Axsome Therapeutics, Inc. AXSM introduced that the FDA has accepted its resubmitted new drug utility (NDA) searching for approval for AXS-07 for the acute remedy of migraine.
A closing resolution from the regulatory physique is anticipated on Jan. 31, 2025. The FDA has designated the NDA resubmission as a Class 2 resubmission.
Shares of AXSM have been up 6.6% on Sept. 4 following the announcement of the information.
Yr so far, shares of Axsome have rallied 20.1% in opposition to the business’s lower of 0.9%.
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The FDA issued an entire response letter to the primary NDA for AXS-07 in April 2022 because it recognized points associated to the chemistry, manufacturing and controls.
The NDA re-submission for AXS-07 for the acute remedy of migraine was accomplished throughout the second quarter of 2024. The FDA has not requested any extra security or efficacy knowledge for the NDA resubmission.
The NDA re-submission was earlier anticipated to be filed throughout the second half of 2023.
FDA Nod for AXS-07 to Diversify AXSM’s Product Portfolio
Axsome at the moment has two marketed merchandise in its business portfolio – Auvelity (AXS-05) for main depressive dysfunction and Sunosi (solriamfetol) for narcolepsy. A possible FDA nod for AXS-07 will diversify Axsome’s business portfolio
Auvelity was launched in the US in 2022 for the remedy of MDD, making it the primary accredited drug within the firm’s portfolio. The drug generated gross sales value $118.4 million within the first half of 2024, up 172.8% yr over yr, owing to sturdy underlying demand.
Axsome’s second marketed drug, Sunosi, is accredited for treating narcolepsy. The corporate acquired U.S. rights to Sunosi from Jazz Prescribed drugs JAZZ in Might 2022. It started promoting Sunosi within the U.S. market in Might 2022 and in sure worldwide markets in November 2022.
Jazz obtained approval for Sunosi as a remedy for narcolepsy in 2019.
The acquisition of Sunosi from Jazz diversified Axsome’s portfolio to 2 marketed medication. Within the first half of 2024, Sunosi’s web product gross sales have been $42.2 million, reflecting a rise of just about 35.2% yr over yr.
Zacks Rank & Shares to Think about
Axsome at the moment carries a Zacks Rank #3 (Maintain).
Some better-ranked shares within the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, every sporting a Zacks Rank #1 (Robust Purchase) at current.
Previously 60 days, estimates for Krystal Biotech’s 2024 earnings per share have elevated from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Yr so far, shares of KRYS have risen 50.6%.
KRYS’ earnings beat estimates in three of the trailing 4 quarters whereas lacking on the remaining event, the typical shock being 49.9%.
Previously 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Yr so far, shares of FULC have jumped 22.2%.
FULC’s earnings beat estimates in every of the trailing 4 quarters, the typical shock being 393.18%.
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