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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].
Zevra Therapeutics Announces MIPLYFFA® (arimoclomol) Featured in Presentations at the National Niemann Pick Disease Foundation Conference
Globenewswire· 2025-07-11 11:30
Core Insights - Zevra Therapeutics, Inc. announced presentations on MIPLYFFA (arimoclomol) at the NNPDF Conference, highlighting its role as the first FDA-approved treatment for Niemann-Pick disease type C (NPC) [1][2] - MIPLYFFA is indicated for use in combination with miglustat for treating neurological manifestations of NPC in patients aged 2 years and older [7][6] Presentation and Research Findings - Dr. Barbara K. Burton presented an overview of MIPLYFFA, emphasizing its unique mechanism that improves lysosomal function and halts disease progression at 12 months in a pivotal study [2][3] - The pivotal trial demonstrated that arimoclomol combined with miglustat halted disease progression compared to placebo, confirmed by a 48-month open-label extension study [4][6] - Two posters were presented: one detailing long-term effectiveness and safety of arimoclomol, and another providing mechanistic evidence of arimoclomol's action through the CLEAR network [4][5] Drug Mechanism and Clinical Significance - MIPLYFFA enhances the activation of transcription factors TFEB and TFE3, leading to the upregulation of CLEAR genes and improved lysosomal function [6][17] - The drug has shown to reduce unesterified cholesterol in NPC fibroblasts, although the clinical significance of this finding remains to be fully understood [6] Company Overview - Zevra Therapeutics focuses on developing therapies for rare diseases with limited treatment options, aiming to create transformational therapies through data-driven strategies [18]
MiNK Therapeutics Announces Publication of Complete Remission Following Allogeneic iNKT Cell Therapy in Metastatic Testicular Cancer
Globenewswire· 2025-07-11 11:30
Core Insights - MiNK Therapeutics has published a significant case study demonstrating the efficacy of its allogeneic iNKT cell therapy, agenT-797, in achieving complete and durable remission in a patient with metastatic testicular cancer who had previously failed multiple treatments [1][2][3] Group 1: Clinical Evidence - The case study published in Nature's Oncogene details a patient who achieved complete clinical, radiologic, and biochemical remission after receiving a single infusion of agenT-797 alongside nivolumab, with no evidence of disease over two years later [2] - The patient had previously undergone multiple lines of therapy, including platinum-based chemotherapy and various immune checkpoint inhibitors, highlighting the potential of iNKT cell therapy in heavily pre-treated patients [2][3] - MiNK presented additional data at the 2025 AACR Immuno-Oncology meeting, showing immune activation and early signals of tumor control in patients with gastric cancer who were previously refractory to checkpoint inhibitors [3][4] Group 2: Mechanism and Development - AgenT-797 is designed to harness both innate and adaptive immunity, functioning as a "master regulator" that combines the cytotoxic capabilities of NK cells with T-cell-like antigen recognition [7] - The therapy is scalable and off-the-shelf, aimed at providing accessible treatment options for patients with solid tumors and severe pulmonary inflammation [8] - MiNK is actively enrolling patients in an ongoing Phase 2 trial for gastric cancer, with further readouts expected in the coming months [4]
Merck's Verona Acquisition: Plugging A $4B Hole In A $20B Gap
Forbes· 2025-07-11 11:10
Photo by Smith Collection/Gado/Getty Images Getty Images Merck's recent acquisition announcement sends a strong signal regarding its urgency to tackle the impending Keytruda patent cliff. The pharmaceutical leader has made an agreement to acquire the COPD drug manufacturer Verona Pharma for $10 billion, adding yet another potential blockbuster to its expanding collection of post-Keytruda assets. The Verona Deal: What Merck Gets The acquisition of Verona Pharma is a step forward, yet it also underscores the ...
FDA to Reward Drugmakers That Don't 'Rip Off' the US
Bloomberg Television· 2025-07-11 11:02
We are talking to industry constantly to figure out how we can be helpful. Which of their products being proposed are in line with our national priorities. That is meeting a large unmet public health need.Domesticating manufacturing as a national security issue. Increasing the affordability of drugs, which is an access problem. This president does not like to see Americans getting ripped off.And we've been paying more for drugs than in many wealthy countries around the world. Can you do anything about that. ...
Milestone Pharmaceuticals Announces Proposed Public Offering
GlobeNewswire· 2025-07-11 10:01
Core Viewpoint - Milestone Pharmaceuticals Inc. has initiated an underwritten public offering of its common shares and warrants to fund the clinical development and commercial launch of etripamil for paroxysmal supraventricular tachycardia (PSVT) [1][2]. Group 1: Offering Details - The offering includes common shares, Series A warrants, Series B warrants, and pre-funded warrants for certain investors [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. - The offering is conducted under a shelf registration statement declared effective by the SEC on November 22, 2024 [3]. Group 2: Use of Proceeds - Net proceeds from the offering will be used alongside existing cash to fund the clinical development and commercial launch of etripamil for PSVT, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Milestone Pharmaceuticals is focused on developing and commercializing innovative cardiovascular medicines, with a recent New Drug Application submitted to the FDA for etripamil targeting PSVT [5].
2 Beaten-Down Stocks That Haven't Hit Rock Bottom Yet
The Motley Fool· 2025-07-11 10:00
Group 1: Canopy Growth - Canopy Growth has been a disappointing investment over the past five years, with a significant decline in net revenue and increased losses per share [3][4] - The cannabis industry faces challenges such as legal and regulatory issues, competition from illicit markets, and oversupply, particularly in Canada [5][6] - Despite cost-cutting efforts and a focus on in-demand products, the long-term outlook for Canopy Growth remains bleak, with expectations of further stock decline [6][7] Group 2: Novavax - Novavax reported substantial revenue growth in the first quarter, with revenue of $666.7 million and a net income of $518.6 million, a significant improvement from the previous year [8] - The company has positive results from phase 3 studies for its influenza and combination COVID-19 vaccines, along with partnerships with major pharmaceutical companies [8][9] - However, the long-term sustainability of Novavax's performance is questionable due to market unpredictability, competition from leaders like Moderna and Pfizer, and reliance on external funding for future trials [10][12][13]
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]
2 Top Stocks Down 16% and 17% This Year to Buy and Hold
The Motley Fool· 2025-07-11 09:36
Core Viewpoint - The article highlights the potential investment opportunities in healthcare companies Merck and Bristol Myers Squibb, which are currently undervalued due to company-specific challenges but have strong long-term prospects. Group 1: Merck - Merck is nearing the loss of patent exclusivity for its key drug Keytruda, which is expected to face biosimilars by the end of the decade [4] - Despite the challenges, Merck's subcutaneous version of Keytruda has shown positive phase 3 results, potentially extending its patent exclusivity into the next decade [5] - The subcutaneous formulation is easier and faster to administer, reducing patient and physician time in the administration process by 49.7% and 45.7% respectively [6] - Merck has a strong pipeline with new approvals, including Winrevair and Enflonsia, and offers a reliable dividend program [7][8] - The stock's forward price-to-earnings ratio is 9.1, significantly lower than the healthcare industry average of 16.3, indicating potential upside for long-term investors [8] Group 2: Bristol Myers Squibb - Bristol Myers Squibb is facing patent expiration for its cancer drug Opdivo and has already lost exclusivity for Revlimid and Sprycel [9] - The company reported a 6% year-over-year revenue decline to $11.2 billion in the first quarter, but its growth portfolio saw a 16% increase in sales to $5.6 billion [11] - BMS has received recent approvals, including a subcutaneous version of Opdivo, which will help mitigate losses from biosimilar competition [10] - The company has a robust pipeline and is expected to secure additional approvals, positioning it to navigate current challenges [12] - Bristol Myers Squibb's stock is undervalued with a forward P/E ratio of 7, suggesting strong long-term return potential despite a 17% decline this year [13]
Crinetics Pharmaceuticals (CRNX) 2025 Earnings Call Presentation
2025-07-11 08:45
Company Overview and Financial Status - Crinetics has a strong financial position with $1.3 billion in cash, cash equivalents, and investments[31] - The company anticipates its first commercial launch this year and holds IP rights into the 2040s[31] Pipeline Programs and Focus - Crinetics is developing paltusotine, with a PDUFA date in September 2025, for acromegaly[27] - The company is developing CRN12755, a TSHR antagonist, for Graves' Hyperthyroidism and Graves' Orbitopathy (TED), with plans for an IND submission[123] - Crinetics is advancing CRN10329, an SST3 agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD), with IND-enabling studies ongoing[150] - The company is developing CRN09682, a nonpeptide drug conjugate (NDC), targeting SST2-expressing tumors, currently in Phase 1/2 study[254] Market and Patient Reach - Graves' Hyperthyroidism affects over 3 million individuals in the US, with a significant portion developing TED[75] - ADPKD affects approximately 145,000 diagnosed patients in the US, with 50% developing end-stage kidney disease[130, 131] - The addressable patient population for Graves' Orbitopathy (TED) is up to approximately 170,000 incident cases[120]