Sarecycline

Almirall's Full-Year 2021 Results : Almirall delivers high end of the 2021 upgraded guidance with solid performance from growth drivers

Retrieved on: 
Monday, February 21, 2022

Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.

Key Points: 
  • Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.
  • Net Salesof 827.2 MM represent a 2.5% year-on-year growth, driven by positive contribution from growth drivers and a strong EU dermatology performance.
  • Core EBITDA*was 211.3 MM, a growth of 16.7%, boosted by strong performance of the growth drivers.
  • Almirall achieved solid operating results, delivering on the upgraded 2021 guidance, as the core business continued to perform well in line with expectations.

Almirall's Full-Year 2021 Results : Almirall delivers high end of the 2021 upgraded guidance with solid performance from growth drivers

Retrieved on: 
Monday, February 21, 2022

Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.

Key Points: 
  • Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.
  • Net Salesof 827.2 MM represent a 2.5% year-on-year growth, driven by positive contribution from growth drivers and a strong EU dermatology performance.
  • Core EBITDA*was 211.3 MM, a growth of 16.7%, boosted by strong performance of the growth drivers.
  • Almirall achieved solid operating results, delivering on the upgraded 2021 guidance, as the core business continued to perform well in line with expectations.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Monday, May 3, 2021

b"BOSTON, May 03, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and\xc2\xa0military use, today announced that on April 30, 2021, the Company granted stock options to seven new employees of the Company.

Key Points: 
  • b"BOSTON, May 03, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and\xc2\xa0military use, today announced that on April 30, 2021, the Company granted stock options to seven new employees of the Company.
  • Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.\nParatek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA\xc2\xae (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.\nIn 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.\nFor more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.\nNUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
  • A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.\nFor more information, visit www.ParatekPharma.com or follow @ParatekPharma\xc2\xa0on Twitter.\n"

Paratek Pharmaceuticals Presenting New Data on NUZYRA® (Omadacycline) at IDWeek 2020

Retrieved on: 
Wednesday, October 21, 2020

Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.

Key Points: 
  • Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.
  • Paratek exclusively licensedU.S.rights and rights to the greaterChinaterritory for SEYSARA(sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, toAlmirall, LLC(Almirall).
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
  • In 2019, Paratek was awarded a contract from BARDAto support the development of NUZYRA for the treatment of pulmonary anthrax.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, September 1, 2020

These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

Key Points: 
  • These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.
  • Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
  • In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Monday, August 3, 2020

These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

Key Points: 
  • These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.
  • Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
  • In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

CymaBay Announces Positive Topline Results from ENHANCE for Seladelpar in Patients with Primary Biliary Cholangitis

Retrieved on: 
Monday, August 3, 2020

ET

Key Points: 
  • ET
    NEWARK, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced positive topline results from ENHANCE, a placebo-controlled, randomized, Phase 3 study evaluating the safety and efficacy of seladelpar for the treatment of primary biliary cholangitis (PBC).
  • Sujal Shah, CEO and President of CymaBay Therapeutics, said, We are thrilled with the results which highlight the safety and efficacy of seladelpar in patients with PBC.
  • We would like to thank all of the patients and investigators who participated in ENHANCE and who continue to support our efforts.
  • ENHANCE was a double-blind, placebo-controlled, global study that randomized 265 PBC patients to placebo, seladelpar 5 mg, or seladelpar 10 mg once daily.

Almirall Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets

Retrieved on: 
Thursday, June 18, 2020

Seysara is a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne, and was approved by the FDA in October 2018.

Key Points: 
  • Seysara is a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne, and was approved by the FDA in October 2018.
  • Seysara is one of thirteen branded products marketed in the US by Almirall, a global family-owned company focused on medical dermatology and skin health.
  • Ron Menezes, President and General Manager at Almirall, LLC, underscores "We are delighted that the FDA recognized the importance of this data and approved the update to our label.
  • To learn more about Seysara, please visit Seysara.com
    To learn more about Almirall LLC, please visit almirall.us .

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Monday, March 2, 2020

These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

Key Points: 
  • These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.
  • Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
  • In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority(BARDA)to support the development of NUZYRA for the treatment of pulmonary anthrax.

Paratek Announces License Grant to Almirall for SEYSARA® (sarecycline) for Greater China Region

Retrieved on: 
Monday, February 24, 2020

Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales in the greater China region.

Key Points: 
  • Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales in the greater China region.
  • As part of this agreement, Paratek and Almirall also finalized a license granting Paratek exclusive rights to develop, manufacture and commercialize sarecycline outside of the U.S.
  • Under the terms of the agreement, Paratek will share with Almirall any potential revenues of SEYSARA (sarecycline) outside of the U.S. and greater China region.
  • Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.