Health Check: Avecho is awake to the possibilities after interim phase III insomnia trial win | Stockhead
Investors today are wide awake after Avecho's interim insomnia trial results - but for all the right reasons. Pic: Getty Images. Avecho shares soar 80% after news its synthetic cannabinoid insomnia trial will. . .
Investors today are wide awake after Avecho's interim insomnia trial results - but for all the right reasons. Pic: Getty Images. Avecho shares soar 80% after news its synthetic cannabinoid insomnia trial will continue as intendedAFT Pharma gets the FDA go-ahead for humungous iron deficiency trialCalmer Co hopes its new kava product is a real FZZRA dream result, so farIn much-needed positive tidings for the drug development sector,Avecho (ASX:AVE)reports that its phase III insomnia trial has passed an interim analysis. After having a sneak peek at the unblinded data, an independent data monitoring board unanimously recommended the phase III study should continue with its originally planned enrolment of 519 participants. The study has “successfully met the pre-specified criteria” to date. Avecho says the news is “highly encouraging and consistent with the treatment effect and data variability” the company assumed in trial design. “This was a binary event,” Avecho says CEO Dr Paul Gavin. “This provides confidence that the product is working. ”He said if the board had found no difference between the CBD and placebo, it would have recommended the trial be discontinued for ‘futility’ reasons. The program also has passed the safety hurdle, with the board finding no serious adverse events across the 244 participants assessed to date. Roughly evenly, these patients received 75 milligrams or 150mg of Avecho’s proprietary synthetic cannabinoid, or a placebo. There is currently no approved CBD therapies for insomnia, globally. Pursuing the OTC routeUltimately, Avecho aims for marketing approval under the local over the counter (OTC) route. This means chemists can sell the therapy without a patient prescription. Bear in mind that the gel capsules do not contain the psychoactive ingredient, THC. The company now is identifying additional recruitment sites and expects to enroll all patients within 12 months. In 2025, Avecho licensed the Australian commercial rights to big pharma giant Sandoz. This was for a US$3 million upfront payment, plus potential milestones up to US$16 million and tiered royalties. Given today’s tidings, management also expects to ramp up partnering discussions for other jurisdictions. Gavin says accelerated US approval may be possible. “There may be a scenario where we can ram this product through the US Food and Drug Administration (FDA) much quicker than expected,” he says. Avecho shares this morning surged 80% to 1. 2 cents. AFT adds another iron to the R&D fireThe FDA has allowed specialty drug makerAFT Pharmaceuticals (ASX:AFP)to undertake a large injectable iron clinical study. To be undertaken with Belgian development partner Hyloris Pharmaceuticals, the confirmatory study will enroll 1366 patients. This will be at sites across AFT’s home geography of NZ, the US, Europe, India, Japan and Armenia. Iron deficiency affects about 15% of the world’s population. CSL has targeted the sector since its 2022, $18 billion purchase of renal specialist Vifor Pharmaceuticals. In a prezzo to the 2026 Bio International Convention in San Diego this week, AFT founder and CEO Dr Hartley Atkinson said intravenously (IV) delivered iron posed an addressable market of US$7. 41 billion. The program is licensed to the Chengdu-based Grand Life Sciences. AFT’s best-known products include the ibuprofen-paracetamol combination Maxigesic and Hylo, Australia’s biggest-selling lubricating eye drop. The company also sells the Crystaderm anti-acne cream and Kiwisoothe for gut discomfort and constipation. AFT’s development program covers dermatology indications including keloid scars, strawberry birthmarks and port wine stains. But IV iron is the big kahuna. AFT posted sales of NZ$254. 7 million in the year to March 2026, with a 38% net profit boost to NZ$24. 4m. The company strives for NZ$300 million of revenue this financial year. Calmer Co kavas out a new product nicheGrocery chain Coles says it will stockThe Calmer Co International’s (ASX:CCO)new line of kava products that negate the “challenging” taste of the mildly stimulating South Pacific root-derived beverage. Branded FZZR, the products deploy an “innovative” supplement delivery format that combines powders and effervescent granules. “Consumers are able to dissolve the product in water as a sparkling beverage and consume it direct-to-mouth for a fizzing sensation,” Calmer says. Or they can chew it, creating a “differentiated and highly accessible wellness format”. Calmer sells the product via the Therapeutic Goods Administration’s complementary medicine pathway, which enables “flavour innovation”. The company has chosen Piña Colada. And why not? One never knows when one might get caught in a tropical Fijian downpour. Calmer Co already distributes its Fiji Kava-branded powder via Coles and Woolworths. The company claims number-one and number-three status on Coles shelves – for the 150 grams and 50g packets respectively. The company is also keen on US expansion, where it claims a 10% share of US Amazon kava sales. “Recent industry research indicated that approximately 10. 7% of US adults surveyed reported consuming kava within the past year,” Calmer founder and CEO Zane Yoshida says. “This highlights growing consumer awareness and category adoption within the US wellness market. ”At Stockhead, we tell it as it is. While Calmer Co is a Stockhead advertiser, the company did not sponsor this piece.