FC2

Veru Reports Fiscal 2024 First Quarter Financial Highlights

Retrieved on: 
Thursday, February 8, 2024
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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  • An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months.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.

Global Sexual Wellness Market Outlook 2023-2028 - Opportunities in the Rising Shift Toward Female Condoms - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 2, 2023
Other Retail, AIDS, Other Health, Health, Specialty, Women, Marketing, Communications, Men, Retail, Consumer, Diamond, Male, Female, AliExpress, Pharmacy, Perception, Adam and Eve, Woman, EBay, Reckitt, Supermarket, Government, Condom, Norm (mathematics), FC2, Growth, OEM, FDA, Ali Baba, Social media, Generic drug, Birth control, Online shopping, Toy, Amazon

The sexual wellness market has long remained male-dominated and required a glance by the vendors to refocus their growth strategies.

Key Points: 
  • The sexual wellness market has long remained male-dominated and required a glance by the vendors to refocus their growth strategies.
  • The global sexual wellness market is witnessing significant growth in focus on women customers.
  • One of the key growth drivers for the global sexual wellness market is persistently evolving gender-neutral products for a wide array of customers.
  • The global sexual wellness market is categorized into the male and female segments based on the diverse needs of both genders.

Dr. Kate Balestrieri Shares the Ultimate Summer Sexual Health Toolkit

Retrieved on: 
Monday, July 31, 2023
Other Consumer, Women, Generation Z, Other Health, Retail, Teens, Parenting, Men, Consumer, LGBTQ+, Other Communications, Alternative Medicine, Millennials, Other Retail, Health, Communications, Specialty, Lifestyle, Pregnancy, HIV, STI, Infection, Condom, Gonorrhea, IHeartRadio, Lubricant, Friction, Medicare Physician Group Practice Demonstration, FC2, Pleasure, Apple, Chlamydia, Hand, Mental health, Internal, Skin, Female, Birth control, Spotify

As the summer heat sizzles, renowned licensed psychologist, certified sex therapist and founder of the group practice, Modern Intimacy , Dr. Kate Balestrieri, is making waves by introducing her “Summer Sexual Health Toolkit”—a must-have collection of product recommendations to have a safe, pleasurable and sexy season.

Key Points: 
  • As the summer heat sizzles, renowned licensed psychologist, certified sex therapist and founder of the group practice, Modern Intimacy , Dr. Kate Balestrieri, is making waves by introducing her “Summer Sexual Health Toolkit”—a must-have collection of product recommendations to have a safe, pleasurable and sexy season.
  • With a focus on promoting responsible choices and sexual well-being, Dr. Balestrieri encourages individuals to pack their personal Summer Sexual Health Toolkit, just like they pack their toiletries and beauty essentials.
  • “Sexual health should be a priority wherever you go, just like keeping your skin safe with sunscreen for on-the-go protection,” says Dr. Balestrieri.
  • “Remember to consult with a healthcare provider for any concerns related to your sexual health that may be influenced by seasonal or environmental changes, as well as changes to your routine,” adds Dr. Balestrieri.

Veru Reports Fiscal 2023 Second Quarter Financial Results

Retrieved on: 
Thursday, May 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 Sells ENTADFI® Business for $20 Million Plus up to an Additional $80 Million from Sales Milestones

Retrieved on: 
Thursday, April 20, 2023
SARS-CoV-2, BPH, Bluewater, Sale, Tadalafil, Finasteride, FC2, Pharmaceutical industry

MIAMI, FL, April 20, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases, today announced the sale of its ENTADFI® (finasteride and tadalafil) capsules business for benign prostatic hyperplasia (BPH) to Blue Water Vaccines, Inc. (NASDAQ: BWV) for $20 million and up to an additional $80 million from sales milestones.

Key Points: 
  • MIAMI, FL, April 20, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases, today announced the sale of its ENTADFI® (finasteride and tadalafil) capsules business for benign prostatic hyperplasia (BPH) to Blue Water Vaccines, Inc. (NASDAQ: BWV) for $20 million and up to an additional $80 million from sales milestones.
  • Under the terms of the agreement, Veru received $6 million at closing and Blue Water is obligated to pay the Company an additional $4 million in the Company’s fiscal year 2023, and an additional $10 million in installments in the Company’s fiscal year 2024.
  • In addition, Veru could receive up to an additional $80 million if certain ENTADFI sales milestones are achieved.
  • “The sale of ENTADFI and revenues from our FC2 business provide Veru with financial flexibility and resources to advance our important drug candidates, enobosarm for 2nd line AR+ ER+ HER2- metastatic breast cancer and sabizabulin for SARS-CoV-2 viral ARDS, that could yield Phase 3 clinical trial data in 2024,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc.

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

Retrieved on: 
Thursday, August 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.

European Medicines Agency’s Emergency Task Force Has Initiated the Review of Veru's Sabizabulin Treatment for Hospitalized COVID-19 Patients for Emergency Use in European Union Countries

Retrieved on: 
Wednesday, July 27, 2022
Form 10-Q, Flash, CDK, Zuclomifene, European Medicines Agency, Safety, Review, Company, Security (finance), Infection, Emergency Task Force (Toronto Police Service), Death, Public sector, MHRA, U.S. Securities and Exchange Commission, EMA, Finasteride, COVID, Breast, AR, GLOBE, Capsule, Insurance, Female, Medicine, Telehealth, Government, Fast Track, COVID-19, Pregnancy, Eli Lilly and Company, FDA, ETF, Man, Vaccine, Tadalafil, Trial of the century, NEJM, Forward-looking statement, Acute respiratory distress syndrome, FC2, Prostate cancer, Private Securities Litigation Reform Act, Collection, Management of prostate cancer, Risk, The New England Journal of Medicine, NASDAQ, Lilly, CHMP, Gonadotropin-releasing hormone, Patient, Efficiency, WHO, Pharmaceutical industry, Birth control, Medical imaging, EU

The results of this study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo (a dummy treatment).

Key Points: 
  • The results of this study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo (a dummy treatment).
  • .The review will assist EU Member States who may consider allowing use of the medicine before a possible authorisation.
  • The ETF will conduct this review and send recommendations to the Agencys human medicines committee (CHMP), which will issue the Agencys opinion.
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the EU.

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Supports Expedited Review of Marketing Authorization Application for Sabizabulin Treatment in Hospitalized COVID-19 Patients

Retrieved on: 
Monday, July 25, 2022
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We are pleased that the MHRA has agreed to support the expedited review of our sabizabulin UK marketing authorization submission.

Key Points: 
  • We are pleased that the MHRA has agreed to support the expedited review of our sabizabulin UK marketing authorization submission.
  • Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with current standard of care.
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the UK and elsewhere.
  • The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

Veru Reports Second Quarter Fiscal 2022 Results and Progress of Sabizabulin for COVID-19 Toward a Request for Emergency Use Authorization

Retrieved on: 
Thursday, May 12, 2022
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-- Company to Host Investor Conference Call Today at 8 AM ET--

Key Points: 
  • FDA agreed that our development program had sufficient efficacy and safety data to support a request for EUA application.
  • The Agency has been incredibly responsive, and we look forward to submitting a request for Emergency Use Authorization application as soon as possible.
  • Dr. Steiner added: We continue to make great progress on our clinical programs for breast and prostate cancer.
  • We now have 2 enrolling Phase 3 metastatic breast cancer clinical trials and one Phase 3 prostate cancer clinical trial.

SWK Holdings Provides Portfolio Update Highlighting Recent Achievements

Retrieved on: 
Wednesday, February 9, 2022
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DALLAS, Feb. 9, 2022 /PRNewswire/ -- SWK Holdings Corporation (Nasdaq: SWKH) ("SWK" or the "Company"), a life science focused specialty finance company catering to small- and mid-sized commercial-stage companies, today provided an update on the progress and achievements of its portfolio and partner companies during the second half of 2021 and recent weeks.

Key Points: 
  • DALLAS, Feb. 9, 2022 /PRNewswire/ -- SWK Holdings Corporation (Nasdaq: SWKH) ("SWK" or the "Company"), a life science focused specialty finance company catering to small- and mid-sized commercial-stage companies, today provided an update on the progress and achievements of its portfolio and partner companies during the second half of 2021 and recent weeks.
  • The recent financings to MolecuLight and Biotricity demonstrate SWK remains a partner of choice for emerging life science companies.
  • December 2021, Enteris received a $5.0 million payment, of which Enteris was entitled to keep $3.0 million pursuant to the terms of SWK Holdings' acquisition of Enteris.
  • InJune 2019, 4Web entered a$20.0 millionstructured credit agreement with SWK Holdings which was amended in May 2021 with SWK advancing an additional $2.25 million to support the company's ongoing growth.