Solid Biosciences Says FDA Grants Fast Track Designation For Gene Therapy Candidate SGT-003

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Stocktwits
Solid Biosciences Says FDA Grants Fast Track Designation For Gene Therapy Candidate SGT-003

(RTTNews) - Life sciences company Solid Biosciences Inc. (SLDB) announced Thursday that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SGT-003, the company's next-generation Duchenne muscular dystrophy gene therapy candidate.

IND clearance by the FDA for SGT-003 was received in November 2023. The planned Phase 1/2 trial, SGT-003-101, is a first-in-human, open-label, multicenter trial to determine 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 4 to < 6 years of age with DMD. Long-term safety and efficacy will be evaluated for a total of 5 years following treatment.

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Singapore Bourse May Reclaim 3,900-Point Level

Singapore Bourse May Reclaim 3,900-Point Level

The Singapore stock market has alternated between positive and negative finishes through the last four trading days since the end of the two-day winning streak in which it had risen just 6 points or 0.15 percent. The Straits Times Index now sits just shy of the 3,900-point plateau and it's expected to open higher again on Wednesday.
RTTNews | il y a 25 minutes
Malaysia Stock Market Tipped To Open In The Green

Malaysia Stock Market Tipped To Open In The Green

The Malaysia stock market has moved lower in back-to-back sessions, slipping almost 10 points or 0.7 percent in that span. The Kuala Lumpur Composite Index now sits just above the 1,525-point plateau although it's due for support on Wednesday.
RTTNews | il y a 55 minutes
Win Streak May Continue For Japan Stock Market

Win Streak May Continue For Japan Stock Market

The Japan stock market has tracked higher in three straight sessions, accelerating almost 750 points or 2 percent along the way. The Nikkei 225 now sits just shy of the 27,725-point plateau and it may add to its winnings again on Wednesday.
RTTNews | il y a 1h 10min
KOSPI Expected To Erase Tuesday's Losses

KOSPI Expected To Erase Tuesday's Losses

The South Korea stock market headed south again on Tuesday, one day after ending the two-day slide in which it had given up almost 35 points or 1.4 percent. The KOSPI now rests just above the 2,635-point plateau although it's expected to rebound again on Wednesday.
RTTNews | il y a 1h 25min
New Zealand Rate Decision On Tap For Wednesday

New Zealand Rate Decision On Tap For Wednesday

The Reserve Bank of New Zealand will wrap up its monetary policy meeting on Wednesday and the announce its decision on interest rates, highlighting a light day for Asia-Pacific economic activity. The RBNZ is widely expected to trim its Official Cash Rate by 25 basis points, to 3.25 percent from 3.50 percent.
RTTNews | il y a 2h 25min
U.S. Dollar Strengthens On Trump's Tariff Delay

U.S. Dollar Strengthens On Trump's Tariff Delay

The U.S. dollar was higher against its major counterparts in the New York session on Tuesday amid easing trade tensions between the U.S. and the European Union.
RTTNews | il y a 6h 3min
European Stocks Close Broadly Higher On Strong Data, Easing Trade Tensions

European Stocks Close Broadly Higher On Strong Data, Easing Trade Tensions

European stocks closed on a positive note on Tuesday, continuing to benefit from U.S. President Donald Trump's decision to amid slightly easing concerns about a potential trade war following U.S. President Donald Trump's decision decision to wait till July 9th to implement the 50% tariffs he had threatened to impose on imports from the European Union.
RTTNews | il y a 7h 31min
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