Arguably the most significant event for the Australian biotech sector is approaching with a decision expected from the FDA on the approval of trofinetide, developed by Neuren Pharmaceuticals (NEU: $7.16), on 12 March.

EBR Systems (EBR: $0.60) is a relatively new biotech on the ASX, having listed in November 2021 at $1.08 per share, raising $110 million. It is developing the world's first and only wireless electronic heart pacing system for the left ventricular, called WiSE. It is being trialled with commercially available right ventricle pacers (both with leads and wireless) to offer a novel cardiac resynchronisation therapy (CRT).

Cogstate (CGS: $1.18) came close to being acquired in the recent weeks with discussions with an interested group beginning in December and negotiations ending last week.

Aortic heart valve company Anteris Technologies (AVR: $21.71) has completed a $35 million capital raise, conducted at $24 per share. Investors also received a free two-year option to buy an additional share at $29.

Aroa Biosurgery (ARX: $1.15) delivered another consistent quarter of growth. Net cash receipts were up 88% over the PCP to NZ$17 million for the quarter, and up 83% over the PCP for the last nine months to NZ$42 million.

Insecticide development company Bio-Gene Technology (BGT: $0.096) has signed a development and product access deal with Israeli group STK Bio-Ag Technologies.

Going into to 2023, Pharmaxis will have two Phase II study results to report. One is with PXS-6302 in the treatment of scars, and the second is with PXS-5505 for the treatment of myelofibrosis.

Wound healing products company Aroa Biosurgery (ARX: $1.10) is proving to be a very predictable performer, meeting or exceeding its sales forecasts.

For the first half of its 2023 financial year (ending 30 September) the company achieved a 44% growth in sales to NZ$29 million. The company is forecasting to be EBITDA neutral by the end of March next year.

Last year novel antibody company Adalta (1AD: $0.044) announced that it would be moving to develop an inhaled formulation of its lead drug candidate, AD-214. This followed preclinical studies that showed high accumulation of the compound in the liver, although no liver toxicity was observed in patients in the Phase I study.

Dimerix (DXB: $0.17) has completed recruitment of the first part of its Phase III study in the kidney disease FSGS (focal segmental glomerulosclerosis) with 72 patients. It will now move into the second part where an additional 72 patients will be treated for 35 weeks with placebo or active drug.