News

• Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation 

Waltham, MA -- November 15, 2024 -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Revuforj. The New Drug Application (NDA) received approval through the FDA's Real Time Oncology Review (RTOR) program.

"The approval of Revuforj is a remarkable achievement that reflects the dedication and tenacity of everyone involved, especially the patients and clinicians who participated in our trial and our talented Syndax team," said Michael A. Metzger, Chief Executive Officer of Syndax. "We are well-prepared to launch Revuforj this month and we are committed to rapidly advancing the development of Revuforj across the treatment continuum for KMT2A-rearranged acute leukemias and mutant NPM1 AML."

• Acquisition to complement electrophysiology portfolio with solution to advance the treatment of complex atrial fibrillation

November 4, 2024 -- Marlborough, MA -- Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Cortex, Inc., an Ajax Health company. Cortex is a privately held medical technology company focused on the development of a diagnostic mapping solution which may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (AF), a heart rhythm disorder affecting nearly 38 million people globally.¹ Cardiac ablation – the process of delivering energy to areas of the heart responsible for creating abnormal heart rhythms – is a common treatment for AF. During these procedures, physicians often use a mapping system to examine and analyze a heart's electrical patterns to guide therapeutic applications. The OptiMap™ System developed by Cortex uses a basket catheter and proprietary algorithm to identify potential active AF sources, providing physicians with precise insights to efficiently deliver an individualized ablation strategy for their patients.

Boston, MA -- October 28, 2024 -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs, including MRT-6160. MRT-6160 is currently in an ongoing Phase 1, single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions. Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completion of the ongoing Phase 1 clinical study of MRT-6160.ⁱ “We are thrilled to announce this agreement with Novartis, a key player in immune-mediated conditions, and we are excited about the transformative potential it provides for Monte Rosa and MRT-6160. We expect this will accelerate and broaden the scope of clinical development of MRT-6160 to advance this unique, orally bioavailable modality while retaining substantial value for Monte Rosa. We believe the transaction validates our unique and industry leading QuEEN™ discovery engine, and it further increases our conviction to rationally design and develop highly selective and safe MGDs for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “The financial resources provided by this agreement are expected to extend our operational runway, enable us to advance our pipeline to potential value-creating milestones and anticipated proof-of-concept readouts, and further leverage our QuEEN™ discovery engine.”

– Collaboration combines Dren’s targeted cell depletion platform with Novartis research, development and commercial expertise to advance innovative therapies for cancer – – Dren Bio to receive total upfront consideration of $150 million and is eligible to receive milestone payments and tiered royalties-   July 24, 2024 – Foster City, CA – Dren Bio, Inc. (“Dren Bio” or the “Company”), a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, today announced that it has entered into a strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. “Our agreement with Dren Bio is a promising opportunity to discover novel bispecific antibody therapies for cancer, building on our longstanding expertise in immuno-oncology science at Novartis,” said Shiva Malek, Ph.D., Global Head of Oncology for Biomedical Research at Novartis. “We’re excited to collaborate to bring forward new therapeutic options for patients living with cancer, complementing our strategic efforts across a wide range of modalities, including targeted therapies, biologics, radioligand therapies and CAR-Ts.”

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

WATERTOWN, Mass.--(BUSINESS WIRE)--Tectonic Therapeutic, Inc. (“Tectonic”) (NASDAQ: TECX), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs, today announced the completion of its previously announced merger with AVROBIO, Inc. ("AVROBIO"). The combined company will operate under the name Tectonic Therapeutic, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on June 21, 2024 under the ticker symbol "TECX". Concurrent with the merger, Tectonic completed a $130.7 million private placement with a syndicate of new and existing investors, including a major mutual fund, TAS Partners, 5AM Ventures, EcoR1 Capital, Polaris Partners, certain funds and accounts advised by Farallon Capital Management, Vida Ventures, the PagsGroup, and other undisclosed investors. Following these transactions, Tectonic’s cash, cash equivalents and investments of approximately $181 million at close, before payment of final transaction-related expenses, is expected to fund current operational plans into mid-2027.

• The oversubscribed financing was led by Cormorant Asset Management and co-led by Omega Funds with participation from affiliates of Deerfield Management, GV (Google Ventures), EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital (a Citadel company), Aisling Capital, Casdin Capital, and Longwood Fund
• This capital raise provides BBOT with runway to achieve significant clinical inflection points over the next 18-24 months as it progresses multiple assets into the clinic to treat patients with a wide variety of RAS and PI3Kα pathway malignancies

PALO ALTO, Calif., May 02, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, has announced the completion of a $200M private financing of its former subsidiary, TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT), to accelerate the development of its oncology portfolio. The oversubscribed financing was led by Cormorant Asset Management and co-led by Omega Funds with participation from affiliates of Deerfield Management, GV (Google Ventures), EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital (a Citadel company), Aisling Capital, Casdin Capital, and Longwood Fund. BBOT will be advancing three initial programs:

• BBO-8520, a direct inhibitor of KRAS^G12C that binds to both the ON and OFF states of the protein; BBOT is currently enrolling patients in the ONKORAS-101 trial for patients with KRAS^G12C mutant non-small cell lung cancer
• BBO-10203, a PI3Kα:RAS breaker that blocks the specific interaction between RAS and PI3Ka to inhibit PI3Kα / AKT effector signaling in tumors while bypassing glucose metabolic signaling to avoid hyperglycemia; BBOT expects to file an Investigational New Drug application (IND) for BBO-10203 in Q2 2024 and, subject to clearance of the IND, will begin enrolling patients later this year
• BBO-11818, a pan-KRAS inhibitor that targets both the ON and OFF states of KRAS^G12X for which BBOT expects to file an IND in early 2025

NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the completion of the acquisition of AnHeart Therapeutics Ltd. (AnHeart), a late-stage, global biopharmaceutical company developing novel precision therapies for people with cancer. With the acquisition’s completion, AnHeart is now a wholly-owned subsidiary of Nuvation Bio. “The closing of the acquisition transforms Nuvation Bio into a late-stage, global oncology company that is well-capitalized and positioned to develop our newly expanded pipeline as we move toward becoming a commercial organization,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We welcome the AnHeart team and look forward to leveraging our combined expertise to bring new cancer therapies to patients who need them most.”