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BFRG

BullFrog AI Holdings, Inc. announced the issuance of an Australian patent for novel prodrugs of mebendazole for cancer treatment. The compounds, including BF-223, show improved solubility and bioavailability, addressing challenges in using mebendazole for oncology. This follows a U.S. patent issued in July 2023 and positive preclinical study results for glioblastoma treatment. The company aims to monetize this asset with strategic partners.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:15 pm

DCTH

Delcath Systems has initiated the commercial use of its HEPZATO KIT for the treatment of metastatic uveal melanoma. This marks a significant milestone for the company as it begins to generate revenue from the product.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:13 pm

STLA

SIXT and Stellantis have announced a multi-billion euro agreement for SIXT to purchase up to 250,000 Stellantis vehicles by 2026 for its rental fleet in Europe and North America. The deal includes a variety of vehicle classes and propulsion types, including battery electric vehicles (BEVs), and aligns with both companies' decarbonization strategies. Deliveries will start in Q1 2024. The partnership also explores cooperation in data services and aims to enhance customer experience with connected vehicles and streamlined rental processes. Stellantis aims for a 100% BEV sales mix in Europe and 50% in the US by 2030, while SIXT targets a 70-90% electrified fleet in Europe by 2030.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:12 pm

SLDB

Solid Biosciences Inc. (NASDAQ:SLDB) has received FDA Orphan Drug Designation for its Duchenne muscular dystrophy gene therapy candidate, SGT-003. The company, which focuses on precision genetic medicines for neuromuscular and cardiac diseases, also received Fast Track Designation last month. Patient dosing for the Phase 1/2 clinical trial of SGT-003 is expected to begin in mid-to-late Q1 2024. SGT-003 features a novel capsid and muscle tropic vector, which may offer improved transduction and muscle resiliency. The Orphan Drug Designation provides benefits such as financial incentives and the potential for seven years of market exclusivity upon approval.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:08 pm

SLGG

Super League (NASDAQ: SLE) reported a record preliminary Q4 revenue of approximately $9.4 million, a 32% increase YoY, and annual revenues of about $25.0 million. The company anticipates profitability in 2024, backed by a record contract and pipeline expansion. Super League's CEO Ann Hand highlighted the company's growth, streamlined operations, and success in immersive 3D experiences on platforms like Roblox, Minecraft, and Fortnite. The company served almost 100 brands in 2023, with significant engagement and media coverage. Super League aims to transition from short-term campaigns to larger, recurring deals with notable clients like Visa, Disney, and Wal-Mart. The company raised $24.8 million and secured a $4.0 million accounts receivable facility, improving its balance sheet for future growth.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:07 pm

PGEN

Precigen has been granted Orphan Drug Designation by the European Commission for PRGN-2012, a treatment for Recurrent Respiratory Papillomatosis (RRP). This designation is expected to provide Precigen with certain benefits, including market exclusivity upon regulatory approval, assistance with clinical development, and reduced regulatory fees.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:07 pm

TAK

The FDA has approved Takeda's HYQVIA as a maintenance therapy for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). HYQVIA is the only subcutaneous immunoglobulin infusion treatment for CIDP that can be administered monthly and can be self-administered after proper training. The approval is based on the Phase 3 ADVANCE-CIDP 1 study, which showed a significant difference in relapse rate in favor of HYQVIA versus placebo at 6 months. CIDP is a rare neuromuscular disorder that can cause weakness or loss of feeling in the arms and legs.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:05 pm

APLD

Applied Digital (APLD) has announced that due to delayed delivery of networking components for GPU clusters, the company's revenue and EBITDA for fiscal year 2024 will be below the previously guided range.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:03 pm

BIOR

Biora Therapeutics, Inc. (NASDAQ:BIOR) provided guidance on anticipated milestones for 2024, including the phase 1 study of BT-600, part of the NaviCap platform, aimed at treating ulcerative colitis (UC). The company expects initial phase 1 data in 2-3 months, with a potential phase 1B study in UC patients and a 56-day GLP tox study planned for the second half of 2024. Biora also highlighted progress with its BioJet platform, with ongoing preclinical data generation and potential expansion of pharma collaborations. The NaviCap platform is designed for targeted delivery of therapeutics to the GI tract, and the BioJet platform is for oral delivery of large molecules.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:02 pm

CLPT

ClearPoint Neuro has announced that the FDA has cleared its SmartFrame OR stereotactic system, a device designed to assist surgeons during brain surgeries. This clearance represents a significant milestone for the company, potentially leading to increased adoption of the system in hospitals and surgical centers.

Portfolio Pulse from Benzinga Newsdesk

January 16, 2024 | 1:01 pm