NAMS

NewAmsterdam Pharma Announces Appointment of William “BJ” Jones, formerly of Biohaven Pharmaceuticals, as Chief Commercial Officer

Retrieved on: 
Monday, August 14, 2023
Industrial engineering, Dyslipidemia, Marketing, Texas A&M University, Cardiovascular disease, Business, NAMS, Apolipoprotein, Bristol Myers Squibb, CCO, AstraZeneca, Boehringer Ingelheim, Migraine, Patient, CETP, M.B.A, Stanford Graduate School of Business, Pfizer, Takeda Pharmaceutical Company, Common, Pharmaceutical industry, Nitrome

Mr. Jones brings 30 years of commercial and launch experience in the U.S. and globally, with particular experience in driving mass market product launch strategies for industry-leading brands.

Key Points: 
  • Mr. Jones brings 30 years of commercial and launch experience in the U.S. and globally, with particular experience in driving mass market product launch strategies for industry-leading brands.
  • At NewAmsterdam, he will build and lead all commercial functions, including marketing, market access, sales, medical science engagement and commercial operations.
  • Most recently, he served as CCO, Migraine & Common Diseases at Biohaven Pharmaceuticals, which was acquired by Pfizer for $11.6B.
  • During his tenure, Mr. Jones led the commercial enterprise that launched Biohaven’s Nurtec® ODT.

NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 BROADWAY Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia and/or Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Tuesday, July 25, 2023
Food, Dyslipidemia, Myocardial infarction, Triglyceride, Cardiovascular disease, NAMS, Apolipoprotein, Patient, CETP, Physician, Risk, LDL, Cerebral infarction, ASCVD, Moyamoya disease, Safety, FESC, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 BROADWAY clinical trial evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or established atherosclerotic cardiovascular disease (“ASCVD”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally. NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.

Key Points: 
  • The target enrollment of 2,400 subjects was exceeded due to strong interest from patients and physicians globally.
  • NewAmsterdam expects over 2,500 patients to be randomized following the completion of ongoing patient screening and remains on track to report topline data in the second half of 2024.
  • The mean baseline LDL-C for enrolled patients is approximately 100 mg/dL despite high intensity statin use reported by greater than 60% of patients during screening.
  • “It has become increasingly clear that lower levels of LDL-C are directly correlated with a reduced risk for major adverse cardiovascular events.

Daré Bioscience Announces Additional Positive Data from Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women

Retrieved on: 
Tuesday, July 11, 2023
Cream, Desire, KOL, SST, Obstetrics, North American Menopause Society, Orgasm, International Society of Sculptors, Painters and Gravers, Diagnosis, FSAD, OBGYN, DSM-IV, NAMS, Woman, FACOG, Doctor of Philosophy, EDT, Trial of the century, NCMP, University Hospitals Cleveland Medical Center, Arousal, Medical director, Diagnostic and Statistical Manual of Mental Disorders, SAN, CCD, Gynaecology, Behavioral medicine, Erectile dysfunction, FDA, ITT, George Washington University, Female, Medical device, Management, Pharmaceutical industry

SAN DIEGO, July 11, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced additional positive data from the exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% (Sildenafil Cream) as a treatment for female sexual arousal disorder (FSAD). Additional data reported today support continued clinical development of Sildenafil Cream to evaluate its potential to treat FSAD and/or female sexual interest/arousal disorder (FSIAD). Specifically, an exploratory endpoint regarding sexual desire demonstrated a statistically significant improvement from baseline to the 8-week mark after randomization in women in the intent to treat (ITT) population who used Sildenafil Cream compared to placebo, at P value = 0.022. The improvement in sexual desire at the 8-week mark compared to baseline in the Sildenafil Cream ITT group persisted through 12 weeks post-randomization (end of study).

Key Points: 
  • Additional data reported today support continued clinical development of Sildenafil Cream to evaluate its potential to treat FSAD and/or female sexual interest/arousal disorder (FSIAD).
  • The improvement in sexual desire at the 8-week mark compared to baseline in the Sildenafil Cream ITT group persisted through 12 weeks post-randomization (end of study).
  • “In this study, improvement was seen in arousal and orgasm, as well as sexual desire.
  • Daré will host a virtual Key Opinion Leader (KOL) webinar on Tuesday, July 11, 2023, at 4:30 p.m. EDT to review data from the exploratory Phase 2b RESPOND clinical study.

Daré Bioscience Announces Upcoming Webinar to Review Additional Data from Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

Retrieved on: 
Thursday, July 6, 2023
Cream, KOL, Obstetrics, North American Menopause Society, International Society of Sculptors, Painters and Gravers, OBGYN, FSAD, Woman, NAMS, FACOG, Doctor of Philosophy, EDT, Trial of the century, University Hospitals Cleveland Medical Center, NCMP, Medical director, CCD, Gynaecology, Behavioral medicine, Diagnosis, George Washington University, Female, Pharmaceutical industry

SAN DIEGO, July 06, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it will host a virtual Key Opinion Leader (KOL) webinar on Tuesday, July 11, 2023, at 4:30 p.m. EDT to review additional data from its exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in women with female sexual arousal disorder (FSAD). In addition to the data presentation, the webinar will include discussions on the diagnosis and treatment of FSAD, the unmet medical need among women and the market opportunity for a pharmacologic treatment for FSAD. Daré and its collaborator, Strategic Science & Technologies, LLC, a Cambridge, MA based novel topical drug delivery company, previously announced positive topline data from the study.

Key Points: 
  • In addition to the data presentation, the webinar will include discussions on the diagnosis and treatment of FSAD, the unmet medical need among women and the market opportunity for a pharmacologic treatment for FSAD.
  • Daré and its collaborator, Strategic Science & Technologies, LLC, a Cambridge, MA based novel topical drug delivery company, previously announced positive topline data from the study.
  • A link to access the live webinar will be available under “Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com .
  • Following the conclusion of the live event, a replay will be available under “Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com until September 1, 2023.

Sermonix Pharmaceuticals to Present Two Posters at The Menopause Society 2023 Annual Meeting

Retrieved on: 
Thursday, June 29, 2023
North American Menopause Society, Era, Therapy, ESR1, Life, Fulvestrant, Woman, NAMS, Trustee, Patient, Medicine, Annual general meeting, Menopause, Safety, Birth control, Lasofoxifene, COLUMBUS

We look forward to engaging with our peers at The Menopause Society 2023 Annual Meeting and sharing our most recent findings.”

Key Points: 
  • We look forward to engaging with our peers at The Menopause Society 2023 Annual Meeting and sharing our most recent findings.”
    Sermonix will share its two posters Thursday, Sept. 28, from 6:15-7:15 p.m.
  • “The theme of this year’s meeting is ‘Midlife Women’s Health in the Era of Precision Medicine,’” said Dr. Lisa Larkin, president-elect of The Menopause Society board of trustees.
  • We look forward to Sermonix’s participation in The Menopause Society Annual Meeting and as a member of our 2023 Corporate Liaison Council.”
    Sermonix in March initiated ELAINE-3, a registrational Phase 3 study of 400 patients assessing the efficacy of lasofoxifene and abemaciclib.
  • To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com .

NewAmsterdam Pharma Announces Closing of Upsized Secondary Offering of Ordinary Shares

Retrieved on: 
Friday, June 9, 2023
Exercise, William Blair & Company, Telephone, Common stock, Cardiovascular disease, Jefferies, NAMS, L.L.C, EDGAR, Sale, Prospectus, Jefferies Group, State Street, Patient, SVB, ATTN:, Offering, Form, Madison Avenue, SEC filing, Van Lanschot Kempen, SVB Securities, Security (finance), Financial adviser

The Company did not receive any proceeds from the Offering.

Key Points: 
  • The Company did not receive any proceeds from the Offering.
  • Jefferies and SVB Securities acted as joint book-running managers for the Offering.
  • 1 to the Form F-1, declared effective by the SEC on April 24, 2023.
  • Cantor Fitzgerald & Co. and Van Lanschot Kempen N.V. acted as financial advisers to the Company.

NewAmsterdam Pharma Announces Pricing of Upsized Secondary Offering of Ordinary Shares

Retrieved on: 
Wednesday, June 7, 2023
Telephone, Cardiovascular disease, Jefferies, NAMS, EDGAR, Sale, Prospectus, Jefferies Group, State Street, Patient, SVB, ATTN:, Offering, Form, Madison Avenue, SEC filing, SVB Securities, Security (finance)

In connection with the Offering, certain of the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 2,078,612 Ordinary Shares at the public offering price, less the underwriting discount.

Key Points: 
  • In connection with the Offering, certain of the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 2,078,612 Ordinary Shares at the public offering price, less the underwriting discount.
  • The Offering is expected to close on or about June 9, 2023, subject to customary closing conditions.
  • The Company will not receive any proceeds from the Offering.
  • Jefferies and SVB Securities are acting as joint book-running managers for the Offering.

NewAmsterdam Pharma Announces Commencement of Secondary Offering of Ordinary Shares

Retrieved on: 
Tuesday, June 6, 2023
F-1, Telephone, Cardiovascular disease, Jefferies, NAMS, Sale, Prospectus, Jefferies Group, State Street, Patient, SVB, ATTN:, Form, Madison Avenue, SVB Securities, Property management, Security (finance)

The Company will not receive any proceeds from the proposed Offering.

Key Points: 
  • The Company will not receive any proceeds from the proposed Offering.
  • Jefferies and SVB Securities are acting as joint book-running managers for the proposed Offering.
  • The Ordinary Shares are being offered pursuant to a registration statement on Form F-1, including a base prospectus, that was initially declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on January 30, 2023, as amended by the Post-Effective Amendment No.
  • 1 to the F-1, declared effective by the SEC on April 24, 2023.

NewAmsterdam Pharma Announces Positive Topline Results from Phase 2b Dose-Finding Trial Evaluating Obicetrapib in Japanese Patients

Retrieved on: 
Monday, June 5, 2023
Dyslipidemia, Public, Cardiovascular disease, National Lipid Association, NAMS, Apolipoprotein, Osaka Medical and Pharmaceutical University, Ongo, Patient, China Pharmaceutical University, Moyamoya disease, Conference, Safety, Pharmaceutical industry

-- Management to Host Conference Call Today at 8:00 a.m. E.T. --

Key Points: 
  • Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan.
  • The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients.
  • NewAmsterdam anticipates sharing full data from this Phase 2b clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.
  • ET to review these data, as well as the full data from the Phase 2 ROSE2 clinical trial, which were presented on Saturday.

NewAmsterdam Pharma Presents Full Data from Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy at NLA Scientific Sessions 2023

Retrieved on: 
Saturday, June 3, 2023
Consensus, Journal of Clinical Lipidology, Therapy, Cardiovascular Research, Ezetimibe, Cardiovascular disease, Clinical trial, National Lipid Association, Baylor University, NAMS, Apolipoprotein, Low-density lipoprotein, Journal, Patient, Risk, LDL, Baylor College of Medicine, Apolipoprotein B, Hand, Conference, Pharmaceutical industry

ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed.

Key Points: 
  • ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed.
  • In addition, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo.
  • “The data presented today are highly encouraging, showing that the combination of obicetrapib and ezetimibe delivers robust impacts on multiple atherogenic lipid parameters.
  • The table below shows the median percent change from baseline in patients receiving the combination of obicetrapib and ezetimibe, obicetrapib monotherapy and placebo.