Centene quarterly revenue beats estimates driven by higher premiums

 Centene Corp beat Wall Street estimates for fourth-quarter revenue on Tuesday, on the back of higher premiums in its commercial insurance business.

The health insurer's quarterly profit, however, only narrowly beat estimates as medical costs were slightly higher than expectations.

Centene, which earns a significant part of its revenue through government-backed Medicaid plans for low-income people, is "less exposed" to increased medical care utilization by older adults through Medicare Advantage compared to other health insurers, analysts say.

A recovery in elective surgeries, such as joint replacements, that were deferred during the pandemic led to an increase in utilization of Medicare, the federal health insurance program for people aged 65 and over.

Centene had said at an investor conference last month that although Medicare utilization was running at elevated levels, it was consistent with expectations and planned for in the outlook.

The company's quarterly medical loss ratio (MLR), or the percentage of premiums paid out for medical services, was 89.5%, compared with analysts' estimates of 89.49%, according to LSEG data.

"Overall, this MLR print is a positive given the misses by some other MCOs (managed care organizations)," Bernstein analyst Lance Wilkes wrote in a note.

The insurer earned $7.41 billion in revenue from its commercial business offering private health insurance plans to individuals and families, up 68% year-over-year.

Commercial unit memberships jumped nearly 72% to 4.3 million, as of Dec. 31.

Betting on continued growth in the commercial unit, Centene raised its full-year 2024 premium and service revenue outlook to $134.5 billion-$137.5 billion, an increase of more than $2.5 billion at the mid-point from its previous forecast.

Centene posted quarterly revenue of $39.46 billion, above analysts' estimates of $36.14 billion.

On an adjusted basis, Centene earned 45 cents per share in the quarter, above estimates of 44 cents. 

https://finance.yahoo.com/news/1-centene-quarterly-revenue-beats-112608145.html

Lipocine Confirms Dosing Regimen for Pivotal Study of LPCN 1154 for postpartum depression

 

• Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study
• On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing 

 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).

Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates top line results late in the second quarter of 2024 from the crossover pivotal study of LPCN 1154 with the reference product IV brexanolone.

https://www.biospace.com/article/releases/lipocine-announces-confirmation-of-dosing-regimen-for-pivotal-study-of-lpcn-1154/

Aprea: IND Application for APR-1051, a Next Generation WEE1 Kinase Inhibitor

  Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to initiate clinical trials of APR-1051. APR-1051 is an oral inhibitor of WEE1 kinase, which plays important role in cell cycle regulation and DNA damage repair.

Based on preclinical studies, we believe APR-1051 is potentially differentiated from other WEE1 inhibitors in its: 1) molecular structure; 2) selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases; and 3) potentially superior pharmacokinetic properties.* Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule may have highly potent anti-tumor activity, with a potentially favorable pharmacokinetic (PK) profile.  

https://www.biospace.com/article/releases/aprea-therapeutics-announces-submission-of-ind-application-for-apr-1051-a-next-generation-wee1-kinase-inhibitor/

GSK’s Blenrep Combo Scores Phase III Win in Multiple Myeloma

 GSK on Monday posted findings from an interim analysis of the Phase III DREAMM-7 trial showing that its antibody-drug conjugate Blenrep (belantamab mafodotin), when used in a three-drug regimen, led to a significant improvement in progression-free survival in patients with relapsed or refractory multiple myeloma.

DREAMM-7, an open-label, randomized and head-to-head study, combined Blenrep with Takeda’s Velcade (bortezomib) and dexamethasone (BorDex) and compared it against J&J’s Darzalex (daratumumab) plus BorDex. Results showed that the Blenrep regimen reduced the risk of disease progression or death by 59% versus the Darzalex-based combo, an effect that was highly statistically significant, according to GSK’s announcement.

At a median follow-up of 28.2 months, progression-free survival (PFS) in the Blenrep arm was 36.6 months, which was nearly three times the 13.4-month PFS in the comparator arm.

GSK will present these data at the 2024 meeting of the American Society of Clinical Oncology Plenary Series on Tuesday.

Hesham Abdullah, senior vice president and global head of Oncology R&D at GSK, said in a statement that Blenrep’s PFS benefits in DREAMM-7 “reinforce our belief in the potential for belantamab mafodotin … to redefine the treatment of multiple myeloma at or after first relapse.” The company said it will share these data with global health regulatory authorities.

In addition to PFS, DREAMM-7 is designed to assess the overall survival (OS) outcomes of treatment with the Blenrep regimen. At the time of the interim analysis, the Blenrep-based combo elicited a “strong and clinically meaningful” trend in improving OS by reducing the risk of death by 43% relative to the Darzalex arm.

However, this OS effect “has not yet reached the interim criteria for statistical significance,” according to GSK. The OS p-value was 0.00049, but the criteria for meeting statistical significance was a p-value of at most 0.00037. GSK said it will continue to follow DREAMM-7 for OS analysis.

In terms of safety, the study documented several eye-related side effects, which is a known risk of Blenrep treatment. Overall, 34% of patients in the Blenrep group developed grade 3 or higher ocular adverse events, including blurred vision, dry eye, eye irritation and visual impairment. Most were generally reversible and manageable with dose changes. GSK noted that 9% of patients dropped out due to eye-related side effects.

Monday’s readout could set Blenrep up for a return to the U.S. market. In August 2020, the antibody-drug conjugate won accelerated approval from the FDA for the treatment of relapsed or refractory multiple myeloma in adults who had been exposed to at least four prior lines of treatment.

However, in November 2022, Blenrep missed the primary endpoint in its confirmatory Phase III DREAMM-3 study, failing to significantly outperform pomalidomide plus dexamethasone in terms of PFS. GSK took Blenrep off the U.S. market a few weeks later, following a request from the FDA.

https://www.biospace.com/article/gsk-s-blenrep-scores-phase-iii-win-in-multiple-myeloma/