|Over a week ago|
Fulcrum Therapeutics appoints Judith Dunn as president of R&D » 09:2903/2403/24/21
Fulcrum Therapeutics announced that Judith Dunn, Ph.D. has been appointed President of Research and Development. Most recently, she supported the development of new companies targeting areas of unmet need in neuroscience as an Entrepreneur in Residence at Atlas Venture.
Fulcrum Therapeutics initiated with an Outperform at Credit Suisse » 06:1803/2203/22/21
Credit Suisse analyst…
Credit Suisse analyst Martin Auster initiated coverage of Fulcrum Therapeutics with an Outperform rating and $26 price target. The analyst believes FTX-6058 for sickle cell disease offers a "notable investment opportunity." While the program is just now in a Phase 1 study in healthy volunteers, it should move into patients in 2021 and existing comps highlight the potential for rapid 100%-plus "de-risking" for shares from encouraging data, Auster tells investors in a research note.
Fulcrum Therapeutics announces presentation of new FSHD biomarker data » 11:3203/1803/18/21
Fulcrum Therapeutics announced the presentation of new data related to the use of imaging biomarkers and clinical outcome assessments for facioscapulohumeral muscular dystrophy, or FSHD, at the 2021 Muscular Dystrophy Association virtual Clinical and Scientific Conference. Presentations included evaluation of disease severity and progression with whole body musculoskeletal magnetic resonance imaging, FSHD-TUG, a modified Timed Up and Go assessment for FSHD patients, and in-home passive measurements of mobility and sleep. Chris Moxham, Ph.D., Fulcrum's chief scientific officer, said, "As we advance our clinical development program for losmapimod for the treatment of FSHD, we are also continually working to improve our ability to assess disease progression based on the most clear and effective outcome measures. Assessments based on musculoskeletal MRI and clinical outcomes may be key to demonstrating patient benefit in this population. We expect full data from our Phase 2b ReDux4 trial late in the second quarter of this year, which will provide additional insights to inform the path forward for losmapimod in the treatment of FSHD."
Morgan Stanley to hold a virtual conference » 10:1203/1603/16/21
ALEC, AVRO, BOLT, CABA, FHTX, FULC, FUSN, HAE, IMRA, INSM, IVC, IRWD, KPTI, KYMR, LEGN, PRLD, RDUS, RGNX, RPTX, SGTX, TNDM, ZNTL
Healthcare Corporate Access Virtual Day to be held on March 16.
|Over a month ago|
Fulcrum Therapeutics price target lowered to $20 from $22 at Piper Sandler » 14:1103/0403/04/21
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff lowered the firm's price target on Fulcrum Therapeutics to $20 from $22 and keeps an Overweight rating on the shares. Fulcrum discontinued the Phase III LOSVID trial of losmapimod due to changes in COVID-19 treatment paradigm. As such, Tenthoff removed losmapimod COVID value from his model. Fulcrum is developing a "rich" preclinical pipeline with the goal of filing two new drug applications in the next 24 months, the analyst tells investors in a research note.
Fulcrum Therapeutics CEO Robert Gould to retire, Bryan Stuart to succeed » 07:2303/0403/04/21
Fulcrum Therapeutics announced that Bryan Stuart, the company's COO, will become Fulcrum's president and CEO and will be appointed to the Board of Directors. Mr. Stuart will succeed current president and CEO Robert Gould, Ph.D. who will be retiring as of March 31, 2021. Dr. Gould will remain as a member of the Board of Directors and will serve as an advisor to the company. Additionally, Mark Levin, Fulcrum's Board chair, will assume the role of executive chair effective upon Dr. Gould's retirement.
Fulcrum Therapeutics expects cash to fund requirements into 4Q22 » 07:1603/0403/04/21
The company said,…
The company said, "As of December 31, 2020, cash, cash equivalents, and marketable securities were $112.9 million, as compared to $96.7 million as of December 31, 2019. Based on current plans, the company expects that its cash, cash equivalents, and marketable securities as of December 31, 2020, together with the net proceeds of $46.4 million from the sale of its common stock in a public offering on January 22, 2021, will be sufficient to enable Fulcrum to fund operating expenses and capital expenditure requirements into the fourth quarter of 2022."
Fulcrum Therapeutics decides to discontinue LOSVID Phase 3 trial » 07:1603/0403/04/21
After careful consideration, Fulcrum is discontinuing LOSVID, a Phase 3 trial with losmapimod for hospitalized subjects with COVID-19, due to significant changes in the COVID-19 treatment paradigm, including new therapeutic options and emerging vaccines. The company has decided to redeploy its resources to other clinical programs and discovery efforts, with a continued focus on rare diseases. Losmapimod was generally well tolerated in LOSVID, and an independent data safety monitoring board did not identify any safety concerns related to losmapimod.
Fulcrum Therapeutics reports Q4 EPS (64c), consensus (72c) » 07:1503/0403/04/21
Reports Q4 revenue $4.2M,…
Reports Q4 revenue $4.2M, consensus $1.31M. "In 2020, we made meaningful progress in advancing our pipeline despite the extraordinary challenges brought on by COVID-19," said Robert J. Gould, Ph.D., president and chief executive officer. "We have laid the foundation to achieve several key milestones in 2021, including a comprehensive assessment of our Phase 2 ReDUX4 trial with losmapimod in facioscapulohumeral muscular dystrophy late in the second quarter and completing our Phase 1 trial in healthy adult volunteers with FTX-6058, a highly potent small molecule EED inhibitor in development for the treatment of select hemoglobinopathies, including sickle cell disease and beta-thalassemia. Additionally, after careful consideration and a strategic review of the COVID-19 landscape, we are discontinuing our LOSVID trial. This enables us to focus on rare diseases. I would like to thank the patients and investigators who participated in this trial and the Fulcrum team who worked tirelessly to rapidly design and launch the LOSVID trial during a global pandemic. Furthermore, we have made great progress with our next-generation product engine including new levels of validation in our internal research efforts and externally through our strategic collaborations," continued Dr. Gould. "With the additional capital from our recent public offering, we have extended our cash runway into the fourth quarter of 2022 and we believe that we are well positioned to continue progress on our goal to advance therapies to improve the lives of patients with genetically defined rare diseases."
Fulcrum Therapeutics initiated with a Buy at Stifel » 16:3703/0103/01/21
Stifel analyst Dae Gon Ha…
Stifel analyst Dae Gon Ha initiated coverage of Fulcrum Therapeutics with a Buy rating and $18 price target. To say 2021 "marks an important year" for Fulcrum "is an understatement," said Ha, who notes that Phase 2b ReDUX4 data are expected in Q2. The "the comprehensive nature of the readout, and its implications on losmapimod and the facioscapulohumeral muscular dystrophy program," should be expected to create volatility, said Ha, who assigns 40% probability of success to reflect his view ahead of this readout. However, Ha also believes another asset, FTX-6058, "may be emerging as an attractive thesis for investors."