Leukogene Therapeutics’ Lead Asset Granted Orphan Drug Designation

On November 26, 2025 Leukogene Therapeutics Inc. (LTI), a biopharmaceutical company developing next-generation immunotherapies for hematologic and other malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s lead product candidate, M2T-CD33 (LTI-214), for the treatment of Acute Myeloid Leukemia (AML).

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This designation underscores the significant unmet medical need for AML patients and recognizes the therapeutic potential of LTI-214 as a novel and differentiated approach for this aggressive blood cancer. The designation may provide LTI with a range of development incentives, including eligibility for tax credits on qualified clinical trial costs, waiver of certain FDA fees, and U.S. market exclusivity upon approval.

"We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation," said Dr. Sandeep Gupta, CEO of Leukogene. "AML remains one of the most challenging hematologic cancers, and outcomes for relapsed or refractory patients remain poor. The LTI-214 program embodies our commitment to advancing new immunotherapy approaches that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML."

Nathan Dolloff, PhD, Founder and CSO of Leukogene stated, "This is an important step forward for Leukogene and the company’s Major Histocompatibility Complex Class II (MHCII) engager technology. The M2T platform is a completely new approach to cancer immunotherapy and the endorsement from FDA is a testament to its high impact potential."

(Press release, Leukogene Therapeutics, NOV 26, 2025, View Source [SID1234660971])

Galmed Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update

On November 26, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, reported financial results for the three and nine months ended September 30, 2025 and recent developments.

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Financial Summary – Third Quarter 2025 vs. Third Quarter 2024

Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $19.2 million as of September 30, 2025, compared to approximately $15.4 million at December 31, 2024.
Net loss amounted to approximately $2.0 million, or $0.33 per share, for the three months ended September 30, 2025, compared to a net loss of approximately $1.9 million, or $2.31 per share, for the three months ended September 30, 2024.
Research and development expenses amounted to approximately $1.1 million for the three months ended September 30, 2025, compared to approximately $0.7 million for the three months ended September 30, 2024. The increase resulted primarily from clinical and pre-clinical studies expenses.
General and administrative expenses amounted to approximately $1.0 million for the three months ended September 30, 2025, compared to approximately $1.3 million for the three months ended September 30, 2024. The decrease resulted primarily from decrease in salaries and benefit expenses.
Financial income, net amounted to approximately $0.2 million for the three months ended September 30, 2025, compared to financial income of $0.1 million for the three months ended September 30, 2024.
Recent Business Updates

On November 17, 2025, Galmed announced top-line results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol’s effect on overcoming drug resistance in gastrointestinal (GI) cancers, which showed that a 3-drug combination of Aramchol, Stivarga and Metformin significantly enhanced gastrointestinal tumor cells, killing in-vivo and in-vitro
On November 18, 2025, Galmed announced meaningful top-line results from its AM-001 Study, a Phase 1 bioavailability study of Aramchol Meglumine
During 2025, Galmed raised approximately $9.3 million through its equity line and ATM facilities.

(Press release, Galmed Pharmaceuticals, NOV 26, 2025, View Source [SID1234660970])

Bristol Myers Squibb to Participate in Citi’s 2025 Global Healthcare Conference

On November 26, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in Citi’s 2025 Global Healthcare Conference on Thursday, December 4, 2025.

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The company will take part in a fireside chat beginning at 9:00 a.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

(Press release, Bristol-Myers Squibb, NOV 26, 2025, View Source [SID1234660969])

BioNTech Shares Progress on Exchange Offer for CureVac Shares and Highlights December 3, 2025, at 9:00 a.m. Eastern Time Expiration

On November 26, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported the approval of matters relating to the exchange offer (the "Offer") for all outstanding shares of CureVac N.V. (Nasdaq: CVAC, "CureVac") at the extraordinary general meeting ("EGM") held by CureVac on November 25, 2025. At the EGM, over 99.16% of votes cast by CureVac shareholders were in favor of the proposals relating to the Offer. BioNTech expects to complete the pending Offer as soon as reasonably practicable.

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CureVac shareholders are advised to tender their shares by 6:00 p.m. Eastern Time on Tuesday, December 2, 2025, to ensure processing before the scheduled expiration time of 9:00 a.m. Eastern Time on Wednesday, December 3, 2025. Although the Offer technically expires at 9:00 a.m. Eastern Time on December 3, 2025, operational deadlines at the Depository Trust Company and the exchange agent require shares to be tendered by 6:00 p.m. Eastern Time on December 2, 2025. No guaranteed delivery procedures apply.

Assuming that the Offer expires at 9:00 a.m. Eastern Time on December 3, 2025, the exchange ratio (the "Exchange Ratio") is 0.05363 of a BioNTech ADS per CureVac share. This calculation of the Exchange Ratio is based on the volume weighted average price of a BioNTech ADS as reported on Nasdaq for each of the 10 consecutive trading days ending on, and including, November 25, 2025, or $101.88. If the Offer is extended, BioNTech will recalculate the Exchange Ratio based on the later expected final expiration time and announce the new exchange ratio by issuing a press release.

Shareholders of CureVac who hold shares through a brokerage firm, bank or other nominee should tender their shares by providing instructions to their broker, bank or other nominee. Other CureVac shareholders may tender their shares by following the instructions provided in the Letter of Transmittal circulated on October 21, 2025. CureVac shareholders who have questions or requests for assistance should contact Georgeson LLC, the Information Agent for the Offer, by phone at +1 (888) 686-7195 (toll free) or +1 (732) 353-1948 (collect), or via email at [email protected] the time of acceptance for exchange of tendered CureVac shares by BioNTech in connection with the Offer, BioNTech will provide a subsequent offering period in accordance with Rule 14d-11 promulgated under the Securities Exchange Act of 1934 (as amended, the "Exchange Act"), of not less than 10 business days (calculated in accordance with Rule 14d-1(g)(3) under the Exchange Act) (the "Subsequent Offering Period").

The Offer is conditioned upon receipt by BioNTech of a number of CureVac shares having been validly tendered and not properly withdrawn that would allow BioNTech to acquire at least 80% of the issued and outstanding CureVac shares at the closing of the Offer (the "Minimum Condition"). If all of the Offer conditions have been met besides the Minimum Condition, and BioNTech has extended the Offer on four or more occasions, BioNTech may elect to reduce the Minimum Condition to 75% of the issued and outstanding CureVac shares, in which case the Offer shall be extended for at least ten business days.

As promptly as practicable following the expiration of the Subsequent Offering Period, the parties shall initiate the post-offer reorganization. If all conditions are satisfied or waived, the post-offer reorganization will result in non-tendering holders of CureVac shares receiving BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization (rather than the Offer). Non-tendering holders of CureVac shares who receive BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization generally will be subject to a 15% Dutch dividend withholding tax.
With respect to the public offering of BioNTech ADSs to the shareholders of CureVac in Austria, Germany, France, Italy, the Netherlands and Spain made under the EU Prospectus (as referred to below), the announcement of the Exchange Ratio constitutes a pricing notice for the purposes of Article 17 of Regulation (EU) 2017/1129, as amended.

(Press release, BioNTech, NOV 26, 2025, View Source [SID1234660968])

Arvinas to Present at Piper Sandler 37th Annual Healthcare Conference

On November 26, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Noah Berkowitz, M.D., Ph.D., Chief Medical Officer, and Andrew Saik, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4 at 11:00 a.m. ET in New York.

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A live audio webcast of the presentation will be available here and on the Events and Presentations section of the Company’s website.

(Press release, Arvinas, NOV 26, 2025, View Source [SID1234660967])