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Regulatory

MDRX

Veradigm announced it will not meet Nasdaq's deadline of February 27, 2024, for filing required financial statements, risking suspension of trading. The company is working to file the necessary documents and has adopted a stockholder rights plan in anticipation of potential trading suspension.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 12:25 pm

IINN

Inspira Technologies OXY B.H.N. Ltd. (IINN) is on track to receive its first FDA 510(k) clearance for the INSPIRA ART100 in H1 2024, with plans for more submissions. It has secured three US patents and signed $546M in distribution agreements, pending regulatory approvals.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 12:15 pm

ACXP

Acurx Pharmaceuticals announced that the FDA has granted an end of Phase 2 meeting for its drug, Ibezapolstat, aimed at treating C. difficile infection. Additionally, the European Medicines Agency has granted SME (Small and Medium-sized Enterprises) designation for the development of Ibezapolstat in the EU. This marks significant regulatory milestones for Acurx, potentially accelerating the drug's development and approval process in both the US and Europe.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 12:11 pm

ACXP

Acurx Pharmaceuticals announced that the FDA has granted an end of Phase 2 meeting for its drug, Ibezapolstat, aimed at treating C. difficile infection. Additionally, the European Medicines Agency has granted SME (Small and Medium-sized Enterprises) designation for the development of Ibezapolstat in the EU. This marks significant regulatory milestones for Acurx in advancing the drug's development and potential market entry in both the US and Europe.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 12:10 pm

BCLI

Brainstorm Cell Therapeutics announced it will present a poster on the design for a Phase 3b trial of NurOwn in ALS at the MDA Clinical and Scientific Conference. The trial will be a two-part, multicenter study focusing on the efficacy and safety of NurOwn in mild-to-moderate ALS patients, with a primary endpoint based on the ALSFRS-R scale.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 11:39 am

BYDDF

BYDDY

BYD Co Limited refutes the EU's allegations that Chinese car companies' success is due to state aid, attributing it instead to their early investment in technology and efficient management. Despite the EU's investigation into subsidies and potential for increased tariffs, BYD is confident and prepared to stabilize prices. The company, backed by Warren Buffett's Berkshire Hathway, is expanding in Europe with plans to increase its EV factory capacity in Hungary.

Portfolio Pulse from Benzinga Neuro

February 27, 2024 | 11:33 am

LQDA

UTHR

United Therapeutics has filed a motion for a preliminary injunction against Liquidia Technologies in a patent litigation case. The case concerns Liquidia's efforts to seek FDA approval for its inhaled treprostinil product for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD), which United Therapeutics claims infringes on its patent expiring in 2042. Liquidia's product is tentatively approved for pulmonary arterial hypertension (PAH) but not for PH-ILD.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 11:18 am

GLSI

Greenwich LifeSciences has received approval to expand its Flamingo-01 Phase 3 trial of GLSI-100, an immunotherapy for preventing breast cancer recurrences, into Spain, France, Germany, Italy, and Poland. Site initiation visits are scheduled for the week of March 4, 2024.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 11:09 am

BGNE

BeiGene, Ltd. announced FDA approval for a Biologics License Application for TEVIMBRA (tislelizumab) for first-line treatment of gastric or gastroesophageal junction cancers. The FDA's action date is expected in December 2024.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 11:02 am

RNLSY

The European auto industry, represented by the ACEA and led by Renault CEO Luca de Meo, has agreed not to contest the EU's decision to ban fossil-fuel vehicles by 2035. This decision is seen as a significant step towards the global transition to electric vehicles (EVs), despite challenges such as the need for more government subsidies and a widespread charging infrastructure. The industry's acceptance of the ban reflects a commitment to reducing reliance on fossil fuels, amidst slowing EV demand and competition from affordable Chinese models.

Portfolio Pulse from Benzinga Neuro

February 27, 2024 | 10:56 am