Foveal LLP Independent Investment Research Foveal Research

Since our first ADC report over a year ago, our analysis has demonstrated significant doubts about all three leading TROP2 ADCs (AZN, GILD, MRK, SKB) achieving overall survival in first-line lung cancer, and we continue to see substantial hurdles for the class..

Despite the recent large PD1 beat by Summit/Akeso’s ivonescimab (SMT112) versus gold standard Keytruda [MRK] in lung cancer at WCLC24, our unique analysis reveals why we do not share the markets optimism by raising several concerns about replacing the Keytruda standard of care in US/EMA and continue to see Keytruda’s Lung cancer franchise intact.

Following the success of Novartis ’ Factor B complement inhibitor Fabhalta , Roche has partnered with IONIS to exploit Factor B inhibition through a form of gene therapy known as antisense oligonucleotide (ASO). However...

With the recent approval of Roche’s paroxysmal nocturnal haemoglobinuria (PNH) orphan drug C5 inhibitor Piasky, with its unique subcutaneous delivery, as well as Novartis’s alternative Factor B mechanism of action oral Fabhalta potentially changing the treatment paradigm in PAH , we assess the prospects of the various complement inhibitors in PNH and find oral Fabhalta data compelling and see significant hurdles for Roche’s subcutaneous self-administered Piasky

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...