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Health care stocks were flat to higher pre-bell Friday as the iShares Biotechnology ETF was unchanged and the Health Care Select Sector SPDR Fund was up 0.5% recently.

Cardinal Health shares advanced by over 2% after the company reported higher fiscal Q1 non-GAAP earnings and raised its full-year guidance for non-GAAP earnings per share.

Waters Corporation shares rose past 11% after the company reported higher fiscal Q3 adjusted earnings and net sales. The company also raised its guidance for full-year adjusted earnings per share.

ESSA Pharma shares were down more than 68% after the company said it decided to terminate the phase 2 trial evaluating the combination of masofaniten and enzalutamide in patients with metastatic castration-resistant prostate cancer compared with enzalutamide alone.

US stocks look set to open higher in Friday's trading session as investors analyze key inflation and manufacturing data released earlier in the morning.

The Dow Jones Industrial Average futures were up 0.54%, S&P 500 futures gained 0.53%, and Nasdaq futures were rising 0.54%.

Oil prices were higher, with front-month global benchmarks Brent crude and West Texas Intermediate crude up 1.80% and 1.95% respectively.

The unemployment rate for October remained unchanged at 4.1%, meeting analyst forecasts, while non-farm payrolls added only 12,000 in October, far below the Bloomberg estimate of 106,000.

The US Bureau of Labor Statistics said Friday it is likely that in some industries payroll employment estimates were affected by Hurricanes Helene and Milton. However, it also said it is "not possible to quantify the net effect on the over-the-month change in national employment."

The BLS also said manufacturing employment decreased by 46,000 in October, which includes a decline of 44,000 in transportation equipment manufacturing "that was largely due to strike activity."

In other world markets, Japan's Nikkei tumbled 2.63%, Hong Kong's Hang Seng was up 0.93%, and China's Shanghai Composite was down 0.24%. Meanwhile in Europe's early afternoon session, the UK's FTSE 100 was moving nearly 1% higher, while Germany's DAX and France's CAC were up 0.61% and 0.78% respectively.

In equities, shares of Globalstar jumped 43% after it said in a regulatory filing Friday it has updated its service agreements with Apple (AAPL) to expand its mobile satellite services network. Theriva Biologics shares surged 40% after it said late Thursday that it has been named as one of five finalists for Merck's (MRK) Advance Biotech Grant. Shares of Athira Pharma (ATHA) climbed 34% after losing about 5% on Thursday. Pro-Dex shares climbed 27% after it reported late Thursday that it swung to a profit in fiscal Q1. And shares of Atlassian rose 24% after it reported fiscal Q1 earnings and revenue that topped analyst forecasts.

On the losing side, shares of ESSA Pharma plummeted 69% after it said it is terminating a phase 2 trial evaluating the combination of masofaniten and enzalutamide in patients with metastatic castration-resistant prostate cancer compared with enzalutamide alone. Lexicon Pharmaceuticals shares plunged 40% after it said late Thursday that the US Food and Drug Administration denied a new drug application for Zynquista to treat glycemic control in adults with type 1 diabetes and chronic kidney disease. The FDA said that the benefits of Zynquista do not outweigh the risks in adults. Shares of Advent Technologies fell 20% after a 34% gain on Thursday. CIMG's I stock dropped 17%, eating into its 32% gain on Thursday. And shares of Visionary Holdings were down 13%, adding to a 5% loss the previous session.

Technology stocks were edging higher premarket Friday as the SPDR S&P Semiconductor ETF rose by 1.1% and the Technology Select Sector SPDR Fund was up 0.3% recently.

Atlassian shares nearly 23% after the company reported higher fiscal Q1 non-GAAP earnings and revenue.

Intel shares were up 6% after the company said it expects to swing to non-GAAP earnings in Q4 after reporting a loss in Q3.

Apple was down nearly 2% even after the company reported higher fiscal Q4 adjusted earnings and net sales.

On Thursday, Lexicon Pharmaceuticals Inc. announced the outcome of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin).

The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).

The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks, as having an estimated glomerular filtration rate (eGFR) >45 to <60 mL/min.1.73 m2 or eGFR >60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) > 30mg/g.

As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks.

As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 20.

The FDA approved Sotagliflozin, branded as Inpefa, in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

In 2019, the FDA issued a complete response letter (CRL) regarding the NDA for sotagliflozin for type 1 diabetes. Despite FDA rejection, the European Medicines Agency approved the drug in April 2019, covering TID patients who could not achieve adequate glycemic control despite optimal insulin therapy.

In 2021, at Lexicon's request, the FDA issued a public Notice of Opportunity for Hearing (NOOH) on whether there were grounds for denying such approval.

Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance to discuss a path forward for resubmission and potential approval of the NDA.

Lexicon Pharmaceuticals resubmitted its NDA for sotagliflozin in June. The company anticipated a six-month review and a potential launch in early 2025.

Also, in 2019, after four years of collaboration, Sanofi SA terminated the sotagliflozin-related agreement and paid Lexicon Pharmaceuticals $260 million.

Two weeks ago, Viatris Inc. obtained an exclusive license from Lexicon to commercialize sotagliflozin in all indications outside of the U.S. and Europe. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the U.S. and Europe.

Price Action: LXRX stock is down 38.46% at $1.22 during the premarket session at last check Friday.

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