- AVITA Medical disclosed that the US Food and Drug Administration (FDA) has authorised its request to amend the RECELL® System pivotal trial.
- Pharmaxis has granted Aptar Pharma an exclusive 12-month option for developing and promoting its proprietary inhaler Orbital.
- Telix revealed that the London-based Great Ormond Street Hospital (GOSH) has obtained UK research ethics authorisation to initiate a Phase 2 trial of TLX66.
Despite the markets opening in the red today with the ASX200 down 63.90 points at 12:34 PM AEST, some stocks have garnered attention with some positive updates. A few such players from the healthcare space include AVITA Medical Inc, Pharmaxis Limited, and Telix Pharmaceuticals Limited.
Let us discuss the developments of these three ASX-listed healthcare stocks.
AVITA Medical Inc (ASX:AVH)
ASX and NASDAQ-listed regenerative medicine player AVITA Medical Inc announced that the US Food and Drug Administration (FDA) has authorised its request to amend the pivotal clinical trial assessing the safety and effectiveness of the RECELL® System. The trial is evaluating RECELL® for the repigmentation of stable vitiligo lesions.
The Company disclosed that the clinical trial is amended to a streamlined single-arm trial design. The new single-arm design trial for RECELL® will evaluate 23 volunteers at 15 clinical sites, vs. a previously authorised 3-arm study of 84 volunteers.
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Dr Mike Perry, CEO of AVITA Medical, commented-
Dr Perry also added that the trial is on track, and the Company is confident that it could be in a position to enter the US market after completion of the clinical study, as early as the H2 CY2023.
On 17 August 2021, AVH shares were trading at AU$4.760, up 0.847% at 12:40 PM AEST.
Pharmaxis Limited (ASX:PXS)
Clinical stage drug developer Pharmaxis has entered into an agreement with Aptar Pharma. Under this agreement, Aptar Pharma can acquire the worldwide rights to the proprietary inhaler Orbital of Pharmaxis. Orbital is a distinctive device that is intended for delivering high payload dry powder to the lungs.
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With this agreement, Aptar Pharma will assess the commercial use for the Orbital device and further develop the prototype device for the unmet medical needs. Aptar Pharma will pay approximately US$250K to Pharmaxis for the 12-month option as well as a further US$2.5 million on the exercise of the option.
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Moreover, Pharmaxis preserves the rights to devices containing Orbital intellectual property (IP) used for inhaled mannitol delivery.
Gary Phillips, CEO of Pharmaxis, commented-
On 17 August 2021, PXS shares were trading at AU$0.115, down 4.167% at 12:40 PM AEST.
Telix Pharmaceutical Limited (ASX:TLX)
Telix Pharmaceuticals Limited announced that the London-based GOSH has obtained UK research ethics approval for initiating Phase 2 academic trial of TLX66, Telix’s investigational product. The study will be conducted to evaluate TLX66 in children with high-risk leukaemia.
Moreover, Telix has also obtained approvals from the Administration of Radioactive Substances Advisory Committee (ARSAC) and the Medicines and Healthcare products Regulatory Agency (MHRA).
The Company disclosed that an independent trial will register 25 volunteers and follows the successful completion of Phase 1 study of ten patients suffering from relapsed refractory leukaemia.
The investigational product, TLX66, has obtained orphan drug designation status in Europe for the treatment of bone marrow conditioning (BMC) for hematopoietic stem cell transplantation.
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Dr Colin Hayward, Chief Medical Officer of Telix, said-
On 17 August 2021, TLX shares were trading at AU$6.150, down 3.381% at 12:40 PM AEST.