watch_it_drop77@yahoo.com
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I saw that people are so excited about the launch of CD by RVNC. The launch will not be materialized until the next couple quarters. In the meantime, it is a good time for the day-traders and the shorts. Stay away from the stock and wait another 6 months to see the real actions.
It is because this year is a leap year.
What happens if other companies such as PFE to make higher offers?
Thanks Dew!
Their guess is as good as anybody's guess!
Hello All,
Does any of you follow GRTS?
Thanks!
WID
The 60-Year-Old Scientific Screwup That Helped Covid Kill
ON FRIDAY, APRIL 30, the WHO quietly updated a page on its website. In a section on how the coronavirus gets transmitted, the text now states that the virus can spread via aerosols as well as larger droplets. As Zeynep Tufekci noted in The New York Times, perhaps the biggest news of the pandemic passed with no news conference, no big declaration. If you weren’t paying attention, it was easy to miss.
https://www.wired.com/story/the-teeny-tiny-scientific-screwup-that-helped-covid-kill/
That's part of the option 2.
Yes. You are right Dew.
I assumed that there is no issues with the drug manufacturing process and the drug itself but because of the Covid--FDA may require the company to have the Covid safety plans. Sometimes, companies focus more on the products and forget about some minor issues.
That is the one I worry about.
Thanks!
Dew,
Let me clarify: The company is actively working with FDA to clear some inspection issues, i.e., correcting some minor issues such as Covid mitigation plans, etc.
RVNC - Does anyone expect what the company will say today at the earning call?
Here are some scenarios that we might encounter at the earning call today:
1. FDA already inspected the plant
2. FDA tentatively scheduled to inspect the plant on ....
3. Company collaborates with FDA for the plant inspection
...
What do you think?
Thanks!
Hope that we will have news on the CMC inspection soon.
Stay tuned!
WID
Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy.
FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date!
https://finance.yahoo.com/news/karyopharm-announces-fda-approval-xpovio-163000840.html
Per CDC Mortality Data, US Deaths per year:
2015 Deaths: 2,71 Mil
2016 Deaths: 2,74 Mil
2017 Deaths: 2,81 Mil
2018 Deaths: 2,83 Mil
2019 Deaths: 2,90 Mil
2020 Deaths: 2,50 Mil (as of November)
I don't see a big spike on US deaths this year. The politics and data don't seem to agree with each other.
PSNL - I just wonder if any of you have followed PSNL. This company provides sequencing and data analysis services to support the development of cancer therapies. They provide liquid biopsy assay that analyzes various human genes.
This company seems to be very interesting.
Thanks!
WID
That's what I have worried about. Revance Therapeutics, Inc. RVNC announced that the FDA has deferred its decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the time being.
The candidate is an investigational neuromodulator product and the BLA is seeking approval of the same for the treatment of moderate-to-severe glabellar (frown) lines.
The agency informed on Nov 24, 2020, that an inspection of the company’s manufacturing facility is required as part of the BLA approval process. However, it was unable to conduct a required inspection of the company’s Northern California manufacturing facility due to the travel restrictions associated with the COVID-19 pandemic. Hence, the delay in the decision.
I think that FDA needs to inspect BCRX's facility too. Hope that I'm wrong.
I actually like VNDA. The company has $340 millions in cash, no debt, cash flow positive and this approval of HETLIOZ for treatment of SMS will generate more revenue.
The company has two products and two in the pipeline.
VNDA will be a safe investment but not high risk/reward like RVNC.
Thanks!
WID
That's the reason RVNC drops today. It's time to buy more. Just loaded a few more shares today. We look for FDA inspection of the CMC and then full approval.
WID
I like your holdings too. Have you been following ESPR?
Thanks!
WID
RVNC: Just wait for the dust to settle and load up more shares of RVNC? Can anyone give us an educated guess of how long FDA will inspect the manufacturing facility?
Thanks!
WID
Just read the PR and it seems to be big for RIGL if this drug works for COVID-19 patients.
I like the last part of the PR: "In addition, researchers at The Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard led a recent screen to identify FDA-approved compounds that reduce mucin-1 (MUC1) protein abundance. MUC1 is a biomarker used to predict the development of ALI and ARDS and correlates with poor clinical outcomes. Of the 3,713 compounds that were screened, fostamatinib was the only compound identified which both decreased expression of MUC1 and is FDA approved, and so allows for rapid repurposing for patients with COVID-19 lung injury. Fostamatinib demonstrated preferential depletion of MUC1 from epithelial cells without affecting cell viability. The research was focused on drug repurposing for the much lower risk of toxicity and the ability of FDA-approved treatments to be delivered on a shortened timescale, which is critical for patients afflicted with lung disease resulting from COVID-19."
The reason why NY has more infected people compared to other state is because of NY City Major and its elected officials. See the video clip below:
https://video.foxnews.com/v/6145069779001?fbclid=IwAR0P-eUQTlRhK3bmfnld6arSPsmp_r_654hZkDhhpi-EkZi588ioJ4UgsCo#sp=show-clips
NKTR 181 FDA Briefing document is out.
https://www.fda.gov/media/134084/download
Thanks Dew. PBYI revenue doesn't look good.
EOLS - From Minx at Investor Village:
Stifel $EOLS list pricing of $610/100U (compared to Botox’s $601)— pricing reflective of the"premium product it aims to be. key will lie volume discounts physicians&affordability/access it offers to consumers,with net pricing likely still in line with prior assumptions (~20-30%).
PBYI Earning Call Summary
During 2019, we anticipate the following key milestones for Puma:
(i) meeting with the FDA and the European Medicines Agency to discuss data from the Phase III trial in third-line metastatic breast cancer patients in the first half of 2019;
(ii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the first half of 2019;
(iii) announcing regulatory decisions on neratinib for the extended adjuvant HER2-positive early stage breast cancer indication in countries outside of the United States and Europe in the first half of 2019;
(iv) presenting data from the Phase III trial in third-line HER2-positive metastatic breast cancer treatment (NALA) in the first half of 2019;
(v) reporting additional data from the Phase II CONTROL trial in the first half of 2019; and
(vi) reporting Phase II data from the SUMMIT basket trial of neratinib in patients with HER2 mutations in the first half of 2019.
For fiscal year 2019, Puma anticipates NERLYNX net US sales will be in the range of $255 million to $280 million. We also assume that the gross to net will be approximately 9% in 2019. We further anticipate that Puma will receive licensing and royalty revenues from its licensing partners in the range of $5 million to $10 million in 2019. Based on this information, PBYI share price should be around $55 ($290x7.5/39).
This calculation does not include revenue from European countries. So, it should be higher than $55.
I worry that it may get another CRL.
Good luck!
Nhan
RVNC - With the overall market pulling back, is this a good time to buy RVNC?
NKTR Presentation slides for tomorrow:
https://www.nektar.com/application/files/5915/4180/4710/SITC_2018_NKTR-214_PIVOT_MEL_09Nov2018-FINAL.pdf
Have a great weekend!
Thanks!
WID
ACADIA Pharmaceuticals Initiates Phase III Study of Pimavanserin in Dementia-Related Psychosis and Granted BTD by FDA
ACADIA Pharmaceuticals Inc. (ACAD) today announced the initiation of HARMONY, a Phase III study to evaluate pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis, a serious medical condition for which there is no therapy approved by the U.S. Food and Drug Administration (FDA). The company also announced that the FDA has granted Breakthrough Therapy Designation to pimavanserin for dementia-related psychosis. Dementia-related psychosis includes psychosis in patients with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia.
HARMONY is a Phase III, randomized, double-blind, placebo-controlled study, evaluating the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The objective of the study is to evaluate the ability of pimavanserin to prevent relapse of psychotic symptoms in a broad population of patients with the most common subtypes of dementia: Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia and frontotemporal dementia. The study will be conducted globally and is expected to enroll approximately 360 patients.
The study includes a 12-week open-label stabilization period during which patients with dementia-related psychosis will be treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg once daily will be allowed if clinically justified. Following the 12-week stabilization period, patients who meet pre-specified criteria for treatment response will then be randomized into the double-blind period of the study to continue their pimavanserin dose (34 mg or 20 mg per day) or be switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurs. The primary endpoint in the study is time to relapse in the double-blind period.
https://finance.yahoo.com/news/acadia-pharmaceuticals-initiates-phase-iii-200500323.html
SGEN - Impressive result from ADCETRIS.
-Estimated Five-Year Overall Survival Rate was 60 Percent and Five-Year Progression-Free Survival Rate was 39 Percent-
-In the 66 Percent of Patients who Achieved Complete Remission, Both Median Overall Survival and Progression-Free Survival Not Yet Reached-
-Long-Term ADCETRIS Data Continue to Support Development Strategy to Establish ADCETRIS as Foundation of Therapy for CD30-Expressing Lymphomas -
The median overall survival was not yet reached and median progression-free survival was estimated at 20 months (95% confidence interval [CI]: 9.4, -). The estimated five-year overall survival and progression-free survival rates were 60 percent and 39 percent, respectively.
Of the 58 patients treated, 38 patients (66 percent) had a complete remission, with the median response duration not reached. For patients who had a complete remission, the median overall survival and progression-free survival were not yet reached.
Sixteen of the 38 patients (42 percent) who achieved a complete remission continued to be followed and remained in remission for over five years at study closure. Of these patients, eight underwent either autologous or allogenic consolidative stem cell transplants while in remission, and eight received no further therapy.
The most common adverse events of any grade occurring in 20 percent or more of patients were peripheral neuropathy, nausea, fatigue, pyrexia, diarrhea, rash, constipation and neutropenia. Of the 33 patients who experienced peripheral neuropathy, 30 patients (91 percent) experienced complete resolution or some improvement of symptoms at last follow-up.
https://finance.yahoo.com/news/seattle-genetics-takeda-announce-publication-120000995.html
Biotech is down today due to uncertainty about Trump team meeting with biotech leaders this week. Can anyone shed the light on this?
Thanks!
WID
Fat finger by DEW. It should be $8M debt.
venBio tries to keep a cap on the stock to make investors believe that the deal doesn't work so they can win the proxy fight.
People need to be smarter to identify this bad strategy/behavior!
They acted like a bad behaved kid!
I am not going to vote for them.
NVLN might benefit from AMGN PCSK9 patent lawsuit against REGN and SNY.
We will see.
The investigation by SDNY is an old news. Shorts try to scare people with this old news in hope that they can get out while it's not too high.
The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm
Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement -- like eating, writing and shaving. Early symptoms of the disease are subtle and occur gradually. In some people Parkinson’s disease progresses more quickly than in others. As the disease progresses, the shaking, or tremor, which affects the majority of people with Parkinson’s disease, may begin to interfere with daily activities. Other symptoms may include depression and other emotional changes; hallucinations and delusions; difficulty in swallowing, chewing, and speaking; urinary problems or constipation; skin problems; and sleep disruptions.
The effectiveness of Nuplazid was shown in a six-week clinical trial of 199 participants. Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease.
As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.
In clinical trials, the most common side effects reported by participants taking Nuplazid were: swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state).
Nuplazid was granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with Parkinson’s disease. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The drug was also granted a priority review. The FDA’s priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition.
Nuplazid is marketed by Acadia Pharmaceuticals Inc. of San Diego, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
RVNC Releases Fourth Quarter and Full Year 2015 Results
https://finance.yahoo.com/news/revance-releases-fourth-quarter-full-210500556.html
Clinical Development - DaxibotulinumtoxinA for Injection (RT002)
Reported positive top-line interim data from BELMONT Phase 2 Active Comparator Trial of RT002 injectable for the treatment of glabellar (frown) lines in October 2015 and have begun preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration planned for the first half of 2016. Revance expects to initiate a Phase 3 clinical program in the second half of 2016.
Bristol-Myers bout out Amylin in 2012.
CLVS - FDA Request Trial Data
http://finance.yahoo.com/news/clovis-oncology-announces-regulatory-rociletinib-130000272.html
Clovis Oncology, Inc. (CLVS) today announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. The Company will provide this information in a Major Amendment to the FDA by close of business today.
“We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer, said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We will continue to work diligently with the FDA on our NDA submission.”
In the Mid-Cycle Communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses. The New Drug Application (NDA) submitted by Clovis to the FDA contained immature data sets based on both unconfirmed response rates and confirmed response rates. These data sets were updated in the 90 day efficacy update the Company submitted at the end of October.
As the rociletinib clinical trials were rapidly enrolling, Clovis presented interim data publicly and at medical meetings and these data therefore included a data set based primarily on unconfirmed responses. This was also true of the Company’s Breakthrough Therapy designation submission. In the Company’s NDA submission, both immature confirmed and unconfirmed response analyses were submitted. As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected.
In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients’ responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30 percent.
The Company anticipates that the review of this additional information will result in a delay of a potential approval. This additional review could lead to an extension of the Company’s March 30, 2016 Prescription Drug User Fee Act (PDUFA) date.
AEGR - Do you know any reasons why AEGR postponed the quarterly earning conference for today until Monday? CEO is sick or a surprise announcement of something on Monday?
Thanks!
WID