Oracle Popping on AI Demand

 Oracle shares soared in late trading Tuesday after the cloud computing giant said it added several large new clients and boosted its outlook for cloud infrastructure sales on booming AI demand.

Shares of Oracle (ORCL) were up over 25% in after-hours trading. The stock has added close to half of its value in 2025 through Tuesday's close, with most of the gains coming after the company posted strong quarterly results in June.

Oracle on Tuesday said it now sees cloud infrastructure sales jumping 77% to $18 billion this fiscal year as AI demand grows, up from a June forecast of more than 70%.1 And that figure could surge to $144 billion over the next four years, CEO Safra Catz said.

"We expect to sign-up several additional multi-billion-dollar customers," in the coming months, Catz said, after a "brilliant start" to its new fiscal year with four multibillion-dollar contracts signed in the quarter ended in August.

Oracle posted adjusted earnings per share of $1.47 in the fiscal first quarter on revenue that rose 12% year-over-year to $14.9 billion. Both figures were slightly below Wall Street analysts' estimates as compiled by Visible Alpha. Oracle said its growing backlog from new contracts contributed to its more robust outlook, and Catz said the company intends to offer more details on its financial plan at an event scheduled for next month.

Co-founder and CTO Larry Ellison said the company also plans to use the event to unveil a new service called "Oracle AI Database" that will allow customers to use top AI models, including OpenAI's ChatGPT, xAI's Grok, and Google's Gemini, on top of the Oracle Database to analyze their data.2

Ellison said he expects Oracle's AI offerings to support "dramatically" larger cloud demand and consumption in the years to come, adding "AI changes everything."

https://www.investopedia.com/oracle-had-a-brilliant-quarter-ceo-says-its-stock-is-popping-on-ai-demand-11806942

Sanofi : Tzield Approved In China To Delay Stage 3 Type 1 Diabetes

 Sanofi SA (SNY, SNYNF, SAN.PA) announced that the Chinese National Medical Products Administration (NMPA) approved Tzield (teplizumab) as the first disease-modifying therapy in autoimmune type 1 diabetes indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 type 1 diabetes. The review was completed under priority review, following the recognition by NMPA of Tzields innovative profile and the benefit it brings to pediatric patients.

Tzield is approved for the treatment of adult and pediatric individuals aged eight years and older, living with stage 2 type 1 diabetes, in the US, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait. Regulatory reviews are ongoing in the EU and other jurisdictions around the world.

https://www.nasdaq.com/articles/sanofi-tzield-approved-china-delay-stage-3-type-1-diabetes-pediatric-and-adult-patients

Greenwich LifeSciences FDA fast track for breast cancer therapy

 Shares of Greenwich LifeSciences (NASDAQ:GLSI) up on Wednesday after the company announced its breast cancer therapy received a key regulatory designation.

The cancer therapy developer said its GLSI-100 treatment obtained "fast track" designation from the U.S. Food and Drug Administration (FDA).

This designation is designed to accelerate the development and review process for drugs targeting serious conditions with unmet medical needs.

GLSI-100 is currently being evaluated in a late-stage clinical trial for patients with HER2-positive breast cancer who have the HLA-A02 genotype and have completed standard treatment protocols.

https://www.investing.com/news/stock-market-news/greenwich-lifesciences-jumps-on-fda-fast-track-for-breast-cancer-therapy-93CH-4233010

Travere FDA Advisory Committee Meeting Not Needed for FILSPARI® (sparsentan) in FSGS

 Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.

https://www.businesswire.com/news/home/20250910301976/en/Travere-Therapeutics-Provides-Update-on-FDA-Advisory-Committee-Meeting-for-FILSPARI-sparsentan-in-FSGS

GE HealthCare to acquire brain MRI software developer icometrix

 GE HealthCare aims to further build out its portfolio of programs focused on brain scans, with a deal to acquire the MRI artificial intelligence developer icometrix following years of collaborating.

That includes the Belgium-based company’s icobrain aria platform, an FDA-cleared and CE-marked imaging solution for detecting and quantifying the side effects of Alzheimer’s disease therapies targeting amyloid plaque buildups, which can include brain swelling and small bleeds.

GE HealthCare said that, with the recent approvals of new anti-amyloid therapies, patients with Alzheimer’s may need more frequent MRI scans to track the progress and safety of their regimens.

“This effort marks a pivotal step in our journey to advance precision care in neurology,” GE HealthCare’s imaging president and CEO, Roland Rott, said in a statement. “By integrating icometrix’s AI-powered insights with our advanced imaging technologies, we aim to empower care teams with the clarity and confidence needed to navigate complex neurological conditions.”

The deal’s financial terms were not disclosed, though GE HealthCare said it plans to fund it with cash on hand. 

Icometrix, founded in 2011, also maintains AI-powered programs for diagnosing and monitoring Parkinson’s disease, multiple sclerosis, epilepsy and dementia, as well as for identifying strokes, traumatic brain injuries and tumors.

Nearly one year ago, GE HealthCare’s previously acquired MIM Software division received an FDA clearance for software to quantify amyloid plaque density from PET images, as it prepares itself to offer solutions across the patient’s journey from diagnosis through treatment. The company estimates that by 2050 nearly 13 million people in the U.S. will be diagnosed with Alzheimer’s.

https://www.fiercebiotech.com/medtech/ge-healthcare-acquire-brain-mri-software-developer-icometrix

FDA Files Corcept’s New Drug Application for Relacorilant in Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a PDUFA date of July 11, 2026 for the application.

Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.

https://www.stocktitan.net/news/CORT/fda-files-corcept-s-new-drug-application-for-relacorilant-as-a-rw5k00sll76z.html

Hims Launches New Offerings for Men With Low Testosterone

 

Hims & Hers Health Inc. is launching new offerings for men with low testosterone, marking the telehealth company’s long-awaited move into the fast-growing hormonal health category.

The products expand Hims’ core sexual health franchise amid a slowdown in weight-loss drug sales that has dragged on its stock price in recent months. The company will start with a compounded version of enclomiphene, a drug that’s used off-label to treat low testosterone in men.

https://www.bloomberg.com/news/articles/2025-09-10/hims-to-launch-new-offerings-for-men-with-low-testosterone