Merck Announces First-Quarter 2024 Financial Results

On April 25, 2024 Merck & Co reported its First-Quarter 2024 Financial Results (Presentation, Merck & Co, APR 25, 2024, View Source [SID1234642450]).

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Astrazeneca reported its Q1 2024 results

On April 25, 2024 AstraZeneca reported a very strong start in 2024 with substantial Total Revenue growth of 19% in the first quarter (Press release, AstraZeneca, APR 25, 2024, View Source [SID1234642405]).

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Our strong pipeline momentum continued and already this year we announced positive trial results for Imfinzi and Tagrisso that were unprecedented in lung cancer, the data from both of these studies will be presented during the ASCO (Free ASCO Whitepaper) plenary in June. We are also looking forward to seeing the results of several other important trials throughout the year.

At our Annual General Meeting we were pleased to announce a 7% increase in the annual dividend, and at our Investor Day on 21 May 2024 we will outline the evolution of our company, underscoring our confidence in sustaining industry-leading growth.

Consolidated Financial Results for Year Ended March 31, 2024 (Fiscal 2023)

On April 25, 2024 Daiichi Sankyo reported its Consolidated Financial Results for Year Ended March 31, 2024 (Fiscal 2023) (Press release, Daiichi Sankyo, APR 25, 2024, View Source [SID1234642393]).

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Vincerx Pharma Announces Pricing of Underwritten Public Offering of Common Stock and Warrants

On April 25, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC) reported the pricing of an underwritten public offering of (i) 6,000,000 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 6,000,000 shares of common stock, and (ii) to certain investors, pre-funded warrants to purchase up to an aggregate of 16,000,000 shares of common stock and accompanying common stock warrants to purchase up to an aggregate of 16,000,000 shares of common stock (Press release, Vincerx Pharma, APR 25, 2024, View Source [SID1234642392]). Each share of common stock and accompanying common stock warrant are being sold together at a combined public offering price of $0.75, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined public offering price of $0.7499. Each pre-funded warrant will have an exercise price of $0.0001 per share and will be exercisable immediately after the original issue date until the pre-funded warrant is exercised in full. Each common stock warrant will have an exercise price of $1.00 per share, will be exercisable immediately after the original issue date and will expire 5 years from the date of issuance.

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All of the shares, pre-funded warrants and common stock warrants in the offering are being sold by Vincerx. The gross proceeds to Vincerx from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $16.5 million. The offering is expected to close on or about April 30, 2024, subject to customary closing conditions.

Leerink Partners is acting as the sole bookrunning manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-262239) that was declared effective by the Securities and Exchange Commission (the "SEC") on January 28, 2022. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at [email protected].

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.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

On April 25, 2024 Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, reported the approval to expand the use of vebreltinib (also referred to as PLB1001, APL-101, bozitinib, CBT-101) from the Chinese National Medical Products Administration (NMPA) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant Astrocytoma (World Health Organization grade 4) with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments (Press release, Avistone Pharmaceuticals, APR 25, 2024, View Source [SID1234642370]). This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration. In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.

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"The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma"

Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1]. Surgery, radiotherapy and chemotherapy are current standard treatment strategies for gliomas, and the prognosis is poor. The 5-year overall survival (OS) rate of patients with malignant glioma is less than 10% [2]. In previous studies in Chinese patients, about 12% of brain gliomas were found to have MET fusion [3]. Among the representative type PTPRZ1-MET fusion gene (hereinafter referred to as ZM fusion) occurs in about 14% of glioblastomas with a history of lower-grade disease, often co-occurring with MET Exon 14 skipping mutations and is associated with poor prognosis [3-4].

The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619). The FUGEN study is a randomized controlled, open label, multicenter clinical registration phase II/III study. This 84-patient study compared the efficacy and safety of vebreltinib with the dose-dense regimen of temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint. The median OS for the vebreltinib monotherapy regimen was 6.31 months, compared to 3.38 months for the control group, reducing the risk of death by 48% and significantly improving the survival of patients with recurrent relapsing ZM fusion glioma, with an acceptable safety profile.

"The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma," said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone.