The surge and plunge in ASX biotech shows what the FDA giveth, the FDA taketh away
Health & Biotech
Health & Biotech
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Over the past month, a number of US FDA approvals have moved the share prices of global pharma stocks, including those traded here on the ASX.
The biggest FDA announcement during the month came out of US-based Biogen, which received a controversial green light for its Alzheimer’s drug, Aduhelm.
That announcement benefited ASX-listed Cogstate (ASX:CGS), which lifted by 60 per cent soon after the news came out.
Cogstate has an exlcusive partnership with Japan-based Eisai to develop and distribute its digital cognitive assessment technologies. Esai, in turn, is a partner of Biogen.
In Monday’s trading, the FDA has also played a major hand in some of the biggest moves on the ASX.
The tech company was the biggest beneficiary of an FDA approval on Monday, rising by 75 per cent.
Hydrix has just received an FDA approval for its AngelMed Guardian device for commercial release in the US.
The Guardian is the world’s only implantable cardiac monitor intended to detect and alert patients of a potential heart attack, including a silent one.
It includes a cardiac monitoring and alerting device that is implanted in a manner similar to that of a pacemaker.
The FDA approval opens the door for Hydrix to submit regulatory applications in other jurisdictions, including Australia and Singapore.
The FDA has just given Atomo’s CareStart COVID-19 drug an Emergency Use Authorisation (EUA), essentially meaning it can be rolled out.
The CareStart EZ COVID-19 IgM/IgG was developed with Korean-listed company, Access Bio.
It’s basically a blood test intended to identify recent or prior COVID-19 infections utilising Atomo’s platform.
EUA is not full approval, but requires less due diligence to get to market, and is employed in times of medical emergencies in the US.
The company told Stockhead that it was in discussions with Access Bio about a number of applications outside COVID.
Just as the FDA giveth, the FDA also taketh away and Cyclopharm shares were dumped on Monday following an announcement that US health regulators had declined to immediately approve its nuclear lung imaging agent, Technegas.
The FDA issued what’s known as a complete response letter, raising questions about the characteristics, production and delivery of Technegas particles.
These particles are breathed in by patients before a CT scan so doctors can better detect a pulmonary embolism, a life-threatening condition that occurs when a blood clot blocks an artery in the lungs.
With this setback, the company now expects FDA approval in the second half of 2022, rather than the second half of this year.
The burns treatment company received an FDA approval earlier this month for its ’spray-on’ rapid cell harvesting device, RECELL.
While the American regulator gave RECELL the initial green light in September 2018, it was only for severe thermal burns in patients 18 years and over.
The latest approval means that RECELL can now be used in all sizes of acute full-thickness thermal burn wounds, as well as in patients under 18 (although it is still restricted for patients under a month old).
The Avita share price rose by 15 per cent immediately after the announcement.
Not all FDA announcements relate to apporvals, however.
The FDA will often give companies its recommendations and feedback as a criteria to progress to the next stage.
These ASX-listed stocks have recently received feedbacks from the FDA, which had sent their share prices rocketing in June.
The dementia-focused biotech company received positive feedback from the FDA last week on its upcoming trial against the Fragile X syndrome (FXS).
The company is planning a study of its Xanamem drug – which blocks cortisol (stress hormones) in the brain caused by FXS.
The FDA has told the company that its data package and trial design would be sufficient for a formal IND ( Investigational New Drug) submission, which it plans to file next quarter.
Actinogen’s share prise rose by 17 per cent on the news, and has surged by more than 700 per cent in 2021.
The FDA signed off last week on Acrux’s generic version of Jublia, a treatment for nail fungus delivered topically (via the skin).
Jublia is a solution already made by Canadian listed pharmaceutical firm Bausch Health, but other companies have long sought to produce the active ingredient of it and have contested in courts as to whether Bausch’s patent still stands.
Acrux settled the legal case in 2019, and now has the American regulator’s approval to market its topical solution.
The company says it will now seek a commercial licensee to launch it to the US market.
Acrux’s share price soared by 30 per cent after the announcement.
The company’s prostate cancer imaging device, Illuccix, has received feedback from the FDA this month following a late-cycle review.
The FDA said there are no outstanding issues with Telix’s submission.
The company is now set to work closely with its commericial partners to prepare for product launch.
Invex has received a feedback from the FDA this month on its Presendin hypertension treatment drug.
The FDA has recommended Invex to consider a more “clinically meaningful” effect when measuring a change in the patient’s vision as a primary endpoint for the trial.
Further, the FDA said it considered intracranial pressure as an appropriate secondary endpoint of a study, but not a primary endpoint that would support approval of Presendin.
Invex responded by saying the advice contrasted with feedback from the European Medicines Agency (EMA).
The IXC share price has dropped by almost 10 per cent this month.
The company received a positive feedback from the FDA on its Phase-2 ATL1102 trial, an open-label study conducted at Royal Children’s Hospital in Melbourne.
The feedback will enable ANP to conduct larger studies.
ATL1102 is an antisense inhibitor to treat Duchenne muscular dystrophy (DMD), a fatal genetic musle inflamattion disorder that affects every 3,500 to 5,000 males worldwide.
The ANP share price has dropped by 7 per cent this month.
The company has received positive guidance from the FDA on its NNZ-2591 in three serious neurological disorders.
The FDA guidance was an important milestone that enables Neuren to proceed with preparing IND applications for clearance to proceed with the Phase 2 trials.
NNZ-2591 is a drug that treats Phelan-McDermid, Angelman and Pitt Hopkins syndromes, neurodevelopment disorders that emerge in childhood.
The Neuren share price has surged by 30 per cent this month.