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Solid Biosciences (SLDB) Rises 271% in 3 Months: Here's Why
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Shares of Solid Biosciences Inc. (SLDB - Free Report) have skyrocketed 270.7% in the past three months compared with the industry’s increase of 7.5%.
In November 2023, the FDA cleared the company’s investigational new drug (IND) application to begin clinical studies on its novel gene therapy candidate, SGT-003, for the treatment of Duchenne Muscular Dystrophy (DMD).
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 IND clearance was based on encouraging data from a pre-clinical study of SGT-003. In the pre-clinical study, SGT-003 demonstrated increased biodistribution to cardiac and skeletal muscle, including the diaphragm, compared with AAV9 in nonhuman primates. This could have been one of the factors driving the stock’s rise in the said time frame.
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Following the IND clearance by the regulatory body, Solid Biosciences is planning to begin the phase I/II SGT-003-101 study, which will evaluate the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg.
SGT-003 will be administered as a one-time intravenous infusion to patients in two cohorts with a minimum of three patients each, with the potential for cohort expansion. Cohort 1 will study patients aged between four and six years of age with DMD. Long-term safety and efficacy will be evaluated for a total of five years following treatment.
In December 2023, the FDA granted a Fast Track designation to SGT-003 for the treatment of DMD.
Progress with the ongoing studies and successful development of SGT-003 should continue the upward momentum for Solid Biosciences in 2024.
However, upon potential approval, SGT-003 is likely to face competition from Sarepta’s (SRPT - Free Report) Elevidys, a newly approved gene therapy for treating ambulatory pediatric patients aged between four and five years with DMD.
SRPT is currently seeking to expand the treatment label for Elevidys to treat all DMD patients, irrespective of age and ambulation status.
Sarepta has developed Elevidys in collaboration with Roche.
Zacks Rank & Other Stocks to Consider
Solid Biosciences currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 22 cents to 6 cents. In the past year, shares of CTMX have plunged 39.5%.
CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 2.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Solid Biosciences (SLDB) Rises 271% in 3 Months: Here's Why
Shares of Solid Biosciences Inc. (SLDB - Free Report) have skyrocketed 270.7% in the past three months compared with the industry’s increase of 7.5%.
In November 2023, the FDA cleared the company’s investigational new drug (IND) application to begin clinical studies on its novel gene therapy candidate, SGT-003, for the treatment of Duchenne Muscular Dystrophy (DMD).
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 IND clearance was based on encouraging data from a pre-clinical study of SGT-003. In the pre-clinical study, SGT-003 demonstrated increased biodistribution to cardiac and skeletal muscle, including the diaphragm, compared with AAV9 in nonhuman primates. This could have been one of the factors driving the stock’s rise in the said time frame.
Following the IND clearance by the regulatory body, Solid Biosciences is planning to begin the phase I/II SGT-003-101 study, which will evaluate the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg.
SGT-003 will be administered as a one-time intravenous infusion to patients in two cohorts with a minimum of three patients each, with the potential for cohort expansion. Cohort 1 will study patients aged between four and six years of age with DMD. Long-term safety and efficacy will be evaluated for a total of five years following treatment.
In December 2023, the FDA granted a Fast Track designation to SGT-003 for the treatment of DMD.
Progress with the ongoing studies and successful development of SGT-003 should continue the upward momentum for Solid Biosciences in 2024.
However, upon potential approval, SGT-003 is likely to face competition from Sarepta’s (SRPT - Free Report) Elevidys, a newly approved gene therapy for treating ambulatory pediatric patients aged between four and five years with DMD.
SRPT is currently seeking to expand the treatment label for Elevidys to treat all DMD patients, irrespective of age and ambulation status.
Sarepta has developed Elevidys in collaboration with Roche.
Zacks Rank & Other Stocks to Consider
Solid Biosciences currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are CytomX Therapeutics, Inc. (CTMX - Free Report) and Puma Biotechnology, Inc. (PBYI - 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 CytomX Therapeutics’ 2024 loss per share have narrowed from 22 cents to 6 cents. In the past year, shares of CTMX have plunged 39.5%.
CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 2.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.