Hoffmann-La Roche

EQS-News: OTC Market Group’s Most Active List In November: A Dive Into The Names Experiencing Volume Changes

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Sunday, December 18, 2022
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OTC Market Group’s Most Active List In November: A Dive Into The Names Experiencing Volume Changes

Key Points: 
  • OTC Market Group’s Most Active List In November: A Dive Into The Names Experiencing Volume Changes
    The issuer is solely responsible for the content of this announcement.
  • ASM International N.V. (OTCQX: ASMIY) claimed the 17th spot on OTCQX’s Most Active list, experiencing a 98% increase in trading volume.
  • (OTCQX: JBSAY) claimed the 27th spot on OTCQX’s Most Active list, experiencing a 94% increase in trading volume.
  • (OTCQX: BDRBF) claimed the 28th spot on OTCQX’s Most Active list, experiencing a 203% increase in trading volume.

Spark Therapeutics Announces Updated Phase 1/2 Study Results Supporting the Durability of Investigational Gene Therapy SPK-8011 in Patients With Hemophilia A

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Monday, December 12, 2022
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“The updated results of this Phase 1/2 study add to the growing body of preliminary evidence suggesting that investigational SPK-8011 provides durable FVIII expression for the treatment of hemophilia A,” said Gallia Levy, M.D., Ph.D., Chief Medical & Product Strategy Officer, Spark Therapeutics.

Key Points: 
  • “The updated results of this Phase 1/2 study add to the growing body of preliminary evidence suggesting that investigational SPK-8011 provides durable FVIII expression for the treatment of hemophilia A,” said Gallia Levy, M.D., Ph.D., Chief Medical & Product Strategy Officer, Spark Therapeutics.
  • “At Spark, we are focused on developing a gene therapy for people with hemophilia A that demonstrates safety, predictability, efficacy, and durability at the lowest effective dose with an optimal immunomodulatory regimen.
  • Interim results from the phase 1/2 study were published online in the New England Journal of Medicine (NEJM) in November 2021.
  • (Trial identifier NCT03003533)
    We believe gene therapy has the potential to revolutionize medicine and improve the lives of patients with genetic and other serious diseases.

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

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Friday, December 9, 2022
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Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Key Points: 
  • Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
  • For more than 170 years, we have worked to make a difference for all who rely on us.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
  • This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

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Thursday, December 8, 2022
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Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Key Points: 
  • Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
  • For more than 170 years, we have worked to make a difference for all who rely on us.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
  • This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

Immunocore presents ovarian cancer expansion data for ImmTAC® candidate IMC-C103C targeting MAGE-A4

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Thursday, December 8, 2022
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The Phase 1 data, presented in a poster at the ESMO Immuno-Oncology 2022 Congress, include 33 heavily pre-treated patients with ovarian cancer, who received doses of ≥ 90 mcg intravenously.

Key Points: 
  • The Phase 1 data, presented in a poster at the ESMO Immuno-Oncology 2022 Congress, include 33 heavily pre-treated patients with ovarian cancer, who received doses of ≥ 90 mcg intravenously.
  • This includes 16 new patients, and 17 patients previously reported at the ESMO Immuno-Oncology 2021 Congress, now with longer follow-up.
  • All patients had platinum relapsed/refractory ovarian cancer (70% PARP inhibitors experienced) and were enrolled regardless of MAGE-A4 protein expression, which was analyzed retrospectively.
  • Of the 33 patients, 39% (13/33) were MAGE-A4 negative as measured by immunohistochemistry (IHC), and 2 patients had an unknown H score.

Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 in Combination With KEYTRUDA® (pembrolizumab) in Patients with HPV16-Positive Head and Neck Cancer

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Tuesday, December 6, 2022
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The candidate has reported interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349).

Key Points: 
  • The candidate has reported interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349).
  • The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively).
  • The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses.
  • Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for the treatment of cancer and infectious diseases.

Circle Pharma Appoints Stephen Kelsey, MB ChB, MD, to its Board of Directors

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Thursday, December 15, 2022
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Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Stephen Kelsey as an independent member of its Board of Directors.

Key Points: 
  • Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Stephen Kelsey as an independent member of its Board of Directors.
  • Dr. Kelsey has had key roles in the development of many oncology therapeutics including Sutent, Perjeta, Kadcycla, Erivedge and imetelstat.
  • Im delighted to welcome Steve to our Board, said David J. Earp, JD, PhD, Circles president and CEO.
  • Im excited to join Circles Board and to help the company bring its promising therapies to cancer patients.

WD-40 Company Announces Board Changes

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Tuesday, December 13, 2022
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WD-40 Company (NASDAQ:WDFC) announced the appointment of Gregory A. Sandfort as non-executive chairman of the board of directors, effective today.

Key Points: 
  • WD-40 Company (NASDAQ:WDFC) announced the appointment of Gregory A. Sandfort as non-executive chairman of the board of directors, effective today.
  • Mr. Sandfort had served as chief executive officer of Tractor Supply Company from 2012 until his retirement in 2020.
  • The Company also announced that Cynthia B. Burks was elected to the Companys board at the Annual Meeting of Stockholders following her nomination by the board earlier this year.
  • On behalf of the board, I would like to thank Garry for his leadership of our Company and its people over the last three and a half decades, said Mr. Sandfort, chairman of the board.

Genentech Presents New and Updated Data for Polivy in Previously Untreated Diffuse Large B-Cell Lymphoma at ASH 2022

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Sunday, December 11, 2022
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Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).

Key Points: 
  • Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).
  • Too many patients with diffuse large B-cell lymphoma see their cancer relapse or progress after initial treatment.
  • These updated POLARIX data indicate the potential benefits that this Polivy based-regimen could bring to people living with this aggressive type of lymphoma, and demonstrate our commitment to developing new treatment options.
  • Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkins lymphoma (NHL), accounting for about one in three cases of NHL.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

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Sunday, December 11, 2022
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The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Key Points: 
  • The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
  • Hemlibra provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • HAVEN 7 is a Phase III, multi-center, open-label study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of Hemlibra in infants with severe hemophilia A without factor VIII inhibitors.
  • Genentech also presented data from the European Haemophilia Safety Surveillance (EUHASS) database and the prospective observational ATHN 7 study at ASH 2022.