Industry Challenge - Clinical trial bottlenecks cause delays in new drug launches [1] AI Solution - AI-enabled technology aims to accelerate the clinical trial process [1] Company Focus - Two cancer doctors developed the AI solution [1]

Key Takeaways NVS reported that Cosentyx missed the primary endpoint in a phase III study for giant cell arteritis. Cosentyx plus a 26-week steroid taper showed no significant remission benefit over placebo and 52-week taper. While endpoints were missed, Cosentyx showed lower steroid exposure and consistent safety in the GCA study.Novartis (NVS) announced that a late-stage study of its interleukin-17A inhibitor, Cosentyx (secukinumab), has failed to meet the primary endpoint of sustained remission at week ...

Oncology Pipeline & Strategy - BioNTech has a multiplatform oncology portfolio with over 20 ongoing Phase 2 or 3 trials[7] - BNT327, a PD-L1/VEGF-A antibody, is a priority program with potential as a next-generation IO-backbone, with clinical activity observed across multiple indications in over 750 patients enrolled in 20+ clinical trials[7, 19, 20] - BNT327 combined with chemo in 1L TNBC showed an objective response rate (ORR) of 769% in PD-L1 negative, 563% in PD-L1 low, and 100% in PD-L1 high patients[25] - FixVac and iNeST are novel mRNA cancer immunotherapies targeting tumor-associated antigens and cancer mutations[7, 37] COVID-19 Vaccine & Financials - BioNTech anticipates maintaining a high market share in the U S, EU, and Japan for its COVID-19 vaccine[49] - The company expects total revenues between €1700 million and €2200 million for the financial year 2025[51] - R&D expenses for FY 2025 are projected to be between €2600 million and €2800 million[51] - SG&A expenses are estimated to be between €650 million and €750 million, with capital expenditure for operating activities between €250 million and €350 million[51] Financial Position - As of December 31, 2024, BioNTech's total cash plus security investments amounted to €174 billion, including €97619 million in cash and cash equivalents, €65362 million in current security investments, and €10611 million in non-current security investments[7, 8]

Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...

Global Healthcare Biopharma catalysts to watch in 3Q25 With macroeconomic volatility and healthcare policy uncertainty persisting likely into the back half of the year, we continue to advocate for and highlight idiosyncratic catalysts with attractive risk/reward setups to drive alpha generation. Herein, we highlight and preview key catalysts in 3Q25 across the GS biotechnology coverage universe from pivotal studies: BMY's Cobenfy ADEPT-2 in Alzheimer's disease psychosis; LLY's orforglipron ATTAIN-1 in obesi ...

New drugs take too long to get to market because of clinical trial bottlenecks. Two cancer doctors built AI-enabled tech to speed up the process. (Photo: Maria Ponce) https://t.co/h2z5abwqHe https://t.co/7k3mmUwhfT ...

Brings More Than Twenty Years of Biopharmaceutical Leadership ExperienceANN ARBOR, Mich., July 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it has appointed Craig Thompson, Chief Executive Officer of Cerevance, to its Board of Directors. Mr. Thompson will serve as an independent director. With Mr. Thompson’s appointment, Esperion’s Board of Directors now comprises eight members. “We are thrilled to welcome Craig to our Board of Directors. With more than two decades of biopharmaceutic ...

Phase 2 protocol submitted to HREC to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere Briefing documents submitted to FDA for a Type D meeting request to continue discussions on path forward for accelerated approval of TXM for bird flu Phase 2 study protocol submitted to HREC to evaluate ratutrelvir in newly diagnosed COVID patients, with extensions to measure disease rebound and development of Long COVID NEWTOWN, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- ...

Sevasemten Update June 26, 2025 Forward Looking Statement This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding sevasemten, statements regarding the potential marke ...

BeOne's Innovative Pipeline Progress Investor R&D Day JUNE 26, 2025 Forward-looking Statements Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, constitute forward looking statements. Examples of such forward-looking statements include statements regarding the projected size of the oncology market and related sectors; BeOne's research, discovery, pre-clinical and early-stage clinica ...