Cogent Biosciences Announces Participation in the Jefferies Global Healthcare Conference

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

Merck to Acquire Cidara Therapeutics, Inc., Diversifying Its Portfolio to Include Late-Phase Antiviral Agent

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

Merck Q3 2025 results

On November 13, 2025 Merck KGaA reported third quarter 2025 results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, Merck KGaA, NOV 13, 2025, View Source [SID1234661674])

Q3 2025: Merck Shows Solid Organic Growth Across All Sectors

On November 13, 2025 Merck, a leading science and technology company, reported solid organic growth in the third quarter of 2025. This performance demonstrates resilience amid geopolitical uncertainty and strong currency headwinds. Growth was mainly driven by Process Solutions in the Life Science business sector, Rare Diseases in Healthcare, and Semiconductor Solutions in Electronics. The company confirms its guidance for the full year 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Net sales of the Group grew by 1.0% compared with the year-earlier quarter to € 5.3 billion. Negative currency headwinds of –4.9% were offset by organic growth of 5.2%. EBITDA pre rose by 3.1% to € 1.7 billion with strong organic growth of 8.8% exceeding negative foreign exchange effects of –6.5%. The EBITDA pre margin increased by 0.7 percentage points to 31.4%. Favorable one-time effects, including from local legislative changes in South America and the sale of a priority review voucher from the U.S. Food and Drug Administration (FDA), supported this high margin. Earnings per share pre reached € 2.32 and were thus approximately at the level of the year-earlier quarter (Q3 2024: € 2.30).

"We delivered solid organic growth across all three business sectors, illustrating the resilience of our diversified portfolio against significant external headwinds. As we confirmed at our recent Capital Markets Day, our powerful value drivers and cashgenerating businesses are poised to create sustainable value for years to come," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "We remain focused on disciplined execution of our strategy. Our recent agreement with the U.S. administration will further strengthen our presence in this highly attractive market, while providing affordable access to innovative fertility treatments to families with the dream of having children."

In October 2025, Merck agreed with the U.S. administration to expand access to its portfolio of in vitro fertilization therapies in the United States. The company has also entered into an agreement with the U.S. Secretary of Commerce to exclude its pharmaceutical products and ingredients from Section 232 tariffs, provided it invests in future biopharmaceutical manufacturing and research in the country. To further expand therapeutic options for patients with complex fertility issues, Merck will also file Pergoveris for accelerated review under the U.S. FDA Commissioner’s National Priority Voucher program.

(Press release, Merck KGaA, NOV 13, 2025, View Source [SID1234661673])

ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])