Health Check: Could the White House be about to welcome LSD and magic mushrooms into the Oval Office?

Emyria says the Trump administration’s expected liberalisation of psychedelic therapies was the likely reason for yesterday’s 42% share spurt
Avita Medical brings it home with an Aussie distribution deal
EBR System expects US approval for its innovative ticker-kicker lead by March next year

Donald Trump’s win has unleashed all manner of speculation about the likely sectoral winners and losers, the dramatic appreciation of Bitcoin being an outstanding example.

In some cases, the investor reaction is sheer overreach.

Our case in point is psychedelic therapies developer Emyria (ASX:EMD), which yesterday copped an ASX query after its shares soared 42% on elevated volumes.

The company attributed the likely cause to “recent media speculation regarding potential policy shifts by the incoming Trump administration … which may favour the use [of] psychedelics in therapeutic settings”.

Dampening the fervour, management said the media chatter pertained to the broader psychedelics sector, rather than specifically Emyria.

The hopes centre partly on former independent Robert F. Kennedy’s Junior’s advocacy of psychedelics research, along with support for the healing goodness of raw milk, chelating compounds and sunshine (and hatred of vaccines).

This is pertinent because RFK Jr expects a senior healthcare role in return for exiting the presidential race and supporting Trump.

Writing on X – Elon Musk’s fount of all truth – RFK Jr. alleges the US Food & Drug Administration (FDA) has engaged in “aggressive suppression” of psychedelics.

“If you work for the FDA and are part of this corrupt system, I have two messages for you: [firstly], preserve your records and [secondly] pack your bags.”

The White House’s vaunted pending embrace of blue meanies and gold tops would be a stunning departure from the ‘war on drugs’ mantra, as echoed by successive presidents ever since Richard Nixon’s crackdown on trippy hippies in the 1970s.

In doing so, Nixon nixed legitimate trials of substances including LSD and psilocybin (magic mushrooms).

For its part, the FDA in August rejected drugmaker Lykos Therapeutics’ application to treat post-traumatic stress disorder (PTSD) with MDMA (aka Molly, or ecstasy).

The agency contended the benefits did not outweigh the risks.

RFJ Jr aside, Trump is also surrounded by pro-psychedelic supporters including Musk, who admits to using small amounts of ketamine and reportedly has dabbled in other mind-altering substances as well.

A mentor to vice president-elect JD (James David) Vance, Silicon Valley venture capitalist Peter Thiel has invested millions in psychedelic drug maker Atai.

A slew of Republican congressmen supports the use of MDMA to treat veterans’ PTSD.

Meanwhile, Emyria is the only ASX-listed psychedelic pure play, having recently won ethics approval for a psilocybin-assisted therapy program for treatment-resistant depression.

The company also has an MDMA program for PTSD.

The psilocybin program remains subject to local Therapeutic Goods Administration consent.

Having peaked at 4.4 cents yesterday, Emyria shares this morning were at 3.5 cents, up 3%.

Avita Medical honours its spray-on skin origins with a local compact

Revenue wise, Australia will never move the dial for wound care house Avita Medical (ASX:AVH) , but its entry into the local market is apt.

That’s because its foundation spray-on skin burns product was developed by Perth burns surgeon and Australian of the Year Fiona Wood and used on victims of the Bali bombings.

Avita has entered an exclusive distribution agreement with Revolution Surgical Pty Ltd, covering Australia and New Zealand.

The deal includes Recell GO, the company next-gen kit which is subject to regulatory approval.

Recell GO is an easier-to-use version of Recell, the company’s mainstay product for thermal burn wounds and full-thickness skin defects, as well as vitiligo lesions.

“Our collaboration with Revolution Surgical marks the return of Recell to Australia,” says Avita’s US-based CEO Jim Corbett, adding that Recell has “revolutionised” US burns care.

Other weapons in Avita’s armoury are its rights to Permeaderm a biosynthetic wound matrix, and Cohealyx, an Avita-branded collagen-based dermal matrix.

Avita last week reported revenue of US$19.5 million for the September (third) quarter, up 44% with a loss of US$13.8 million compared with a US$9.3 million deficit previously.

In a prezzo today, the company affirmed expectations of calendar 2024 revenue of US$68-70 million, up 37-41% year-on-year.

Management also promises cash flow breakeven “no later than [the September quarter] of 2025.”

Avita shares gained 4% to $3.83.

Wise up! EBR expects FDA approval by as early as March

Meanwhile, EBR Systems (ASX:EBR) expects US approval of its ground-breaking wireless cardiac pacing device by the end of the March 2024 quarter, with an expected commercial launch late in the year.

In September the FDA formally accepted EBR’s application, thus starting the clock on a formal review period.

EBR’s flagship product Wise – as in ‘wireless stimulation endocardially’ – gets around the problem of accessing the tricky left ventricle with cardiac resynchronisation therapy (CRT) devices.

In essence, Wise enables CRT for patients otherwise unable to receive lead-based devices, or who are at high risk from an upgrade procedure (from implanted pacemaker or defibrillator to lead-based CRT).

Wise is the only wireless device small enough to stimulate the left side of the heart and deliver CRT.

EBR cites a US market opportunity of US$3.6bn initially.

“Preparation is currently underway to support key commercialisation activities such as manufacturing scale-up,” the company says.

“EBR will leverage established partnerships and presence in the US to drive initial sales, targeting sites that participated in the [supportive clinical trial] and other high-volume sites.”

EBR shares ticked up 2% to $1.03.

At Stockhead, we tell it as it is. While EBR Systems is a Stockhead advertiser, it did not sponsor this article