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CASSAVA SCIENCES, INCCASSAVA SCIENCES, INCCASSAVA SCIENCES, INC

CASSAVA SCIENCES, INC

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savaCassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, announced today that the U.S. Food and Drug Administration ("FDA") denied a Citizen Petition that was filed in August 2021 by an attorney on behalf of short-selling clients. FDA also denied four supplements to the August 2021 Citizen Petition. FDA also denied a September 2021 Citizen Petition, and a supplement, that were also filed by the same attorney on behalf of short-selling clients. “The news is very welcome but not surprising,” said Remi Barbier, President & CEO. “We said from the outset that the allegations are false. I think the message may be that the FDA’s citizen petition privilege is not to be trifled with by stock market participants.” In Fall 2021, Cassava Sciences advanced its lead drug candidate, simufilam, into a Phase 3 pivotal program in patients with mild-to-moderate Alzheimer’s disease. This Phase 3 program is being conducted under Special Protocol Assessments (SPA) from FDA. An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, etc.).
NASDAQ:SAVALong
by Jd009
Cassava Sciences Stock Is Worth Almost 4x MoreCassava Sciences Stock Is Worth Almost 4x More After Adjusting for Risk * 1/10/2022 1:45pm EST * By Mark R. Hake, CFA Cassava Sciences (NASDAQ:SAVA) stands to gain a good deal this year. This will all depend on the company’s Phase 3 clinical trials progress in the results on actual patients with Alzheimer’s disease. SAVA stock could become a major winner as a result, or potentially a loser. The upside will also be subject to how well the results are received both by the medical community and the market. As a result, SAVA stock is either going to be seen as a winner or a huge loser. There is probably not too much room in between. As one author pointed out recently, the market thinks there is only about a 6% chance that the company’s Alzheimer’s drug, Simufilam, will be successful. But if it is successful, the author believes there is a 66% chance that the stock could rise 11 times before the U.S. Food and Drug Administration (FDA) approves the drug for Alzheimer’s treatment. Where Things Stand With Cassava Sciences The trials conducted up until now involve “the distribution of 147,000 Simufilam to more than 250 Alzheimer’s patients in at least 16 investigator sites.” So far there have been no drug-related serious adverse events. However, these were open-label studies involving no placebos. The two Phase 3 clinical trials now underway involve a placebo and blind study. In fact, on page 17 of the company’s Jan. 2022 presentation on their website, it says: “Treatment effects observed in an open-label study are not proof of drug safety or efficacy, nor can open-label data predict clinical success in a Phase 3 program.” So, the company has been more or less compelled to proceed to a Phase 3 study in order to assure its efficacy. However, on page 23 of the slide deck, the company said that the FDA approved its Phase 3 protocol: “FDA agrees that the completed Phase 2 program, together with an upcoming and well-defined Phase 3 clinical program, are sufficient to show evidence of clinical efficacy.” So, you can see that if the Phase 3 trials go well, the FDA could well approve the drug for the treatment of Alzheimer’s disease. Therefore, in a way, it won’t matter what the market thinks about the results. The only issue is whether the FDA will approve the drug. And that alone will make the company. Where This Leaves Cassava Sciences I suspect that once the first study results come out for the Phase 3 trials the market will begin to focus on the mechanics of how the drug will get distributed once it is approved. The company’s Chief Executive Officer Remy Barbier has made it clear in interviews that the company will likely have to partner with a major drug manufacturer/distributor. This could lead to a revenue-sharing deal. What is even more interesting here is the possibility that the company could announce a royalty/revenue-sharing deal prior to any results for Phase 3. This could also act as a major catalyst for SAVA stock. I suspect that will happen some time late in the first quarter and/or in the second quarter. Expect to see analysts begin to project the company’s valuation based on this. So far, not many observers of the stock have put together cogent models with a major drug partner for Cassava Sciences. However, at today’s price, $47.95, the stock has a almost $2 billion market capitalization. There are no analyst forecasts for 2023 or beyond. This goes to show that everyone is virtually waiting on the edge of their seat for the results of the Phase 3 clinical trials. What To Do With SAVA Stock I am personally very positive on SAVA stock and indeed have a position in the company. In fact, now that the stock is down off of its highs, I intend to buy more of the stock. However, I freely admit that this is a highly speculative position to take. For example, as I pointed out above, there are no real estimates for the company’s earnings going forward. Moreover, there is no real assurance that the FDA will approve the drug as a treatment for Alzheimer’s. Here is a simple probability exercise that shows why I have taken a position. Analysts seem to believe that if the drug is approved, the stock will be worth 11 times its price today. That represents a 10 times gain. But if it is not approved and the trials are a bust, the stock could easily fall 80% to 90%. Let’s call it negative 95%. Now, let’s give the chance that it is going to be a success a one-third chance. That leaves a two-thirds chance it will bust. So, here is the expected return (ER). We multiply 10 x 0.333, and get an ER of 3.333 times. But the downside results in an ER of -63.37% (i.e., negative 95% x 0.6666). So, if we add the total ERs together, the total ER is still positive. In other words, SAVA stock is worth 3.7 times (i.e. 1 + 270% return) its price today, or $177.42. So, despite the risks, this looks like a pretty good risk-adjusted return on investment candidate.
NASDAQ:SAVALong
by binancash
#SAVA, rounded bottom, long biasA quick brief, Cassava Sciences, Inc. engages in the development of novel drugs. It focuses on developing product candidates intended for the treatment of Alzheimer's disease, including PTI-125 and PTI-125Dx. The company was founded by Remi Barbier and Barry M. Sherman in May 1998 and is headquartered in Austin, TX. Quick take on the price action for SAVA, the stock’s volatility has been largely based on the events surrounding Simufilam – the company’s prospective treatment for the difficult-to-treat Alzheimer’ disease (AD). Average Analyst rating for SAVA is a price target of USD 147. (CMP : 68.53) I am expecting to see some resistance around $76, which is also the 20 week Moving Average. This stock has given a great move over the last 3 days and is currently 24% away from the 5 day Moving Average, 34% away from the 20 Day Moving Average and about 25% away from the 200 Day Moving Average Given the formations on the chart, looks like a nice rounding bottom being formed on SAVA. There Is likelihood price will test the 76 dollars range soon. If it holds there, next target could be 96 dollars, else look for a move back towards the 20 Day Moving average I think this stock is great "buy the dip" stock and would be looking to accumulate Do note, this stock is extremely volatile, do your research.
NASDAQ:SAVALong
by LoveForCharts
4
What's next on SAVAPosting this as many of you have asked about what's my view on SAVA. I haven't initiated any trade yet on this ticker but here is my understanding for now. As detailed in the previous trade update, we went down to $47.77 and bounced back, right above golden zone retracement level at $45.98. While i like the Doji candlestick formed yesterday, i don't see much impulse buying yet and volumes are low. I would wait a few more sessions to see if it closes above $54 with high volume than average and then buy back again.
NASDAQ:SAVA
by rbswingtrader
8