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Solid Biosciences (SLDB) Falls Despite FDA Rare Tag for DMD Drug
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Solid Biosciences Inc. (SLDB - Free Report) announced that the FDA has granted a Rare Pediatric Disease Designation to its next-generational investigational candidate, SGT-003, which is being developed as a gene therapy for Duchenne muscular dystrophy (DMD).
The Rare Pediatric Disease designation is granted by the FDA to medicines that treat serious or life-threatening diseases, usually affecting less than 200,000 children in the United States aged 18 years and less. Upon potential approval for SGT-003 by the FDA, the company may become eligible to receive a priority review voucher. This priority review voucher can be used either by SLDB in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.
Despite the positive regulatory update for the DMD candidate, shares of the company were down 6.6% on Apr 1. However, the stock recovered soon after and was up 2% in after-hours trading on Monday.
Year to date, shares of Solid Biosciences have skyrocketed 102.6% compared with the industry’s increase of 0.4%.
Image Source: Zacks Investment Research
DMD is a progressive and degenerative disorder that leads to weakness and wasting of the body’s muscles. The candidate is being developed using SLDB’s proprietary and rationally designed capsid (AAV-SLB101).
The investigational gene therapy, SGT-003, already enjoys the FDA’s Fast Track designation in the United States for the treatment of DMD. The regulatory body also granted an orphan drug designation to SGT-003 for treating DMD in January 2024.
We remind investors that in November 2023, the FDA cleared Solid Biosciences’ investigational new drug (IND) application to begin clinical studies on SGT-003 to treat DMD. The IND clearance was based on encouraging data from a pre-clinical study of SGT-003, which demonstrated the candidate’s potential to significantly improve on existing treatments for DMD.
Patient screening for the early to mid-stage study will commence shortly. The company is looking to dose the first patient in the planned phase I/II study of SGT-003 for DMD in the second quarter of 2024.
The planned phase I/II INSPIRE Duchenne study is designed to evaluate the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg. Initial data from the study is expected in the fourth quarter of 2024.
Zacks Rank & Stocks to Consider
Solid Biosciences currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. So far this year, shares of ADMA have risen 44.7%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. Year to date, shares of VNDA have declined 2.4%.
VNDA’s earnings beat estimates in each of the trailing three quarters, the average surprise being 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. So far this year, shares of ANIP have increased 23.1%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
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Solid Biosciences (SLDB) Falls Despite FDA Rare Tag for DMD Drug
Solid Biosciences Inc. (SLDB - Free Report) announced that the FDA has granted a Rare Pediatric Disease Designation to its next-generational investigational candidate, SGT-003, which is being developed as a gene therapy for Duchenne muscular dystrophy (DMD).
The Rare Pediatric Disease designation is granted by the FDA to medicines that treat serious or life-threatening diseases, usually affecting less than 200,000 children in the United States aged 18 years and less. Upon potential approval for SGT-003 by the FDA, the company may become eligible to receive a priority review voucher. This priority review voucher can be used either by SLDB in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.
Despite the positive regulatory update for the DMD candidate, shares of the company were down 6.6% on Apr 1. However, the stock recovered soon after and was up 2% in after-hours trading on Monday.
Year to date, shares of Solid Biosciences have skyrocketed 102.6% compared with the industry’s increase of 0.4%.
Image Source: Zacks Investment Research
DMD is a progressive and degenerative disorder that leads to weakness and wasting of the body’s muscles. The candidate is being developed using SLDB’s proprietary and rationally designed capsid (AAV-SLB101).
The investigational gene therapy, SGT-003, already enjoys the FDA’s Fast Track designation in the United States for the treatment of DMD. The regulatory body also granted an orphan drug designation to SGT-003 for treating DMD in January 2024.
We remind investors that in November 2023, the FDA cleared Solid Biosciences’ investigational new drug (IND) application to begin clinical studies on SGT-003 to treat DMD. The IND clearance was based on encouraging data from a pre-clinical study of SGT-003, which demonstrated the candidate’s potential to significantly improve on existing treatments for DMD.
Patient screening for the early to mid-stage study will commence shortly. The company is looking to dose the first patient in the planned phase I/II study of SGT-003 for DMD in the second quarter of 2024.
The planned phase I/II INSPIRE Duchenne study is designed to evaluate the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg. Initial data from the study is expected in the fourth quarter of 2024.
Zacks Rank & Stocks to Consider
Solid Biosciences currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Vanda Pharmaceuticals Inc. (VNDA - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. So far this year, shares of ADMA have risen 44.7%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. Year to date, shares of VNDA have declined 2.4%.
VNDA’s earnings beat estimates in each of the trailing three quarters, the average surprise being 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. So far this year, shares of ANIP have increased 23.1%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.