MTD

Taysha Gene Therapies Announces Updates to TSHA-102 Clinical Program in Rett Syndrome

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목요일, 2월 29, 2024

DALLAS, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or “the Company”), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced updates to its TSHA-102 program in clinical evaluation for the treatment of Rett syndrome. The Independent Data Monitoring Committee (IDMC) approved the Company’s request to proceed to dose escalation in the REVEAL Phase 1/2 adolescent and adult trial, enabling earlier advancement to the high dose cohort of 1x1015 total vg. The IDMC also approved the dosing of the second patient in cohort one (low dose) of 5.7x1014 total vg in the REVEAL Phase 1/2 pediatric trial. The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102. The Company also announced the expansion of its ongoing REVEAL Phase 1/2 adolescent and adult trial in Canada into the United States (U.S.) following submission of the adolescent and adult trial protocol to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The decisions follow IDMC review of available clinical data from the patients dosed with TSHA-102.
  • The trial is taking place in Canada and the U.S. TSHA-102 is administered as a single lumbar intrathecal injection.
  • Update on available clinical data from completed cohort one of 5.7x1014 total vg expected in the first quarter of 2024.
  • Initial safety and efficacy data from cohort two (high dose, n=3) of 1x1015 total vg expected in the second half of 2024.

Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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목요일, 2월 29, 2024

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
  • As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.
  • For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share.

Cybersecurity startup Morphisec appoints Ron Reinfeld as CEO

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목요일, 2월 29, 2024

BOSTON, Feb. 29, 2024 /PRNewswire-PRWeb/ -- Morphisec endpoint security system (MTD) has announced the appointment of Ron Reinfeld as the new CEO of the company. Reinfeld joined Morphisec three years ago as its Chief Financial Officer. He replaces Ronen Yehoshua at the helm. Yehoshua will remain at the company in the role of President after nine years as CEO.

Key Points: 
  • Reinfeld, who previously served as the company's CFO, replaces Ronen Yehoshua, who was appointed President after nine years as CEO.
  • BOSTON, Feb. 29, 2024 /PRNewswire-PRWeb/ -- Morphisec endpoint security system (MTD) has announced the appointment of Ron Reinfeld as the new CEO of the company.
  • Yoav Tzruya, JVP General Partner and board member at Morphisec: "We want to thank Ronen for the great results in bringing Morphisec from an academic idea to a successful growth-stage startup.
  • We remain steadfast in our support of the team and our collective mission, and we welcome Ron to his new role as Morphisec CEO.

Kazia Therapeutics Reports Early Conclusion of Clinical Trial After Reaching Primary Endpoint

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수요일, 2월 21, 2024

SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial evaluated the use of paxalisib (an oral PI3K/mTOR dual inhibitor) with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors.

Key Points: 
  • SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial.
  • After reviewing the Part II patient data generated to date, the three lead investigators have determined that the primary endpoint of the study has been reached.
  • In addition, the investigators continued to observe encouraging signs of clinical response in patients in the expansion cohort.
  • The increasing incidence of brain metastasis and the low response rates to existing treatments underscores the need for new treatment options.

Mettler-Toledo International Inc. Reports Fourth Quarter 2023 Results

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목요일, 2월 8, 2024

Mettler-Toledo International Inc. (NYSE: MTD) today announced fourth quarter results for 2023.

Key Points: 
  • Mettler-Toledo International Inc. (NYSE: MTD) today announced fourth quarter results for 2023.
  • In local currency, sales decreased 13% in the quarter as currency increased sales growth by 1%.
  • Excluding these delays, our results came in as we had expected as we continued to face challenging market conditions in the fourth quarter.
  • Included in the first quarter guidance is an estimated 4% headwind to Adjusted EPS growth due to adverse currency.

Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

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화요일, 1월 23, 2024

The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.

Key Points: 
  • The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023.
  • ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.
  • Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance.
  • Continued development of SYS6002 (CRB-701) as both a monotherapy and in combination is planned both in China (CSPC), U.S. and Europe (Corbus Pharmaceuticals Holdings, Inc.).

Taysha Gene Therapies Announces First Pediatric Patient Dosed with TSHA-102 in REVEAL Phase 1/2 Pediatric Trial in Rett Syndrome

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수요일, 1월 10, 2024

DALLAS, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that the first pediatric patient has been dosed with TSHA-102 in the REVEAL Phase 1/2 pediatric trial in the United States (U.S.) evaluating the safety and preliminary efficacy of TSHA-102 in stage three female patients 5-8 years of age with Rett syndrome. The Company also announced the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Clinical Trial Application (CTA) for TSHA-102 in pediatric patients, enabling expansion of the ongoing U.S. REVEAL pediatric trial into the U.K.

Key Points: 
  • Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome
    MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S.
  • “Dosing the first pediatric patient with Rett syndrome marks an important step forward in our efforts to broaden the clinical evaluation of TSHA-102 to younger patients with earlier stages of Rett syndrome.
  • “The pediatric trial will build on our ongoing REVEAL adolescent and adult trial, where early data demonstrated improvements across multiple clinical domains in adult patients with the most advanced stage of disease.
  • TSHA-102 is also being evaluated in the ongoing first-in-human REVEAL Phase 1/2 adolescent and adult trial in females aged 12 and older with Rett syndrome in Canada.

Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC

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수요일, 1월 10, 2024

Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.

Key Points: 
  • Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.
  • In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases.
  • Brain metastases are common among patients with ROS1+ NSCLC and intracranial activity of approved ROS1 TKIs can be suboptimal.
  • In November 2023, the U.S. Food and Drug Administration approved repotrectinib for use in adult patients with locally advanced or metastatic ROS1+ NSCLC in the United States.

Mettler-Toledo International Inc. Provides Update on Fourth Quarter 2023 Financial Results

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목요일, 1월 4, 2024

For the fourth quarter ended December 31, 2023, the Company estimates, based upon preliminary information, that reported sales declined approximately 12% and local currency sales declined approximately 13% as currency increased sales growth by approximately 1%.

Key Points: 
  • For the fourth quarter ended December 31, 2023, the Company estimates, based upon preliminary information, that reported sales declined approximately 12% and local currency sales declined approximately 13% as currency increased sales growth by approximately 1%.
  • This compares with previous fourth quarter local currency sales decline guidance of approximately 7% to 8%.
  • The Company is evaluating the impact of the shipping delays on its fourth quarter 2023 Adjusted EPS results, and therefore also withdrew its previously-issued Adjusted EPS guidance.
  • Additionally, the Company will release its fourth quarter 2023 financial results after the market close on February 8th, and will host a conference call at 8:30 a.m. Eastern Time on February 9th.

ADC Therapeutics Provides Business Updates

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목요일, 1월 4, 2024

LAUSANNE, Switzerland, Jan. 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today provided business updates.

Key Points: 
  • ZYNLONTA®1 4Q 2023 net sales expected to be ~$16.5 million, a double-digit percentage increase as compared to 3Q 2023
    ADCT-601 (targeting AXL): Reached MTD and currently in dose optimization; Early signs of antitumor activity in both monotherapy and in combination
    LAUSANNE, Switzerland, Jan. 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today provided business updates.
  • “During 2023, we took a number of decisive actions to help position the Company for success in 2024 and beyond.
  • We prioritized our pipeline, strengthened our organization and implemented a disciplined capital allocation model to generate cost efficiencies,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics.
  • The Company ended the fourth quarter of 2023 with cash and cash equivalents of ~$278.5 million.