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Regulatory

AGIO

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced its strong cash position, which is expected to support the completion of ongoing programs and disciplined pipeline expansion into at least 2026. The company highlighted its PK Activator Franchise's clinical efficacy in four hematological diseases and expects four additional Phase 3 readouts by the end of 2025, with potential FDA approvals in Thalassemia in 2025 and Sickle Cell Disease in 2026. Agios will present at the 42nd Annual J.P. Morgan Healthcare Conference and will provide a live webcast.

Portfolio Pulse from Charles Gross

January 08, 2024 | 12:21 pm

CRSP

CRISPR Therapeutics has outlined its strategic priorities and outlook for 2024, emphasizing its strong financial position with $1.9 billion in cash and marketable securities. This includes a $200 million milestone payment from the FDA approval of CASGEVY. The company is focused on resource efficiency and ROI as it progresses with clinical trials in various therapeutic areas.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:18 pm

MREO

Mereo BioPharma Group plc (NASDAQ:MREO) has reiterated its previous cash runway guidance, stating that its current cash reserves are expected to fund operations into 2026. The company provided updates on its pipeline programs, including the Phase 3 Orbit Study and Cosmic Study of setrusumab for Osteogenesis Imperfecta, and the design alignment for a Phase 3 study of alvelestat in AATD-LD following FDA interactions. Additionally, Mereo announced a global licensing deal for the development and commercialization of leflutrozole.

Portfolio Pulse from Charles Gross

January 08, 2024 | 12:18 pm

DCPH

Deciphera Pharmaceuticals reported a preliminary unaudited Q4 2023 net product revenue of approximately $46M for Qinlock, marking a 40% increase year-over-year. The company also announced plans to submit a New Drug Application for Vimseltinib in Q2 2024 and a Marketing Authorisation Application in Q3 2024 for the treatment of Tenosynovial Giant Cell Tumor. Additionally, Deciphera is preparing for a Phase 2 study of Vimseltinib for Chronic Graft Versus Host Disease to begin in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:17 pm

NRIX

Nurix Therapeutics has announced its key objectives and anticipated milestones for the year 2024. The company is expected to provide updates on its progress and achievements throughout the year, which may include clinical trial results, regulatory filings, partnerships, or other significant developments. Investors will be closely monitoring Nurix's progress towards these goals as they can have a substantial impact on the company's performance and stock valuation.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:11 pm

CABA

Cabaletta Bio has received additional FDA Fast Track Designations for its investigational drug CABA-201, aimed at treating dermatomyositis and systemic sclerosis. The company has previously obtained FDA clearance for IND applications for CABA-201 in various autoimmune conditions such as SLE, myositis, SSc, and gMG.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 12:05 pm

AAPL

Jefferies research note predicts further declines in Apple Inc.'s (AAPL) iPhone sales in China, despite new releases. Sales dropped 30% year-on-year and are expected to continue falling into 2024. Discounts haven't led to volume growth, and Apple's market share is affected by Huawei's resurgence with its Mate 60 Pro. The U.S. sanctions have led Huawei to develop its own software ecosystem. Apple's sales are also impacted by China's ban on Apple devices for state-backed firms and government departments, contributing to the sales decline.

Portfolio Pulse from Ananya Gairola

January 08, 2024 | 11:54 am

MDT

Medtronic has received CE Mark approval in Europe for its MiniMed 780G system, which includes the Simplera Sync, a disposable continuous glucose monitor that eliminates the need for fingersticks or overtape. This regulatory milestone could enhance Medtronic's product offering in the diabetes care market in Europe.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 11:47 am

ASLN

ASLAN Pharmaceuticals has received a deficiency notice from Nasdaq due to its stock price not meeting the minimum bid price requirement. The company's shares have closed below the $1 minimum bid price for the last 30 consecutive business days. ASLAN must regain compliance by either maintaining a closing bid price of at least $1 for a minimum of 10 consecutive business days or by implementing a reverse stock split. The company has a compliance period of 180 calendar days to meet the requirement, which can be extended if they meet all other listing standards and provide a written notice of their intention to cure the deficiency.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 11:46 am

VRSK

Verisk (NASDAQ:VRSK), a data analytics and technology provider, has received approval from the California Department of Insurance for its ISO wildfire mitigation filings. These filings allow insurers to apply specific wildfire mitigation discounts to their rating plans, complying with a CDI regulation. Verisk's proactive engagement with CDI and its position as an industry leader is highlighted by being among the first to have its filings approved.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 11:18 am