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Aeterna (AEZS) Falls 5% on US Sales Halt of Growth Hormone Drug
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Aeterna Zentaris (AEZS - Free Report) stock dropped 4.8% on Wednesday after the company announced that sales of Macrilen (macimorelin) will be temporarily halted in the United States, effective May 23, 2023. This halt is currently for an indefinite period until the company finds an alternate commercialization partner for Macrilen’s re-launch. The stock price drop signifies investors’ anticipation of a severe blow to Aeterna’s revenues in the upcoming quarters.
Aeterna’s former commercialization partner, Novo Nordisk (NVO - Free Report) , severed ties for Aeterna’s adult growth hormone deficiency (AGHD) diagnosis drug, Macrilen. Novo Nordisk exercised its right to terminate the licensing agreement in August 2022. Aeterna is scheduled to regain all rights to Macrilen from Novo Nordisk in the United States and Canada on May 23, 2023, at the end of the 270-day notice period.
In the past year, shares of Aeterna have plunged 72% compared with the industry’s 16.6% fall.
Image Source: Zacks Investment Research
Aeterna reaffirmed in the press release that it is committed to finding alternate development and commercialization partners for Macrilen in the United States and other territories that are yet to be ventured. Management stated that the temporary decision to discontinue sales of Macrilen in the U.S. market will not impact the sales and commercialization efforts of the drug in the UK and European Economic Area (EEA).
Macrilen is marketed under the brand name Ghryvelin in UK and EEA. Last month, the company announced entering into an exclusive licensing agreement to commercialize Ghryvelin in the UK and EEA with Pharmanovia. The exclusive right to commercialize Aeterna’s Ghryvelin was shifted from its former EEA and UK partner, Consilient Health, to Pharmanovia.
In the same press release, Aeterna announced that the United States Patent and Trademark Office has issued a Notice of Allowance in its favor to use Macimorelin in assessing growth hormone deficiency in children. The company expects the issue of the formal registration of this U.S. patent application in the coming months.
Aeterna further reiterated the advancement of its pivotal phase III DETECT study to expand the current indication for macimorelin to include the childhood-onset growth hormone deficiency diagnosis, under its label. The possible approval of the drug for this indication will enable the diagnosis of growth hormone deficiency in pediatric patients in the United States, UK and EEA.
We would like to remind the investors that macimorelin was approved by the FDA for the diagnosis of AGHD in 2017. Subsequently, the drug also received approval from the European Medicine Agency in 2019 for the same indication. Both approvals were based on results from a phase III study showing that oral macimorelin provides accuracy comparable to standard insulin tolerance testing (ITT) while portraying a better safety profile than ITT. Oral macimorelin also reduces false positive test results, helping avoid unnecessary treatment of patients.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 44 cents. In the past year, shares of Aptinyx have fallen by 89.9%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for ACADIA’s 2023 loss per share has narrowed from 87 cents to 56 cents. In the past year, shares of ACADIA have fallen by 32.4%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 6.33%.
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Aeterna (AEZS) Falls 5% on US Sales Halt of Growth Hormone Drug
Aeterna Zentaris (AEZS - Free Report) stock dropped 4.8% on Wednesday after the company announced that sales of Macrilen (macimorelin) will be temporarily halted in the United States, effective May 23, 2023. This halt is currently for an indefinite period until the company finds an alternate commercialization partner for Macrilen’s re-launch. The stock price drop signifies investors’ anticipation of a severe blow to Aeterna’s revenues in the upcoming quarters.
Aeterna’s former commercialization partner, Novo Nordisk (NVO - Free Report) , severed ties for Aeterna’s adult growth hormone deficiency (AGHD) diagnosis drug, Macrilen. Novo Nordisk exercised its right to terminate the licensing agreement in August 2022. Aeterna is scheduled to regain all rights to Macrilen from Novo Nordisk in the United States and Canada on May 23, 2023, at the end of the 270-day notice period.
In the past year, shares of Aeterna have plunged 72% compared with the industry’s 16.6% fall.
Image Source: Zacks Investment Research
Aeterna reaffirmed in the press release that it is committed to finding alternate development and commercialization partners for Macrilen in the United States and other territories that are yet to be ventured. Management stated that the temporary decision to discontinue sales of Macrilen in the U.S. market will not impact the sales and commercialization efforts of the drug in the UK and European Economic Area (EEA).
Macrilen is marketed under the brand name Ghryvelin in UK and EEA. Last month, the company announced entering into an exclusive licensing agreement to commercialize Ghryvelin in the UK and EEA with Pharmanovia. The exclusive right to commercialize Aeterna’s Ghryvelin was shifted from its former EEA and UK partner, Consilient Health, to Pharmanovia.
In the same press release, Aeterna announced that the United States Patent and Trademark Office has issued a Notice of Allowance in its favor to use Macimorelin in assessing growth hormone deficiency in children. The company expects the issue of the formal registration of this U.S. patent application in the coming months.
Aeterna further reiterated the advancement of its pivotal phase III DETECT study to expand the current indication for macimorelin to include the childhood-onset growth hormone deficiency diagnosis, under its label. The possible approval of the drug for this indication will enable the diagnosis of growth hormone deficiency in pediatric patients in the United States, UK and EEA.
We would like to remind the investors that macimorelin was approved by the FDA for the diagnosis of AGHD in 2017. Subsequently, the drug also received approval from the European Medicine Agency in 2019 for the same indication. Both approvals were based on results from a phase III study showing that oral macimorelin provides accuracy comparable to standard insulin tolerance testing (ITT) while portraying a better safety profile than ITT. Oral macimorelin also reduces false positive test results, helping avoid unnecessary treatment of patients.
AEterna Zentaris Inc. Price and Consensus
AEterna Zentaris Inc. price-consensus-chart | AEterna Zentaris Inc. Quote
Zacks Rank and Stocks to Consider
Aeterna currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are Aptinyx and ACADIA Pharmaceuticals (ACAD - 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.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 44 cents. In the past year, shares of Aptinyx have fallen by 89.9%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for ACADIA’s 2023 loss per share has narrowed from 87 cents to 56 cents. In the past year, shares of ACADIA have fallen by 32.4%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 6.33%.