Crinetics Pharmaceuticals to Participate in the 43rd Annual J.P. Morgan Healthcare Conference

On January 6, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 14, 2025 at 4:30 p.m. Pacific Time (Press release, Crinetics Pharmaceuticals, JAN 6, 2025, View Source [SID1234649425]).

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To access the live webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

Verastem Oncology’s Announcement Regarding Avutometinib (FDA Acceptance and Priority Review of New Drug Application for Avutometinib (in Combination with Defactinib) for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer)

On January 6, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Verastem Oncology issued a press release on December 30, 2024 that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation (Press release, Chugai, JAN 6, 2025, View Source [SID1234649424]). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. Avutometinib was created by Chugai, and its clinical development is being conducted by Verastem Oncology.

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BioLineRx Announces $10 Million Registered Direct Offering

On January 6, 2025 BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has entered into definitive agreements for the purchase of an aggregate of 50,000,000 of the Company’s American Depositary Shares (ADSs) (or ADS equivalents) and accompanying warrants to purchase up to an aggregate of 50,000,000 ADSs, at a purchase price of $0.20 per ADS (or per ADS equivalent) and accompanying warrant in a registered direct offering (Press release, BioLineRx, JAN 6, 2025, View Source [SID1234649423]). The warrants will have an exercise price of $0.20 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for research and development activities, the expansion of the Company’s pipeline of potential drug candidates, and working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-276323) filed with the Securities and Exchange Commission ("SEC") on December 29, 2023 and declared effective on January 5, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Ascendis Pharma to Participate in the 43rd Annual J.P. Morgan Healthcare Conference

On January 6, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California (Press release, Ascendis Pharma, JAN 6, 2025, View Source [SID1234649422]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

Adcentrx Therapeutics Announces First Patient Dosed in the Phase 1a/b Study of ADRX-0405, a Potential First-in-Class ADC Targeting STEAP1 for the Treatment of Advanced Solid Tumors

On January 6, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, reported the first patient dosed in the Phase 1a/b study of ADRX-0405 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, JAN 6, 2025, View Source [SID1234649421]).

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"Advancing our second program into clinical trials marks an important milestone for Adcentrx and further validates the potential of our ADC technology platform," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "STEAP1 is an attractive ADC target, and we are excited about the first-in-class potential for ADRX-0405. We believe this novel ADC offers a unique approach to treating patients with STEAP1-expressing cancers, such as metastatic castration-resistant prostate cancer, where a significant unmet need remains for new targeted therapies."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label dose escalation and dose expansion study being conducted across sites in the U.S. The trial is enrolling patients with select advanced solid tumors, with the primary objectives of characterizing the safety and tolerability of ADRX-0405 and determining its optimal dose. The company anticipates an initial data readout in 4Q 2025.

About ADRX-0405

ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in normal healthy tissue.

Adcentrx’s proprietary i-Conjugation technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.