Day: November 27, 2023

Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma

Written by Customer Service on November 27, 2023. Posted in Public Companies.

Media Release COPENHAGEN, Denmark; November 27, 2023U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy European Medicines Agency (EMA) validates regulatory application for epcoritamab for the same indication The regulatory actions are supported by data from the phase 1/2 EPCORE™ NHL-1 trialGenmab A/S (Nasdaq: GMAB) today announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with...

Autolus Therapeutics Submits Biologics License Application to U.S. Food and Drug Administration for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL)

Written by Customer Service on November 27, 2023. Posted in Public Companies.

BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for obecabtagene autoleucel (obe-cel). Obe-cel is Autolus’ lead investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The...

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Written by Customer Service on November 27, 2023. Posted in Public Companies.

If approved, ~3,000 people with DEB in the European Union could receive VYJUVEK to treat the underlying cause of the disease for the first timeVYJUVEK received Orphan Drug Designation and PRIME designation from the EMAPITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP...

Genelux Corporation Receives FDA Fast Track Designation for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer

Written by Customer Service on November 27, 2023. Posted in Public Companies.

– Pivotal Phase 3 Study of Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer Initiated in September 2022 – – Phase 2 Trial of Olvi-Vec- Demonstrated Clinical Reversal of Platinum Resistance and Refractoriness and Met Primary Endpoint of Objective Response Rate with Durable Responses – WESTLAKE VILLAGE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) — Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the development program of Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum resistant/refractory ovarian cancer. “The Fast Track designation granted for Olvi-Vec underscores its potential to address unmet medical needs in ovarian cancer,...

Colliers recognized by Forbes as one of the World’s Top Companies for Women in 2023

Written by Customer Service on November 27, 2023. Posted in Public Companies.

TORONTO, Nov. 27, 2023 (GLOBE NEWSWIRE) — Global professional services and investment management firm Colliers (NASDAQ and TSX: CIGI) has been recognized once again by Forbes as one of the world’s top companies for women. Colliers was the only global, full-service commercial real estate firm to receive this prestigious accolade, which highlights the company’s commitment to supporting women both inside and outside of the workplace. The Forbes list is based on a survey of approximately 70,000 women working for multinational corporations across 37 countries. Participants were asked if they would recommend their employer to friends or family, and to rate the corporation on both general workplace practices and gender-specific issues including gender pay equity, the management of employee discrimination cases, and whether men and women...

TFF Pharmaceuticals to Participate in the 2023 Benchmark Discovery One-on-One Investor Conference – December 7, 2023

Written by Customer Service on November 27, 2023. Posted in Public Companies.

FORT WORTH, Texas, Nov. 27, 2023 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that company management will be participating in the 2023 Benchmark Discovery One-on-One Investor Conference being held December 7, 2023 at the New York Athletic Club in New York City. The company has two products in Phase 2 development and continues to guide for a December release of interim data from both studies. Please contact your Benchmark representative to schedule one-on-one meetings with the management team during the conference. ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals’ proprietary Thin Film Freezing...

Neumora Therapeutics Announces NMRA-266 IND Clearance and Initiation of Phase 1 Clinical Study

Written by Customer Service on November 27, 2023. Posted in Public Companies.

NMRA-266 is a highly selective positive allosteric modulator of the M4 muscarinic receptor, a clinically validated target for the treatment of schizophrenia WATERTOWN, Mass., Nov. 27, 2023 (GLOBE NEWSWIRE) — Neumora Therapeutics, Inc. (Neumora), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced the initiation of a Phase 1 single ascending dose / multiple ascending dose study evaluating NMRA-266 in healthy adult participants. NMRA-266 is a highly selective positive allosteric modulator of the M4 muscarinic receptor that Neumora is developing as a treatment for schizophrenia and other neuropsychiatric disorders. “The initiation of this Phase 1 study is an important step in the development of NMRA-266. In pre-clinical studies NMRA-266 demonstrated a favorable pharmacologic profile...

Cerence Announces Fourth Quarter and Fiscal Year 2023 Results

Written by Customer Service on November 27, 2023. Posted in Earnings Releases And Operating Results.

HeadlinesRevenue and profitability exceed the high end of the initially guided range for the full fiscal year Five consecutive quarters of strong execution Fourteen strategic design wins in the fiscal year including five competitive winbacks Maintain a leadership position with Cerence penetration staying strong at 54% of global auto production Fine-tuned LLM with Cerence vertical automotive dataset delivered to customers, advancing Destination Next software platformBURLINGTON, Mass., Nov. 27, 2023 (GLOBE NEWSWIRE) — Cerence Inc. (NASDAQ: CRNC), AI for a world in motion, today reported its fourth quarter and fiscal year 2023 results for the year ended September 30, 2023. Results Summary (1) (in millions, except per share data) Three Months Ended Twelve Months Ended September 30, September 30, 2023 2022 2023 2022GAAP...

Form 8.3 – [Young & Co.’s Brewery 24 11 2023] – (CGWL)

Written by Customer Service on November 27, 2023. Posted in Mergers And Acquisitions.

FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORERule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION(a) Full name of discloser: CANACCORD GENUITY WEALTH LIMITED (for Discretionary clients)(b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named. N/A(c) Name of offeror/offeree in relation to whose relevant securities this form relates: Use a separate form for each offeror/offeree Young & Co.’s Brewery plc(d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree: N/A(e) Date...

Auction result of Treasury Bills – RIKV 24 0221 – RIKV 24 0515

Written by Customer Service on November 27, 2023. Posted in Public Companies.

Series RIKV 24 0221 RIKV 24 0515Settlement Date 11/29/2023 11/29/2023Total Amount Allocated (MM) 20,410 14,700All Bids Awarded At (Price / Simple interest) 97.814 / 9.578 95.669 / 9.701Total Number of Bids Received 23 24Total Amount of All Bids Received (MM) 45,910 28,700Total Number of Successful Bids 15 17Number of Bids Allocated in Full 15 17Lowest Price / Highest Simple Interest Allocated 97.814 / 9.578 95.669 / 9.701Highest Price / Lowest Simple Interest Allocated 97.878 / 9.291 95.845 / 9.290Lowest Price / Highest Simple Interest Allocated in Full 97.814 / 9.578 95.669 / 9.701Weighted Average of Successful Bids (Price/Simple Interest) 97.825 / 9.529 95.706 / 9.614Best Bid (Price / Simple Interest) 97.878 / 9.291 95.845 / 9.290Worst Bid (Price / Simple Interest) 97.787 / 9.699 95.584 / 9.900Weighted...

Day: November 27, 2023

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