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Cardiff Oncology - Blair Initiates Outperform
Unusual Comment “ In the Realm of Kras -Mutated Tumors, One Precious Compound, Onvansertib, To Rule Them All; Initiating with an Outperform Rating”. Discusses addressable market of $ 14B.
LifeSciFocus (@Jeff) Tweeted: $CRDF WILLIAM BLAIR INITIATES AT OUTPERFORM
ESPECIALLY INTRIGUED BY PLK1 SYNTHETIC LETHAL INTERACTIONS WITH THE RAS ONCOGENE ?? https://twitter.com/lifescifocus/status/1478682886278725634?s=27
Any thoughts on Cardiff Oncology (CRDF) drug onvansertib to be considered as a legitimate pan Kras inhibitor? Trials ongoing in mCRPC at Mass Gen, and other trials in m(CRC), AML. Has fast track approval and expanded coverage use. Kras mutations , considered untouchable until recently, is 30% Involved in all cancers and 95% of pancreatic tumors. No Safety issues seen and treatment added on in pill form to present treatments prescribed.
Attached is a NiH paper on its potential in triple negative breast disease.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6872222/
Need thoughts on Trovagene’s PLK 1 Inhibitor with orphan status. Tiny bio just reported another trial result on end stage CRPC patients conducted at Dana Farber and Mass General. To my untrained eye results seemed quite positive. Also has open label trial results on CRC and KRAS mutation which appears responsive, and an ongoing AMl trial. Drug may have synergy with other drugs and reduce resistance to existing treatment regiment. Could it receive early special conditional approval for patients with no other treatment options?
AVEO - Agee there is a place for a more tolerorable TKI. Do not agree that the ship has " sailed" on TIVO as Axitinib in the recent combo trial with Avelumab reported that 96% of participants reported adverse events, 56 % with diarrhea and significant hypertension in participants.
AVEO Does AVEO remind anyone of EXEL? AVEO has had redemption with Tivinabid. The drug is ready for approval in EU for possible first line renal cancer. Low toxicity profile and use in combination could be a big disrupter in space. Appears really undervalued with near term catalysts. Any additional viewpoints desired?
Dew Diligence and CNAT
Dew, why would CNAT rip their stock price now, on a small offering, after their recent deal with Novartis? Is the CEO deranged?
Due Diligence,
Any success in establishing/finding the Yahoo healthcare/ biotech news stream? Miss it!
Trillium- Still under pressure. Any reaction or impression from just released abstracts in advanced of meeting. Sound positive, but selling for cash, like at a dead end.
Prana's PBT2 AD drug is supported by Dr. Tanzi at Harvard for its unique properties in eliminating tau tangles. It is an analog of clioquinal, an anti fungal antibiotic and crosses the blood brain barrier. Any potential with this approach? thanks!
PRAN. Whitehead Institute website (front and center) presented today an article on a yeast model that mentions and appears to bolster Prana's claim for efficacy for their AD drug .
XNPT - Company in recent update said they are considering a 505 (b) 2 pathway for XP23829 for MS. Àny thoughts on their efforts and ultimate success in advancing this drug? BIIB has to be watching big time.
Biomaven and Masterlongevity,
My impression is that PBT2 in the Imagine trial for MCI patients is at at least double the dose of the phase 1 and twice as long (12 months) including those patients who joined the extension trial when it was granted. The drug may prove to have a unique MOA,to have fast clearance, and be safe. It is an interesting speculation that could be " Intercept " like given the larger indications.
The Aussie scientists have been working on this metal thesis for over a decade without much acceptance or attention. With little institutional interest as a barometer of validation, the odds appear long.
Dear Biomaven and Longevity,
Thanks for the insights and thoughtful comment.
PRAN - Biomaven
Your concern about the Imagine Trial seems to be the consensus.
However, the trial is relying on pet scans to prove target engagement and plaque removal as the primary bio marker (as well as others like cognition). Kadaicher on this board asserts that a smaller trial can indeed be powered to validate this MOA. Could the before and after PET scans be sufficiently definitive ? Thanks
JNJ is proposing today to sell diagnostics division for $5b. Could JNJ have interest?
ZLCS. Does anyone have opinion on this company. Has novel pain candidates, one is in Phase 2 (Z160) with significant potential, former Sepracor executives, Cambridge based, and 100m cap. Reverse split is contemplated.
Please weigh in as I don't understand the market cap valuation.
Trius, Optimer, now ASTX go for less than worth IMO. Are these companies being surrendered to bidders and the management being rewarded inordinately to go along?
Stem Cell (SCTPF) Don Just an observation- David Allan, Chairman of the Board of SCTPF was former CEO and Chairman of the Board of YM BioSciences who sold this company to Gilead for $510M more recently. Can he do it again?
Prana- Biomaven
If the results of the Imagine trial comes back with significantly lower amyloid levels, safety, positive pet scans for volume and cognitive improvement, how will the FDA and investment community react?
What results from your viewpoint would be convincing, if any, given the small scale of this 2nd trial?
The float and market cap are so tiny, if they have a real shot on goal, compared to the outsized targets of Az, HD and Pk.
I remember decades ago how Doctors from Australia were scoffed at when they proclaimed ulcers were more related to bacteria, not stress, as ulcer removal operations were rampant. Thanks again for your always thoughtful insights.
Need understanding of the Bottom Line on the Ariad EU approval today.
Why is the stock actually declining? In appears the label is more restrictive than in US (bad?)but is there also no black box warning (good?). How does the announcement square with Harvey's guidance that he has given?
Thanks!
NitroMimantine for Alzheimer's was mentioned by Biomaven in an interesting Science Daily article. Uses two approved FDA drugs to restore synapses with a definitive MOA.
Does anyone know if this drug has any entity that can be invested in? Forest Labs?
DVAX Dear Biomaven. I know that in the past you had some interest in DVAX. What are your current thoughts?
With the recent setback, and with enterprise value now at $147M,some cash, is this a potentially good entry point or still a landmine?
Any chance they get it approved for dialysis patients or even a European approval? Stock seems inexpensive, drug works, but ships passing in the night with the FDA. Thanks!
Heavily Shorted Stocks Thank you for your insight on investing in shorted stocks. Does this bode, in your opinion, bad karma for a stock like EXEL?
DDXS - Biomaven and GHMM, thank you for your insights.
DDXS does have an approved code and medicare reimbursement of $48 for the test. If GSK is successful, the pressure will be on to get their drug to market and have the test incorporated into cardiac panels, quickly I would assume.
But you are correct the trial is risky, but GSK has committed full bore to these huge phase 3 event base outcomes. We should soon know.
Plaque Reduction - Biomaven, GSK is concluding two trials for Darapladib(27,000 patients) with the goal of stabilizing the plaque in vessels to prevent Mi and stroke. What do you think of their chances at success and would DDXS as the only approved diagnostic for LPA be well positioned? Thank you for your opinion!
Masterlongevity.
Your comments are simply not accurate as I understand them.
There are 9 trials,several were added for early onset and PET scanning, and 4 are still recruiting, totaling 943 patients, not 200 If the trials show high significance, a phase 3 trial may not be needed for initial approval.
Eln Folly?
The AB ACC-001 conjugate vaccine trials that ELN has >25% share with PFE and JNJ, initiated in 2007, will be opened this Spring. What odds do you place on success?
Perhaps the events of today, lifting a poison pill, will now allow JNJ to purchase Eln at a big premium. Any thoughts on this possibility.
XNPT Biomaven, Any new consideration or update of Xp23928 as a worthy speculation. The stock has been quiet- has interest waned?
DSCO Biomavin, thank you for your thoughtful input. They need a partner who has critical care presence.
It appears that getting a drug approved for tiny neonates and other critical care patients was one mountain to climb. DSCO has a vision for a whole new delivery system that may be attracting interest. The approved drug is the cornerstone.
Biomaven Question - DSCO This stock appears cheap with enterprise value of 75 Million after years of dilution and frustration.
Two newly approved drugs and a potential new platform for delivery. Stock on a run today. In your opinion is this a value propositon or a trap? I value your opinion.
Mesothelin Intel prize winner uses mesothelin as marker for pancreatic cancer, where it is highly expressed.
Of related note is that IMUC recently acquired exclusive world wide license to intellectual property rights from John Hopkins surrounding the tumor associated antigen mesothelin for use in their pancreatic and ovarian vaccine.
My assumption is that it is the phase 2 trial.
Individual is on tarceva and began mm-121 trial recently.
Biomavin,
Know individual who is EGFR positive NSCLC on Mack's MM-121. States he is starting to feel the itch come back from his Tarceva use and is encouraged. Just a random observation of little import.
Any opinions on MM-121's MOA and collaboration with Sanofi?
Glaxo versus HGSI Its not about the lupus drug. The battle in my opinion is all about Darapladinib. HGSI retails 10% world wide rights and 20% co-promotion or roughly a third of the action. The two trial results with over 12000 patients are maturing and could be announced shortly. Glaxo has to have a good feel for the results and the drug could be a true, bonifide, game changer in coronary care - billions are at stake.
I would welcome any other opinions on how this contest will be settled.
Biomavin (VIVUS),
Do you feel there is any probability of an FDA approval before the June options expire or a buyout or partnership announcement?
Thanks for your opinion!
Biomaven,
Have you given up on Exel?
Carbo, I believe has nine presentations scheduled.
HGSI
Game changer may be the announcement of the GSK phase3 trails of darapladib later this year. GSK has huge trial going with over 20,000 patients for heart drug that has a remote chance of rivaling lipitor in revenues. Drug is suppose to shrink and stabilize coronary lesions.
HGSI has 10% world wide royalties and 20% copromotion for North America and Europe or perhaps over 30-35% of the action. Success with this drug would make the lupus drug seem small change in comparison! So there is considerable upside if the drug is approved.
Can anyone comment on chances of success?
VVUS The potential numbers of patients and earnings appear to me to be staggering if finally approved. But in the real world, these singularities seldom present or never seem to fulfill.
Then I take due note. One third of USA is obese and rest of developed world is catching up. Huge apparent impact on diabetes and progression. Panel member called it a "diabetes drug". Huge publicty, enormous unmet need, and the apparent inside track for some duraton.
When will we get a better approximation of its intrinsic value?
Dew,
Thank you for your revision. Using the 5 million patients and the revenue metrics and your conservative assumption of 20 % after tax margin, I still calculate EPS of 24.54. In your opinion, is that number feasible? Thanks!