Pregnanes

Flexion Therapeutics Reports Second-Quarter 2021 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, August 4, 2021
Steroids, Chemical compounds, Chemistry, Flexion Therapeutics, Acetonides, Diketones, Glucocorticoids, Pregnanes, Triamcinolone acetonide

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) net sales were $28.2million in Q2 2021, reflecting growth of 15% over the previous quarter

Key Points: 
  • ZILRETTA (triamcinolone acetonide extended-release injectable suspension) net sales were $28.2million in Q2 2021, reflecting growth of 15% over the previous quarter
    Net loss in Q2 2021 decreased by $10.4million (32%), as compared to Q2 2020, during the height of the COVID-19 impact on ZILRETTA sales
    BURLINGTON, Mass., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended June30, 2021.
  • Net sales of ZILRETTA were $28.2million and $15.5million for the three months ended June30, 2021 and 2020, respectively.
  • Loss per share for the second quarter of 2021 was $0.44, compared to $0.76 for the same period of 2020.
  • Research and development expenses were $12.7million and $12.5million for the three months ended June30, 2021 and 2020, respectively.

Marinus Pharmaceuticals Announces Exclusive Collaboration with Orion Corporation for European Commercialization of Ganaxolone

Retrieved on: 
Tuesday, August 3, 2021
Biotechnology, Pharmaceutical, Health, Chemical compounds, Anticonvulsants, GABAA receptor positive allosteric modulators, Ketones, Pregnanes, Sterols, Spacecraft, Ganaxolone, Spaceflight, Seizure, Maa, Orion, Ganaxolone, Marinus Pharmaceuticals, Orion Corporation, GANAXOLONE, MARINUS PHARMACEUTICALS, ORION CORPORATION

This collaboration not only serves as an important step in our global development strategy for ganaxolone, it also represents the confidence Orion has in its potential.

Key Points: 
  • This collaboration not only serves as an important step in our global development strategy for ganaxolone, it also represents the confidence Orion has in its potential.
  • Satu Ahomki, Senior Vice President, Commercial Operations of Orion Corporation said, We are pleased to be the partner of choice for Marinus in Europe.
  • What we have seen so far with ganaxolone is encouraging and signifies an ongoing commitment to the rare epilepsy communities.
  • Marinus expects to file a European marketing authorization application (MAA) for ganaxolone for the treatment of seizures associated with CDD by the end of Q3 2021.

Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update

Retrieved on: 
Tuesday, August 3, 2021
Biotechnology, FDA, Pharmaceutical, Health, Chemical compounds, Anticonvulsants, GABAA receptor positive allosteric modulators, Orphan drugs, Ganaxolone, Pregnanes, Sedatives, Health care, Health, CDKL5 Deficiency Disorder, Ganaxolone, Marinus Pharmaceuticals, CDKL5 DEFICIENCY DISORDER, GANAXOLONE, MARINUS PHARMACEUTICALS

We look forward to working with the FDA in their review process and remain focused on preparing for the anticipated U.S. launch.

Key Points: 
  • We look forward to working with the FDA in their review process and remain focused on preparing for the anticipated U.S. launch.
  • Ganaxolone was generally well-tolerated with a safety profile consistent with previous clinical trials, with the most frequent adverse event being somnolence.
  • Marinus received Rare Pediatric Disease (RPD) Designation from the FDA for ganaxolone for the treatment of seizures associated with CDD in July 2020.
  • Further details are available in Marinus press release distributed August 3, 2021 (Marinus Pharmaceuticals Announces Exclusive Collaboration with Orion Corporation for European Commercialization of Ganaxolone).

Marinus Pharmaceuticals to Provide Business Update and Announce Second Quarter 2021 Financial Results on August 10, 2021

Retrieved on: 
Tuesday, August 3, 2021
Biotechnology, Mental health, Health, Pharmaceutical, Managed care, GABAA receptor positive allosteric modulators, Psychoactive drugs, Anticonvulsants, Chemical compounds, Health sciences, Ketones, Pregnanes, Sterols, CDKL5 deficiency disorder, Ganaxolone, CDKL5, Allosteric modulator

Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Key Points: 
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects.
  • Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.
  • Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year and is conducting a Phase 2 trial in tuberous sclerosis complex and a Phase 3 trial in refractory status epilepticus.

Santhera and ReveraGen to Present Findings from Pivotal VISION-DMD Study with Vamorolone at Parent Project Muscular Dystrophy 2021 Conference

Retrieved on: 
Thursday, June 24, 2021
Glucocorticoids, Organ systems, Medicine, Medical specialties, Prodrugs, Pregnanes, Muscular dystrophy, Diols, Vamorolone, Prednisone, Dystrophy, Duchenne

The study also demonstrated superiority of both vamorolone dose levels (2 and 6mg/kg/day) versus placebo across multiple secondary endpoints.

Key Points: 
  • The study also demonstrated superiority of both vamorolone dose levels (2 and 6mg/kg/day) versus placebo across multiple secondary endpoints.
  • Vamorolone did not stunt growth, as validated in the current 24-week study, in which vamorolone 6mg/kg/day versus prednisone 0.75mg/kg/day showed a significant difference in growth velocity (p=0.02).
  • The primary endpoint of the study is TTSTAND velocity at 24 weeks comparing the 6mg/kg/day dose of vamorolone to placebo.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Affron Associated with Improvements in Psychological Symptoms of Menopause According to New Study

Retrieved on: 
Tuesday, June 15, 2021
Hormones, Endocrine system, Organ systems, Hepatotoxins, Prolactin releasers, Spices, Pregnanes, Progestogens, Menopause, Estrogen, Saffron, Medroxyprogesterone acetate

The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.

Key Points: 
  • The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.
  • Affron is produced and marketed by Pharmactive using green proprietary technology to extract pure, highly concentrated saffron.
  • "This is the first study of affron examining menopause symptoms in average perimenopausal women," explains Alberto Espinel, Manager of Strategic R&D in Active and Functional Natural Ingredients for Pharmactive.
  • "This means that in comparison to other botanical extracts that target menopause symptoms, affron doesn't have undesirable estrogenic effects.

Marinus Pharmaceuticals to Present at Multiple Upcoming Investor Conferences

Retrieved on: 
Friday, June 11, 2021
Research, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Chemical compounds, GABAA receptor positive allosteric modulators, Psychoactive drugs, Anticonvulsants, Ketones, Pregnanes, Sterols, Organic compounds, Ganaxolone, Allosteric modulator, Antidepressant

Vice President, Clinical Development

Key Points: 
  • Vice President, Clinical Development
    Speakers: Scott Braunstein, M.D., Chief Executive Officer and Joe Hulihan, M.D., Chief Medical Officer
    All of the above public webcasts may be accessed through the Events & Presentations page of the Investors & Media section of the Marinus website, www.marinuspharma.com .
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects.
  • The company has initiated a Phase 3 trial in refractory status epilepticus.

Deciphera Pharmaceuticals Presents Data from QINLOCK® and Rebastinib Programs at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 4, 2021
Oncology, Health, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Carbonyl compounds, Oxygen compounds, Gynaecological cancer, Taxanes, Diketones, Pregnanes, Progestogens, Paclitaxel, Endometrial cancer, Medroxyprogesterone acetate

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.
  • As of a March 19, 2021 cutoff date, 38 patients with endometrial cancer initiated treatment with rebastinib in combination with weekly paclitaxel 80 mg/m2.
  • Of the 38 patients with endometrial cancer who initiated treatment with rebastinib, the median duration of treatment was 3.7 months.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA

Retrieved on: 
Tuesday, May 25, 2021
Women, Consumer, Health, Pharmaceutical, Baby, Maternity, Drugs, Steroids, Sex hormones, Pregnanes, Progestogens, Diketones, Hepatotoxins, Prolactin releasers, Estradiol/progesterone, Estradiol, Progesterone, Estrone, BIJUVA, TherapeuticsMD, Inc., BIJUVA, THERAPEUTICSMD, INC.

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, announced today that the Company submitted a supplemental New Drug Application (sNDA) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, announced today that the Company submitted a supplemental New Drug Application (sNDA) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (FDA).
  • We are pleased to have identified a path forward for submission to the FDA of our sNDA for low-dose BIJUVA.
  • BIJUVA is the only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule.
  • To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Sparrow Pharmaceuticals Presents Data on SPI-62 at the European Congress of Endocrinology

Retrieved on: 
Saturday, May 22, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Steroids, Endocrine system, Glucocorticoids, Organ systems, Corticosteroids, Anxiety, Cortisol, Otologicals, Pregnanes

Sparrow\xe2\x80\x99s novel approach to treatment of CS is based on recognition that the predominant source of intracellular cortisol is HSD-1.

Key Points: 
  • Sparrow\xe2\x80\x99s novel approach to treatment of CS is based on recognition that the predominant source of intracellular cortisol is HSD-1.
  • That\xe2\x80\x99s formed mostly by HSD-1,\xe2\x80\x9d said Dr. David Katz, Chief Scientific Officer of Sparrow.
  • \xe2\x80\x9cSPI-62 can reduce that pool by up to 90% and was associated with favorable clinical changes in patients with diabetes.
  • Its lead product, SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular corticosteroids in key tissues.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210522005003/en/\n'