Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative risk reduction) in BSIs, and support potential for live biotherapeutics to address inflammatory and immune diseases Company advances SER-155 strategic partnership discussions to acce

AI platform combined with autonomous labs will accelerate discovery across every domain of science Company has raised $200M in seed financing to further develop platform and build first AI Science Factories CAMBRIDGE, Mass., March 10, 2025 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, today unveiled Lila Sciences, a company building the world's first scientific superintelligence platform and fully autonomous labs for life, chemical, and materials sciences. The company, which was founded in Flagship's labs in 2023, is pioneering an advanced form of AI that can not only process vast amounts of data and make predictions, but also assist scientists in designing and con

First-in-class oral selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784) continues enrollment in Phase 1 trial for SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population FHD-909 preclinical combination data with pembrolizumab and KRAS inhibitors to be presented at AACR 2025 Selective degradation of ARID1B achieved with program update expected in 2025; continued progress of Selective CBP degrader and Selective EP300 degrader towards IND Strong balance sheet with cash, cash equivalents, and marketable securities of $243.7 million as of December 31, 2024, provides cash runway into 2027 CAMBRIDGE, Mass., March 06, 2025 (GLOBE NEWSWIRE) -

Citigroup initiated coverage of Moderna with a rating of Neutral and set a new price target of $40.00

Morgan Stanley resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $33.00 from $41.00 previously

Barclays downgraded Moderna from Overweight to Equal Weight and set a new price target of $45.00 from $111.00 previously

4 - Moderna, Inc. (0001682852) (Issuer)

4 - Moderna, Inc. (0001682852) (Issuer)

4 - Sana Biotechnology, Inc. (0001770121) (Issuer)

4 - Sana Biotechnology, Inc. (0001770121) (Issuer)

4 - Sana Biotechnology, Inc. (0001770121) (Issuer)

4 - Sana Biotechnology, Inc. (0001770121) (Issuer)

DEF 14A - Seres Therapeutics, Inc. (0001609809) (Filer)

S-8 - Seres Therapeutics, Inc. (0001609809) (Filer)

10-K - Seres Therapeutics, Inc. (0001609809) (Filer)

For Immediate Release: April 26, 2023 Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI.  “Today’s approval provides patients and healthcare p

For Immediate Release: September 07, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Kaleido Biosciences, Inc. for not complying with federal laws and regulations, including laws and regulations to protect individuals participatin

For Immediate Release: November 30, 2020 The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna, Inc. “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Comm

Owen joins to lead new phase of growth for the medical device company in clinical trial, diagnostic, and reference laboratory applications CAMBRIDGE, Mass., Feb. 19, 2025 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and YourBio Health, a pioneer in remote blood collection technology, today announced the appointment of Paul Owen as Chief Executive Officer of YourBio Health and CEO-Partner of Flagship Pioneering. Owen joins YourBio Health and Flagship after a corporate leadership and strategic planning career spanning more than 35 years. He was most r

CAMBRIDGE, Mass., Nov. 20, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Metaphore Biotechnologies, a Flagship-founded biotechnology company designing novel therapeutics by combining machine learning and molecular mimicry, today announced that Angela Hwang, MBA, will join Flagship Pioneering as CEO-Partner, and Metaphore as Chief Executive Officer, effective January 1, 2025. Most recently, Hwang served as Chief Commercial Officer and President of the Global Biopharmaceuticals Business at Pfizer. During her tenure at Pfizer, Hwang helped brin

Established clinical proof-of-mechanism and validation of epigenomic controllers as potential new class of medicines from completed Phase 1 MYCHELANGELO™ I trial for c-MYC in HCC; Company exploring strategic partnership opportunities for Phase 2 development of OTX-2002Company is focusing capital resources on three prioritized programs that reflect Omega's unique value proposition to enable precision epigenomic control for potential therapeutic advantages versus existing modalitiesBoard has appointed Kaan Certel, Ph.D., as Omega's President and Chief Executive Officer, and Jennifer Nelson, Ph.D., as Chief Scientific OfficerCompany is pursuing strategic partnership opportunities to support dev

Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative risk reduction) in BSIs, and support potential for live biotherapeutics to address inflammatory and immune diseases Company advances SER-155 strategic partnership discussions to acce

CAMBRIDGE, Mass., March 04, 2025 (GLOBE NEWSWIRE) --  Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading live biotherapeutics company, today announced that management will host a conference call and live audio webcast on March 13, 2025 at 8:30 a.m. ET to discuss fourth quarter and full year 2024 financial results and provide business updates. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 6331602. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com. A webcast replay will be available on the Seres website beginning approximately tw

First-in-Human Study Provides Evidence that Sana's Hypoimmune (HIP) Technology Enables Transplanted Islet Cells to Avoid Immune Rejection and Produce Insulin Without Immunosuppression Results Demonstrate HIP-Engineered Primary Pancreatic Islet Cells Avoid Immune Detection, Function, and Persist after Intramuscular Transplantation in First Treated Patient with Type 1 Diabetes Function and Persistence of Pancreatic Islets Were Detectable by Production of Consistent Levels of Circulating C-Peptide, a Marker of Insulin Production, and Increased C-Peptide Levels with a Mixed Meal Tolerance Test (MMTT) MRI Shows Signals Consistent with Graft Survival 28 Days after Transplantation Study Contin

SC 13G/A - Sana Biotechnology, Inc. (0001770121) (Subject)

SC 13G/A - Sana Biotechnology, Inc. (0001770121) (Subject)

SC 13G/A - Sana Biotechnology, Inc. (0001770121) (Subject)