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Axsome (AXSM) Focuses on Auvelity Launch to Fuel Its Growth
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Axsome Therapeutics (AXSM - Free Report) is progressing well with the launch of its first product, Auvelity (AXS-05), in October 2022. The drug is aimed at treating patients with major depressive disorders. The company received FDA approval for Auvelity in August 2022.
With an encouraging early launch, the drug earned revenues of $5.2 million in the fourth quarter of 2022. Earlier this year, AXSM contacted the largest group purchasing organization (GPO) for the potential commercial coverage of Auvelity. Pharmacy benefit managers and health plans are making coverage decisions for the drug under GPO.
Axsome is also conducting several studies on AXS-05 for smoking cessation and treating other central nervous system (CNS) disorders like AD agitation. It is currently working on the ADVANCE-2 pivotal phase III study on AXS-05, which will support the NDA filing for AXS-05 for AD agitation.
The study is expected to be completed in the first half of 2024, with an NDA submission planned thereafter. The company also plans to initiate a phase II/III pivotal study for evaluating AXS-05 in smoking cessation, in collaboration with Duke University in the fourth quarter of 2023.
Axsome's shares have plunged 5% in the year-to-date period against the industry's 4.8% decline.
Image Source: Zacks Investment Research
In May 2022, the company completed its acquisition of Sunosi, a commercialized drug targeting narcolepsy, from Jazz. In February 2023, AXSM entered into a licensing agreement with Pharmanovia to market Sunosi in European and certain Middle East/North African countries. Its top line presently comprises of product revenues from Sunosi and Auvelity sales.
Axsome has an impressive portfolio of pipeline candidates, including AXS-07, AXS-09, AXS-12 and AXS-14. All of these are being developed for various CNS indications.
AXS-07 is being developed for the acute treatment of migraine. However, in April 2022, Axsome received a complete response letter for an NDA, seeking approval for AXS-07. The company intends to resubmit the NDA by the second half of 2023.
However, any regulatory setback or further developmental delay in the pipeline can hurt the stock.
Axsome faces stiff competition from other companies developing treatments for CNS disorders. ACADIA Pharmaceuticals (ACAD - Free Report) is developing Nuplazid (pimavanserin) in several studies, targeting different CNS indications. ACAD’s Nuplazid is already approved for hallucinations and delusions associated with Parkinson’s disease. Sunosi may also face stiff competition from Jazz’s sleep disorder drugs, which currently have a robust market share.
Axsome also faces commercial launch risks for AXS-05. It may face several hurdles, such as a slow medicare coverage across the United States, which could derail the commercialization of the drug.
While there are several potential challenges ahead, the addition of Sunosi and launch of Auvelity are significant achievements for the company.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 22.7% in the year-to-date period.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 20.7% in the year-to-date period.
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Axsome (AXSM) Focuses on Auvelity Launch to Fuel Its Growth
Axsome Therapeutics (AXSM - Free Report) is progressing well with the launch of its first product, Auvelity (AXS-05), in October 2022. The drug is aimed at treating patients with major depressive disorders. The company received FDA approval for Auvelity in August 2022.
With an encouraging early launch, the drug earned revenues of $5.2 million in the fourth quarter of 2022. Earlier this year, AXSM contacted the largest group purchasing organization (GPO) for the potential commercial coverage of Auvelity. Pharmacy benefit managers and health plans are making coverage decisions for the drug under GPO.
Axsome is also conducting several studies on AXS-05 for smoking cessation and treating other central nervous system (CNS) disorders like AD agitation. It is currently working on the ADVANCE-2 pivotal phase III study on AXS-05, which will support the NDA filing for AXS-05 for AD agitation.
The study is expected to be completed in the first half of 2024, with an NDA submission planned thereafter. The company also plans to initiate a phase II/III pivotal study for evaluating AXS-05 in smoking cessation, in collaboration with Duke University in the fourth quarter of 2023.
Axsome's shares have plunged 5% in the year-to-date period against the industry's 4.8% decline.
Image Source: Zacks Investment Research
In May 2022, the company completed its acquisition of Sunosi, a commercialized drug targeting narcolepsy, from Jazz. In February 2023, AXSM entered into a licensing agreement with Pharmanovia to market Sunosi in European and certain Middle East/North African countries. Its top line presently comprises of product revenues from Sunosi and Auvelity sales.
Axsome has an impressive portfolio of pipeline candidates, including AXS-07, AXS-09, AXS-12 and AXS-14. All of these are being developed for various CNS indications.
AXS-07 is being developed for the acute treatment of migraine. However, in April 2022, Axsome received a complete response letter for an NDA, seeking approval for AXS-07. The company intends to resubmit the NDA by the second half of 2023.
However, any regulatory setback or further developmental delay in the pipeline can hurt the stock.
Axsome faces stiff competition from other companies developing treatments for CNS disorders. ACADIA Pharmaceuticals (ACAD - Free Report) is developing Nuplazid (pimavanserin) in several studies, targeting different CNS indications. ACAD’s Nuplazid is already approved for hallucinations and delusions associated with Parkinson’s disease. Sunosi may also face stiff competition from Jazz’s sleep disorder drugs, which currently have a robust market share.
Axsome also faces commercial launch risks for AXS-05. It may face several hurdles, such as a slow medicare coverage across the United States, which could derail the commercialization of the drug.
While there are several potential challenges ahead, the addition of Sunosi and launch of Auvelity are significant achievements for the company.
Axsome Therapeutics, Inc. Price and Consensus
Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Axsome has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector areCRISPR Therapeutics (CRSP - Free Report) and Allogene Therapeutics (ALLO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 22.7% in the year-to-date period.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 20.7% in the year-to-date period.