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Immix Biopharma Announces Class-Leading Safety Profile, Allowing Potential Future Indication Expansion
Globenewswire· 2025-07-11 13:36
Core Insights - Immix Biopharma, Inc. has announced a class-leading safety profile for its CAR-T therapy NXC-201, with no neurotoxicity observed in low-volume disease to date, which supports potential future indication expansion [1][3] - The company is focused on completing the NEXICART-2 study for Biologics License Application (BLA) submission, aiming for FDA approval [2][3] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is projected to grow at 12% annually, reaching approximately 33,277 patients by 2024, with the amyloidosis market expected to increase from $3.6 billion in 2017 to $6 billion by 2025 [5] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies specifically for AL Amyloidosis and other serious diseases [3] - The lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [3] Industry Context - AL Amyloidosis is caused by abnormal plasma cells producing misfolded amyloid proteins, leading to organ damage and high mortality rates [4] - The market for amyloidosis treatments is expected to grow significantly, indicating a rising demand for effective therapies [5]
Milestone Pharmaceuticals Announces Pricing of $52.5 Million Public Offering of Common Shares, Pre-Funded Warrants, Series A Common Warrants and Series B Common Warrants
Globenewswire· 2025-07-11 13:30
MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 co ...
Daré Bioscience Receives $6 Million Non-Dilutive Grant Installment; $37.8M to Date of up to $49M Commitment Supporting Smart Drug Delivery Device for Contraception; Platform has Broader Application Potential in Obesity and Metabolic Disorders
Globenewswire· 2025-07-11 12:00
Core Insights - Daré Bioscience, Inc. has received a $6 million non-dilutive funding installment, increasing total funding to approximately $37.8 million out of a potential $49 million for the development of DARE-LARC1, a contraception-focused application of its intelligent drug delivery system [1][10] - DARE-LARC1 is a preclinical-stage long-acting reversible contraceptive utilizing a programmable drug delivery device to administer levonorgestrel, with broader applications in various chronic conditions [2][6] - The DARE-IDDS platform, originally developed at MIT, has been enhanced by Daré to improve its functionality and is capable of delivering multiple doses over extended periods without the need for recharging or surgical replacement [3][4] Funding and Development - The recent funding milestone will support the advancement of DARE-LARC1 and the development of a versatile drug delivery platform across high-value therapeutic areas [3][10] - Daré is eligible for additional non-dilutive funding of up to approximately $11.2 million, contingent on achieving specified technical milestones [10] Market Potential - The DARE-IDDS platform has potential applications beyond reproductive health, including obesity, diabetes, and other chronic conditions, which could significantly improve patient adherence and reduce healthcare costs [6][7] - The platform's features include precision dosing, extended duration of action, and remote programmability, making it suitable for various therapeutic areas [9] Strategic Partnerships - Daré is actively exploring strategic partnerships to expand the evaluation of the DARE-IDDS platform into additional therapeutic categories [2][10] - The company aims to leverage its innovative technology to address unmet needs in women's health and enhance treatment options [11]
Cerevance Announces Presentations at the Alzheimer's Association International Conference 2025
Globenewswire· 2025-07-11 12:00
Core Insights - Cerevance is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases and obesity, with presentations scheduled at the Alzheimer's Association International Conference (AAIC) 2025 [1] Group 1: Upcoming Presentations - Cerevance will present a Phase 1 study on CVN293, an investigational inhibitor targeting NLRP3-mediated neuroinflammation, on July 28, 2025 [2] - Another presentation will focus on the NETSseq platform, revealing insights into astrocyte function in Alzheimer's disease, scheduled for July 30, 2025 [2] Group 2: NETSseq Platform - The NETSseq platform allows for the identification of subtle molecular changes driving disease progression by analyzing brain tissue from over 20,000 donors aged 8 to 104 [3] - This platform aids in identifying low-level expressed targets and rare cell types, enhancing the understanding of neurodegenerative diseases [3] Group 3: CVN293 Overview - CVN293 is a selective oral inhibitor of KCNK13, aimed at reducing neuroinflammation and potentially modifying disease progression in neurodegenerative disorders [4] - The mechanism of CVN293 may also provide therapeutic benefits for obesity, identified through the NETSseq platform [4] Group 4: Company Pipeline - Cerevance's lead investigational treatment, solengepras, is in Phase 3 development for Parkinson's disease, while CVN766 targets binge eating disorder and schizophrenia [5] - CVN293 represents a novel intervention point for both neurodegenerative disorders and obesity [5]
Ikena Oncology Announces ISS and Glass Lewis Recommend Stockholders Vote “FOR” Proposed Merger with Inmagene Biopharmaceuticals
Globenewswire· 2025-07-11 12:00
BOSTON, July 11, 2025 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena,” the “Company”) today announced that Institutional Shareholder Services Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recommend that stockholders vote FOR the issuance of shares in connection with the previously disclosed proposed merger with Inmagene Biopharmaceuticals (“Inmagene”) at Ikena’s upcoming Annual Meeting of Stockholders on July 15, 2025. ISS and Glass Lewis are leading U.S. institutional voting advisory ...
Helix Acquisition Corp. II and BridgeBio Oncology Therapeutics Announce Effectiveness of Registration Statement for Proposed Business Combination
Globenewswire· 2025-07-11 11:43
Core Viewpoint - Helix Acquisition Corp. II is set to hold an extraordinary general meeting on August 4, 2025, to discuss the business combination with TheRas, Inc. (BridgeBio Oncology Therapeutics), following the SEC's declaration of the registration statement as effective [1][2][3]. Company Overview - Helix Acquisition Corp. II is a special purpose acquisition company (SPAC) that raised $184 million in its initial public offering on February 9, 2024, and is sponsored by Cormorant Asset Management [5]. - TheRas, Inc. (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapeutics targeting RAS and PI3Kα malignancies [4]. Business Combination Details - The business combination agreement was finalized on February 28, 2025, and is subject to various conditions before closing [6]. - Upon completion of the transaction, the company will be renamed "BridgeBio Oncology Therapeutics" [6]. - The proxy statement/prospectus will be mailed to Helix's shareholders of record as of June 30, 2025, for their consideration [2][6].
MiNK Therapeutics Announces Publication of Complete Remission Following Allogeneic iNKT Cell Therapy in Metastatic Testicular Cancer
Globenewswire· 2025-07-11 11:30
New report adds to growing evidence of iNKT cell therapy’s potential in solid tumorsNEW YORK, July 11, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced the publication of another landmark case in Nature’s Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment wi ...
Milestone Pharmaceuticals Announces Proposed Public Offering
GlobeNewswire· 2025-07-11 10:01
MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying Series A warrants to purchase common shares (the “Series A Warrants”) and accompanying Series B warrants to purchase common shares (the “Series B Warrants”), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase ...
Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray
Globenewswire· 2025-07-11 10:00
Core Points - The FDA has accepted Milestone Pharmaceuticals' response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, with a new PDUFA target action date set for December 13, 2025 [1][5] - Milestone has extended its $75 million Royalty Purchase Agreement with RTW Investments until December 31, 2025, to support the planned launch of CARDAMYST following FDA approval [2][4] FDA Review and Response - The FDA's acceptance of the response to the CRL is a significant milestone for CARDAMYST, and the company is optimistic about a potential approval decision later this year [3] - Milestone's response to the CRL included results from additional in-vitro studies and a plan to transfer manufacturing duties to vendors with recent FDA inspection history [5][6] Royalty Purchase Agreement - The Royalty Purchase Agreement allows RTW to purchase tiered royalty payments on etripamil's annual net product sales in exchange for a $75 million purchase price, contingent on FDA approval by December 31, 2025 [4] - The amendment to the agreement reflects RTW's ongoing commitment to Milestone and provides a future funding source for the company [2][3] Product Overview - Etripamil is a novel calcium channel blocker nasal spray designed for self-administration to treat paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular response (AFib-RVR) [7][9] - If approved, CARDAMYST™ aims to offer a new treatment option for patients, allowing for on-demand care and self-management [7][9] Clinical Development - Etripamil has completed a Phase 3 clinical program for PSVT and a Phase 2 trial for AFib-RVR, indicating a robust clinical development pathway [8]
Biogen (BIIB) Earnings Call Presentation
2025-07-11 08:08
Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]