Abraham Joffe has documented wildlife in the ocean and the Arctic in films including Ghosts of the Arctic, Our Oceans and Big Cat Tales. While on an Arctic trip in 2013, he learned about the polar bear trade and set out to investigate it. The…
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Lacosamide Displays Positive Efficacy and Safety in Phase 2 Clinical Trial of Neonatal Seizures | NeurologyLive
A phase 2 multicenter, randomized, open-label, active comparator (AC) trial, coined SP0968 (NCT04519645), revealed positive efficacy, safety, and pharmacokinetic data for investigational lacosamide (LMC) in treating neonates with repeated electroencephalographic neonatal seizures (ENS).
Findings from the study indicated that LCM both reduced seizure burden and was well tolerated by patients. The study also found that despite the increased LCM exposure observed in neonates, their serum concentrations remained broadly consistent with adult levels at a dose of 400 mg/day in the absence of inducers.1
Presented at the
2025 American Epilepsy Society (AES) Annual Meeting , held December 5-9, in Atlanta Georgia, the study randomized participants 1:1 to either LCM 15 mg/kg/day (5 mg/kg every 8-hours via 30-min intravenous infusions) or AC, selected and dosed according to local standard of care and treatment guidelines. The primary outcome of the study was the change in seizure burden, measured as minutes of electrographic neonatal seizures (ENS) per hour, from baseline video electroencephalography (vEEG; −2 to 0 hours before treatment) to the evaluation period vEEG (1 to 3 hours after treatment). Secondary outcomes included the incidence of treatment-emergent adverse events (TEAEs) and mean serum concentrations of LCM.Rescue medication (RM) was permitted when needed; however, participants who received RM within 3 hours after the first dose were excluded from the primary efficacy analysis and were considered non-responders for responder outcomes. Patients who benefited from their randomized treatment were eligible to continue in an extension period of up to 28 days postnatal age.
Led by Wendy Waldman Zadeh, MD, a neurologist at Broadlawns Medical Center in Des Moines, Iowa, the study included 26 patients who received at least one dose of study treatment: 14 were assigned to LCM and 12 to the AC (mean PNA 3.7 days; 53.8% female; Safety Set [SS]). Among patients who did not receive rescue medication (RM)(LCM n=11; AC n=9), the median reduction in seizure burden from baseline to the evaluation period was 4.74 min/h (range: −0.9 to 22.0) with LCM and 2.51 min/h (range: −32.4 to 19.6) with AC. In the LCM and AC groups, 9/15 (60.0%) and 6/9 (66.7%) were responders; 9/15 (60.0%) and 4/9 (44.4%) achieved ≥80% response; and 9/14 (64.3%) and 6/8 (75.0%) were seizure-free at 24 hours, respectively.
Regarding adverse events, 9 patients (64.3%) in the LCM group experienced 21 TEAEs, 1 patient (7.1%) had 2 drug-related TEAEs, and 2 patients (14.3%) had a single serious TEAE each. In the AC group, 5 (41.7%) patients had 21 TEAEs. Furthermore, the geometric mean serum concentration of LCM was 7.003 μg/mL at 30–90 min (n = 11) and 5.949 μg/mL at 6–8 h (n = 12) after start of first infusion (Pharmacokinetic Per-Protocol Set).
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Lacosamide Provides Benefit as Second-Line Treatment for Refractory Trigeminal Neuralgia Lacosamide was previously studied in a retrospective descriptive cohort trial. Findings from that trial demonstrated that the antiepileptic agent can be a valid alternative for patients with trigeminal neuralgia (TN) who fail first-line treatments, apart from its potential previously reported use as an intravenous rescue medication.2
Data were collected on 86 patients with refractory TN who has previously tried the treatments carbamazepine or oxcarbazepine. More than half (54%) of the cohort continued on either of those therapies as a concomitant treatment, and 14% were treated with lacosamide as monotherapy.
At the conclusion of the analysis, two-thirds (66%) of patients achieved pain relief from their condition. AEs, found in 33% of the cohort, were mild in all cases. During the follow-up, 44% (n = 38) of patients suspended lacosamide treatment, with reasons that included clinical improvement (34%; n = 13), inefficacy (45%; n = 17), and intolerance (21%; n = 8). Investigators found no statistically significant differences in demographical and clinical data between responders and nonresponders, except for bilateral pain distribution, for which the 3 patients were all nonresponders.
REFERENCES
1. Moseley B, Cleveland J, Krauwinkel W, et al. Efficacy, Safety, and Pharmacokinetics of Lacosamide in NeonatesWith Seizures: Results of a Phase 2/3, Open-Label, Randomized, Active Comparator Trial . Presented at 2025 American Epilepsy Society Annual Meeting; December 5-9, Atlanta, Georgia.
2. Munoz-Vendrell A, Tena-Cucala R, Campoy S, et al. Oral lacosamide for the treatment of refractory trigeminal neuralgia: a retrospective analysis of 86 cases. Headache. Published online April 10, 2023. doi:10.1111/head.14505Continue Reading
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Filmmakers Need to Put ‘Foot Down’ to Netflix–Warners Deal
Multi-Oscar winner Sean Baker has some straightforward structural advice for how the film industry should respond to Netflix’s seismic acquisition of Warner Bros.
“We should actually be expanding theatrical windows, not shortening…
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Has Klarna’s 2025 Share Price Slide Reset Expectations After BNPL Expansion Push?
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If you are wondering whether Klarna Group is a bargain or a value trap at today’s price, you are not alone. This article unpacks what the current share price really implies.
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After sliding 0.4% over the last week and 13.4% in the last month, the stock is now down 31.6% year to date. This move has sharply reset expectations and risk perceptions.
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Recent headlines have focused on Klarna’s push to expand its buy now, pay later footprint in key markets and deepen partnerships with major retailers, which many investors view as important for reigniting growth. At the same time, regulators and industry commentators have been scrutinizing the BNPL model more closely, adding a layer of uncertainty that appears to be influencing recent price action.
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Right now Klarna Group scores just 1 out of 6 on our valuation checks. We will break down what that means across different valuation methods and then finish by looking at a more intuitive way to think about what the market is really pricing in.
Klarna Group scores just 1/6 on our valuation checks. See what other red flags we found in the full valuation breakdown.
The Excess Returns model asks a simple question: does Klarna earn enough on its equity to justify its current valuation once the true cost of that equity is accounted for? It looks at what shareholders put into the business versus what they are getting back over time.
For Klarna, the starting point is a Book Value of $6.49 per share and a Stable EPS estimate of $0.27 per share, based on weighted future Return on Equity forecasts from 8 analysts. Against this, the model applies a Cost of Equity of $0.67 per share, implying an Excess Return of $-0.39 per share, meaning Klarna is expected to earn less than its equity cost on a per share basis.
The average Return on Equity is just 3.37%, while the Stable Book Value is projected to rise to $8.09 per share, based on estimates from 5 analysts. When these modest returns are projected forward, the Excess Returns valuation implies an intrinsic value near zero, making the shares look roughly 18179.1% overvalued at today’s price.
Result: OVERVALUED
Our Excess Returns analysis suggests Klarna Group may be overvalued by 18179.1%. Discover 908 undervalued stocks or create your own screener to find better value opportunities.
KLAR Discounted Cash Flow as at Dec 2025 Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Klarna Group.
For companies like Klarna that are still normalizing profitability, the price to sales ratio is often the cleanest way to compare value, because it looks at what investors are paying for each dollar of revenue rather than volatile earnings.
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From Museums to Stores, Handbags and More
Frank Gehry, the famed architect who died Friday at age 96, had close ties to the worlds of luxury and retail, in later years working closely with Bernard Arnault and the LVMH Moët Hennessy Louis Vuitton group on everything from one of…
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How Analysts See Innovative Aerosystems Entering a New Growth Era and Shifting Its Story
Innovative Aerosystems has seen its fair value estimate climb from roughly $10.70 to about $16.47 per share, even as analysts dial back their revenue growth outlook from around 16.8% to about 9.3% annually. Bulls argue that a more visible, retrofit driven demand pipeline and a sharpened strategic focus justify the higher valuation, despite more conservative top line assumptions and a modest uptick in the discount rate from roughly 6.4% to about 7.8%. Read on to see how you can stay ahead of these shifting expectations and keep updated on the evolving narrative around the stock.
Analyst Price Targets don’t always capture the full story. Head over to our Company Report to find new ways to value Innovative Aerosystems.
🐂 Bullish Takeaways
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Northland analyst Robert Brooks has initiated coverage of Innovative Aerosystems with an Outperform rating and a $16.50 price target, effectively endorsing the recent step up in the stock’s fair value.
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Northland highlights the company’s focus on the retrofit market and domestic manufacturing as key advantages that align with the secular trend of aging airplane fleets, supporting a durable growth runway.
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The analyst points to recent niche product acquisitions and a revamped management team as evidence of improving execution quality and strategic focus, framing Innovative Aerosystems as entering a “new growth era.”
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Even with the bullish stance, Northland’s target implies that a meaningful portion of the growth story is already reflected in the share price, which may limit upside if execution or demand trends disappoint.
🐻 Bearish Takeaways
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Beyond Northland’s initiation, there is limited published dissenting research. However, the single $16.50 target suggests that, at current levels, investors have to assume continued flawless execution and sustained retrofit demand, leaving less room for error on valuation and near term results.
Do your thoughts align with the Bull or Bear Analysts? Perhaps you think there’s more to the story. Head to the Simply Wall St Community to discover more perspectives or begin writing your own Narrative!
NasdaqGS:ISSC Community Fair Values as at Dec 2025 -
On October 14, 2025, the company rebranded from Innovative Solutions and Support to Innovative Aerosystems, a move intended to better reflect its core focus on aircraft retrofit programs and integrated avionics systems.
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The rebrand is accompanied by updated marketing materials and customer messaging that emphasize lifecycle support, cockpit modernization, and fleet efficiency solutions for commercial and defense operators.
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Innovative Aerosystems has been added to the S&P Global BMI Index, a change that may boost trading liquidity and attract additional institutional investors that benchmark to or track the index.
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Index inclusion is expected to support demand for the shares over time, particularly from passive and rules based strategies that allocate capital according to index membership and free float weighting.
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Minute’s silence at the Bernabéu
The Bernabéu held a minute’s silence before the start of the matchday 15 LaLiga clash between Real Madrid and Celta in memory of Xabier Azkargorta, one of the greatest coaches in the history of Spanish and international football, who was…
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Replicor publishes data from its compassionate access program in HBV/HDV
MONTREAL, Dec. 7, 2025 /PRNewswire/ – Replicor Inc. announced the publication of data from its first global compassionate access program in the Journal of Hepatology (see
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Scientists make breakthrough that could give major boost to food supply: ‘A huge positive’
Scientists at the University of Guelph in Ontario, Canada, have developed a gene editing technique that improves canola yield for farmers by introducing a particular starch-producing enzyme into the crop’s genetic material.
According to the…
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Capturing The Truth And Humor Of ALS
The documentary short The Hemingway captures co-director Patrick Sean O’Brien’s life with ALS. O’Brien reached out to longtime collaborator Evan Mathis with a script asking for help bringing it to fruition. The pair spoke with…
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