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Veru Inc (VERU.OQ)

VERU.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

Veru Says Veru-111 Reduced Key Cytokines Involved In Acute Respiratory Distress Syndrome In COVID-19 In Toxic Shock Model
Tuesday, 4 Aug 2020 

Aug 4 (Reuters) - Veru Inc ::VERU-111 SUPPRESSES KEY CYTOKINES RESPONSIBLE FOR SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME IN COVID-19.VERU INC - VERU-111 SIGNIFICANTLY REDUCED KEY CYTOKINES INVOLVED IN ACUTE RESPIRATORY DISTRESS SYNDROME IN COVID-19 IN A TOXIC SHOCK MODEL.VERU INC - PHASE 2 CLINICAL STUDY IN HOSPITALIZED COVID-19 PATIENTS AT HIGH RISK FOR ACUTE RESPIRATORY DISTRESS SYNDROME ACTIVELY ENROLLING PATIENTS.VERU INC - VERU-111'S ABILITY TO DISRUPT MICROTUBULES HAS POTENTIAL FOR DUAL DRUG ACTION AGAINST COVID-19.  Full Article

Veru Posts Q2 Loss Per Share Of $0.01
Wednesday, 13 May 2020 

May 13 (Reuters) - Veru Inc ::VERU REPORTS STRONG FISCAL 2020 SECOND QUARTER RESULTS AS NET REVENUES INCREASE 43%, GROSS PROFIT UP 61%.Q2 LOSS PER SHARE $0.01.Q2 EARNINGS PER SHARE ESTIMATE $-0.04 -- REFINITIV IBES DATA.Q2 REVENUE $9.9 MILLION VERSUS REFINITIV IBES ESTIMATE OF $11 MILLION.  Full Article

Veru Secures FDA Agreement To Initiate Phase 2 Study Of VERU-111 To Combat COVID-19
Tuesday, 12 May 2020 

May 12 (Reuters) - Veru Inc ::VERU SECURES FDA AGREEMENT TO INITIATE PHASE 2 STUDY OF VERU-111, NOVEL MICROTUBULE DEPOLYMERIZATION DRUG TO COMBAT COVID-19.VERU - PHASE 2 CLINICAL STUDY EXPECTED TO COMMENCE IN HOSPITALIZED COVID-19 PATIENTS AT HIGH RISK FOR ACUTE RESPIRATORY DISTRESS SYNDROME IN 2 WEEKS.VERU INC - RECEIVED FDA PERMISSION TO INITIATE A PHASE 2 CLINICAL TRIAL TO ASSESS EFFICACY OF VERU-111.VERU INC - STUDY IS EXPECTED TO COMMENCE IN NEXT 2 WEEKS..  Full Article

Veru Reports Positive Clinical Results From Trial In Men With Metastatic Castration-Resistant Prostate Cancer
Tuesday, 5 May 2020 

May 5 (Reuters) - Veru Inc ::VERU REPORTS POSITIVE CLINICAL RESULTS FROM VERU-111 PHASE 1B/2 TRIAL IN MEN WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, ADVANCING TO PIVOTAL PHASE 3 CLINICAL PROGRAM.VERU INC - VERU-111 SAFE AND WELL TOLERATED AT DAILY DOSES 63 MG AND LOWER; NO SIGNIFICANT NEUTROPENIA OR NEUROTOXICITY OBSERVED.VERU INC - IN 8 MEN TREATED WITH AT LEAST 4 21-DAY CONTINUOUS CYCLES, MEDIAN DURATION OF TUMOR RESPONSE WITHOUT CANCER PROGRESSION IS 10 MONTHS.VERU INC - 7 OF 8 MEN TREATED WITH AT LEAST FOUR 21-DAY CONTINUOUS CYCLES STILL RECEIVING VERU-111 TREATMENT WITHOUT EVIDENCE OF CANCER PROGRESSION.VERU INC - PLANS TO MEET WITH FDA NEXT QUARTER TO GAIN AGREEMENT ON REGISTRATION PHASE 3 CLINICAL TRIAL DESIGN FOR VERU-111 IN THIS INDICATION.  Full Article

Veru Q1 Loss Per Share $0.05
Wednesday, 12 Feb 2020 

Veru Inc ::VERU CONTINUES STRONG POSITIVE SALES MOMENTUM IN FISCAL 2020 FIRST QUARTER; NET REVENUES INCREASE 66%, GROSS PROFIT UP 57%.Q1 LOSS PER SHARE $0.05.Q1 EARNINGS PER SHARE ESTIMATE $-0.02 -- REFINITIV IBES DATA.Q1 REVENUE $10.6 MILLION VERSUS REFINITIV IBES ESTIMATE OF $8.8 MILLION.COMPLETION OF VERU-111 PHASE 1B CLINICAL TRIAL AND INITIATION OF PHASE 2 PROSTATE CANCER CLINICAL TRIAL IN Q2 FY 2020.COMPANY WILL SUBMIT AN NDA FOR TADFIN WHICH IS EXPECTED IN SECOND HALF OF 2020.VERU SEES ZUCLOMIPHENE ENTERING PIVOTAL PHASE 3 CLINICAL TRIAL FOR TREATING HOT FLASHES IN MEN WITH PROSTATE CANCER ON ADT AFTER MEETING WITH FDA.  Full Article

Veru Announces Positive Top-Line Interim Data From Phase 2 Clinical Trial Of Zuclomiphene
Monday, 13 Jan 2020 

Jan 13 (Reuters) - Veru Inc ::VERU ANNOUNCES POSITIVE TOP-LINE INTERIM DATA FROM PHASE 2 CLINICAL TRIAL OF ZUCLOMIPHENE TO TREAT HOT FLASHES IN MEN WITH PROSTATE CANCER ON ANDROGEN DEPRIVATION THERAPY.VERU INC - PLANS TO ADVANCE ZUCLOMIPHENE INTO PIVOTAL PHASE 3 CLINICAL TRIAL IN FIRST HALF OF 2020.VERU - TOPLINE INTERIM RESULTS DEMONSTRATE STATISTICALLY SIGNIFICANT FALL IN MODERATE TO SEVERE HOT FLASHES FROM BASELINE WAS OBSERVED IN 50MG GROUP.VERU INC - 10MG TREATMENT GROUP, AS EXPECTED, DID NOT SHOW A STATISTICALLY SIGNIFICANT REDUCTION IN HOT FLASHES FROM BASELINE.VERU INC - ZUCLOMIPHENE APPEARS TO BE WELL TOLERATED.VERU - THERE HAVE BEEN NO REPORTS OF DRUG RELATED SERIOUS ADVERSE EVENTS NOR DRUG RELATED SEVERE ADVERSE EVENTS FROM ZUCLOMIPHENE.  Full Article

Veru Reports Q4 Loss Per Share $0.05
Thursday, 12 Dec 2019 

Dec 12 (Reuters) - Veru Inc ::VERU REPORTS FISCAL 2019 FULL-YEAR NET REVENUES DOUBLED, GROSS PROFIT UP 147%.Q4 LOSS PER SHARE $0.05.Q4 REVENUE $8.7 MILLION VERSUS REFINITIV IBES ESTIMATE OF $9.2 MILLION.Q4 EARNINGS PER SHARE ESTIMATE $-0.05 -- REFINITIV IBES DATA.ADVANCING VERU-111 INTO THREE PHASE 2 CLINICAL STUDIES IN ADDITIONAL CANCER TYPES.VERU-111 APPEARS TO BE WELL TOLERATED WITH A WIDE SAFETY MARGIN.VERU-111 HAS SIGNS OF ANTITUMOR ACTIVITY AND AN ACCEPTABLE SAFETY PROFILE.VERU-111 HAS PROMISING SIGNS OF PROGRESSION FREE SURVIVAL.PLAN TO SUBMIT IND APPLICATION FOR VERU-100 IN EARLY 2020.COMPANY BELIEVES THAT IT HAS SUFFICIENT RESOURCES TO EXECUTE CLINICAL DRUG TRIAL PROGRAMS THROUGH YEAR END 2021.  Full Article

Veru Q3 Loss Per Share $0.04
Thursday, 8 Aug 2019 

Aug 8 (Reuters) - Veru Inc ::VERU REPORTS HIGHER NET REVENUES AND GROSS PROFIT FOR ITS FISCAL 2019 THIRD QUARTER.Q3 LOSS PER SHARE $0.04.Q3 REVENUE $9.7 MILLION VERSUS REFINITIV IBES ESTIMATE OF $8.1 MILLION.SEES FY 2019 REVENUE $29 MILLION TO $32 MILLION.Q3 EARNINGS PER SHARE ESTIMATE $-0.04 -- REFINITIV IBES DATA.REITERATED ITS FISCAL 2019 FULL YEAR GUIDANCE OF NET REVENUES AND GROSS MARGIN.FY2019 REVENUE VIEW $30.4 MILLION -- REFINITIV IBES DATA.  Full Article

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

BRIEF-Veru Inc Files For Up To $150 Million Of Mixed Shelf Offering

* VERU INC FILES FOR UP TO $150 MILLION OF MIXED SHELF OFFERING - SEC FILING Source text for Eikon: (https://bit.ly/38722qB) Further company coverage: