Clover Vaccine: Strong Cross-Neutralization Against Omicron as Booster

  Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced new positive clinical data in individuals vaccinated with a third dose of SCB-2019 (CpG 1018/Alum) as a homologous booster against the Omicron variant. A homologous booster dose of SCB-2019 (CpG 1018/Alum) demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants.

https://finance.yahoo.com/news/clover-covid-19-vaccine-candidate-100400336.html

Acutus: FDA Clearance, Commercial Launch of AcQCross™ Line Extension

 Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the commercial launch of an expanded suite of left-heart access products to now include the AcQCross™ Qx system for use with the TruSeal (TM) and FXD(TM) delivery system for the Watchman™ LAAC Device.

Gaining access to the left atrium requires physicians to cross the septum, a multi-step process that often involves the exchange of wires and needles while trying to achieve the proper angle and location on the septum. AcQCross is the first and only transseptal system engineered with an integrated needle and dilator to reduce these exchanges. US Left-atrial appendage closure procedures are expected to total over 50,000 in 2022, according to the Millennium Research Group. With this clearance, Acutus now offers sheath-compatible transseptal access devices that cover 409,000 electrophysiology and structural heart procedures in the US.

https://finance.yahoo.com/news/acutus-medical-announces-fda-clearance-100000088.html

Vir: New Clinical Data From Broad Hepatitis B Program

 – Results from ongoing trials of VIR-2218 and VIR-3434 presented at the International

Liver Congress™ (ILC) 2022 demonstrate durable reductions in hepatitis B surface antigen with no safety signals –

– Company expects to dose first patient in Part B of the Phase 2 MARCH trial by the end of June –

https://finance.yahoo.com/news/vir-biotechnology-announces-clinical-data-110000962.html

Nuvation: FDA Partial Clinical Hold for Phase 1 Study

 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

https://finance.yahoo.com/news/nuvation-bio-announces-fda-partial-110000284.html

Axsome Shares Rally Premarket on Proposed AXS-05 Labeling

 Shares of Axsome Therapeutics Inc. jumped more than 30% in premarket trading Monday after the biopharmaceutical company reported a positive development in its efforts to secure U.S. Food and Drug Administration approval of AXS-05 for the treatment of major depressive disorder.

In a brief filing with the U.S. Securities and Exchange Commission, the New York company said it received proposed labeling for AXS-05 from the FDA.

Axsome said it is reviewing the proposed labeling and will reply to the FDA to secure final agreement.

The FDA had previously set an August 2021 target action date for the application, but Axsome last year said the agency had flagged deficiencies with the application that precluded the discussion of labeling and post-marketing requirements and commitments, raising fears the agency might reject the application.

While the FDA missed the target action date, its review of Axsome's application has continued, and Axsome in April said it had agreed to post-marketing requirements and commitments proposed by the agency, and that it expected the FDA could act on its application during the second quarter.

https://www.morningstar.com/news/dow-jones/202206273038/axsome-shares-rally-premarket-on-proposed-axs-05-labeling

Stealth Bio Gets Non-Binding Proposal

 Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that its Board of Directors (the "Board") has received a preliminary non-binding proposal letter dated June 24, 2022 (the "Proposal Letter") from Morningside Venture (I) Investments Ltd. for itself and on behalf of its affiliates ("Morningside") and J. Wood Capital Advisors LLC ("J. Wood Capital") to acquire all outstanding ordinary shares (the "Shares") of the Company not already beneficially owned by Morningside, including Shares represented by American Depositary Shares of the Company (the "ADSs", each representing 12 Shares), in a going-private transaction (the "Proposed Transaction") for US$0.026 in cash per Share and US$0.313 in cash per ADS. A copy of the Proposal Letter is attached hereto as Exhibit A. The Board previously formed a committee of three independent directors (the "Special Committee"), consisting of Mr. Kevin McLaughlin, Dr. Francis Chen, and Dr. Lou Lange to, among other authority delegated to the Special Committee, evaluate all strategic alternatives available to the Company. The Special Committee expects to retain a financial advisor to assist with its evaluation of the Proposed Transaction or any alternative transaction the Company may pursue. Consistent with the powers granted by the Board, the Special Committee will evaluate the Proposed Transaction and all other strategic alternatives available to the Company.

https://finance.yahoo.com/news/stealth-biotherapeutics-corp-announces-receipt-113000445.html

Reliance in Talks to Raise Up to $8 Billion for Boots

 Reliance Industries Ltd. is in talks with several global banks to raise as much as $8 billion for its planned leveraged buyout of Walgreens Boots Alliance’s international arm, according to a report from Mint on Sunday. 

The report, which cited two people familiar with the discussions, said that Reliance is in talks with Barclays Bank Plc, Deutsche Bank AG, HSBC and Standard Chartered Bank to buy the Boots drugstore chain.

https://www.bloomberg.com/news/articles/2022-06-26/reliance-in-talks-to-raise-up-to-8-billion-for-boots-mint-says