Total
0
Shares
Cyclopharm (ASX:CYC) - Managing Director and CEO, James McBrayer
Managing Director and CEO, James McBrayer
Source: Cyclopharm
Market Herald logo

Subscribe

Be the first with the news that moves the market
  • Cyclopharm (CYC) has provided an update on the new drug application (NDA) for its Technegas product
  • Technegas is a lung ventilation imaging agent, which is used to assess a patient’s lung function
  • At the end of this month, the U.S. Food and Drug Administration (FDA) will begin its pre-approval audit of Cyclopharm’s manufacturing facility
  • Once this has been completed, the FDA will give Cyclopharm the product labelling requirements by early May
  • The FDA’s goal date to complete the review of the NDA is June 26 2021 and once this has been officially approved, Cyclopharm can market Technegas across the U.S.
  • Cyclopharm ended the day 9.24 per cent in the green with shares closing at $2.60

Cyclopharm (CYC) has provided an update on its new drug application (NDA) for its Technegas product.

Technegas is a lung ventilation imaging agent, which is used to assess a patient’s lung function.

The NDA was sent off to the U.S. Food and Drug Administration (FDA) and, if it’s approved, the company can market the product across the U.S.

At the end of the month, the FDA is expected to begin its pre-approval audit of Cyclopharm’s manufacturing facility. The company has reportedly been assisting the healthcare regulator with the audit by providing more information.

Once the pre-approval audit has been completed and the FDA reviews the relevant documents, it will provide Cyclopharm with the proposed labelling requirements for Technegas by early May.

The FDA’s goal date to complete the review of the NDA is June 26, 2021. Cyclopharm says this broadly aligns with its expectations and reaffirms its anticipation to commence sales early in the second half of the year.

Cyclopharm ended the day 9.24 per cent in the green with shares closing at $2.60.

CYC by the numbers
More From The Market Herald
APM (ASX:APM) - CEO, Michael Anghie

" APM Human Services (ASX:APM) expands, acquiring Lifecare

APM Human Services International (APM) has acquired physiotherapy and home care group Lifecare for $68 million.
Resonance Health (ASX:RHT)

" Resonance Health (ASX:RHT) submits LiverSmart to FDA

Resonance Health (RHT) has submitted its LiverSmart device to the Food and Drug Administration (FDA) for US regulatory clearance.
Dotz Nano (ASX:DTZ) - CEO, Gideon Shmuel

" Dotz Nano (ASX:DTZ) signs Malaysian distribution deal for COVID-19 tests

Dotz Nano (DTZ) has entered into a distribution agreement with ScienceVision to promote, sell and distribute its COVID-19 virus detection technology in Malaysia.
Kazia Therapeutics (ASX:KZA) - CEO, Dr James Garner

" Kazia Therapeutics (ASX:KZA) releases “positive” second-phase study results for brain cancer treatment

Kazia Therapeutics (KZA) has opened the trading day green after reporting positive final results from a second-phase clinical study of its paxalisib drug