Foveal LLP Independent Investment Research Foveal Research

Following ASCO 24, we update our detailed analysis of the current phase late-stage data from AZN/Daiichi’s TROPION Gilead’s EVOKE and MRK

While updated ASCO data from MRNA/MRK KEYNOTE 942 suggests maintenance of the RFS difference seen last year, it continues to be driven by an unusual difference in distant spread only, against an underperforming control arm. Our latest analysis continues to demonstrate significant differences in key baseline characteristics that leaves us with concerns over the true treatment effect of Moderna’s addon.

Despite the headline failure of the phase 3 EMBARK trial in Duchenne, the FDA accepted an efficacy supplement aimed to remove the 4-5y age restriction and the ambulatory requirement and to convert to a traditional approval, based on data from both the new EMBARK and existing ENDEAVOR trials. We assess the likelihood of the FDA converting Elevidys’s approval from accelerated to traditional, lessening the current 4-5y age restriction and the likelihood of the removal of the amb

We continue to see well below consensus prospects for Roche’s selective oestrogen receptor degrader (SERD) giredestrant, facing stiff competition from AZN’s camizestrant and already FDA approved alternative elacestrant [Menarini]. Despite the apparent broader success of the AZN competitor, we only see real first line prospects restricted

While at first sight, the body of aficamten data in obstructive hypertrophic cardiomyopathy (oHCM) may appear slightly ahead of Camzyos on efficacy and safety, with no cases of low heart strength (LVEF) and so fewer dose interruptions, our detailed analysis reveals key differences in...

MRK: A second sotatercept market expansion prospect awaits in 1.5 million common heart failure patients who also suffer from pulmonary hypertension. While only preclinical animal model data suggest promising proof of concept, phase 2 placebo-controlled trial CADENCE-PH is due to readout by October 2024. Should this demonstrate a modest benefit, a successful phase 3 could generate multi billion additional revenue...

MRK: We examine in detail, the prospects of five median term Merck pipeline assets, over the next 6 years and find that there are good...

MRK: Ahead of the first of 3 upcoming 2025 oral PCSK9 CORALreef phase III results in 2Q25, our in-depth analysis suggests a favourable...

Bayer announced Monday that its Factor XIa phase III trial of asundexian to prevent strokes in high risk patients with atrial...

AZN/GILD/Daiichi: Market expectations are running high for ADC’s toxic payload in NSCLC We undertake a detailed analysis the current...