On March 6, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, BridgeBio, MAR 6, 2023, View Source [SID1234628181]). BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

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Goldman Sachs & Co. LLC, Evercore, and Morgan Stanley are acting as book-running managers for the proposed offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR that was previously filed with the U.S. Securities and Exchange Commission (SEC) on July 7, 2020 and automatically became effective upon filing. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, New York 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Morgan Stanley & Co. LLC, by mail at 1585 Broadway, New York, New York 10036, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On March 6, 2023 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported a collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial that will evaluate the safety and feasibility of the Company’s lead clinical candidate motixafortide to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease (SCD), one of the most common genetic diseases globally (Press release, BioLineRx, MAR 6, 2023, View Source [SID1234628180]). Currently available mobilization regimens can carry serious risks and side effects for patients with SCD or may not reliably yield optimal numbers of HSCs for gene therapy.

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The clinical trial is part of the Company’s long-term growth strategy for motixafortide across multiple therapeutic areas, including a potential future indication as a stem cell mobilization agent to support gene therapy development.

"Autologous hematopoietic stem cell-based gene therapies now offer curative potential for patients with SCD, but they are dependent upon the collection of significant quantities of stem cells, including early progenitor stem cells," said John DiPersio, MD, PhD, Professor of Medicine and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine, and principal investigator of the trial. "The common mobilization agent G-CSF is contraindicated in patients with sickle cell disease, significantly limiting their stem cell mobilization options. The development of novel mobilization regimens has the potential to overcome this unmet need for patients."

"We are excited to be advancing this important collaboration, which has the potential to ultimately support sickle cell disease gene therapy for patients," said Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. "Motixafortide is being developed across multiple therapeutic areas, including stem cell mobilization for multiple myeloma, treatment of pancreatic cancer, and now in support of stem cell mobilization for gene therapy development for genetic disorders, which, we believe, demonstrates its broad potential."

The proof-of-concept trial, which will study motixafortide as a single agent and in combination with natalizumab, will assess the safety and tolerability of the two regimens as mobilization agents of CD34+ hematopoietic stem cells in patients with SCD. The study is anticipated to begin enrollment in the second half of 2023.

About the Clinical Trial of Motixafortide in Sickle Cell Disease (SCD)
The trial is a safety and feasibility study to evaluate motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. The study will enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial’s primary objective is to assess the safety and tolerability of motixafortide alone and the combination of motixafortide + natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the kinetics of CD34+ HSPCs mobilization to peripheral blood in response to motixafortide alone and motixafortide + natalizumab in SCD patients.

About Sickle Cell Disease
Sickle cell disease (SCD) is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. Sickle cell disease arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells that tend to stick to blood vessels causing their occlusion. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.

On March 6, 2023 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the third quarter of fiscal year 2023 on March 13, 2023, after market close and will host a webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, MAR 6, 2023, View Source [SID1234628179]). Members of Avid’s senior management will discuss financial results for the third quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

On March 6, 2023 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune, kidney and rare diseases, reported that the Company’s Compensation Committee granted 3 new employees inducement stock options to purchase an aggregate of 89,830 common shares, at a per share exercise price of $8.99, the closing price of Aurinia’s common stock on March 3, 2023, and an aggregate of 54,850 inducement restricted stock units (RSUs) (Press release, Aurinia Pharmaceuticals, MAR 6, 2023, View Source [SID1234628178]). The inducement stock options and RSUs have a grant date of March 6, 2023. The stock options and RSUs were granted as inducements material to the new employees entering employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4).

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The inducement stock options have a ten-year term and vest over three years with one-third of the shares vesting on the twelve month anniversary from the grant date, and the remaining options vesting in twenty-four equal monthly installments thereafter.

The inducement RSUs shall vest in three equal annual installments on the first, second and third anniversary of the grant date.

On March 6, 2023 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, reported a business update and reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Allakos, MAR 6, 2023, View Source [SID1234628177]). The Company’s most advanced antibodies are lirentelimab (AK002) and AK006.

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