Enobosarm

Veru Announces the Appointment of Louis Aronne MD as Chief Medical Advisor for its Enobosarm Program for High Quality Weight Loss

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화요일, 3월 12, 2024
Research, Internal medicine, Overweight, Weill Cornell Medicine, The Obesity Society, Facial muscles, Obesity, Weight loss, SARM, Enobosarm, Education, Flyte, Metabolism, Patient, Weight, Pfizer, Obesity medicine, Davidoff, MD, Weill Cornell Medical Center, Jacobi Medical Center, Eli Lilly and Company, Bangladesh Technical Education Board, MOVE, Boehringer Ingelheim, Directory, Pharmaceutical industry

He is founder and Chief Scientific Advisor of Intellihealth a cloud-based weight management system which delivers obesity treatment online as flyte.

Key Points: 
  • He is founder and Chief Scientific Advisor of Intellihealth a cloud-based weight management system which delivers obesity treatment online as flyte.
  • Weight loss through any modality produces muscle loss, and there is an unmet need to minimize that in certain groups of patients in order to produce better quality weight loss.
  • In conjunction with a GLP-1 drug, enobosarm has the potential to deliver better quality weight loss while utilizing lower doses of the GLP-1 drug.
  • We are fortunate that Dr. Aronne and the other senior expert members of our Scientific Advisory Board will help guide the enobosarm development program.”

Veru Reports Fiscal 2024 First Quarter Financial Highlights

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목요일, 2월 8, 2024
Internet, Weight, COVID-19, Androgen, Weight loss, Mortality, Calendar, Investigational New Drug, Overweight, Trial of the century, Telehealth, Obesity, Telephone, Clinical trial, Government, Therapy, Patient, IND, Safety, Condom, Facial muscles, FDA, LaTeX, Pharmacy, FC2, Enobosarm, Pregnancy, Muscle weakness, Frailty, Female, Drug discovery, U.N, Death, Health, SARM, Cancer, NDA, Woman, Dietary supplement

MIAMI, FL, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for potentially higher quality weight loss, oncology, and viral induced acute respiratory distress syndrome (ARDS), today announced financial highlights for its fiscal 2024 first quarter and provided a business update.

Key Points: 
  • The clinical study is expected to begin in April 2024 with the topline clinical results from the trial expected in the end of the fourth calendar quarter of 2024.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.
  • An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months.
  • A telephonic replay will be available on February 8, 2024 at approximately 12:00 p.m.

Veru to Host Investor Call on January 4th, 2024 to Discuss Recent Financing and Strategy to Prioritize the Development of Enobosarm as a Combination Treatment to Prevent Muscle Loss and Augment Fat Loss Associated with Weight Loss GLP-1 Drugs

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화요일, 12월 19, 2023
Telephone, Overweight, Woman, Weight, Enobosarm, Weight loss, Muscle weakness, MD, Facial muscles, Clinical trial, Atrophy, Obesity, Patient

ET to discuss the recent financing and the Company’s strategy to prioritize the development of enobosarm for weight loss as well as provide an update on the Company’s drug pipeline.

Key Points: 
  • ET to discuss the recent financing and the Company’s strategy to prioritize the development of enobosarm for weight loss as well as provide an update on the Company’s drug pipeline.
  • “Veru is a late clinical stage biopharmaceutical company focusing on developing novel medicines for the treatment of obesity and oncology.
  • We have made a major change on the clinical development of enobosarm, our novel small molecule, first-in-class oral selective androgen receptor modulator.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

Veru Announces Pricing of Public Offering of Common Stock

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목요일, 12월 14, 2023
Telephone, Syndicate, Overweight, Sale, Drug development, Broad Street, Weight, Form, Enobosarm, Attention, Muscle weakness, Form S-3, DSM-IV codes, Facial muscles, Prospectus, Patient, Safety, Security (finance)

MIAMI, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today the pricing of an underwritten public offering of 45,833,333 shares of its common stock at a price to the public of $0.72 per share.

Key Points: 
  • MIAMI, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today the pricing of an underwritten public offering of 45,833,333 shares of its common stock at a price to the public of $0.72 per share.
  • The aggregate gross proceeds to Veru from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $33 million.
  • In addition, Veru has granted the underwriters a 30-day option to purchase up to an additional 6,874,999 shares of common stock at the public offering price, less underwriting discounts and commissions.
  • All of the securities being sold in the offering are being offered by Veru.

Veru Announces Proposed Public Offering of Common Stock

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수요일, 12월 13, 2023
Telephone, Syndicate, Overweight, Sale, Drug development, Broad Street, Weight, Form, Enobosarm, Attention, Muscle weakness, Form S-3, DSM-IV codes, Facial muscles, Prospectus, Patient, Safety, Security (finance)

MIAMI, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today that it has commenced an underwritten public offering of shares of its common stock.

Key Points: 
  • MIAMI, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology and viral-induced acute respiratory distress syndrome, announced today that it has commenced an underwritten public offering of shares of its common stock.
  • All shares of common stock to be sold in the offering will be offered by Veru.
  • In addition, Veru intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Veru Reports Muscle Data from 5 Clinical Studies of Enobosarm that Support the Advancement of Enobosarm in Combination with Weight-Loss GLP-1 Drugs, Ozempic®, Wegovy®, or Mounjaro®, to Optimize Weight Loss by Preventing Muscle Wasting and Further Increasi

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수요일, 10월 4, 2023
Well, Exercise, Insulin resistance, Human, Obesity, Journal of Cachexia, Sarcopenia and Muscle, SCP, Osteoporosis, Enobosarm, Diabetes, Metabolism, Adapted automobile, Bone, Facial muscles, E pluribus unum, Weight loss, Clinical trial, Cancer, Ageing, Woman, Sarcopenic obesity, Falls, BMD, Trial of the century, Muscle weakness, Strength, Villarreal, Appendix, Bloomberg, Patient, Division, Risk, Overweight, Baylor College of Medicine, Type, Mortality, DEXA, Atrophy, Dietary supplement, Soft drink, Endocrinology

MIAMI, FL, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, breast cancer and for viral induced ARDS, today announced that the Company will advance its proprietary novel agent, enobosarm, a selective androgen receptor modulator (SARM), into a Phase 2b clinical trial in combination with weight-loss GLP-1 drugs, Ozempic (semaglutide), Wegovy (semaglutide), or Mounjaro (tirzepatide) to evaluate the efficacy and the safety of enobosarm to further increase fat loss while preventing the significant muscle wasting that occurs with weight-loss GLP-1 drugs.

Key Points: 
  • Specifically, enobosarm therapy could augment the preferential loss of fat mass while preventing the loss of critical muscle mass and bone mineral density.
  • Enobosarm treatment could also preserve or improve muscle strength and physical function in older adults being treated with a weight loss drug.
  • The primary endpoint of the study will be change in total lean body mass (muscle) from baseline to 4 months.
  • Key secondary endpoints will be change from baseline to 4 months in total fat mass, insulin resistance (HOMA-IR), and body weight.

Veru Reports Clinical Data from the Discontinued ARTEST Study of Enobosarm, Novel Selective Androgen Receptor Targeting Agonist, in AR+ ER+ HER2- Metastatic Breast Cancer

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월요일, 9월 11, 2023
CDK, Clutch (eggs), Quality of life, Androgen, Enobosarm, Patient, Hematocrit, Pharmaceutical industry, Safety

MIAMI, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced clinical data from the discontinued Phase 3 ARTEST clinical trial of enobosarm monotherapy for the 3rd line or greater in the metastatic setting of AR+ER+HER2- breast cancer. Enrollment was discontinued in order to prioritize and focus the clinical development of enobosarm therapy earlier in the treatment sequence, the 2nd line metastatic setting, for AR+ER+HER2- metastatic breast cancer in the Phase 3 ENABLAR-2 (enobosarm +/- abemaciclib CDK 4/6 inhibitor) study. Data reported from the discontinued trial, which is based on an analysis of available data, may not be predictive of the results of larger, later-stage controlled clinical trials.

Key Points: 
  • “The clinical results from the ARTEST study provide promising scientific support and validation for the potential of enobosarm therapy in the ongoing Phase 3 ENABLAR-2 study.
  • The AR+ER+HER2- metastatic breast cancer patients enrolled in the Phase 3 ARTEST study were heavily pretreated.
  • On average, either enobosarm or the standard of care active control in ARTEST was given as 4th line treatment.
  • We are encouraged by these early results, and it appears to be the right decision to move and focus enobosarm’s clinical development earlier to the 2nd line metastatic setting for ER+HER2- metastatic breast cancer patients in the Phase 3 ENABLAR-2 study.”

Veru Reports Fiscal 2023 Second Quarter Financial Results

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목요일, 5월 11, 2023
Operating cost, Internet, Telephone, Oxygen, Survival, Incidence, Capsule, Patient, Finasteride, Eli Lilly and Company, GPO, SERD, Agreement, Telehealth, BPH, Drug discovery, Animal law, Enobosarm, Metastasis, Comorbidity, FC2, FDA, IND, Combination, Safety, EUA, High Risk, CDK, COVID-19, Metastatic breast cancer, AGS, Trust, Mortality, LPC, ORR, SARS-CoV-2, NDA, Quality of life, Pharmacy, Prostate, Sale, Trial of the century, Emergency Use Authorization, Tadalafil, Treatment, Breast cancer, Vaccine, Pharmaceutical industry, Birth control, Reinsurance, Cryptocurrency, Virus

ET

Key Points: 
  • ET
    MIAMI, FL, May 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced financial results for its fiscal 2023 second quarter and provided a business update.
  • On March 30, 2023, the Company met with the FDA to gain further regulatory clarity for the ongoing Phase 2b/3 clinical trial design and program.
  • Cash and cash equivalents were $23.5 million as of March 31, 2023 versus $80.2 million as of September 30, 2022.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

Veru Reports Fiscal 2023 First Quarter Financial Results

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목요일, 2월 9, 2023
Treatment, Telephone, Breast, Food and Drug Administration, Patient, Enobosarm, High Risk, COVID-19, EU, BPH, Medicines and Healthcare products Regulatory Agency, Pregnancy, Article 18 of the European Convention on Human Rights, Eli Lilly and Company, CDK, Prostate cancer, Tadalafil, Capsule, MFDS, Ministry of Education (Malaysia), Combination, Prostate, FDA, Health care, Death, Finasteride, TGA, WHO, EMA, Mortality, Gonadotropin-releasing hormone, MHRA, Pharmaceutical industry, Birth control, Medical imaging, Food

MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update.

Key Points: 
  • ET
    MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update.
  • We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.
  • A telephonic replay will be available on February 9, 2023 at approximately 12:00 p.m.

Veru Reports Third Quarter Fiscal 2022 Financial Results; Progresses Sabizabulin Treatment for COVID-19 Towards Regulatory Decisions in Key Territories

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목요일, 8월 11, 2022
FDA, Death, Woman, Fulvestrant, The New England Journal of Medicine, Everolimus, Risk, Emergency Use Authorization, Trial of the century, Article 18 of the European Convention on Human Rights, GLOBE, FC2, Breast, Standard of care, EUA, Clinical, High Risk, COVID, Sale, Infection, Medicines and Healthcare products Regulatory Agency, Medicine, CDK, Enobosarm, Government, Patient, Review, COVID-19, Company, Lilly, Breast cancer, European Medicines Agency, Expression, Safety, Metastatic breast cancer, Capsule, NASDAQ, U.S. FDA, Â, MHRA, SERM, WHO, Fast Track, Combination, AR, Pharmaceutical industry, Reinsurance, Cryptocurrency, Medical device, Birth control, Verus Pharmaceuticals

--Company Prepares for U.S. and Ex-U.S. Commercial Launches if Emergency Authorizations Are Granted--

Key Points: 
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19.
  • The Company has Completed a Positive Phase 3 COVID-19 Study in Hospitalized Moderate to Severe COVID-19 Patients at High Risk for ARDS.
  • On July 25, 2022, the UKs Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company that the sabizabulin marketing authorization application will receive expedited review.
  • On July 27, 2022, the European Medicines Agencys Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.