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Small-cap player Acrux (ASX:ACR) wins FDA approval; shares jump ~36%

  • January 12, 2021 04:26 PM AEDT
  • Kunal Sawhney
    CEO Kunal Sawhney
    2212 Posts

    Kunal Sawhney is founder & CEO at Kalkine and is a richly experienced and accomplished financial professional with a wealth of knowledge in the Australian Equities Market. Kunal obtained a Master of Business Administration degree from University of T...

Small-cap player Acrux (ASX:ACR) wins FDA approval; shares jump ~36%


  • Drug development company Acrux Limited has got the green light from the US FDA for its generic product, equivalent to Testosterone Topical Solution from Perrigo.
  • The Company can now produce and market the generic drug.
  • The topical drug developer is thrilled to partner with Dash Pharmaceuticals to bring its generic product in the market this financial year.
Gold MTF non-AMP

ASX-listed topical drug development company Acrux Limited (ASX:ACR) announced that the US Food and Drug Administration (FDA) had approved its generic product based on Testosterone Topical Solution (30mg/1.5mL) of Perrigo.

Following the significant development, ACR shares skyrocketed, ending the day’s session 36.363% higher at A$0.225. The Company’s market capitalisation stood at A$34.81 million.

©Kalkine Group 2020

About Acrux Limited

Small-cap pharmaceutical company Acrux Limited is engaged in the development and commercialisation of topical pharmaceuticals. The Company has developed and marketed several topical pharmaceutical products in Europe and the US. ACR is well-placed to discuss partnering as well as product development and also encourages collaboration.

FDA Approval - A Significant Milestone for Acrux

On 12 January 2020, Acrux disclosed that the FDA has notified that the Abbreviated New Drug Application (ANDA) has now been approved for marketing its generic product. The Company can now manufacture and commercialise the generic drug, which is equivalent to Perrigo’s 30mg/1.5mL Testosterone Topical Solution. Acrux submitted an ANDA in August 2018, for FDA authorisation to commercialise its generic drug.

Acrux and Dash to Share Profits

On 12 October 2020, Acrux announced that the Company entered into exclusive marketing and supply deal with a specialty pharmaceutical player- Dash Pharmaceuticals.

With this agreement, Dash Pharmaceutical will be accountable to market the product across the US market. Moreover, Dash will also coordinate for commercial manufacturing along with the management of marketing and distribution.

In the US, sales generated by the product with which the generic drug of Acrux will compete surpassed US$25 million in the one year to the end of September 2020 (as per IQVIA data). Both the companies will share the earnings generated from the sales of the generic drug.

Michael Kotsanis, Acrux CEO and Managing Director commented:



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