Streetbeat News

Regulatory

PIK

Kidpik Corp. has been granted a 180-day extension by Nasdaq to meet its minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The company now has until March 18, 2024, to meet the requirement. If necessary, Kidpik may implement a reverse stock split to regain compliance, a move approved by stockholders at the June 19, 2023, annual meeting.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 8:16 pm

PBYI

Puma Biotechnology has secured FDA Orphan Drug Designation for Alisertib, a treatment for small cell lung cancer. This designation provides certain benefits, including tax credits for clinical testing.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 8:11 pm

TNYA

Tenaya Therapeutics, Inc. (NASDAQ:TNYA) will present data related to its TN-201 and TN-301 programs at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions and the Heart Failure Society of America (HFSA) Annual Scientific Meeting. The data includes results from the Phase 1 clinical trial of TN-301 and interim data from an ongoing seroprevalence study of TN-201.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 8:10 pm

QDEL

QuidelOrtho Corporation (NASDAQ:QDEL) has been granted a CLIA Waiver from the U.S. Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen+ FIA, a rapid antigen test that detects COVID-19. The waiver means the test is simple and low risk enough to be used in any point-of-care setting equipped with Sofia 2 instruments, without the need for trained clinical laboratory personnel. The Sofia 2 analyzer provides an accurate, objective and automated result in just 10 minutes.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 8:08 pm

CBAY

ICPT

IVA

MDGL

CymaBay Therapeutics has initiated the AFFIRM Phase 3b/4 confirmatory study to evaluate the effect of seladelpar on clinical outcomes in patients with compensated cirrhosis due to primary biliary cholangitis (PBC). The study's commencement alleviates a regulatory concern that has loomed over the industry. The decision by Intercept Pharmaceuticals to halt a similar study had raised concerns among investors. Companies like Madrigal Pharmaceuticals and Inventiva S.A. also utilize outcome studies involving cirrhotic patients.

Portfolio Pulse from Vandana Singh

September 21, 2023 | 8:06 pm

HRMY

The FDA has responded to Scorpion Capital's citizen petition, stating that it has been unable to reach a decision due to the complex issues raised requiring extensive review and analysis by agency officials.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 7:53 pm

HRMY

Scorpion Capital has received an interim response from the FDA regarding their petition to withdraw approval of Harmony Biosciences' drug Wakix. The FDA has stated that the petition raises complex issues requiring extensive review and analysis. The final decision is expected within two weeks.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 7:50 pm

GOOG

GOOGL

MSFT

NVDA

PLTR

Max Tegmark, MIT professor and co-founder of the Future of Life Institute, warns of a relentless “race to the bottom” among tech companies in the development of advanced artificial intelligence (AI) systems. Despite an open letter signed by over 30,000 people including Elon Musk and Steve Wozniak, calling for a six-month hiatus on the creation of AI models exceeding the power of GPT-4, tech companies continue to compete in AI development. The race has sparked fears of creating unmanageable, superintelligent AI, prompting calls for government intervention. Tech executives from companies like Alphabet Inc’s Google, Microsoft Corporation, Nvidia Corp, Palantir Technologies Inc, OpenAI, Anthropic, and others are involved in global discussions on AI.

Portfolio Pulse from AJ Fabino

September 21, 2023 | 7:41 pm

SPRY

The FDA has issued a Complete Response Letter regarding ARS Pharmaceuticals Inc's New Drug Application for neffy, an EpiPen alternative. This has delayed the approval and launch of neffy in the U.S. Wedbush analysts remain bullish on the stock, but have cut the price target from $15 to $5. William Blair downgraded the stock to a Market Perform rating due to extended timelines and heightened risk.

Portfolio Pulse from Vandana Singh

September 21, 2023 | 7:38 pm

COIN

XRPUSD

Ripple's legal expenses have surged to $200 million, doubling from the $100 million reported in July 2022, due to the ongoing legal tussle with the U.S. Securities and Exchange Commission (SEC). Ripple's CEO, Brad Garlinghouse, criticized SEC Chairman Gary Gensler for his aggressive stance. Amidst the regulatory turmoil in the U.S., Ripple and Coinbase Global Inc. are considering Asia for future expansion.

Portfolio Pulse from Murtuza Merchant

September 21, 2023 | 7:04 pm