross

July 10, 2023 | 11:36 am

IOVA

Iovance Biotherapeutics has announced regulatory and clinical updates for its polyclonal tumor infiltrating lymphocyte therapy in advanced non-small cell lung cancer. The updates could potentially impact the company's future prospects and stock performance.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 11:19 am

NVS

The US Food and Drug Administration (FDA) has approved a label update for Novartis' Leqvio (inclisiran) to enable its use in patients with elevated LDL-C who have an increased risk of heart disease. This includes patients with comorbidities such as hypertension and diabetes who have not yet had a first cardiovascular event.

Portfolio Pulse from Charles Gross

July 10, 2023 | 11:16 am

IOVA

Iovance Biotherapeutics has announced regulatory and clinical updates for its TIL therapy in advanced non-small cell lung cancer. The updates could potentially impact the company's future operations and stock performance.

Portfolio Pulse from Benzinga Newsdesk

July 10, 2023 | 11:10 am