Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia

NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia.

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Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia

Celularity Inc. Announces Receipt of Nasdaq Notification

FLORHAM PARK, N.J., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced that on November 21, 2024, the Company received notification from the Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company does not comply with the Nasdaq continued listing requirements due to the Company’s inability to timely file its Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Q3 Form 10-Q”). Nasdaq’s notice has no immediate effect on the listing of Celularity’s common stock and warrants, which continue to trade on the Nasdaq Capital Market under the symbols “CELU” and “CELUW,” respectively.

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Celularity Inc. Announces Receipt of Nasdaq Notification

HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement.

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HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms

MEDSIR, Featured Company at the Shanghai International Medical Oncology Symposium (7th SIMOS)

BARCELONA, Spain, Nov. 29, 2024 (GLOBE NEWSWIRE) -- MEDSIR, a leading company dedicated to advancing independent clinical research in oncology on an international level, participated in the 7th Shanghai International Medical Oncology Symposium (SIMOS) in China, one of the most prestigious academic events in the global oncology field. Through this, the company reaffirms its commitment to scientific advancement, improving breast cancer treatments worldwide, and fostering the exchange of knowledge across regions.

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MEDSIR, Featured Company at the Shanghai International Medical Oncology Symposium (7th SIMOS)

Rakovina Therapeutics Announces Increase in Private Placement Offering to $2.5 Million

VANCOUVER, British Columbia, Nov. 28, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV, the “Company” or “Rakovina Therapeutics”) a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies is pleased to announce that, in response to investor demand, the Company intends to increase the size of the previously announced $1.25 million non-brokered private placement (the “Offering”) to $2.5 million.

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Rakovina Therapeutics Announces Increase in Private Placement Offering to $2.5 Million

Oculis Publishes Notifications of Transactions by Persons Discharging Managerial Responsibilities and Persons Closely Associated

ZUG, Switzerland, Nov. 29, 2024 (GLOBE NEWSWIRE) -- The attached notifications relate to the vesting of earnout shares and associated removal of restrictions on these ordinary shares.

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Oculis Publishes Notifications of Transactions by Persons Discharging Managerial Responsibilities and Persons Closely Associated