{"id":1549670,"date":"2025-07-29T12:15:00","date_gmt":"2025-07-29T16:15:00","guid":{"rendered":"https:\/\/bugaluu.com\/news\/?p=1549670"},"modified":"2025-07-29T12:15:00","modified_gmt":"2025-07-29T16:15:00","slug":"sarepta-shares-soar-after-fda-reverses-pause-for-controversial-gene-therapy-elevidys","status":"publish","type":"post","link":"https:\/\/bugaluu.com\/news\/sarepta-shares-soar-after-fda-reverses-pause-for-controversial-gene-therapy-elevidys\/1549670\/","title":{"rendered":"Sarepta Shares Soar After FDA Reverses Pause For\u00a0Controversial Gene Therapy Elevidys\u00a0"},"content":{"rendered":"

Sarepta Shares Soar After FDA Reverses Pause For\u00a0Controversial Gene Therapy Elevidys\u00a0<\/span><\/p>\n

\n

Shares of\u00a0Sarepta Therapeutics erupted in\u00a0premarket trading after the Food and Drug Administration (FDA) lifted a voluntary pause on its gene therapy Elevidys, limited to patients who can still walk.\u00a0The decision follows multiple deaths linked to the drug, which is used to treat Duchenne muscular dystrophy.\u00a0<\/p>\n

“Sarepta will resume shipping ELEVIDYS to sites of care for treatment of ambulatory patients with Duchenne imminently<\/strong>,”\u00a0the pharmaceutical company stated in a press release<\/a> on its website.\u00a0This comes ten days after the FDA requested\u00a0Sarepta to halt all\u00a0shipments of the drug after three deaths.\u00a0Sarepta initially\u00a0refused, then caved a few days later.\u00a0<\/p>\n

<\/a><\/p>\n

Sarepta CEO\u00a0Doug Ingram wrote in a statement:<\/p>\n

“Last week, at the suggestion of FDA, Sarepta made the difficult decision to pause shipments of ELEVIDYS to provide the FDA with an opportunity to complete a review of available safety information. <\/em>We are very pleased that FDA chose to rapidly and comprehensively complete that review and to recommend that we remove our voluntary pause and resume shipment of ELEVIDYS for ambulatory patients<\/em><\/strong>. The FDA’s swift review evinces a commitment to the Duchenne population, a commitment shared by Sarepta.\u00a0<\/em><\/p>\n

“We look forward to working collaboratively with the FDA to complete the safety label update for ELEVIDYS and to discussing the approach to risk-mitigation for non-ambulatory patients, who remain on pause pending the outcome of those discussions.”<\/em><\/p>\n

Initial reactions from Wall Street desks suggest that a partial overhang has been lifted for Sarepta, helping to stabilize the company’s financial outlook ahead of\u00a0payments to a biotech partner and $1.2 billion in debt maturing in 2027.\u00a0<\/p>\n

Analyst commentary (courtesy of Bloomberg):<\/p>\n

BMO (market perform, PT raised to $50 from $25) <\/strong><\/p>\n

The FDA’s decision suggests that fatality risk with Elevidys is in ambulatory patients and largely independent of non- ambulatory patient risk, says analyst Kostas Biliouris<\/em><\/p>\n

Sarepta’s financial overhang is partially removed, although physicians and patients may remain hesitant about the treatment in the near term<\/em><\/p>\n

Jefferies (buy, PT $35)<\/strong><\/p>\n

The news significantly improves Elevidys’ sales outlook in the near-term and creates better visibility around the firm’s cost structure, says analyst Andrew Tsai<\/em><\/p>\n

Street will be relieved about the situation, suggesting meaningful upside potential to the stock<\/em><\/p>\n

JPMorgan (raises to neutral from underweight, PT $24)<\/strong><\/p>\n

The FDA update came rather quickly after Sarepta voluntarily paused shipments only one week ago, and should provide confidence in the financial outlook for the company, says analyst Anupam Rama<\/em><\/p>\n

But understanding the Elevidys launch curve following this unprecedented regulatory situation could take a couple quarters, and “we worry about headline risk”<\/em><\/p>\n

Morgan Stanley (equal-weight, PT raised to $20 from $15)<\/strong><\/p>\n

The FDA’s faster-than-expected review and favorable recommendation for ambulatory patients are encouraging, acknowledging the high unmet need and potential benefits of Elevidys, says analyst Michael Ulz<\/em><\/p>\n

Expects the firm to receive about $500m per year for the next two years from Elevidys, up from a previous forecast of no revenue for 2026 and 2027<\/em><\/p>\n

Sarepta noted:<\/p>\n

FDA’s review of the safety data in the ambulatory population included the case of an<\/em> 8-year-old in Brazil whose death was deemed unlikely to be related to treatment with ELEVIDYS by the Brazilian health authorities<\/em><\/strong>. FDA’s investigation has concluded the death was unrelated to treatment with ELEVIDYS and confirmed that Sarepta can resume shipments.<\/em><\/p>\n

Shares of Sarepta jumped 38% in premarket trading<\/strong>, building on Monday’s 16% gain. Year to date, the stock is down 88%.\u00a0<\/p>\n

<\/a><\/p>\n

According to the latest Bloomberg data, there are six sell ratings<\/strong>, 17 holds, and five buys on the stock. The average 12-month price target among Wall Street analysts is $20.64.\u00a0<\/p>\n

<\/a><\/p>\n

Last week:<\/strong><\/p>\n

Sarepta Price Target Slashed To $0 At H.C. Wainwright As Stock Plunge Continues<\/a><\/em><\/p>\n

Sarepta Plunges Again After Europe Rejects Elevidys<\/a><\/em><\/p>\n

. . .<\/p>\n<\/div>\n

Tyler Durden<\/a><\/span>
\nTue, 07\/29\/2025 – 08:15<\/span><\/p>\n

\u200bhttps:\/\/www.zerohedge.com\/markets\/sarepta-shares-soar-after-fda-reverses-pause-controversial-gene-therapy-elevidys<\/a>\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

Sarepta Shares Soar After FDA Reverses Pause For\u00a0Controversial Gene Therapy Elevidys\u00a0 Shares of\u00a0Sarepta Therapeutics erupted in\u00a0premarket trading after the Food and Drug Administration (FDA) lifted…<\/p>\n","protected":false},"author":0,"featured_media":1549671,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-1549670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","wpcat-1-id"],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pbimBl-6v8G","jetpack_featured_media_url":"https:\/\/bugaluu.com\/news\/wp-content\/uploads\/sites\/3\/2025\/07\/2025-07-29_07-44-08-DmQvxU.png","_links":{"self":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1549670","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/comments?post=1549670"}],"version-history":[{"count":0,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1549670\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/media\/1549671"}],"wp:attachment":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/media?parent=1549670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/categories?post=1549670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/tags?post=1549670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}