Edition:
India

Clearside Biomedical Inc (CLSD.OQ)

CLSD.OQ on NASDAQ Stock Exchange Global Market

1.11USD
9:32pm IST
Change (% chg)

$0.00 (+0.00%)
Prev Close
$1.11
Open
$1.10
Day's High
$1.12
Day's Low
$1.10
Volume
11,603
Avg. Vol
159,058
52-wk High
$1.90
52-wk Low
$0.56

Latest Key Developments (Source: Significant Developments)

Clearside Biomedical Announces Third Quarter Results
Thursday, 7 Nov 2019 

Nov 6 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL ANNOUNCES THIRD QUARTER 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q3 LOSS PER SHARE $0.17.Q3 EARNINGS PER SHARE ESTIMATE $-0.16 -- REFINITIV IBES DATA.CASH AND CASH EQUIVALENTS TOTALED $22.6 MILLION AS OF SEPTEMBER 30, 2019.EXPECTS TO RESUBMIT ITS NDA FOR XIPERE IN Q1 OF 2020.  Full Article

Bausch Health Licenses Clearside Biomedical's Xipere, An Investigational Treatment For Macular Edema Associated With Uveitis
Wednesday, 23 Oct 2019 

Oct 23 (Reuters) - Bausch Health Companies Inc ::BAUSCH HEALTH LICENSES CLEARSIDE BIOMEDICAL'S XIPERE™ (TRIAMCINOLONE ACETONIDE SUPRACHOROIDAL INJECTABLE SUSPENSION), AN INVESTIGATIONAL TREATMENT FOR MACULAR EDEMA ASSOCIATED WITH UVEITIS.BAUSCH HEALTH COMPANIES INC - CLEARSIDE EXPECTS TO RESUBMIT ITS NDA FOR XIPERE TO FDA FOR REVIEW IN Q1 OF 2020.BAUSCH HEALTH COMPANIES INC - UNDER TERMS OF AGREEMENT, CLEARSIDE WILL RECEIVE UP TO $20 MILLION IN PAYMENTS PRIOR TO LAUNCH.BAUSCH HEALTH COMPANIES INC - CLEARSIDE ALSO ENTITLED TO RECEIVE TIERED ROYALTIES BASED ON ANNUAL NET SALES OF XIPERE IN UNITED STATES AND CANADA.  Full Article

Clearside Biomedical Inc Says On Oct 18 Received CRL From FDA Regarding Its New Drug Application For XIPERE
Monday, 21 Oct 2019 

Oct 21 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL INC - ON OCT 18 RECEIVED CRL FROM FDA REGARDING ITS NEW DRUG APPLICATION FOR XIPERE - SEC FILING.CLEARSIDE BIOMEDICAL INC - FDA DID NOT IDENTIFY ANY EFFICACY ISSUES, AND THERE WERE NO REQUESTS FOR FURTHER CLINICAL EFFICACY STUDIES.CLEARSIDE BIOMEDICAL - CRL INCLUDED ONE NEW REQUEST FOR ADDITIONAL DATA ON CLINICAL USE OF FINAL TO-BE-MARKETED SCS MICROINJECTOR(TM) DELIVERY SYSTEM.  Full Article

Regenxbio Announces Exclusive Worldwide Option And License Agreement With Clearside Biomedical
Wednesday, 4 Sep 2019 

Sept 4 (Reuters) - Regenxbio Inc ::REGENXBIO ANNOUNCES EXCLUSIVE WORLDWIDE OPTION AND LICENSE AGREEMENT WITH CLEARSIDE BIOMEDICAL FOR EVALUATION OF IN-OFFICE DELIVERY PLATFORM FOR RGX-314.REGENXBIO INC - PLANS TO EVALUATE RGX-314 USING CLEARSIDE'S SCS MICROINJECTOR FOR IN-OFFICE, NON-SURGICAL DELIVERY INTO SUPRACHOROIDAL SPACE.REGENXBIO - IN RETURN FOR RIGHTS,CLEARSIDE TO RECEIVE FEE UPON CO'S EXERCISE OF OPTION, $34 MILLION IN DEVELOPMENT MILESTONES ACROSS MULTIPLE INDICATIONS.REGENXBIO INC - CLEARSIDE TO RECEIVE UP TO $102 MILLION IN SALES MILESTONES & MID-SINGLE DIGIT ROYALTIES ON NET SALES OF PRODUCTS USING SCS MICROINJECTOR.REGENXBIO INC - CO WILL BE RESPONSIBLE FOR ALL DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES FOR GENE THERAPY PRODUCT CANDIDATES.REGENXBIO - UNDER AGREEMENT, CLEARSIDE TO BE RESPONSIBLE FOR SUPPLYING SCS MICROINJECTOR, SUPPORTING PRECLINICAL STUDIES,CLINICAL STUDIES,COMMERCIAL USE.  Full Article

Clearside Biomedical Provides New Drug Application Update For Xipere
Thursday, 22 Aug 2019 

Aug 22 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL PROVIDES NEW DRUG APPLICATION UPDATE FOR XIPEREᵀᴹ (TRIAMCINOLONE ACETONIDE SUPRACHOROIDAL INJECTABLE SUSPENSION).CLEARSIDE BIOMEDICAL INC - PLANS TO RE-SUBMIT NDA IN Q1 OF 2020 WITH REQUESTED STABILITY DATA..CLEARSIDE BIOMEDICAL INC - CLEARSIDE EXPECTS TO RECEIVE A COMPLETE RESPONSE LETTER FROM FDA ON OR BEFORE ITS OCTOBER 19, 2019 PDUFA GOAL DATE.CLEARSIDE BIOMEDICAL INC - BELIEVES FDA WILL REVIEW NDA WITHIN SIX MONTHS OF RECEIPT OF RESUBMISSION.CLEARSIDE BIOMEDICAL INC - CONTINUE TO EXPECT THAT WE WILL HAVE SUFFICIENT RESOURCES TO FUND OPERATIONS INTO Q3 OF 2020.CLEARSIDE BIOMEDICAL INC - DISCUSSIONS WITH POTENTIAL XIPERE OUT-LICENSING PARTNERS REMAIN ONGOING.CLEARSIDE BIOMEDICAL INC - FDA'S OPQ REQUESTED CO PROVIDE STABILITY DATA FOR TA SUSPENSION PRODUCED UTILIZING ENHANCED MANUFACTURING PROCESS.CLEARSIDE BIOMEDICAL INC - REQUESTED DATA DOES NOT RELATE TO OR AFFECT SCS MICROINJECTOR PLATFORM.  Full Article

Clearside Biomedical Announces License Agreement With Aura Biosciences
Tuesday, 9 Jul 2019 

July 9 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL ANNOUNCES LICENSE AGREEMENT WITH AURA BIOSCIENCES FOR SUPRACHOROIDAL SPACE MICROINJECTOR™ DESIGNED TO OPTIMIZE OCULAR ONCOLOGY DRUG DELIVERY.CLEARSIDE BIOMEDICAL INC - CO ELIGIBLE TO RECEIVE PAYMENTS RELATED TO PRE-SPECIFIED DEVELOPMENT, REGULATORY AND SALES MILESTONES.CLEARSIDE BIOMEDICAL INC - CO IS ELIGIBLE TO RECEIVE ROYALTIES ON PRODUCT SALES THAT UTILIZE SCS MICROINJECTOR.CLEARSIDE BIOMEDICAL INC - IF COLLABORATION PROVES SUCCESSFUL, AURA MAY UTILIZE SCS MICROINJECTOR FOR CERTAIN FUTURE DEVELOPMENT PROGRAMS.  Full Article

Clearside Biomedical Appoints George Lasezkay As Interim CEO
Monday, 8 Apr 2019 

April 8 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL APPOINTS DR. GEORGE LASEZKAY AS INTERIM CEO.CLEARSIDE BIOMEDICAL INC - LASEZKAY SUCCEEDS DANIEL H. WHITE.CLEARSIDE BIOMEDICAL INC - BOARD IS INITIATING A SEARCH TO IDENTIFY A PERMANENT CEO.CLEARSIDE BIOMEDICAL INC - WHITE RESIGNED AS PRESIDENT AND CEO AND AS A MEMBER OF BOARD.  Full Article

Clearside Biomedical Posts Q4 Loss Per Share of $0.68
Wednesday, 13 Mar 2019 

March 12 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL ANNOUNCES FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q4 LOSS PER SHARE $0.68.Q4 EARNINGS PER SHARE ESTIMATE $-0.57 -- REFINITIV IBES DATA.XIPERE NDA ACCEPTED AND ON TRACK FOR OCTOBER 19, 2019 PDUFA DATE.CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS TOTALED $40.9 MILLION AS OF DECEMBER 31, 2018.  Full Article

Clearside Biomedical Receives Notification Of FDA Acceptance Of NDA Filing For Xipere
Wednesday, 20 Feb 2019 

Feb 20 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL RECEIVES NOTIFICATION OF FDA ACCEPTANCE OF NDA FILING FOR XIPERE™ (TRIAMCINOLONE ACETONIDE OPHTHALMIC SUSPENSION) FOR SUPRACHOROIDAL INJECTION WITH PDUFA DATE SET FOR OCTOBER 19, 2019.CLEARSIDE BIOMEDICAL INC - FDA HAS DETERMINED THAT APPLICATION IS SUFFICIENTLY COMPLETE TO PERMIT A SUBSTANTIVE REVIEW..  Full Article

Clearside Biomedical Q3 Loss Per Share $0.75
Thursday, 8 Nov 2018 

Nov 8 (Reuters) - Clearside Biomedical Inc ::CLEARSIDE BIOMEDICAL ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q3 LOSS PER SHARE $0.75.Q3 EARNINGS PER SHARE VIEW $-0.63 -- THOMSON REUTERS I/B/E/S.BELIEVES IT WILL HAVE SUFFICIENT RESOURCES TO FUND ITS PLANNED OPERATIONS INTO Q1 OF 2020.  Full Article