TGA approves Pfizer jab; Nyrada, Mach7 hit all-time high

Australia’s Therapeutic Goods Administration has approved the Pfizer/BioNTech coronavirus vaccine, seven weeks after inoculations began in the United Kingdom.

The Government is working with Pfizer on the final date for delivery of the vaccines, according to the prime minister’s office, but the company’s latest advice is that shipping and first vaccinations are expected in late February.

“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” Scott Morrison told reporters.

“Our priority has always been to keep Australians safe and protect lives and livelihoods.”

The rollout will begin at 30 to 50 hospital sites, with aged care workers, disability care residents and workers, frontline health care workers and quarantine and border workers set to get the jab first.

Health Minister Greg Hunt says that GPs will play a key role in the next phase of vaccine delivery – people over 70, adults with underlying medical conditions and Aboriginal and Torres Strait Islander people over 55 years old.

Elsewhere in the ASX biotech space:

Nyrada hits all-time high

Nyrada (ASX:NYR) shares are up 12.8 per cent to an all-time high of 44c after the Sydney biopharmaceutical company reported further results from a lab study of its cholesterol-lowering drug candidate, NYX-PCSK9i.

In mice genetically modified to have a human-like metabolism, the drug does not appear to affect body weight, food intake or liver function while dramatically reducing LDL (“bad”) cholesterol.

Nyrada made its debut on the ASX just over a year ago, after an IPO that raised $8.5m at 20c a share.

Cyclopharm raises $30 million

Cyclopharm (ASX:CYC) is down 3.1 per cent to $2.85 after completing a $30 million placement at $2.60 a share to break into the US market.

Cyclopharm says it expects its Technegas diagnostic lung imaging agent – already available in 60 countries – will be approved by the US Food and Drug Administration in the first half.

The capital raising will fund the placement of up to 300 Technegas generators in the United States, which Cyclopharm will place for “free” f0r quick market penetration, while charging $US120 ($155) for each test.

Patients suspected of having a pulmonary embolism – a potentially fatal blood clot in the lungs – breathe in Technegas, an aerosol containing tiny radioactive carbon particles that allows clinicians to visualise the lungs in three dimensions with a CT scan.

Retail shareholders will have the opportunity to buy up to $30,000 worth of shares at $2.60 a share, Cyclopharm said.

Mach7 gets $7.9m order

Mach7 Technologies (ASX:M7T) is up 8.7 per cent to all-time high of $1.445 after announcing a $7.9 million contract to deploy its enterprise imaging solutions across hospitals in the Adventist Health System chain in the West Coast of the United States.

The company said it expects to receive further orders from Adventist this financial year.

Nyrada, Cyclopharm and Mach7 shares