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Regulatory

IMNN

IMUNON, Inc. (NASDAQ:IMNN) has announced the enrollment of the first patient in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab for advanced ovarian cancer. The trial aims to enroll 50 patients with Stage III/IV advanced ovarian cancer. Initial data are expected within one year following the completion of enrollment and final data are expected approximately three years after. The company has recently announced encouraging interim data for their OVATION 2 program evaluating the benefits of IMNN-001.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:32 pm

SPY

The Building Permits for September have decreased by 4.4%, compared to a 6.8% increase in the previous month.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:31 pm

SPY

The number of building permits issued in September was 1.473 million, higher than the estimated 1.455 million.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:30 pm

ARDX

The FDA has approved Ardelyx Inc's (NASDAQ:ARDX) kidney disease-related drug, Xphozah, after initially rejecting it. The drug is the first and only phosphate absorption inhibitor, designed to reduce serum phosphorus in adults with chronic kidney disease on dialysis. Ardelyx has also amended its debt financing agreement with SLR Capital Partners, gaining access to an additional $50 million in committed debt financing. ARDX shares are up 16.20% premarket.

Portfolio Pulse from Vandana Singh

October 18, 2023 | 12:29 pm

ABBV

TAK

Takeda Pharmaceutical's (TAK) Phase 3 ADMIRE-CD II study for Alofisel, a treatment for complex Crohn's Perianal Fistulas, did not meet its primary endpoint. The company also settled a tax dispute with the Irish Revenue Commissioners related to a break fee received by Shire plc from AbbVie (ABBV) in 2014. Takeda's shares fell 1.47% in premarket trading.

Portfolio Pulse from Vandana Singh

October 18, 2023 | 12:25 pm

PLNT

Planet Fitness (PLNT) has announced plans to update its franchisee economic model to reflect the current macro environment, according to a recent filing. The announcement was made during its recent franchisee conference.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:16 pm

CBAY

CymaBay Therapeutics (NASDAQ:CBAY) announced that results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD). Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with PBC. The company looks forward to sharing the results, which is an important step forward in obtaining regulatory review and potentially marketing authorization.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:13 pm

RETO

ReTo Eco-Solutions, Inc. (RETO) has received a notification from Nasdaq about a minimum bid price deficiency. The company's shares have been trading below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:13 pm

NVAX

Novavax, Inc. (NASDAQ:NVAX) has received full marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for its prototype COVID-19 vaccine Nuvaxovid for individuals aged 12 and older. The authorization is based on two Phase 3 trials and a Phase 2a/b trial. The company is also working with the MHRA for the rapid review of its updated protein-based non-mRNA COVID-19 vaccine.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:13 pm

FCEL

FuelCell Energy, Inc. (NASDAQ:FCEL) has been contracted by EDF Energy for a project exploring the use of hydrogen to decarbonize asphalt production. The project, part of the Bay Hydrogen Hub consortium, will use FuelCell Energy's 1-Megawatt Solid Oxide Electrolyzer Cell (SOEC) with nuclear generated heat and electricity to produce hydrogen in bulk at a lower cost. The UK's Department for Energy Security and Net Zero has announced £6.1m ($7.4m) for the Bay Hydrogen Hub scheme, a figure that will be matched by the project partners.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 12:11 pm