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Emergent's (EBS) Narcan Gets OTC Status for Opioid Overdose
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Shares of EmergentBiosciences (EBS - Free Report) were up 5.1% on Mar 29, after the FDA granted over-the-counter (OTC) status to a 4 mg dose of Narcan nasal spray for emergency treatment of opioid overdose.
Following this approval, Narcan is the first and currently the only naloxone NCI nasal spray available for opioid overdose in the U.S. market without a prescription. The medication, which will be made available by later summer of this year, will be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations and online stores. The approval will give EBS a first-mover advantage in the market and boost its top line.
The OTC product will have the same formulation as before, a 4mg, two-dose pack of the nasal spray. Narcan was launched in 2016 and has been used in the community setting for opioid overdose reversal since then.
In the past year, shares of Emergent have plunged 77.2% compared with the industry’s 12.6% decline.
Image Source: Zacks Investment Research
The FDA approval is based on five-year post-marketing data generated by Emergent and human factor studies. The researches were conducted by management and the data from the same has exhibited the safety and efficacy of Narcan.
The United States has faced an opioid overdose pandemic for the past few years. Research shows that almost every eight minutes, a person dies from an opioid overdose. Naloxone rapidly reverses or blocks the effects of opioids and restores normal respiration, especially when given within minutes of the first signs of an overdose.
Emergent sought the FDA approval for Narcan a month after the agency’s issuance of a notice encouraging drug-makers to apply for OTC naxolone products. Per the regulatory body, naxolone can counter opioid overdose effects when administered within moments of the first sign of the same, thereby reducing chances of death.
In June 2020, Emergent’s stock fell sharply after a district court of New Jersey passed an unfavorable judgment with respect to the company’s patent, Narcan nasal spray 4mg. The court ruled in favor of the defendant, Teva Pharmaceuticals Industries. Teva launched a generic version of Narcan in the United States in 2021. Emergent granted license to Sandoz in 2021 to commercialize an authorized generic of Narcan. There are several other branded nasal spray products that compete in the same segment as Narcan, such as Kloxxado, developed by Hikma Pharmaceuticals.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.54 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP’s shares have plunged 28.1% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA’s shares have plunged 78.5% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Jasper Therapeutics have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024 in the past 60 days. JSPR's shares have plunged 46.4% in the past year.
JSPR's earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.
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Emergent's (EBS) Narcan Gets OTC Status for Opioid Overdose
Shares of Emergent Biosciences (EBS - Free Report) were up 5.1% on Mar 29, after the FDA granted over-the-counter (OTC) status to a 4 mg dose of Narcan nasal spray for emergency treatment of opioid overdose.
Following this approval, Narcan is the first and currently the only naloxone NCI nasal spray available for opioid overdose in the U.S. market without a prescription. The medication, which will be made available by later summer of this year, will be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations and online stores. The approval will give EBS a first-mover advantage in the market and boost its top line.
The OTC product will have the same formulation as before, a 4mg, two-dose pack of the nasal spray. Narcan was launched in 2016 and has been used in the community setting for opioid overdose reversal since then.
In the past year, shares of Emergent have plunged 77.2% compared with the industry’s 12.6% decline.
Image Source: Zacks Investment Research
The FDA approval is based on five-year post-marketing data generated by Emergent and human factor studies. The researches were conducted by management and the data from the same has exhibited the safety and efficacy of Narcan.
The United States has faced an opioid overdose pandemic for the past few years. Research shows that almost every eight minutes, a person dies from an opioid overdose. Naloxone rapidly reverses or blocks the effects of opioids and restores normal respiration, especially when given within minutes of the first signs of an overdose.
Emergent sought the FDA approval for Narcan a month after the agency’s issuance of a notice encouraging drug-makers to apply for OTC naxolone products. Per the regulatory body, naxolone can counter opioid overdose effects when administered within moments of the first sign of the same, thereby reducing chances of death.
In June 2020, Emergent’s stock fell sharply after a district court of New Jersey passed an unfavorable judgment with respect to the company’s patent, Narcan nasal spray 4mg. The court ruled in favor of the defendant, Teva Pharmaceuticals Industries. Teva launched a generic version of Narcan in the United States in 2021. Emergent granted license to Sandoz in 2021 to commercialize an authorized generic of Narcan. There are several other branded nasal spray products that compete in the same segment as Narcan, such as Kloxxado, developed by Hikma Pharmaceuticals.
Emergent Biosolutions Inc. Price and Consensus
Emergent Biosolutions Inc. price-consensus-chart | Emergent Biosolutions Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Emergent has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Jasper Therapeutics (JSPR - Free Report) , each 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 $7.54 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP’s shares have plunged 28.1% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA’s shares have plunged 78.5% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Jasper Therapeutics have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024 in the past 60 days. JSPR's shares have plunged 46.4% in the past year.
JSPR's earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.