Sarepta Therapeutics gains 37% in pre-market after FDA approval 📃

Open account Download free app

Sarepta Therapeutics' soared by 36% in the pre-market trading following the FDA's decision to grant accelerated approval for its gene therapy, Elevidys, extending its use to include non-ambulatory patients with Duchenne muscular dystrophy (DMD). Additionally, the FDA granted traditional approval for Elevidys to treat ambulatory DMD patients who are at least four years old. This broader approval aims to increase access to Elevidys, which costs around $3.2 million per patient, positioning it as one of the most expensive drugs globally. Sarepta has commenced the ENVISION study, a phase 3 trial, to confirm Elevidys' benefits in non-ambulatory and older ambulatory patients, a requirement for maintaining its FDA approval for these groups.

The FDA's decision marks a significant expansion in the treatment of DMD, a serious muscle-weakening disease that mainly affects men in their 20s. Yesterday's FDA approval offers a potential opportunity to significantly increase the company's revenues. Sarepta's strategy includes partnering with Roche Holdings for global commercialization, excluding the US, where Sarepta will remain fully responsible for commercialization.

Source: xStation 5

4 February 2026, 10:41 PM

Alphabet Results: Record Revenues and Investments Showcase the Company’s Dominance!

4 February 2026, 5:55 PM

Tech selloff accelerates❗️US100 dips 2% 📉

4 February 2026, 4:10 PM

India: New battleground of the trade war?

4 February 2026, 3:23 PM

BREAKING🚨US100 decline extends amid inflationary ISM report and tech stocks sell-off

Stocks

Cookie name	Description
SERVERID
userBranchSymbol	Expiration date 1 day
test_cookie	Expiration date 1 hour
adobe_unique_id	Expiration date 364 days
__hssc	Expiration date 1 hour
SESSID	Expiration date 1 day
__cf_bm	Expiration date 1 hour
intercom-id-iojaybix	Expiration date 270 days
intercom-session-iojaybix	Expiration date 6 days
xtbCookiesSettings	Expiration date 364 days
TS5b68a4e1027
countryIsoCode
xtbLanguageSettings	Expiration date 364 days
userPreviousBranchSymbol	Expiration date 364 days
intercom-device-id-iojaybix	Expiration date 270 days
__cfruid
_cfuvid

Cookie name	Description
_gid	Expiration date 1 day
_gat_UA-98728395-1	Expiration date 1 hour
_gat_UA-121192761-1	Expiration date 1 hour
_gcl_au	Expiration date 89 days
_ga_CBPL72L2EC	Expiration date 729 days
_ga	Expiration date 729 days
__hstc	Expiration date 179 days
__hssrc
_vwo_uuid_v2	Expiration date 365 days
_ga_TC79BEJ20L	Expiration date 729 days
_vwo_uuid	Expiration date 365 days
_vwo_ds	Expiration date 29 days
_vwo_sn	Expiration date 1 hour
_vis_opt_s	Expiration date 99 days
_vis_opt_test_cookie
af_id	Expiration date 394 days
afUserId	Expiration date 730 days
AF_SYNC	Expiration date 6 days
AnalyticsSyncHistory	Expiration date 29 days

Cookie name	Description
MUID	Expiration date 389 days
_omappvp	Expiration date 3998 days
_omappvs	Expiration date 1 hour
_uetsid	Expiration date 1 day
_uetvid	Expiration date 389 days
_fbp	Expiration date 89 days
fr	Expiration date 89 days
_ttp	Expiration date 89 days
_tt_enable_cookie	Expiration date 89 days
hubspotutk	Expiration date 179 days
IDE	Expiration date 389 days
YSC
VISITOR_INFO1_LIVE	Expiration date 179 days
li_sugr	Expiration date 89 days
guest_id_marketing	Expiration date 729 days
guest_id_ads	Expiration date 729 days
guest_id	Expiration date 729 days
muc_ads	Expiration date 729 days
VISITOR_PRIVACY_METADATA	Expiration date 179 days
MSPTC	Expiration date 389 days

Cookie name	Description
bcookie	Expiration date 364 days
lidc	Expiration date 1 day
UserMatchHistory	Expiration date 29 days
bscookie	Expiration date 364 days
li_gc	Expiration date 179 days
personalization_id	Expiration date 729 days