On March 6, 2026 Foresee Pharmaceuticals (6576.TWO), ("Foresee") reported that it has received notification from its licensing partner, Accord Healthcare, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending granting an extension of the marketing authorization for CAMCEVI to include a new 21 mg, 3-month ready-to-use strength of the long-acting injectable formulation for the treatment of advanced prostate cancer.

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This CHMP positive opinion is a regulatory milestone for patients living with advanced prostate cancer and the healthcare providers who treat them. CAMCEVI 21 mg is a ready-to-use subcutaneous leuprolide injection that eliminates the complex, multi-step mixing procedures required by traditional therapies. By offering a convenient 3-month dosing interval, CAMCEVI 21 mg complements CAMCEVI 42 mg by providing more options for stakeholders, streamlining the administration process for clinical staff, and also enhancing patient comfort and treatment compliance.

The European Commission (EC), which has the authority to approve medicine for the European Union, will now review the CHMP recommendation. A final decision regarding marketing authorization is expected in the second quarter of 2026.

Under the partnership framework, CAMCEVI is exclusively licensed to Accord Healthcare for commercialization across the European market. The anticipated approval of the CAMCEVI 21 mg 3-month strength will build upon the commercialization of the CAMCEVI 42 mg (6-month formulation), which officially launched in Europe in 2025.

(Press release, Foresee Pharmaceuticals, MAR 6, 2026, View Source [SID1234663340])

On March 6, 2026 Incyte (Nasdaq:INCY) reported that the European Commission (EC) has approved Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

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"The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades," said Bill Meury, President and Chief Executive Officer, Incyte. "As the first PD-1 immunotherapy approved in Europe in combination with platinum-based chemotherapy in the first-line setting, Zynyz helps expand the standard-of-care options available to clinicians and underscores our commitment to delivering innovative medicines that can have an impact for patients."

The EC decision follows the January 2026 positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This marks the second indication in Europe for Zynyz, which was previously approved by the EC as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

This approval is based on data from the Phase 3 POD1UM-303/InterAACT2 trial (NCT04472429) evaluating Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.1

Results from the trial, also published in The Lancet, demonstrated a statistically significant 37% reduction in the risk of progression or death (P=0.0006).1 Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.1 Clinically meaningful improvement was also demonstrated for all secondary efficacy endpoints, including the key secondary endpoint of overall survival. No new safety signals were identified, and the safety profile was representative of other combinations with PD-1 inhibitors and chemotherapy. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy.1 The most frequent serious adverse reactions (≥ 2% of patients) were sepsis, pulmonary embolism, diarrhea and vomiting.1

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases.2 It is a rare disease for which the incidence increases approximately 3% per year, with an estimated prevalence at around 1 or 2 cases per 100,000 people.3,4,5,6 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.5 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.7,8 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.9

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors.

For more information about the study, please visit View Source

About Zynyz (retifanlimab)

Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in the U.S and Japan and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S., EU, Canada and Switzerland.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

For more information, see the Zynyz SmPC.

(Press release, Incyte, MAR 6, 2026, View Source [SID1234663341])

On March 6, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported the publication of preclinical data describing the discovery and characterization of BBO-11818, a panKRAS inhibitor targeting KRAS in both the ON and OFF states, with significant therapeutic potential for patients with KRAS mutant cancers. The publication, titled "Discovery of BBO-11818, a Potent and Selective Non-covalent Inhibitor of (ON) and (OFF) KRAS with Activity Against Multiple Oncogenic Mutants" was published in the peer-reviewed journal Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper).

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"While advances with current KRASG12C inhibitors have shown promising clinical efficacy, there are currently no approved targeted therapies for most clinically significant KRAS mutants, including KRASG12D and KRASG12V," said Pedro J. Beltran, PhD, Chief Scientific Officer of BBOT. "To address this significant unmet need, we developed BBO-11818 as a potent panKRAS inhibitor with strong binding affinity for KRAS and broad selectivity over HRAS and NRAS, designed to achieve high levels of KRAS inhibition in both the ON and OFF states. BBO-11818 has the potential to be used as a monotherapy treatment, or in combination with standard-of-care therapies, as well as with our RAS:PI3Kα breaker, BBO-10203. These preclinical data underscore the strength of our platform and highlight the promise of BBO-11818 as a foundational therapy that could meaningfully reshape the treatment landscape for KRAS driven tumors."

The preclinical findings in this publication highlight the key properties BBO-11818 and its potential to address critical limitations associated with other compounds targeting mutant KRAS. Unlike several existing inhibitors that primarily target the inactive GDP-bound state, BBO-11818 potently binds and inhibits KRAS in both its ON and OFF states, as demonstrated through structural analysis, surface plasmon resonance, and functional assays. By targeting the active state of KRAS, BBO-11818 may overcome a critical resistance mechanism observed with current KRAS inhibitors, in which tumors upregulate KRAS expression or activate upstream signaling to sustain pathway activation.

Data demonstrate potent activity against multiple clinically relevant KRAS mutants, including KRASG12D, KRASG12V, and KRASG12C, with high selectivity for KRAS, exhibiting >500-fold selectivity over other RAS isoforms. BBO-11818’s activity across a broad range of KRAS mutants is designed to help prevent the emergence of resistance driven by secondary activating KRAS mutations that can limit the efficacy of allele-specific inhibitors. In addition, its high specificity for KRAS may support improved tolerability and greater potential for combination with other therapeutic agents. Monotherapy studies show robust anti-tumor activity across multiple in vitro and in vivo models of KRAS mutant solid tumors, including colorectal, pancreatic, and lung cancers. BBO-11818 also demonstrated strong combination potential with immune checkpoint inhibitors, anti-EGFR antibodies, and BBO-10203, the company’s RAS:PI3Kα breaker compound.

"The discovery and development of BBO-11818 reflect the exceptional collaboration between the BBOT team and our colleagues at Frederick National Lab," said Frank McCormick, PhD, FRS, BBOT Board Director, Advisor to the National Cancer Institute’s RAS Initiative at Frederick National Laboratory for Cancer Research, and Professor of Tumor Biology and Cancer Research at UCSF. "We are incredibly proud of what we’ve accomplished together and are hopeful that our collective efforts will ultimately lead to meaningful improvements in patient outcomes."

BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial (NCT06917079) in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. Initial Phase 1 monotherapy data were announced in January 2026, demonstrating encouraging early anti-tumor activity across dose levels and tumor types, including a confirmed partial response in a patient with pancreatic ductal adenocarcinoma (PDAC) with a 56% tumor reduction. The company plans to provide additional data updates in the second half of 2026 and to study the combination of BBO-11818 with BBO-10203 later in 2026.

The discovery and preclinical characterization of BBO-11818 is the result of a collaborative effort between BBOT, the RAS Initiative at Frederick National Laboratory, and Lawrence Livermore National Laboratory.

About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS mutant preclinical models, including KRASG12D and KRASG12V. In addition, it potently suppresses MAPK signaling and inhibiting cell proliferation in KRAS mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

(Press release, BridgeBio Oncology Therapeutics, MAR 6, 2026, View Source [SID1234663342])

On March 6, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that it has entered into a definitive agreement to be acquired by Kuva Labs Inc. ("Kuva"), a privately-held company.

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Details of the Transaction

Under the terms of the merger agreement, Kuva will commence a tender offer to acquire all the issued and outstanding shares of common stock of the Company for $5.00 per share in cash payable at closing plus one contingent value right ("CVR") per share (the "Transaction"). The CVR entitles the holders of record to receive an additional cash payment of $1.00 per share if a New Drug Application or similar registration is filed or formally accepted for review by the FDA or any governmental authority in any jurisdiction with respect to any pharmaceutical product that contains or incorporates the product candidate referred to as of the date of the merger agreement as certepetide for any indication or patient population prior to the earlier of (a) 11:59 p.m. New York City Time on the seventh (7th) anniversary of the closing date, and (b) termination of the CVR agreement. Should the relevant milestone not be met, then no additional consideration will be payable to the holders of the CVRs in relation to such milestone.

The Transaction is subject to customary offer conditions contained in the merger agreement that will be filed with the SEC, including the tender of a majority of the outstanding shares of the Company’s capital stock. The merger agreement does not include a financing condition. The Transaction is expected to close in the second quarter of 2026, subject to satisfaction of the offer conditions. If the tender offer closes, then Kuva would acquire the untendered shares and convertible securities of the Company through a second-step merger for the same consideration.

Following completion of the Transaction, Lisata will become part of Kuva, a privately-held company, and its common stock will be delisted from the Nasdaq Capital Market. Lisata will also apply to deregister its common stock and cease to be a reporting company under the United States Securities Exchange Act of 1934, as amended.

Board of Directors Recommendation

Following a comprehensive strategic review and thorough evaluation conducted with the assistance of its independent legal and financial advisors, the Lisata board of directors has unanimously determined that the definitive agreement and the transactions contemplated thereby are advisable, fair to, and in the best interests of Lisata and its stockholders. The board of directors has duly authorized and approved the execution and delivery of the merger agreement and unanimously recommends that all stockholders accept the offer and tender their shares.

Advisors

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Lisata and H.C. Wainwright & Co. acted as financial advisor to Lisata. Goodwin Procter LLP is acting as legal counsel to Kuva.

(Press release, Lisata Therapeutics, MAR 6, 2026, View Source [SID1234664401])

On March 6, 2026 Servier, an independent international pharmaceutical group governed by a foundation, and Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported that they have entered into a definitive agreement for Servier to acquire Day One for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The transaction remains subject to customary closing conditions and is expected to close in the second quarter of 2026.

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This acquisition will reinforce Servier’s position in oncology targeted therapies in line with its 2030 ambition to develop innovative treatments for patients with high unmet medical needs. It strengthens Servier’s portfolio and expands its oncology pipeline with programs ranging from early stage to phase 3. The combination of Day One’s scientific expertise with Servier’s established global capabilities advances a shared commitment to delivering innovative solutions for patients worldwide.

"This acquisition of Day One Biopharmaceuticals marks another decisive step in strengthening Servier’s position in rare oncology," said Olivier Laureau, President of Servier. "It reflects our long-term commitment to investing in science that can make a meaningful difference for patients. This announcement is fully aligned with our 2030 ambition, and we believe that combining our expertise will accelerate innovation for people living with a rare cancer."

"Servier’s successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One’s mission to bring medicines to patients of all ages with life threatening diseases" said Jeremy Bender, Ph.D., chief executive officer of Day One. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma. Importantly, Servier’s dedication to the rare disease community preserves the patient-first mindset that has defined our company since the beginning and has driven our deep commitment to the communities we serve."

Transaction terms

Under the terms of the merger agreement, Servier will commence a cash tender offer to acquire all of the issued and outstanding shares of Day One’s common stock for $21.50 per share in cash, representing a total equity value of approximately of $2.5 billion. The offer price represents a premium of approximately 68% over the closing price of Day One on March 5, 2026, and a premium of approximately 86% over the one-month volume weighted average price (VWAP) of Day One as of March 5, 2026.

Servier expects to fund the transaction through existing cash and investments.

The consummation of the tender offer is subject to certain customary closing conditions, including the tender by Day One shareholders of at least a majority of the issued and outstanding shares of Day One common stock and the receipt of U.S. antitrust clearance. Upon the successful completion of the tender offer, Servier will acquire any shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer. Day One’s Board of Directors recommends that Day One shareholders tender their shares in the tender offer.

Advisors

Goldman Sachs Bank Europe SE is serving as exclusive financial advisor to Servier, and Baker McKenzie is serving as legal counsel. Centerview Partners LLC is serving as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel.

(Press release, Day One, MAR 6, 2026, View Source [SID1234663331])