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TICKERS: ATRS

FDA Gives Fast Track Status to Firm for Adrenal Rescue Pen
Research Report

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The Quick Take

  • Ladenburg Thalmann has a Buy rating and a $7 per share price target on Antares Pharma.
  • Ladenburg Thalmann reiterates its Buy on Antares on news the U.S. Food and Drug Administration granted the company fast track status for its endocrine rescue pen, ATRS-1902, analyst Matthew Kaplan reported in a Jan. 19 research note.
  • ATRS-1902 delivers hydrocortisone through a proprietary auto-injector to treat acute adrenal insufficiency, or adrenal crisis, a significant unmet need.
  • The fast track status could result in a shorter regulatory pathway to approval for ATRS-1902.
  • Earlier this month Antares announced that in the Phase 1 study of ATRS-1902 in adrenal crisis, the product candidate was shown to be safe, well tolerated and met the primary endpoint.
  • The trial showed the pharmacokinetic profile of ATRS-1902 100 milligrams (100 mg) to be comparable to that of Solu-Cortef 100 mg and the current standard of care.
  • Unlike ATRS-1902, Solu-Cortef is a hydrocortisone sodium succinate powder that needs reconstituting before injection.
  • Antares plans to launch a second trial of ATRS-1902 in adrenal crisis in Q2/22.
  • In other news, Antares sold Otrexup (methotrexate) to an Assertio Holdings subsidiary for $44 million.

Ladenburg Thalmann analyst Matthew Kaplan wrote about Antares Pharma Inc. (ATRS:NASDAQ) that "we are encouraged by the progress of the ATRS-1902 program, which is in line with the company's renewed focus on its internal pipeline."

In terms of the potential market for ATRS-1902, Antares indicated it could be as much as $100 million at peak, Kaplan noted. Solu-Cortef generates about $70 million of revenue each year.

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Disclosures for Ladenburg Thalmann & Co. Inc., Antares Pharma, Inc., Jan. 19, 2022

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