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Veru Inc (VERU.OQ)

VERU.OQ on NASDAQ Stock Exchange Capital Market

2.32USD
16 Jul 2019
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Latest Key Developments (Source: Significant Developments)

Veru Announces Successful Completion Of Pre-NDA Meeting With FDA For Tadfin
Wednesday, 26 Jun 2019 

June 26 (Reuters) - Veru Inc ::VERU ANNOUNCES SUCCESSFUL COMPLETION OF PRE-NDA MEETING WITH FDA FOR TADFIN (TADALAFIL 5MG AND FINASTERIDE 5MG) COMBINATION FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA.VERU INC - REACHED AGREEMENT WITH FDA ON REGULATORY PACKAGE FOR NDA SUBMISSION UTILIZING 505(B)(2) EXPEDITED REGULATORY PATHWAY.VERU INC - FDA REQUESTED THAT CO SUBMIT 12-MONTH STABILITY DATA ON MANUFACTURING BATCHES TO SUPPORT EXPIRY DATE OF TADFIN AT TIME OF NDA SUBMISSION.  Full Article

Veru Reports Q2 Loss Per Share Of $0.06
Wednesday, 15 May 2019 

May 15 (Reuters) - Veru Inc ::VERU REPORTS STRONG FISCAL 2019 SECOND-QUARTER FINANCIAL RESULTS.Q2 LOSS PER SHARE $0.06.Q2 REVENUE $7.0 MILLION VERSUS REFINITIV IBES ESTIMATE OF $6.9 MILLION.Q2 EARNINGS PER SHARE ESTIMATE $-0.06 -- REFINITIV IBES DATA.SEES FY 2019 REVENUE $29 MILLION TO $32 MILLION.EXPECT NEW ORDERS FROM SOUTH AFRICA TO COMMENCE SHIPPING DURING Q3 OF THIS FISCAL YEAR.MANAGEMENT EXPECTS GROSS MARGIN WILL BE APPROXIMATELY 66% IN FY2019 COMPARED TO 55% IN FY2018.EXPECTS GROSS MARGIN WILL BE APPROXIMATELY 66% IN FY2019 COMPARED TO 55% IN FY2018.DOES NOT ANTICIPATE NEED FOR A NEW EQUITY FINANCING UNTIL AT LEAST FISCAL 2021.FY2019 REVENUE VIEW $28.1 MILLION -- REFINITIV IBES DATA.  Full Article

Veru Prices Public Offering Of 7.14 Mln Shares At $1.40Per Share
Thursday, 27 Sep 2018 

Sept 27 (Reuters) - Veru Inc ::VERU ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK.SAYS PUBLIC OFFERING OF 7.14 MILLION COMMON SHARES PRICED AT $1.40PER SHARE.  Full Article

Veru Reports Q2 Loss Per Share $0.07
Wednesday, 9 May 2018 

May 9 (Reuters) - Veru Inc ::VERU REPORTS FISCAL 2018 SECOND-QUARTER FINANCIAL RESULTS.VERU INC <<>> Q2 SHR LOSS $0.07.VERU INC <<>> Q2 REVENUE $2.6 MLN VS $2.4 MLN.  Full Article

U.S. FDA Grants Fee Waiver For Tamsulosin Drs New Drug Application
Thursday, 22 Mar 2018 

March 22 (Reuters) - Veru Inc ::FDA GRANTS FEE WAIVER FOR TAMSULOSIN DRS NEW DRUG APPLICATION.VERU - U.S. FDA GRANTED APPLICATION FOR SMALL BUSINESS WAIVER OF DRUG APPLICATION FEE OF ABOUT$2.4 MILLION FOR NDA FOR TAMSULOSIN DELAYED RELEASE SACHET.  Full Article

Veru Says On March 5 Entered Into Credit Agreement For Synthetic Royalty Financing Transaction
Tuesday, 6 Mar 2018 

March 6 (Reuters) - Veru Inc ::VERU SAYS ON MARCH 5, ENTERED INTO CREDIT AGREEMENT FOR SYNTHETIC ROYALTY FINANCING TRANSACTION - SEC FILING.VERU - PER TERMS OF CREDIT AGREEMENT, LENDERS TO PROVIDE CO WITH MULTI-DRAW TERM LOAN OF UP TO $12 MILLION.VERU INC - IN CONNECTION WITH CREDIT AGREEMENT, VERU AND SWK FUNDING ALSO ENTERED INTO A RESIDUAL ROYALTY AGREEMENT, DATED AS OF MARCH 5, 2018.VERU INC - CO RECEIVED NET PROCEEDS OF ABOUT $9.9 MILLION FROM INITIAL $10 MILLION ADVANCE UNDER CREDIT AGREEMENT.  Full Article

Veru Q1 Loss Per Share $0.08
Wednesday, 14 Feb 2018 

Feb 14 (Reuters) - Veru Inc ::VERU REPORTS FISCAL 2018 FIRST-QUARTER FINANCIAL RESULTS.Q1 LOSS PER SHARE $0.08.Q1 REVENUE $2.6 MILLION VERSUS $3.2 MILLION.REMAIN ON TRACK TO FILE WITH FDA COMPANY'S FIRST NDA FOR TAMSULOSIN DRS IN 2018.PLAN TO SUBMIT TWO ADDITIONAL NDAS IN 2019.  Full Article

Veru Inc - On Jan 4, 2018, Daniel Haines, CFO, Informed Co That He Was Resigning ‍​
Thursday, 11 Jan 2018 

Jan 10 (Reuters) - Veru Inc ::VERU INC - ON JAN 4, 2018, DANIEL HAINES, CFO, INFORMED CO THAT HE WAS RESIGNING ‍​.VERU SAYS ‍HAINES' DUTIES AS CFO WERE ASSIGNED EFFECTIVE JAN 4, 2018 TO MICHELE GRECO​ - SEC FILING.  Full Article

Veru reports Q4 Loss Per Share $0.10
Tuesday, 2 Jan 2018 

Jan 2 (Reuters) - Veru Inc ::VERU REPORTS FISCAL 2017 FOURTH-QUARTER, FULL-YEAR FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.10.Q4 REVENUE $3.7 MILLION VERSUS $3.6 MILLION.  Full Article

Veru Acquires Novel Proprietary Formulation For Overactive Bladder
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Veru Inc ::VERU ACQUIRES NOVEL PROPRIETARY FORMULATION FOR OVERACTIVE BLADDER.VERU PLANS TO BEGIN SOLIFENACIN DRG BIOEQUIVALENCE STUDY IN 2018 AND TO FILE NDA IN 2019.‍UNDER TERMS OF AGREEMENT WITH CAMARGO, VERU PAID AN UNDISCLOSED UPFRONT FEE TO ACQUIRE ASSET​.UNDER TERMS, VERU TO PAY UNDISCLOSED MILESTONE FEES UPON SUCCESSFUL CLINICAL DEVELOPMENT, LOW SINGLE DIGIT ROYALTY UPON COMMERCIAL SALES​.FDA ‍CONFIRMED IN A MEETING WITH CO THAT REGULATORY APPROVAL FOR SOLIFENACIN DRG WILL REQUIRE A SINGLE BIOEQUIVALENCE STUDY​.  Full Article