@chamath True — trusting any of these companies almost feels ironic.
The race to AGI might be one of the most dangerous games humanity has chosen to play. The focus isn’t on getting it right — it’s on getting there first, at any cost.
$aard halting its Ph 3 trial due to cardiac safety signals perfectly illustrates a reality the broader market has consistently failed to grasp.. PWS trials are uniquely unforgiving!
I will keep saying this! The market is drastically underestimating the moat $slno has built with an approved drug.
I’ve written a lot about PWS, and I’m sure many of you have read my research pieces. PWS is not just about hyperphagia (insatiable hunger), it is a complex, multi systemic neurodevelopmental and metabolic disorder. Pts typically suffer from severe obesity, sleep apnea, endocrine dysfunction and inherent cardiovascular vulnerabilities.
$aard noted reversible cardiac observations at higher doses in HV. In drug development, a mild cardiac signal in HV often becomes an insurmountable barrier in a PWS patient. You can’t introduce a drug with even a theoretical cardiac risk profile to a pt pop whose baseline metabolic and cv systems are already under immense strain.
Proving efficacy requires moving the needle on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). This relies entirely on caregiver observation. Caregivers of PWS patients are chronically exhausted and stressed… Getting clean consistent data across a multi center trial in this environment is incredibly difficult which means you need a drug with profound, undeniable efficacy to separate from pbo.
Going back to $slno I think this is its moment where the reversal starts to happen. 12 mknths of pain… I mean the market often treats biotech approvals as the start of a ticking clock until a fast follower arrives to steal market share. The st have been modeling $aard ARD-101 and other assets as imminent threats to $slno market share. The news today shatters that whole assumption.
I mean $aard pause removes the nearest term competitive threat.. News today pushes any potential ARD-101 approval years into the future assuming the cardiac issue can even be resolved via dose titration without losing efficacy. Personally I’m not sure they can.
Also I’ve been saying this $slno did the impossible. They successfully navigated the regulatory labyrinth, survived the grueling PWS trial execution process AND proved both safety and efficacy in a pop where almost everyone else has failed. With an approved drug on the market, $slno is no longer just "first to market" they are effectively a functional MONOPOLY for the foreseeable future.
Why? Because there are no alternatives and the unmet need is catastrophic (families literally locking their refrigerators to prevent their children from eating themselves to death), Vykat will achieve peak market penetration much faster and sustain it much longer than standard launch curves predict. Ps it’s already on track for a blockbuster launch.
Anyways the st estimates going to have reset again. Scarcity value as well grows for $slno in a rare dx space. St should be valuing it as a company that just pulled up the drawbridge to an empty castle. $aard setback proves that the barrier to entry in PWS is pretty high.
@seedy19tron This is big news, in my mind $aard has been a formidable competitor - the closest to any form of ability to market a drug for PWS in hyperphagia , after $slno
Thanks @seedy19tron
@adamfeuerstein High risk zone for companies priced for best-in-class. If results miss, $OCUL — like $MLTX before it — can fall back to cash value fast.
Commander Adam 🫡, what’s your read from the battlefield?
@Biohazard3737 This is happening to all mid-tier SaaS companies right now, look at $TEAM, $HUBS & many more stellar names. Market is just wonderful 🙂
@seedy19tron@semodough putting you on the spot 😄
What’s the next real inflection point for $SLNO?
• EMA Day 120 questions addressed — when do we hear back?
• Any color on Q1 and CY2026 guidance?
• Anything else?