On November 14, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its participation in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).

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A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

(Press release, Cogent Biosciences, NOV 14, 2025, View Source [SID1234659966])

On November 14, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Cidara Therapeutics, Inc. (Nasdaq: CDTX) ("Cidara"), a biotechnology company developing drug-Fc conjugate (DFC) therapeutics, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Cidara for $221.50 per share in cash, for a total transaction value of approximately $9.2 billion.

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"We continue to execute our science-led business development strategy, augmenting our pipeline with CD388, a potentially first-in-class, long-acting antiviral designed to prevent influenza in individuals at higher risk of complications," said Robert M. Davis, chairman and chief executive officer, Merck. "We intend to build on the Cidara team’s remarkable progress, and are confident that CD388 has the potential to be another important driver of growth through the next decade, creating real value for shareholders."

Cidara’s lead candidate, CD388, consists of a small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody designed to prevent influenza A and B. CD388 is currently being evaluated in the Phase 3 ANCHOR study (NCT07159763) among adult and adolescent participants who are at higher risk of developing complications from influenza. Supported by results from the Phase 2b NAVIGATE study (NCT06609460), the U.S. Food and Drug Administration (FDA) granted CD388 Breakthrough Therapy Designation. The NAVIGATE study met all primary and secondary endpoints associated with preventing symptomatic laboratory-confirmed influenza in healthy unvaccinated adults ages 18 to 64. CD388 was previously granted Fast Track Designation by the FDA.

"This milestone represents a transformational moment for Cidara and for our mission to redefine influenza prevention," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Thanks to the extraordinary dedication of our team, the Phase 2b NAVIGATE study delivered compelling results that demonstrate CD388’s potential to provide an additional option to vaccines and antivirals to help address unmet needs in influenza prevention. Merck’s global development, regulatory, and commercial capabilities provide the expertise and resources needed to bring this important innovation to those individuals who need it most."

"This acquisition expands and complements our respiratory portfolio and pipeline. Influenza continues to pose a significant global health threat, causing widespread illness, morbidity, and death each year especially in older adults and immunocompromised individuals, such as those with cancer and chronic diseases," said Dr. Dean Y. Li, president, Merck Research Laboratories. "CD388 is a novel late-phase candidate with important strain agnostic properties being evaluated for the prevention of symptomatic influenza in high-risk individuals."

The transaction has been approved by both Merck’s and Cidara Therapeutics’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Cidara Therapeutics. The acquisition is subject to a majority of Cidara Therapeutics’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the first quarter of 2026 and is expected to be accounted for as an asset acquisition.

A copy of the merger agreement pursuant to the transaction will be filed with the Securities and Exchange Commission ("SEC") and will be publicly available. In addition, Merck and Cidara will file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Merck’s internet website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or by phone at (908) 740-4000. Copies of the documents filed with the SEC by Cidara Therapeutics may be obtained at no charge from Cidara Therapeutics’ internet website at www.cidara.com or by contacting Cidara at 6310 Nancy Ridge Dr #101, San Diego, CA 92121 or by phone at (858) 283-8821.

Investor Call

Merck will hold an investor call Monday, November 17, 2025 at 8 a.m. ET to discuss the proposed transaction. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink. Additional details to join the call via dial in will be provided at a later time.

About Influenza

Influenza is an acute respiratory infection caused predominantly by influenza viruses A and B. An estimated 1 billion people worldwide are infected by seasonal influenza each year. Of the 1 billion, 3-5 million have severe cases of flu. Complications include pneumonia, exacerbation of chronic conditions, sepsis, myocarditis, encephalitis, and death in the most severe cases. Globally, an estimated 290,000-650,000 deaths occur due to flu each year with 6,300-52,000 deaths in the US.

About CD388

CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to prevent influenza infection in individuals at higher risk of influenza complications with the potential to provide season-long protection. CD388 is not a vaccine, therefore its activity is not dependent on an immune response and is expected to be efficacious in individuals regardless of immune status.

The ANCHOR study

The ANCHOR study (NCT07159763) is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of CD388, a novel long-acting antiviral conjugate, for the prevention of influenza in adults and adolescents at higher risk of developing influenza complication. The first participants were dosed in September 2025 and enrollment is ongoing in 150 sites in the Northern Hemisphere across the U.S. and the United Kingdom. The study has a target enrollment of 6,000 participants. The study will include an interim analysis in the first quarter of 2026 to assess the trial size and powering assumptions and to determine the potential need for additional enrollment.

(Press release, Cidara Therapeutics, NOV 14, 2025, View Source [SID1234659965])

On November 13, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.

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"The FDA’s acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs," said Dr. Celine Wilke, chief medical officer of ITM. "In the Phase 3 COMPETE trial, 177Lu-edotreotide demonstrated extended PFS, a straightforward dosing regimen, and a favorable safety profile, supporting its potential to improve the current treatment paradigm. We look forward to working closely with the FDA toward potential approval."

The NDA submission for 177Lu-edotreotide is supported by results from the Phase 3 COMPETE study, a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs as a first- or second-line treatment. The trial met its primary endpoint, revealing a significantly longer median mPFS in patients treated with agent177Lu-edotreotide compared to everolimus, a targeted molecular therapy. Patients treated with 177Lu-edotreotide also demonstrated a significantly higher ORR compared to everolimus.

"This milestone reflects more than 20 years of leadership and dedication to advancing the radiopharmaceutical field, built on our global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics," said Dr. Andrew Cavey, chief executive officer of ITM. "Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers."

About the COMPETE Trial

The COMPETE trial (NCT03049189) evaluated177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus.177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors.

(Press release, ITM Isotopen Technologien Munchen, NOV 13, 2025, View Source [SID1234661164])

On November 13, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended September 30, 2025, and provided a corporate update.

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"Our productive engagement with the European Medicines Agency (EMA) highlighted by confirmation of eligibility to submit for a conditional marketing authorization marks a significant step forward in our global regulatory strategy, bringing us closer to potential approval and commercialization of iopofosine I-131 for WM in 2027. In parallel, additional data from the CLOVER WaM study and the receipt of breakthrough designation from the FDA continues to support a path toward a New Drug Application for accelerated approval," stated James Caruso, president and CEO of Cellectar. "We believe this regulatory pathway, combined with the compelling clinical results we’ve seen to date, reinforces the value of iopofosine and positions it as a highly attractive asset for collaboration or strategic partnership.

"Looking ahead, we are excited to further advance our promising radioconjugate pipeline of auger- and alpha-emitting drug candidates and have initiated a Phase 1b trial for CLR 125 in triple-negative breast cancer, which builds on strong preclinical data showing reduction or inhibition of solid tumor growth. We are also progressing our early-stage asset, CLR 225, which has shown robust anti-tumor activity in pancreatic cancer models, and has recently completed IND-enabling studies. Each of these achievements brings us closer to our goal of transforming the outlook for patients facing aggressive and life-threatening cancers," concluded Mr. Caruso.

Third Quarter and Subsequent Corporate Highlights

Advised by the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) that filing for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for CMA.
Plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of iopofosine I 131 as a treatment for WM once the confirmatory trial is underway, which is subject to sufficient funding.

The Phase 3 study for iopofosine I 131, a potentially first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory WM will be a comparator, randomized controlled study with approximately 100 patients per arm with full patient enrollment projected within 18-24 months of the first patient admitted to the study.
The Company has received clearance for its Investigational New Drug application for CLR 125, the Company’s lead Auger-emitting (iodine-125) PRC for a Phase 1b/2a dose finding study in triple-negative breast cancer. CLR 125 provides the greatest precision in targeted radiotherapy as emissions only travel a few nanometers.
The Company announced a partnership with Evestia Clinical to provide CRO services to support their upcoming Phase 1b study evaluating CLR 125 for the treatment of triple-negative breast cancer (TBNC).
Received rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).

Interim data from the Phase 1b dose and optimization study, CLOVER-2, was highlighted in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer. Results showed extended progression-free survival along with overall survival, and iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data.
Presented preclinical data from CLR 121225 (CLR 225), a novel actinium-based radio conjugate alpha-emitter for treatment of hypoxic pancreatic ductal adenocarcinoma (PDAC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer Research. In three separate pancreatic cancer xenograft models, CLR 225 demonstrated inhibition of tumor growth or reduction in tumor volume, dependent on dose, with potential survival benefit following treatment.

The Company has entered into a supply agreement with ITM Isotope Technologies Munich (ITM) for Actinium-225 (Ac-225), which will support clinical development of Cellectar’s actinium-labeled compound CLR 225.
CLR 225 has completed the required Investigational New Drug (IND)-enabling studies and the company maintains the option to move into a Phase 1 study. Previous data from CLR 225 has demonstrated activity in multiple solid tumor animal models, including pancreatic, colorectal and breast cancer.
Raised approximately $12.7 million. These funds will be used to advance the Company’s TNBC study and to complete the EMA Conditional Marketing Authorization application for iopofosine I 131 for WM.
Third Quarter 2025 Financial Highlights

Cash and Cash Equivalents: As of September 30, 2025, the company had cash and cash equivalents of $12.6 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of September 30, 2025, is adequate to fund its budgeted operations into the third quarter of 2026. Following the close of the third quarter in October 2025, several institutional investors exercised certain existing warrants for gross proceeds to the company of approximately $5.8 million prior to deducting placement agent fees and estimated offering expenses.
Research and Development Expenses: R&D expenses for the three months ended September 30, 2025, were approximately $2.5 million, compared to approximately $5.5 million for the three months ended September 30, 2024. The overall decrease was primarily a result of reduced clinical trial costs.

General and Administrative Expenses: G&A expenses for the three months ended September 30, 2025, were approximately $2.3 million, compared to approximately $7.8 million for the same period in 2024. The decrease was primarily driven by lower commercialization and personnel costs.

Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2025, was $4.4 million, or $1.41 per basic and diluted share, compared to a net loss of $14.7 million, or $11.18 per basic and $12.13 per diluted share in the three months ended September 30, 2024.

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, November 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, NOV 13, 2025, View Source [SID1234661043])

On November 13, 2025 Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) ("Fennec" or the "Company"), a specialty pharmaceutical company, reported that it intends to offer and sell its common shares in an underwritten registered public offering. In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares sold in the public offering.

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Fennec intends to use the net proceeds of the proposed offering to repurchase and redeem certain indebtedness and the remaining net proceeds, if any, for working capital and general corporate purposes.

Piper Sandler & Co. and Craig-Hallum Capital Group LLC are acting as the joint book-running managers for the proposed public offering.

The common shares are being offered by the Company pursuant to a registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus, when filed with the SEC, may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, by telephone at (800) 747-3924 or by email at [email protected] and Craig-Hallum Capital Group LLC, Attention: Equity Capital Markets, 323 North Washington Ave., Minneapolis, MN 55401, by telephone at (612) 334-6300 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy common shares, nor shall there be any sale of common shares, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The common shares in the proposed offering will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

(Press release, Fennec Pharmaceuticals, NOV 13, 2025, View Source [SID1234660017])