Edition:
United States

Sarepta Therapeutics Inc (SRPT.O)

SRPT.O on Nasdaq

120.31USD
19 Aug 2019
Change (% chg)

$0.00 (+0.00%)
Prev Close
$120.31
Open
--
Day's High
--
Day's Low
--
Volume
411,179
Avg. Vol
1,184,241
52-wk High
$165.87
52-wk Low
$95.21

Latest Key Developments (Source: Significant Developments)

Sarepta Therapeutics Receives Complete Response Letter From The U.S. Food And Drug Administration For Golodirsen New Drug Application
Monday, 19 Aug 2019 05:48pm EDT 

Aug 19 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM THE US FOOD AND DRUG ADMINISTRATION FOR GOLODIRSEN NEW DRUG APPLICATION.SAREPTA THERAPEUTICS INC - CRL GENERALLY CITES TWO CONCERNS.SAREPTA THERAPEUTICS INC - SAREPTA WILL IMMEDIATELY REQUEST A MEETING WITH FDA TO DETERMINE NEXT STEPS..SAREPTA THERAPEUTICS INC - CRL CITES CONCERNS ABOUT RISK OF INFECTIONS RELATED TO INTRAVENOUS INFUSION PORTS AND RENAL TOXICITY.SAREPTA - RENAL TOXICITY WITH GOLODIRSEN WAS OBSERVED IN PRE-CLINICAL MODELS AT DOSES THAT WERE TEN-FOLD HIGHER THAN DOSE USED IN CLINICAL STUDIES.SAREPTA THERAPEUTICS INC - RENAL TOXICITY WAS NOT OBSERVED IN STUDY 4053-101, ON WHICH APPLICATION FOR GOLODIRSEN WAS BASED..SAREPTA - OVER COURSE OF REVIEW, AGENCY DID NOT RAISE ANY ISSUES SUGGESTING NON-APPROVABILITY OF GOLODIRSEN, INCLUDING ISSUES THAT FORMED BASIS OF CRL.SAREPTA - GOT CRL FOR NDA SEEKING ACCELERATED APPROVAL OF GOLODIRSEN INJECTION FOR DMD TREATMENT IN PATIENTS WITH CONFIRMED MUTATION AMENABLE TO EXON 53 SKIPPING.  Full Article

Sarepta Therapeutics Q2 Non-GAAP Loss Per Share $0.83
Wednesday, 7 Aug 2019 04:07pm EDT 

Aug 7 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS AND RECENT CORPORATE DEVELOPMENTS.Q2 NON-GAAP LOSS PER SHARE $0.83.Q2 REVENUE $94.7 MILLION VERSUS REFINITIV IBES ESTIMATE OF $90.9 MILLION.Q2 EARNINGS PER SHARE ESTIMATE $-1.37 -- REFINITIV IBES DATA.  Full Article

Paragon Announces Expansion Of Its Strategic Collaboration In Manufacturing Design And Operation With Sarepta Therapeutics
Monday, 15 Apr 2019 09:25am EDT 

April 15 (Reuters) - Sarepta Therapeutics Inc ::PARAGON - ANNOUNCES EXPANSION OF ITS STRATEGIC COLLABORATION IN MANUFACTURING DESIGN AND OPERATION WITH GENE THERAPY LEADER SAREPTA THERAPEUTICS.PARAGON - WILL EXPLORE POTENTIAL FOR A JV WITH SAREPTA IN MANUFACTURING NEW GENE THERAPY CANDIDATES IN A DEDICATED FACILITY..  Full Article

Sarepta Therapeutics Announces Pricing Of $375 Million Public Offering Of Common Stock
Tuesday, 5 Mar 2019 07:31pm EST 

March 5 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES PRICING OF $375.0 MILLION PUBLIC OFFERING OF COMMON STOCK.PRICED UNDERWRITTEN PUBLIC OFFERING OF AGGREGATE OF 2.6 MILLION SHARES OF ITS COMMON STOCK AT $144.00 PER SHARE.  Full Article

Sarepta Therapeutics Announces Proposed $350 Mln Public Offering Of Common Stock
Tuesday, 5 Mar 2019 04:01pm EST 

March 5 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES PROPOSED $350,000,000 PUBLIC OFFERING OF COMMON STOCK.SAREPTA THERAPEUTICS INC - INTENDS TO USE NET PROCEEDS FROM OFFERING PRINCIPALLY FOR CONTINUATION AND INITIATION OF FURTHER CLINICAL TRIALS, OTHERS.  Full Article

Sarepta Therapeutics Reports Q4 NON-GAAP Loss Per Share Of $0.85
Wednesday, 27 Feb 2019 04:05pm EST 

Feb 27 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES FOURTH QUARTER 2018 AND FULL-YEAR 2018 FINANCIAL RESULTS AND RECENT CORPORATE DEVELOPMENTS.Q4 NON-GAAP LOSS PER SHARE $0.85.Q4 REVENUE $84.4 MILLION VERSUS REFINITIV IBES ESTIMATE OF $86 MILLION.Q4 EARNINGS PER SHARE ESTIMATE $-1.04 -- REFINITIV IBES DATA.Q4 GAAP LOSS PER SHARE $2.05.  Full Article

Sarepta Exercises Option To Acquire Myonexus Therapeutics
Wednesday, 27 Feb 2019 07:30am EST 

Feb 27 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA EXERCISES OPTION TO ACQUIRE MYONEXUS THERAPEUTICS.SAREPTA THERAPEUTICS INC - WILL PAY MYONEXUS SHAREHOLDERS $165 MILLION..  Full Article

Sarepta Therapeutics Says Q4 Rev Was About $84.4 Mln
Monday, 7 Jan 2019 12:04pm EST 

Jan 7 (Reuters) - Sarepta Therapeutics Inc ::COMPANY GENERATED APPROXIMATELY $84.4 MILLION IN REVENUE (UNAUDITED) IN THE FOURTH QUARTER ENDED DECEMBER 31, 2018.CASH POSITION OF $1.1 BILLION AS OF DECEMBER 31, 2018.Q4 REVENUE VIEW $85.8 MILLION -- REFINITIV IBES DATA.  Full Article

Sarepta Therapeutics Announces Pricing Of $500 Mln Public Offering
Thursday, 8 Nov 2018 07:13pm EST 

Nov 8 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES PRICING OF $500,000,000 PUBLIC OFFERING OF COMMON STOCK.SAREPTA THERAPEUTICS INC- PRICED UNDERWRITTEN PUBLIC OFFERING OF AGGREGATE OF 3.8 MILLION SHARES OF ITS COMMON STOCK AT $131 PER SHARE.  Full Article

Sarepta Therapeutics Announces Q3 2018 Financial Results And Recent Corporate Developments
Wednesday, 24 Oct 2018 04:06pm EDT 

Oct 24 (Reuters) - Sarepta Therapeutics Inc ::SAREPTA THERAPEUTICS ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND RECENT CORPORATE DEVELOPMENTS.Q3 NON-GAAP LOSS PER SHARE $0.56.Q3 REVENUE $78.5 MILLION VERSUS I/B/E/S VIEW $79.3 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.81 -- THOMSON REUTERS I/B/E/S.  Full Article

Sarepta shares sink 17% after shock FDA rejection

Shares of Sarepta Therapeutics Inc plummeted 17% on Tuesday after the U.S. health regulator, in a surprise move, declined to approve the drugmaker's newest treatment for a muscle-wasting disorder that mainly affects young boys.