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• RedHill Announces FDA sNDA Approval for Talicia®

  9/18/2023

  RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[.

• BioNTech and CEPI Announce Partnership to Advance mRNA Mpox Vaccine Development and Support CEPI’s 100 Days Mission

  9/18/2023

  BioNTech SE and the Coalition for Epidemic Preparedness Innovations announced a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox, an infectious disease that can lead to severe, life-threatening complications.

• ImmunoGen Appoints Lauren White as Senior Vice President and Chief Financial Officer

  9/18/2023

  ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, announced that Lauren White has been appointed Senior Vice President and Chief Financial Officer.

• FSD Pharma announces Interim Results from First-in-Human Clinical Trial of Lucid-MS (Lucid-21-302) for Multiple Sclerosis; The Report Shows Compound to be Safe and Well Tolerated

  9/18/2023

  FSD Pharma Inc. today announced that an interim report has been received for the first-in-human single ascending dose Phase I clinical trial evaluating the Company's novel drug candidate Lucid-21-302 ("Lucid-MS"), an orally-administered treatment for Multiple Sclerosis ("MS").

• Ainos’ VELDONA Granted Orphan Drug Designation by U.S. FDA for Potential Treatment of Oral Warts in HIV-Seropositive Patients

  9/18/2023

  Ainos, Inc. announced today that the United States Food and Drug Administration granted Orphan Drug Designation ("ODD") for the Company's VELDONA® low-dose oral interferon formulation as a potential treatment for oral warts in HIV-seropositive patients.

• Allurion Featured at the 2023 International Bariatric Club Oxford University World Congress

  9/18/2023

  Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced its participation in the 4th International Bariatric Club (IBC) Oxford World Congress, which takes place at Oxford University, September 18-20, 2023.

• Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023

  9/18/2023

  Shionogi & Co., Ltd. will present two late-breaking posters at the European Scientific Working Group on Influenza and other Respiratory Viruses’ (ESWI), 9th Influenza Conference.

• Tonix Pharmaceuticals Announces Presentation of Non-Clinical Studies Supporting the Mechanism of TNX-1900 (Intranasal Potentiated Oxytocin) at the 2023 International Headache Congress

  9/18/2023

  Tonix Pharmaceuticals Holding Corp. today announced that David C. Yeomans, Ph.D. presented data relevant to the proposed mechanism of TNX-1900 (intranasal potentiated oxytocin) in treating chronic migraine in a poster and an oral presentation at the 2023 International Headache Congress (IHC), being held September 14-17, 2023, in Seoul, South Korea.

• Tango Therapeutics to Highlight Preclinical Data on Precision Oncology Pipeline at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

  9/18/2023

  Tango Therapeutics, Inc. today announced that five abstracts have been selected for poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place from October 11-15, 2023 in Boston, Massachusetts.

• Ambrx to Participate in the Cantor Fitzgerald Global Healthcare Conference

  9/18/2023

  Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that Daniel J. O’Connor, Chief Executive Officer and President of Ambrx, will participate in a fireside chat and one-on-one meetings at the Cantor Fitzgerald Global Healthcare conference, being held in New York, NY.

• Feinstein Institutes AI researchers receive $3.1M NIH grant to develop hospital risk and prevention tools

  9/18/2023

  Hospitalized adult patients whose medical conditions worsen after being admitted, requiring escalation of care, such as transfer to the intensive care unit (ICU) or intervention of a rapid response team, may benefit from monitoring by artificial intelligence (AI).

• Relay Therapeutics to Present Clinical Data on RLY-4008 in Advanced FGFR2-Altered Solid Tumors at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

  9/18/2023

  Relay Therapeutics, Inc. (Nasdaq: RLAY) today announced that data for RLY-4008 (lirafugratinib) in patients with advanced FGFR2-altered solid tumors outside of cholangiocarcinoma will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023.

• Kintara Therapeutics Announces Fiscal 2023 Year Financial Results and Provides Corporate Update

  9/18/2023

  Kintara Therapeutics, Inc. (NASDAQ: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced financial results for its fiscal year ended June 30, 2023 and provided a corporate update.

• Kinnate Biopharma Inc. Announces Pipeline Updates, Strategic Reprioritization and Workforce Restructuring

  9/18/2023

  Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.

• Enanta Pharmaceuticals to Present Data for EDP-323, its Oral, Once-Daily, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus, at the 9th ESWI Influenza Conference

  9/17/2023

  Enanta Pharmaceuticals, Inc. announced that data for EDP-323, its oral, once-daily, L-protein inhibitor in development for the treatment of respiratory syncytial virus, will be presented at the 9th European Scientific Working Group on Influenza Influenza Conference on September 17-20, 2023 at the Palacio de Congresos de Valencia in Valencia, Spain.

• Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anemia

  9/16/2023

  GSK plc announced that the US Food and Drug Administration has approved Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, in adults with anemia.

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  Biotech Financing, IPO Tide May Be Turning – Signs of a Potential Recovery?

  9/15/2023

  In the largest biotech Series C financing so far this year, Generate:Biomedicines raised $273 million, while Neumora and RayzeBio announced IPO pricing valued at more than $560 million combined.

• Scinai Immunotherapeutics Announces $1.33 Million Registered Direct Offering

  9/15/2023

  Scinai Immunotherapeutics Ltd. announced that it has entered into a definitive agreement for the purchase and sale of 1,146,552 of the Company’s American Depositary Shares, each ADS representing four hundred ordinary shares, at a purchase price of yesterday’s closing price of $1.16 per ADS, in a registered direct offering.

• YS Biopharma Granted Patent in the U.S. for Immunotherapy Targeting Chronic Hepatitis B Virus Infection

  9/15/2023

  YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company") today announced that the United States Patent and Trademark Office has issued it a patent covering the Company's PIKA YS-HBV-002, an immunotherapeutic vaccine designed to treat patients suffering from chronic hepatitis B virus ("HBV") infection.

• Ascendis Pharma Launches SKYTROFA® (lonapegsomatropin) in Germany for the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency

  9/15/2023

  Ascendis Pharma A/S (Nasdaq: ASND) today announced the launch in Germany of SKYTROFA® (lonapegsomatropin), its growth hormone approved in the European Union for the once-weekly treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD).