CNS | Jotup

EQS-News: Newron presents 2023 financial results and provides 2024 outlook

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수요일, 4월 10, 2024

Psychosis, Schizophrenia, Clozapine, XETRA, Patient, CNS, Business development, Peripheral nervous system, Psychedelic literature, Safety, TRS, PANSS, EIB, Canadian International Council, Pharmaceutical industry

Milan, Italy, March 19, 2024, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

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Milan, Italy, March 19, 2024, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.
Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint.
These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment.
Patient enrollment has completed and results from this study are expected in April 2024.

EQS-News: Newron enters into an agreement for the subscription of up to 2.05 million newly issued shares; Proceeds of up to EUR 15.0 million

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수요일, 4월 10, 2024

EUR, Frankfurt Stock Exchange, XETRA, CFO, Patient, CNS, SIX Swiss Exchange, Peripheral nervous system, Security (finance)

Newron enters into an agreement for the subscription of up to 2.05 million newly issued shares; Proceeds of up to EUR 15.0 million

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Newron enters into an agreement for the subscription of up to 2.05 million newly issued shares; Proceeds of up to EUR 15.0 million
The issuer is solely responsible for the content of this announcement.
Under the agreement, the fund subscribes to an initial 750,000 newly issued shares at a subscription price of EUR 7.33 per share, which corresponds to gross proceeds of approximately EUR 5.5 million.
In addition, the fund has a right to subscribe to an additional up to 1,300,000 newly issued shares until no later than January 31, 2025, at a subscription price to be calculated pursuant to an agreed formula.
“The investment by this specialist institutional fund is a validation of our strategy to develop innovative CNS therapies,” said Roberto Galli, CFO of Newron.

EQS-News: Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 financing agreement

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수요일, 4월 10, 2024

EIB, Peripheral nervous system, Patient, CNS, Schizophrenia, XETRA, European Investment Bank, BofA Securities, Pharmaceutical industry

Under the amendment, repayment of tranches one to three (out of a total of five) of the financing agreement with due dates from June 2024 to April 2025 will be shifted substantially, with tranche one now scheduled for November 25, 2025, tranche two for April 2026 and tranche three for June 2026.

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Under the amendment, repayment of tranches one to three (out of a total of five) of the financing agreement with due dates from June 2024 to April 2025 will be shifted substantially, with tranche one now scheduled for November 25, 2025, tranche two for April 2026 and tranche three for June 2026.
The due dates for tranches four and five will stay unchanged.
On the amended tranches, Newron will start paying the agreed interest rates.
Details of the 2018 loan agreement can be found in Newron’s 2022 Annual Report which is posted on its website.

EQS-News: Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS)

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수요일, 4월 10, 2024

SIRS, Schizophrenia, Clozapine, XETRA, Incidence, Patient, CNS, Peripheral nervous system, Safety, TRS, Schizophrenia International Research Society, Pharmaceutical industry

The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A.

Key Points:

The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A.
As previously announced by Newron, the study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment.
Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid).

Frontier Medicines Presents New Data for First-In-Class Dual ON+OFF KRAS G12C Inhibitor FMC-376 at the AACR Annual Meeting

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화요일, 4월 9, 2024

Lung cancer, Survival, NSCLC, Immunotherapy, Colorectal cancer, Central nervous system, Patient, CNS, Neoplasm, AACR, PDX, Clinical trial, Pancreatic cancer, Cancer, CRC, Metastasis, Proteome, PD-1, Pharmaceutical industry

- The Phase 1/2 PROSPER clinical trial is currently evaluating FMC-376 in patients with KRASG12C cancers, regardless of prior KRAS inhibitor therapy BOSTON and SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Frontier Medicines Corporation, a clinical-stage precision medicine company seeking to unlock the proteome to advance transformational therapies against otherwise undruggable disease-causing targets, today presented new preclinical data on its KRASG12C inhibitor, FMC-376, at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. The new findings demonstrate FMC-376’s potential to overcome known mechanisms of innate and acquired resistance and in a CNS model of metastasis as a monotherapy and increase the efficacy of PD-1 immunotherapy in combination.

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“These data demonstrate FMC-376’s unmatched potential to overcome over 90 percent of known resistance mechanisms, including those cancers that have become refractory to approved KRAS inhibitors.
The differentiated dual direct mechanism of action of FMC-376 offers the potential to overcome the resistance and lack of response seen with current KRASG12C single-acting treatments.
These results reinforce that FMC-376 has the potential to overcome limitations of single-acting KRASG12C inhibitors.
The combination of FMC-376 with an immune checkpoint inhibitor also leads to an increased response and survival in preclinical models.

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

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화요일, 4월 9, 2024

HER2, ILD, CPI, Survival, Progression-free survival, Central nervous system, Patient, CNS, History, Death, Eribulin, Spacecraft, MD, CBR, TPC, EMBRACE, Life, BCT, AACR, TSX, Therapy, Breast cancer, Safety, Poster, CMO, PFS, ADC, PD-1, Pharmaceutical industry

“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.

Key Points:

“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.
To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks.
BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer.
Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study.

Cogent Biosciences Presents Data Highlighting Potential Best-in-Class Potency and Selectivity of Novel, EGFR Sparing, CNS-Penetrant ErbB2 Inhibitor

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화요일, 4월 9, 2024

Brain, Disease, CNS, Mouse, Neoplasm, IND, AACR, HER2, Poster, Annual general meeting, Cogent, Pharmaceutical industry

and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program.

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and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program.
The data are being presented in a poster session at the American Association for Cancer Research (AACR) 2024 Annual Meeting taking place in San Diego, California.
“These data further demonstrate Cogent’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need.
Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies.

Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management Team

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화요일, 4월 9, 2024

AUSTIN, Texas, April 09, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) has formally joined the Company in a part-time capacity. Dr. Brenner will provide substantial input on the Company’s central nervous system cancer development programs while continuing to maintain his academic practice and laboratory. In addition, Barbara Blouw, Ph.D. joins the Company as Vice President, Clinical Affairs.

Key Points:

Dr. Brenner will provide substantial input on the Company’s central nervous system cancer development programs while continuing to maintain his academic practice and laboratory.
In addition, Barbara Blouw, Ph.D. joins the Company as Vice President, Clinical Affairs.
Dr. Brenner’s academic work focuses on both clinical cancer management and the development of novel therapies to treat breast and central nervous system tumors.
Dr. Brenner has received numerous grants and investigational new drug approvals based on his translational research.

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

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화요일, 4월 9, 2024

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points:

The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
“These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
“The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

Supernus Provides Regulatory Update for SPN-830

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월요일, 4월 8, 2024

Symantec Endpoint Protection, PD, Central nervous system, Patient, CNS, Food and Drug Administration, CRL, NDA, FDA, Food

ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.

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ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830.
The FDA has issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for SPN-830.
The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.
We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” said Jack Khattar, President & CEO of Supernus.