Sarepta Therapeutics

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980, and is headquartered in Cambridge, MA.

Earnings data Q2 2023

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

The FDA extends the review period for Sarepta's (SRPT) BLA for DMD gene therapy by almost four weeks to Jun 22. The agency may limit the use of the therapy in children aged between four and five.

Sarepta (SRPT) Down 11% on FDA Extending DMD Gene Therapy Review

Sarepta focuses on gene therapies to treat rare diseases. SRP-9001 is designed to correct the genetic mutation that can cause Duchenne muscular dystrophy.

Why Shares of Sarepta Therapeutics Are Dropping Wednesday

Sarepta Therapeutics shares fell by more than 12% on the news the US Food and Drug Administration (FDA) requires more time for its review of the company's Biologics License Application (BLA) of its investigational gene therapy SRP-9001 for Duchenne muscular dystrophy. The company said the FDA requires additional time to complete the review, including final label negotiations and postmarketing commitment discussions, and it expects to complete the review by June 22, 2023, almost a month later than its previous regulatory action date of May 29.

Sarepta Therapeutics shares fall as FDA delays decision on gene therapy

Sarepta Therapeutics Inc (NASDAQ:SRPT) is gaining some attention in the biotech realm today.

Biotech Stock Drops on FDA Update

Exelixis

Exelixis and Sarepta are relatively small players in the highly competitive biotech industry. Both drugmakers have found success by focusing most of their efforts on niche areas.

2 Under-the-Radar Biotech Stocks to Buy in 2023

Investors on Wednesday seemed to take the delay as a sign that opponents of approval within the agency were winning out.

Sarepta Stock Plunges. FDA Pushes Back Decision Date on Gene Therapy.

The FDA pushed back its review of a highly anticipated gene therapy from Sarepta Therapeutics on Wednesday, prompting SRPT stock to tumble. The post Sarepta Therapeutics Dives On An Unexpected Hold-Up For Its Gene Therapy appeared first on Investor's Business Daily.

Sarepta Therapeutics Dives On An Unexpected Hold-Up For Its Gene Therapy

The U.S. Food and Drug Administration has deferred its decision on an accelerated approval for Sarepta Therapeutics Inc's gene therapy for a muscle wasting disorder called Duchenne muscular dystrophy from May 29 to June 22, the company said on Wednesday.

FDA defers decision for Sarepta's gene therapy to June 22

Sarepta Therapeutics Inc. SRPT, -1.45% said Wednesday that the U.S. Food and Drug Administration has indicated after talks with the company that it's working toward granting accelerated approval of SRP-9001, its latest treatment for Duchenne muscular dystrophy, or DMD. The agency said that's subject to the completion of its Biologics License Application (BLA) review and that it would initially be for use in patients aged 4 to 5 years old.

Sarepta says FDA is working toward accelerated approval of its latest treatment for Duchenne muscular dystrophy

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene. Following discussions with FDA, the Agency has indicated that, subject to the.

Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001

SRP-9001's pivotal trial surrogate endpoint was highly statistically significant. The FDA's Advisory Committee voted 8-6 on May 12 in support of Accelerated Approval.

Buy Sarepta Therapeutics For A Likely Positive FDA Decision Date

Apellis Pharma

Madrigal Pharmaceuticals

The Federal Trade Commission is suing to block the proposed merger between Amgen and Horizon Therapeutics. This adverse regulatory action rippled out across the small- and mid-cap biotech landscape today.

Why These 3 Nasdaq Stocks Buckled Today

Last week, an FDA advisory committee voted in favor of approving Sarepta Therapeutics, Inc.'s SRP-9001 for treating DMD. Sarepta Therapeutics stock has good near-term momentum as the BLA is scheduled for May 29.

Sarepta Therapeutics: A Virtual Monopoly In Duchenne Muscular Dystrophy

Surging Sarepta can thank patients' families for an FDA victory.

Gene-Therapy Investors Have a Powerful Ally: Patients

Sarepta Therapeutics Inc. NASDAQ: SRPT jumped nearly 31% on May 15, after a Food and Drug Administration committee gave a thumbs up to the company's experimental gene therapy to treat Duchenne muscular dystrophy.

Sarepta Soars 31% As FDA Panel Backs Muscular Dystrophy Therapy

The FDA's CTGTAC narrowly recommends granting accelerated approval to Sarepta's (SRPT) DMD gene therapy. A final decision from the agency is expected by the end of this month.

Sarepta's (SRPT) DMD Gene Therapy Gets Endorsed by FDA Panel

Sarepta (NASDAQ: SRPT ) stock is on the move Monday as investors react to news of FDA advisors voting on its gene therapy for Duchenne muscular dystrophy. The big news here is the FDA advisors voting in favor of the agency supporting the gene therapy treatment.

Why Is Sarepta (SRPT) Stock Up 29% Today?

Sarepta Therapeutics shares added almost 25% on Monday morning after the US Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee voted eight to six in favor of the accelerated approval of the company's therapeutic SRP-9001 for Duchenne muscular dystrophy (DMD).  The company said the vote, while not binding, would be considered by the FDA when considering the potential accelerated approval of SRP-9001.

Sarepta Therapeutics shares soar on FDA panel's support for muscular dystrophy therapeutic

An FDA advisory committee voted 8-6 in favor of accelerated approval for SRP-9001. The FDA doesn't have to go along with the advisory committee's recommendation, but usually does.

Why Sarepta Therapeutics Stock Is Skyrocketing Today

Amylyx Pharmaceuticals

Growth stocks have been top-performers during the first five months of 2023. This broad-based rally is in danger of stalling because of numerous storm clouds on the horizon.

2 Supercharged Growth Stocks to Buy Right Now

U.S. Food and Drug Administration advisers voted 8-6 Friday to recommend the agency grant accelerated approval to Sarepta Therapeutics Inc.'s gene therapy for Duchenne muscular dystrophy despite questions about its clinical benefit and safety.

FDA advisers narrowly back accelerated approval of Sarepta gene therapy

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene. “Today's advisory commit.

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

FDA advisors will vote Friday on the approvability of Sarepta's highly anticipated gene therapy. SRPT stock was halted ahead of the meeting.

Sarepta Halted As FDA Mulls Its Highly Anticipated Gene Therapy

Sarepta Therapeutics Inc. stock SRPT, -0.88% was halted premarket Friday, ahead of a meeting of a Food and Drug Administration advisory panel to discuss the company's SRP-9001 gene therapy for the rare genetic disorder Duchenne muscular dystrophy, or DMD. DMD typically affects boys.

Sarepta Therapeutics stock halted premarket ahead of FDA panel meeting on new Duchenne muscular dystrophy treatment

Sarepta Therapeutics is heading into an important expert panel review this Friday for its Duchenne muscular dystrophy gene therapy candidate. The FDA's briefing documents ahead of this meeting raised concerns about the therapy's efficacy and safety.

News for Sarepta Therapeutics Stock (SRPT)