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GSK's (GSK) Gonorrhoea Vaccine Gets FDA Fast Track Tag
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GSK (GSK - Free Report) announced that the FDA has granted fast-track designation to its Neisseria gonorrhoeae investigational vaccine (“NgG”).
Fast Track is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over the existing treatments. A candidate granted Fast Track designation is also eligible for rolling review.
In the year so far, GSK’s shares have gained 3.2% against the industry’s 9.0% decline.
Image Source: Zacks Investment Research
The NgG vaccine is currently being evaluated in a phase I/II first-time-in-human (“FTiH”) study in adults aged 18 through 50 years, irrespective of gonorrhoea history. GSK has already completed the phase I portion of the study that evaluated a FTiH dose-escalation safety lead-in conducted in healthy adults. The phase II portion of the study, which is currently ongoing, aims to exhibit the vaccine’s efficacy in healthy adults considered at risk of gonorrhoea.
There are currently no approved vaccines for gonorrhoea anywhere. The infection’s global incidence is increasing while existing treatments are becoming ineffective as drug-resistant strains of the infection have increased.
Gonorrhoea is the second most prevalent bacterial sexually transmitted infection (“STI”) across the globe. Management estimates that around 82 million new cases of the infection are reported globally every year. A success in the development of the NgG vaccine will enable the company to access the market with a high unmet need.
In a separate press release, GSK also announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended granting approval to daprodustat for treating symptomatic anaemia in adults with chronic kidney disease (“CKD”). In February, management announced that the drug was approved for a similar indication by the FDA. The drug is being marketed in the United States under the brand name Jesduvroq.
GSK currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include ANI Pharmaceuticals (ANIP - Free Report) , Ligand Pharmaceuticals and Novartis (NVS - Free Report) . While ANI Pharmaceuticals and Ligand Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the estimate for ANI Pharmaceuticals’ 2023 earnings per share (EPS) have increased from $2.42 to $3.31. During the same period, the earnings estimates for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 32.2% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%.
In the past 60 days, the estimate for Ligand’s 2023 earnings EPS increased from $4.16 to $5.25. During the same period, the earnings estimate for 2024 has increased from $4.58 to $4.69. In the year so far, the shares of Ligand have risen 8.2%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters, while missing the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.
In the past 60 days, the estimate for Novartis’ 2023 and 2024 EPS have increased from $6.57 to $6.74 and $7.08 to $7.28, respectively. Shares of Novartis are up 9.7% in the year-to-date period.
Earnings of Novartis beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.15%.
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GSK's (GSK) Gonorrhoea Vaccine Gets FDA Fast Track Tag
GSK (GSK - Free Report) announced that the FDA has granted fast-track designation to its Neisseria gonorrhoeae investigational vaccine (“NgG”).
Fast Track is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over the existing treatments. A candidate granted Fast Track designation is also eligible for rolling review.
In the year so far, GSK’s shares have gained 3.2% against the industry’s 9.0% decline.
Image Source: Zacks Investment Research
The NgG vaccine is currently being evaluated in a phase I/II first-time-in-human (“FTiH”) study in adults aged 18 through 50 years, irrespective of gonorrhoea history. GSK has already completed the phase I portion of the study that evaluated a FTiH dose-escalation safety lead-in conducted in healthy adults. The phase II portion of the study, which is currently ongoing, aims to exhibit the vaccine’s efficacy in healthy adults considered at risk of gonorrhoea.
There are currently no approved vaccines for gonorrhoea anywhere. The infection’s global incidence is increasing while existing treatments are becoming ineffective as drug-resistant strains of the infection have increased.
Gonorrhoea is the second most prevalent bacterial sexually transmitted infection (“STI”) across the globe. Management estimates that around 82 million new cases of the infection are reported globally every year. A success in the development of the NgG vaccine will enable the company to access the market with a high unmet need.
In a separate press release, GSK also announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended granting approval to daprodustat for treating symptomatic anaemia in adults with chronic kidney disease (“CKD”). In February, management announced that the drug was approved for a similar indication by the FDA. The drug is being marketed in the United States under the brand name Jesduvroq.
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Zacks Rank & Other Stocks to Consider
GSK currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include ANI Pharmaceuticals (ANIP - Free Report) , Ligand Pharmaceuticals and Novartis (NVS - Free Report) . While ANI Pharmaceuticals and Ligand Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the estimate for ANI Pharmaceuticals’ 2023 earnings per share (EPS) have increased from $2.42 to $3.31. During the same period, the earnings estimates for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 32.2% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%.
In the past 60 days, the estimate for Ligand’s 2023 earnings EPS increased from $4.16 to $5.25. During the same period, the earnings estimate for 2024 has increased from $4.58 to $4.69. In the year so far, the shares of Ligand have risen 8.2%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters, while missing the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.
In the past 60 days, the estimate for Novartis’ 2023 and 2024 EPS have increased from $6.57 to $6.74 and $7.08 to $7.28, respectively. Shares of Novartis are up 9.7% in the year-to-date period.
Earnings of Novartis beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.15%.