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what kind of English is that, you said you went to college..lol...watch and learn how its done!!
you are the really dummy, bozo the repressed and down lo.
Sure. 8 months of holding a bag… lol
Boom that’s how ya read a chart numnuts
Like I said… 8 months holding a bag for small move it’s meh.
You forget we can see all your postssss. He he
lmao..say hello to 1.65 dummy
Ugh. I’ll let you continue to embarrass your self…
BAG OF GOLD...WATCH AND LEARN...BACK TO PUMPING MONI SON
8 months of holding a bag? What do I have to learn for someone who is wrong all the time?
How many times do you have to be put down to learn? :)
LMAO..WATCH AND LEARN
MREO TARGET GETTING CLOSE...DAILY IN... SO NOW WE WAIT FOR THE WEEKLY TO TAKE HOLD
Great Refresher link, TY :) …keep eyes on BLUE—bla was sub’d 4/24 or so, expect over next week to hear yay or nay on Acceptance and/ or fast track ( 6mos. For pdufa date) or 10mos. If not ( key being accepted) … if denied, delay of prob 6mos-1yr!!! They burn crap load of cash, so an equity raise a certain… downside $2, upside could go parabolic to Double digits (24% shorties)
For sure, climbing steps and with a deep pipe bench/ late stage(s), readouts in Q3/4 could propel to the $5 target (Needham) GLTA
Thanks for that link. The FDA is the biggest government scam in this Solar System. Not only do they fleece trillions from the biotech sector but if you really want approval then bribes and payola will help.
SAD :(
Too bad the FDA didn't follow the protocol for the 'Vaccine'. Over 50 million dead worldwide. Have to dig for those numbers these days, but they're real.
https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
Classic signs of accumulation on chart. I have had this on my radar since .58. Biotech was the most beaten and should have a spectacular recovery.
Good luck to us.
15% in 3 months… what a waste of time when I am chasing bangers… :)
patience is a traders virtue...not otc rinse scams
Ouch. Still no $1.65 3 months later? BAHAHA. Dude.. come on now
keep watching....stick to your scam otc's
Good luck today, prosperous trading!
NP it's all good. Thanks for the heads up on TARA. :)
TY! And I sorta made this reply on Forza thread( by mistake), so here it is on this one:
And good luck with this play, hopefully J.Visconti delivers for y’all ! :) ….somebody I know :)
Take a look at TARA( bio- low float, $90m in cash..under $3 … 3 or so drugs in pipe
Very nice! Wishing you the best in your investment
Saw that, and bought AH @ $1.15 and bought more this a.m @ 1.14….I think anything under $1.5 gets you a double to 3x….also, if other firms cover like:
Mereo BioPharma Group Price Target Maintained With a $5.00/Share by Needham
Perhaps 5x???
Ultragenyx and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI)
Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment
Phase 3 sites beginning to screen patients
Conference call to discuss data planned for 5 p.m. Eastern Time
NOVATO, Calif. and LONDON, June 05, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) today announced data from the dose-selection Phase 2 portion of the Phase 2/3 Orbit study showing that setrusumab rapidly induced bone production in OI-affected patients. Across all patients evaluated setrusumab demonstrated statistically significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months.
“The rate of increasing bone mineralization we're observing on DXA scans is striking, unlike anything I have typically seen with bisphosphonate therapy. This increase in bone mass underscores the potential to make denser and stronger bone,” said Gary Gottesman, M.D., Professor of Pediatrics and Medicine, Washington University School of Medicine.
As of the data cut off, serum P1NP levels through at least 1 month of treatment were available from all 24 patients enrolled in Orbit and demonstrated that treatment with setrusumab significantly increased serum P1NP in both dosing cohorts, peaking at one to two weeks and again, as expected, after the 2-month dosing timepoint. In the 20 mg/kg cohort, there was a mean serum P1NP increase of 57% from baseline over the first month. Because of the higher baseline P1NP level in younger patients, this represents an approximate 8-fold greater increase in serum P1NP over 1 month in pediatric and adolescent patients when compared to adult OI patients. The absolute effect of setrusumab on increasing serum P1NP over the 1-month period with the 20 mg/kg dose, was approximately 80% of the effect achieved with the 40 mg/kg dose, demonstrating a dose response. Patients on placebo at the 1-month timepoint (n=4) showed no significant change in mean serum P1NP from baseline.
The large increase in BMD observed in the Orbit patient population over the first 3 months was consistent with the rapid increase in serum P1NP levels and was similar to results that took 1 year to achieve in the ASTEROID study in adult OI patients. Lumbar spine BMD data were available in 17 of 24 Orbit patients at the 3-month timepoint. Treatment with setrusumab for 3 months resulted in an increase in lumbar spine BMD from baseline of 9.4% at 20 mg/kg (n=10), which represents a substantial mean change in Z-score of +0.65. Treatment with 40 mg/kg (n=7) resulted in a 9.8% BMD increase. Patients on placebo at the 3-month timepoint (n=2) showed no significant change in BMD or change in lumbar spine Z-score.
“The dramatic lumbar spine BMD improvements in children at 3 months show that growing bones are more dynamic, and we anticipate the potential for a greater effect on bone formation and strength in younger patients with maturing bones,” said Eric Crombez, M.D., chief medical officer at Ultragenyx. “Based on the reports from study investigators, we’re encouraged by the impact setrusumab appears to be having on bone health so far.”
As of the data cut-off, there have been no treatment-related serious adverse events observed in the study. Reported adverse events have been generally consistent with those observed in the ASTEROID study and include infusion associated events, headache and sinusitis. There have been no reported hypersensitivity reactions related to setrusumab. There were no safety-related differences observed between dosing groups or age groups.
The totality of data demonstrated meaningful response in serum P1NP and BMD across both cohorts, with the majority of the effect observed at 20 mg/kg, which is the dose planned across the setrusumab Phase 3 program. Screening has begun for the Phase 3 portion of the study, which is designed to enroll approximately 195 patients at more than 40 sites across 12 countries.
Investor Conference Call and Webcast Information
Ultragenyx will host an investor conference call today, Monday, June 5, at 2 p.m. PT / 5 p.m. ET to discuss the results. The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations. To participate in the live call, please register by clicking on the following link (registration link), and you will be provided with dial in details. The replay of the call will be available for one year.
The Setrusumab Phase 3 Program
Ultragenyx and Mereo are developing setrusumab in pediatric and young adult patients across OI sub-types I, III and IV with two late-stage trials: the pivotal Phase 2/3 Orbit study and Phase 3 Cosmic study.
The global, seamless Phase 2/3 Orbit study is evaluating the effect of setrusumab versus placebo on fracture rate in patients aged 5 to <26 years. In the Phase 2 portion, 24 patients were randomized 1:1 to receive setrusumab at one of two doses to determine the optimal dosing strategy for Phase 3. The Orbit study was designed to be placebo-controlled, however the placebo arm was removed from the Phase 2 portion by amendment. All of the placebo patients enrolled in Phase 2 (n=4) were subsequently rerandomized to one of the dosing cohorts.
The pivotal Phase 3 portion of the study will include approximately 195 patients, randomized 2:1 to receive setrusumab or placebo, with a primary efficacy endpoint of annualized clinical fracture rate. All patients will transition to an extension period and receive open-label setrusumab after the Phase 3 primary analysis is complete.
The Phase 3 Cosmic study is an open-label, randomized, active-controlled study in patients aged 2 to <5 years evaluating setrusumab versus intravenous bisphosphonates (IV-BP) therapy on reduction in total fracture rate, including morphometric vertebral fractures. The Cosmic study is anticipated to start in the next few months and will enroll approximately 50-66 patients.
About Osteogenesis Imperfecta (OI)
Osteogenesis Imperfecta (OI) includes a group of genetic disorders impacting bone metabolism. Approximately 85% to 90% of OI cases are caused by mutations in the COL1A1 or COL1A2 genes, leading to either reduced or abnormal collagen and changes in bone metabolism. The collagen mutations in OI can result in increased bone brittleness, which contributes to a high rate of fractures, including at atypical sites. Patients with OI also exhibit increased bone resorption (breakdown of old bone) and inadequate production of new bone, which leads to decreased bone mass, bone fragility and weakness. OI can also lead to bone deformities, abnormal spine curvature, pain, decreased mobility, and short stature. No treatments are approved for OI, which affects approximately 60,000 people in the developed world.
About Setrusumab (UX143)
Setrusumab is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells. The goal of blocking inhibitory effects of sclerostin is to increase new bone formation, bone mineral density and bone strength. Sclerostin inhibition also reduces excessive bone resorption, further enhancing its impact on bone density. In mouse models of OI, the use of anti-sclerostin antibodies was shown to stimulate bone formation, improve bone mass and density, and increase bone strength against fracture force testing.
Mereo BioPharma’s Phase 2b study (ASTEROID) treatment phase of the dose-finding study of setrusumab for the treatment of OI in 112 adults was concluded in 2019. The ASTEROID study demonstrated treatment with setrusumab resulted in a clear, dose-dependent and statistically significant effect on bone formation and bone density at multiple anatomical sites among adult participants with OI.
Ultragenyx and Mereo BioPharma are collaborating on the development of setrusumab globally based on the collaboration and license agreement between the parties. The companies have developed a comprehensive late-stage program to continue development of setrusumab in pediatric and young adult patients across OI sub-types I, III and IV.
About Ultragenyx Pharmaceutical Inc.
Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has two rare disease product candidates, setrusumab for the treatment of Osteogenesis Imperfecta (OI) and alvelestat for the treatment of severe alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD) and Bronchiolitis Obliterans Syndrome (BOS). The Company’s partner, Ultragenyx Pharmaceutical, Inc., has initiated a pivotal Phase 2/3 pediatric study in young adults (5-25 years old) for setrusumab in OI and expects to initiate a study in pediatric patients (<5 years old) in the next few months. The partnership with Ultragenyx includes potential milestone payments of up to $254 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Alvelestat has received U.S. Orphan Drug Designation for the treatment of AATD, Fast Track designation from the FDA, and positive data were reported from a Phase 2 proof-of-concept study in North America, Europe and the UK. In addition to the rare disease programs, Mereo has two oncology product candidates in clinical development. Etigilimab (anti-TIGIT) has completed enrollment in a Phase 1b/2 basket study evaluating its safety and efficacy in combination with an anti-PD-1 in a range of tumor types including three rare tumors and three gynecological carcinomas - cervical, ovarian, and endometrial; navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has been partnered with OncXerna Therapeutics, Inc. in a global licensing agreement that includes payments of up to $300 million in milestones and royalties.
For more information on Mereo BioPharma, please visit www.mereobiopharma.com
Ultragenyx Forward-Looking Statements and Use of Digital Media
Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx's expectations and projections regarding its future operating results and financial performance, business plans and objectives for UX143, expectations regarding the tolerability and safety of UX143, and future clinical and regulatory developments for UX143 are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, the ability of the company and Mereo BioPharma to successfully develop UX143, the company’s ability to achieve its projected development goals in its expected timeframes, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the company’s behalf, the potential for any license or collaboration agreement, including the company’s collaboration agreement with Mereo to be terminated, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx’s products and drug
MONI already ran past the .01 mark which you your self said would never happen.
This has happened many many times to you…
It’s not like I am even making this up. We can see.
watch and learn...moni sinks....mreo rises!
Like I said. It’s hard to even have a real conversation with you.
Calling a tiny gain in 3 months?
What about the soooo many misses you continue to call?
We can see them all?
Watch and learn how not to make your self look bad.
.005-.02 - MONI
$1- $1.30 MREO
Lol
Again, so you even read what you write? It’s hard to even had a conversation when you literally never make sense.
Maybe calm down read and remember we can see all your history.
Calling $1.63 3 months ago? Sometimes I just shake my head.
It’s literally like you forget or don’t realize what you are even saying…
Between affirming buy rating (Mereo BioPharma Group Price Target Maintained With a $5.00/Share by Needham) and interim data soon( Orbit study), Mkt makers keeping It above $1 ( we need 20consec days to stay on Nasdaq I think) .. also, company said in recent release —- ‘In line with previous guidance by the Company, Mereo is exploring potential partnerships to fund the Phase 3 study’…
We shall see, GLTA
Hey, thank you for the heads up. Maybe something behind the scenes?
We’ve done movements today! :)
NEWS
Mereo BioPharma Provides Regulatory Updates on Alvelestat for the Treatment of Alpha-1-Antitrypsin Deficiency-Associated Lung Disease
Clear path forward with proposed single Phase 3 study evaluating alvelestat at the 240 mg dose level versus placebo at 12-18 months for potential full approval in both the U.S. and EU
No additional confirmatory study required
Company to host conference call today at 8:30am ET
LONDON, March 21, 2023 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (Mereo or the Company), a clinical-stage biopharmaceutical company focused on rare diseases, today announced regulatory feedback following recent end-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) related to its alvelestat program for the treatment of alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD).
Based on clear recommendations from the FDA and the EMA, the Company is designing a single, global, Phase 3 study evaluating the 240 mg dose of alvelestat versus placebo in patients with AATD-LD to support applications for full marketing approvals in both the United States (U.S.) and European Union (EU). The Company’s proposed Phase 3 study has two independent primary endpoints, i) a Patient-Reported Outcome (PRO), as guided by the FDA, and ii) lung density measured by CT scan, as guided by the EMA.
In line with previous guidance by the Company, Mereo is exploring potential partnerships to fund the Phase 3 study, and believes that this clear path forward will support these efforts.
Each of the proposed primary endpoints has been shown to be associated with reductions in certain disease activity biomarkers. The proposed PRO of the St. George’s Respiratory Questionnaire (SGRQ) Activity domain was shown to be associated with the reduction of desmosine and Aa-Val360 in the Company’s Phase 2 ASTRAEUS study. The association of desmosine reduction with lung density measured by CT scan was demonstrated in published clinical data in AATD 1.
Both the FDA and EMA recognize the challenges associated with development of new therapeutics for AATD-LD. Consistent with an openness to supporting the advancement of therapeutic development in this space, the EMA has indicated that for the primary endpoint of lung density measured by CT scan, it would accept a more relaxed Type 1 error (i.e., p<0.1) for a potential full approval that is not contingent on the outcome of a confirmatory study. Additional supportive secondary endpoints are being proposed, including biomarker-based endpoints that may provide sufficient data to validate the biomarkers for future studies.
If successful, this proposed Phase 3 study, with an expected duration of 12-18 months and an enrollment target of approximately 200 patients, is expected to support full regulatory approvals in both the U.S. and EU without an additional confirmatory trial. This could provide the Company with a path to full approval of alvelestat based on a Phase 3 trial similar in size and length to what would be required for an accelerated or conditional approval based on biomarkers. Mereo also believes that this proposed study, if successful, will support more productive initial reimbursement discussions with payors following potential regulatory approvals.
“We are very pleased with the feedback from our meetings with both the FDA and EMA, and grateful for the thorough guidance each Agency provided and the clear path forward that the Agencies have each outlined for alvelestat,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “We believe this is the first time a proposed registrational study in AATD-LD will use both a Patient-Reported Outcome approach, and an objective clinical outcome measure of lung density measured by CT scan as independent primary endpoints, allowing for a clinical trial with a reasonable number of patients conducted over a manageable timeframe. We believe this represents a significant step forward in the development of new therapies for AATD-LD, and we look forward to further collaboration with both Agencies as we refine the Phase 3 study design to support alvelestat’s continued efficient clinical development and its timely availability for patients.”
1: Ma et al. The Effect of Alpha-1 Proteinase Inhibitor on Biomarkers of Elastin Degradation in Alpha-1 Antitrypsin Deficiency: An Analysis of the RAPID/RAPID Extension Trials. Chronic Obstr Pulm Dis. 2017;4(1):34-44
Conference Call and Webcast
Mereo BioPharma will hold a conference call today, March 21, at 8:30am ET. To participate by telephone, please dial (877) 418-5268 in the U.S., or (412) 902-6771 internationally, and ask for the Mereo BioPharma Group Conference Call. A live audio webcast of the call can be accessed through the Investors section of the Company’s website at www.mereobiopharma.com/investors. An archived replay of the webcast will be available on the Company’s website for two weeks following the live event.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has developed a robust portfolio of clinical stage product candidates. The Company has two rare disease product candidates, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat for the treatment of severe Alpha-1 antitrypsin deficiency associated lung disease (AATD-LD) and Bronchiolitis Obliterans Syndrome (BOS). The Company’s partner, Ultragenyx Pharmaceutical, Inc., has initiated a pivotal Phase 2/3 pediatric study in young adults (5-25 years old) for setrusumab in OI and expects to initiate a study in pediatric patients (<5 years old) in the first half of 2023. The partnership with Ultragenyx includes potential milestone payments of up to $254 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Alvelestat has received U.S. Orphan Drug Designation for the treatment of AATD, Fast Track designation from the FDA, and positive data were recently reported from a Phase 2 proof-of-concept study in North America, Europe and the UK. In addition to the rare disease programs, Mereo has two oncology product candidates in clinical development. Etigilimab (anti-TIGIT) has completed enrollment in a Phase 1b/2 basket study evaluating its safety and efficacy in combination with an anti-PD-1 in a range of tumor types including three rare tumors and three gynecological carcinomas - cervical, ovarian, and endometrial; Navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has