Check Up: Paradigm targets Phase 3 clinical trial in the US; AI microbiology product fails to impress
Health & Biotech
Health & Biotech
Link copied to
It’s been a mixed two weeks for small-cap health companies, with 64 companies gaining ground, 47 losing it and 25 flatlining.
Actinogen Medical (ASX:ACW) was the biggest gainer, up 31% on no news.
Followed by Paradigm Biopharmaceutical (ASX:PAR) which jumped 27% off the back of written feedback from the US FDA in relation to its Investigation New Drug (IND) submission for pentosan polysulfate sodium (PPS) to treat pain related to knee osteoarthritis.
The FDA has one outstanding question regarding adrenal gland function related to a preclinical finding in the adrenal gland of rats, which is the focus of the ongoing US FDA review.
“I am confident that the FDA and Paradigm have now attained a pathway to commence our Phase 3 clinical trial in the US,” says Paradigm CEO, Paul Rennie.
The company also recently received Australian ethics approval for its pivotal Phase 3 clinical trial, PARA_OA_002, to evaluate the treatment effects of PPS against placebo on participants with knee osteoarthritis pain.
Medical Developments (ASX:MVP) was up 21% after releasing its FY21 annual report which detailed a strong rebound of Penthrox sales in the first half.
Gross Revenue in FY21 was $25.7m, growing 9% from the $23.6m achieved in the comparable period.
Respiratory product sales, whilst slightly improved in the second half, were depressed in FY21 as a result of the milder cold and flu season as well as reduced community movement and ongoing improved community hygiene practices.
Here’s a table showing how ASX-listed healthcare stocks have been performing.
Flat this fortnight was MMJ Group (ASX:MMJ), despite having received an offer from BevCanna Enterprises (CSE:BEV) to acquire 100% of Embark Health Inc for a purchase price of 46.7 million Bevcanna shares – plus potential future earn-outs.
MMJ chairman Peter Wall said the proposed acquisition of Embark Health “would allow MMJ to exit its investment at its book value and retain a share in the potential upside of the larger merged Bevcanna business.”
Creso Pharma (ASX:CPH) was also flat even though wholly-owned psychedelics subsidiary Halucenex Life Sciences secured a research agreement with Acadia University to develop a soft gel capsule drug delivery format containing CBD and psilocybin respectively.
The aim is for the formulation to have a quick release effect, good bioavailability of the active ingredients and rapid action.
“We look forward to receiving the initial results, as they will provide us with valuable insight into the potential steps towards licensing and manufacturing agreements with industry participants,” Creso non-executive chairman Adam Blumenthal.
And despite being awarded the contract for its Hailie sensor and software solution for an upcoming US-based clinical study by AstraZeneca, Adherium (ASX:ADR) also remained flat.
Telix Pharmaceutical (ASX:TLX) was the biggest loser, down 19% after the US FDA has extended the review period for the New Drug Application (NDA) of its prostate cancer imaging investigational product, Illuccix, by three months to 23 December.
And yesterday the company also received a $12.1 million R&D tax refund from the ATO in relation to its activities during the financial year ended 31 December 2020.
Telix also said that its application for an expanded overseas finding to enable partial recovery of essential overseas R&D expenditure, has been accepted by the Department of Industry, Science, Energy and Resources.
And LBT Innovations (ASX:LBT) dropped 17% after its 50% owned joint-venture company signed a five-year agreement for Thermo Fisher to become the exclusive distributor for the APAS Independence in the United States.
The APAS Independence is the first and only FDA-cleared automated culture plate reader available in the US and uses advanced imaging and artificial intelligence to interpret bacterial growth on culture plates.