Novartis agrees to acquire a pan-mutant-selective PI3Kα inhibitor, strengthening its breast cancer pipeline

On March 20, 2026 Novartis reported that it has entered into an agreement with Synnovation Therapeutics, LLC to acquire SNV4818, a pan-mutant‑selective PI3Kα inhibitor, exploring a next-generation approach for the treatment of patients with HR+/HER2- breast cancer and potentially other solid tumor indications.

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SNV4818 is an oral drug currently being evaluated in a Phase 1/2 study for breast cancer and other advanced solid tumors. The biology of mutated PI3Kα in HR+/HER2- breast cancer is well-understood, with approximately 40% of HR+/HER2- breast cancer patients potentially facing worse disease prognosis due to the presence of PIK3CA mutations in their tumors. The program is aligned with the Novartis commitment to developing treatments that improve the lives of patients with breast cancer. It fits naturally alongside CDK inhibitors as well as endocrine (hormonal) therapies as part of a potential combination regimen.

"While mutated PI3Kα is a well‑established driver in HR+/HER2‑ breast cancer, there remains a challenge in achieving effective pathway inhibition with a tolerable therapeutic profile," said Shreeram Aradhye, M.D., President of Development at Novartis. "SNV4818 applies new mutant‑selective chemistry to more precisely target tumor biology while sparing normal cells. This approach has the potential to translate proven biology into improved tolerability and more durable benefit for patients through precision medicine."

SNV4818 is designed to target the mutated PI3Kα enzyme found in cancer cells while sparing the wild-type (normal) PI3Kα in healthy cells. Available PI3Kα inhibitors block both mutant and wild-type PI3Kα, leading to tolerability challenges that make it difficult to keep patients on treatment. By focusing on the mutated form in tumors, SNV4818 aims to reduce unwanted side effects, support more consistent dosing, and make it easier to combine with hormonal therapy and other treatments earlier in care. Preclinical studies show strong activity against common PIK3CA mutations and clear selectivity over the normal enzyme, with clinical evaluation ongoing.

Transaction Details
Under the terms of the agreement, Novartis will pay USD 2 billion upfront and up to USD 1 billion in milestone payments to Synnovation Therapeutics, LLC to acquire Pikavation Therapeutics, Inc., a wholly- owned subsidiary of Synnovation that holds a portfolio of pan-mutant selective PI3Kα inhibitor programs, including SNV4818. The transaction is expected to close in H1 2026, subject to the satisfaction or waiver of customary closing conditions, including regulatory approvals.

(Press release, Novartis, MAR 20, 2026, View Source [SID1234663761])

Evotec Receives $10 M Milestone from Bristol Myers Squibb Protein Degradation Collaboration for Clinical Study Initiation

March 19, 2026 Evotec SE reported that its partner Bristol Myers Squibb (BMS) has initiated a Phase 1 clinical study evaluating CELMoD agent BMS-986506, a cereblon E3 ligase modulator, in clear cell renal cell carcinoma, the most common form of kidney cancer.

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Initiation of the first‑in‑human study represents a significant advancement in the strategic protein degradation collaboration, bringing into the clinic a novel CELMoD or ‘molecular glue’ candidate jointly generated through Evotec’s powerful and fully integrated drug discovery platform. This platform combines high-performance multi-omics screening with AI-enabled data analytics and drug design capabilities, selectively prompting cancer cells to eliminate disease‑driving proteins. As a result of this clinical progression, Evotec will receive a milestone payment of $10 million.

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec said:

"In this unique collaboration, we follow a systematic approach to discovering molecular glues with tremendous therapeutic potential. Together with Bristol Myers Squibb, and building on Evotec’s PanOmics and PanHunter platforms, we have identified a broad portfolio of high-potential molecular glue drug candidates that are now beginning to enter clinical development. The initiation of this Phase 1 clinical trial marks the first clinical milestone in the strategic protein degradation partnership with BMS. Molecular glues have the potential to address significant unmet medical need not only in oncology, but far beyond, by targeting previously undruggable, disease-causing proteins and thereby aiming to reshape future standards of care."

BMS-986506 was developed under the strategic protein degradation partnership between Evotec and Bristol Myers Squibb. The collaboration combines PanOmics, Evotec’s high-performance multi-omics screening platform as well as PanHunter, Evotec’s AI-supported data omics analytics platform with BMS’s industry-leading library of CELMoDs agents. Initiated in 2018 and expanded in 2022, the collaboration is continuing to deliver on its goal to identify novel molecular glue degraders for high-value targets in the field of oncology and beyond.

About Molecular Glue Degraders

Conventional small molecule therapeutics work via a drug-induced interference with a protein activity. This limitation to agonistic or antagonistic functions renders about 90% of proteins "undruggable". Conventional small molecules only work while they are actively binding to the receptor, which typically requires a treatment regimen consisting of one or even several carefully dosed medications every day.

Molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. The induced interaction results in ubiquitination and degradation of the recruited protein. This event-driven mechanism of action significantly expands the range of the druggable proteome. The molecular glue is not degraded in the process and can trigger the degradation process many times over, thus leading to longer-lasting therapeutic effects.

About Evotec’s Strategic Collaboration with Bristol Myers Squibb in Molecular Glues

In 2018, Evotec entered a long-term strategic drug discovery and development collaboration in the field of molecular glues with Celgene, now Bristol Myers Squibb. BMS is a leader in this field based on its unique library of CELMoDs agents. The collaboration aims to discover and develop a leading pipeline of molecular glue degraders for a range of therapeutic indications leveraging all of Evotec’s proprietary PanOmics and PanHunter platforms as well as AI/ML-based drug discovery and development capabilities.

Evotec applies high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates based on comprehensive cell biological profiles. Evotec’s leading PanOmics screening capabilities are delivering unmatched throughput. The selection of the most promising candidates for drug development is facilitated by Evotec’s PanOmics data analysis platform PanHunter. It supports the integration and analysis of these data sets and thereby enables the selection of the most promising CELMoDs for further progression into lead optimization.

(Press release, Evotec, MAR 19, 2026, View Source [SID1234670283])

Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

On March 19, 2026 Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported financial results for the three and twelve months ended December 31, 2025 and provided a business update.

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Fourth Quarter Financial Highlights

Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024.
Gross margins were 82.4%, a roughly 2,400 basis point year over year increase compared to 58.0% in 4Q24, reflecting the transition away from the transfer pricing model under the prior license and supply agreement.
Operating income was $4.6 million in 4Q25 compared to a loss of $1.7 million in 4Q24.
Cash balance was $6.4 million as of December 31, 2025.
Recent Operational Highlights

Announced positive results of its Phase 2b clinical trial evaluating Ameluz topical gel, 10% used in combination with the RhodoLED red-light lamp series for the treatment of moderate to severe acne vulgaris (AV).
Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).
Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk of up to 240 cm2.
Closed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG. New earnout structure reduces payment rate from 25%–35% to 12%–15% of U.S. net sales.
Received the final $2.5 million of $11 million financing led by existing investors in October.
In November, announced the divestiture of its Xepi antibiotic cream to Pelthos Pharmaceuticals for $3 million at closing, $1 million upon commercial availability, and up to $6 million in milestone payments tied to revenue thresholds of $10 million and $15 million.

(Press release, Biofrontera, MAR 19, 2026, View Source [SID1234669305])

PharmaMar looks to accelerate oncology research with AI through collaboration with Globant

On March 19, 2026 Globant (NYSE: GLOB), a digitally native company that helps organizations thrive in a digital and AI-powered future, and PharmaMar, world leader in the discovery, development and commercialization of marine-derived anti-cancer drugs, reported a new collaboration designed to speed up cancer drug discovery through artificial intelligence.

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Through Globant Enterprise AI, the two organizations have created a multi-agent AI system that delivers more than 90% accuracy in complex data retrieval and reduces time to insights up to 15-fold, helping scientists select high-potential drug candidates for clinical development in a fraction of the time previously required.

The platform is capable of analyzing large volumes of scientific, regulatory, and clinical data sources to assist with decision-making across PharmaMar’s R&D ecosystem and enable continuous, self-improving workflows.

Over 20 specialized digital agents are working across preclinical, clinical, regulatory, commercial and strategy areas, uniting human creativity and machine precision in the fight against cancer. Each agent collaborates within GEAI’s secure architecture to process documents, simulate scenarios, and rank the most promising pharmaceutical assets.

The system enables reviews of over 4,500 research documents to prioritize the 10 most viable treatment-indication combinations out of over 8,000 possibilities – work that would have taken months for human researchers to complete.

This intelligent system integrates information from internal databases, scientific publications, and global regulatory sources such as the FDA and EMA, allowing PharmaMar’s teams to identify promising treatment combinations and make more informed, faster decisions.

"Drug discovery has always been a race against time, and in oncology, that time can mean everything," said Dr. Javier Jimenez, Chief Medical Officer at PharmaMar." By integrating Globant’s AI technologies, we can process data from thousands of documents in seconds, simulate scenarios, and focus our research efforts where they have the highest potential to make a difference for patients."

Beyond speed and efficiency, the collaboration strengthens PharmaMar’s ability to reuse institutional knowledge and fosters a new culture of digital innovation across its teams. In the next phase of the project, PharmaMar plans to extend these capabilities to enable hypothesis generation, real-time compliance checks, and automated content creation for scientific reporting.

"PharmaMar’s vision proves what’s possible when human intelligence and AI systems work side by side," said Ariel Capone, CEO of Globant’s Healthcare and Life Sciences AI Studio. "By leveraging agentic AI, we’re building a new model for drug discovery; one that brings precision and scalability to a field that directly impacts millions of lives."

(Press release, PharmaMar, MAR 19, 2026, View Source [SID1234663778])

Kaida BioPharma Announces Executive Leadership Team to Advance KAD-101, Built for the Ovarian Cancer Gap

On March 19, 2026 Kaida BioPharma, a biotechnology company developing targeted therapies for women with hard-to-treat gynecologic cancers, reported its executive leadership team and board. Each member brings decades of experience in biotechnology, clinical development, regulatory strategy, manufacturing, finance, and commercialization to help advance Kaida’s lead product candidate, KAD-101, toward first-in-human clinical evaluation. The company is developing KAD-101 for recurrent ovarian cancer, where treatment options narrow quickly and durable control remains limited.

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Kaida BioPharma is building KAD-101, a next-generation prolactin receptor antagonist for the ovarian cancer gap, the space where patients are too often left cycling through treatment with too few durable options.

In addition to her role as Chairperson of the Board, Kaida founder Dr. Stella Vnook has been named Acting Chief Executive Officer. Dr. Vnook is an accomplished biotechnology founder, executive, and advisor with extensive experience guiding early-stage therapeutics from scientific foundation through capital formation. At Kaida, she leads corporate strategy, development planning, and investor engagement.

"The science brought me here, and the women out there still fighting are why I stay. At Kaida, we are building for the ovarian cancer gap, for patients whose options narrow too fast and whose disease still outpaces available therapies," said Dr. Vnook. "By targeting the survival signals that keep these tumors alive, we believe KAD-101 has the potential to help overcome treatment resistance and create a new path toward more durable control. More options mean more time, and more time means everything."

Craig Pierson, a founder alongside Dr. Vnook, has been appointed Director at Kaida BioPharma. Mr. Pierson is a life sciences investor and company builder with more than 25 years of experience in investment banking and private capital formation. He provides strategic oversight and financing expertise.

George E. Peoples, MD, FACS has been appointed fractional Chief Medical Officer. Dr. Peoples is a surgical oncologist with decades of experience in translational oncology and clinical development. He is also the founder of the Cancer Vaccine Development Program, Cancer Insight, and LumaBridge. At Kaida, he helps guide clinical strategy and IND planning.

John Langenheim, PhD has been appointed fractional Chief Scientific Officer. Dr. Langenheim is a molecular biologist with more than 20 years of experience in therapeutic protein design and preclinical development. His scientific leadership has been instrumental in advancing KAD-101 toward clinical evaluation.

Pamela Swiggard has been appointed Head of Regulatory Affairs. She is a pharmaceutical executive with prior experience at companies including Pfizer and Endo Pharmaceuticals. She brings deep expertise across the product lifecycle, from development through regulatory approval and commercialization. At Kaida, she leads regulatory strategy and FDA engagement in support of IND readiness for KAD-101.

Eric Hacherl, PhD has been appointed Head of Manufacturing. Dr. Hacherl is a senior pharmaceutical operations leader with more than 25 years of experience in biologics manufacturing, cGMP compliance, and process development. At Kaida, he is responsible for helping ensure clinical supply readiness for KAD-101.

Mark Booth has been appointed Chief Commercial Officer. Mr. Booth is a seasoned pharmaceutical and biotechnology executive with more than 25 years of experience building commercial strategies for oncology and rare disease products. His background includes leadership across launch planning, brand strategy, access, and market development for important oncology products, including EMEND, EMEND IV, Zolinza, vintafolide, KEYTRUDA, and the avutometinib plus defactinib combination for low grade serous ovarian cancer. At Kaida, he is responsible for commercial strategy for KAD-101, including positioning, market development, and long-term access planning.

(Press release, Kaida BioPharma, MAR 19, 2026, View Source [SID1234663777])