-=Cassava Sciences (SAVA) : SEC charges

In June 2024, the United States Department of Justice charged an advisor to Cassava Sciences, Hoau-Yan Wang, with fraud over research results related to the experimental drug. Less than a month later, the president, chief executive officer and chairman of the board, Remi Barbier, resigned along with Lindsay Burns, his wife,[1] who was a Cassava senior vice president and Wang's co-author. The U.S. Securities and Exchange Commission (SEC) filed fraud charges in September 2024 against Cassava, Barbier, Burns and Wang. The parties did not admit wrongdoing, but a settlement of the SEC charges, pending court approval, would fine Cassava $US40 million, Barbier $175 thousand, Burns $85 thousand and Wang $50 thousand.

Sep 26, 2024 — The Securities and Exchange Commission today filed charges against Cassava Sciences, Inc., its founder and former CEO, Remi Barbier.

Due to the promise of its experimental Alzheimer's drug, Cassava Sciences stock became the sixth-best stock of 2021, driving the company's value to over $US5 billion, with the stock price reaching $125 per share.

Unusual Options Activity Fri 9/27/24

The following options are exhibiting notable trading, potentially indicating changing sentiment toward the underlying stocks, and/or potentially representing positioning for increased volatility.

Bullish Call Activity

• RKLB Oct04 10 Calls are seeing interest with 2465 contracts trading vs. open int of 974, pushing implied vol up around 6 points to ~91%. Co is expected to report earnings early November. Stock is up 12% in today's session.

• HOOD Oct04 23.5 Calls are seeing interest with 8834 contracts trading vs. open int of 2953, pushing implied vol up around 7 points to ~55.1%. Stock is up 6% in today's session.

Bearish Put Activity

• SAVA Nov15 25 Puts are active with 900 contracts trading vs. open int of 153, pushing implied vol down around 22 points to ~128%. Co is expected to report earnings early November. Stock is down 8% in today's session.

• SAVE Oct04 2.5 Puts are active with 554 contracts trading vs. open int of 424, pushing implied vol down around 62 points to ~133%.

Sentiment: The CBOE Put/Call ratio is currently: 0.79, VIX: (16.00, +0.63, +4.1%).
October 18 is options expiration - the last day to trade October equity options.

Insider Trading : Fri 8/25/23

Notable purchases -- CTO adds to ROOT; notable sales -- Director active in XENE

Buyers:

• AON Director bought 800 shares at $324.575 worth ~$260K.
• AVA Chairman of the Board / 10% owner bought 3,100 shares at $32.39 - $32.40 worth ~$100K.
• EXFY 10% owner bought 67,661 shares at $4.48 - $4.50 worth ~$304K.
• GABC Director bought 6,000 shares at $28.64 worth ~$172K.
• HTLD Chief Executive Officer and Co-Trustee of 10% Owner bought a total of 54,461 shares at $14.935 - $14.99 worth ~$698K.
• OUST Director bought 30,000 shares at $5.7898 to $5.96 worth ~$177K.
• PENN Director bought 20,000 shares at $22.49 - $22.88 worth ~$453K.
• PI 10% owner Sylebra Capital bought another 74,771 shares at $59.49 worth ~$4.5 mln.
• ROOT  Chief Technology Officer bought 17,412 shares at $5.7898 - $5.96 worth ~$163K.
• RRGB 10% owner and the President & CEO bought a total of 237,536 shares at $10.15 - $10.59 worth ~$2.5 mln.
• SAVA Director bought 30,000 shares at $17.21 - $17.64 worth ~$524K.
• SEER CEO, President and Chair bought 40,000 shares at $2.49 - $2.50 worth ~$98K.
• WEST Director bought 20,000 shares at $10.00 - $10.19 worth ~$202K.
• WOLF Director bought 5,000 shares at $47.0136 worth ~$235K.

Sellers:

• CNXN President & CEO sold 35,465 shares at $52.29 - $53.60 worth ~$1.9 mln.
• TZOO 10% owner Azzurro Capital sold 75,369 shares at $6.60 -$7.03 worth ~$511K.
• XENE Director sold 25,000 shares at $38.70 - $38.79 worth ~$968K.

This week's biggest % winners & losers : Nov. 1 - 5, 2021 (wk 44)

The following are this week's top percentage gainers and losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top % gainers

• Healthcare: SAVA (90.91 +110.78), KPTI (8.29 +51.83%), IRTC (104.27 +48.65%), ENDP (6.25 +47.06%), KNSA (14.76 +42.06%), ANIP (50.94 +36.28%), SGMO (10.99 +35.28%), EVLO (11.75 +32.77%), ARWR (80.36 +25.92%)
• Industrials: CAR (298.99 +72.52%), DNOW (9.56 +32.34%)
• Consumer Discretionary: BBBY (22.49 +60.19%), SHAK (92.2 +33.29%), DDS (300.25 +29.9%), GOOS (48.01 +29.39%), GT (24.16 +26.33%)
• Information Technology: ANET (528.58 +29.02%), SYNA (247.67 +27.29%), FN (120.51 +25.53%), MCFE (25.48  +19.23%)
• Financials: DFIN (48.79 +27.32%)

This week's top % losers

• Healthcare: DCPH (9.02 -73%), TRHC (14.33 -47.24%), EBS (30.26 -36.52%), MRNA (234.32 -32.12%), DVAX (15.34 -23.18%), PBYI (4.15 -18.63%), BCRX (12.32 -17.52%), CRL (374.91 -16.44%)
• Materials: TX (38.6 -16.68%), TRQ (10.57 -16.57%)
• Consumer Discretionary: CHGG (30.79 -48.2%), LAUR (11.74 -32.25%), TUP (18.15 -18.41%), RCII (43.65 -18.05%), CPS (21.39 -17.54%)
• Information Technology: HOLI (14.61 -26.77%), AAOI (5.87 -23.33%), UPLD (26.52 -20.53%), UIS (21.47 -16.03%)

-=Cassava Sciences (SAVA) : Journal finds no proof of tampered Alzheimer's data

• Co has been informed by the Journal of Neuroscience that it determined that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease.  
• Allegations of data manipulation caused SAVA stock to plummet in August. One of the claims was that Cassava altered test images called Western blots. The Journal of Neuroscience says there's no evidence to indicate Cassava tampered with those images in a July 2012 paper. That paper was foundational to the company's experimental Alzheimer's drug, simufilam.
• "I've never doubted the integrity of our people or science," Chief Executive Remi Barbier said in a written statement. "We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer's disease."

Cassava Sciences: Review of company's article published July 2012 describing a new approach to treating Alzheimer's disease finds no data manipulation

• SAVA has been informed by the Journal of Neuroscience that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease. The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Company's lead drug candidate for the proposed treatment of Alzheimer's disease.
• In August 2021, a law firm representing anonymous short sellers submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) that alleges, among other things, data manipulation in Western blots in a science article published by the Journal of Neuroscience in July 2012. (Western blotting is a complex laboratory technique used to separate and measure proteins). In response to this and similar on-line allegations, the Journal of Neuroscience requested raw data for the article, including images of original, uncropped Western blots. Having received that data and completed its review, the Journal of Neuroscience states: "No evidence of data manipulation was found for Western blot data." One human error that does not impact data conclusions was identified (a duplicated panel in Figure 8B of the article), and the publisher is expected to print a correction.
• In October 2021, a second Citizen Petition was submitted to FDA by an individual unknown to Cassava Sciences. This second petitioner "is requesting the FDA for approval of simufilam and immediate initiation of Phase 4 trials for further efficacy, safety assessment and, most critically, to address one of the greatest needs in modern medicine."
• FDA has not engaged with the Company regarding either Citizen Petition.

Cassava began enrolling patients in a Phase 3 study of its drug, simufilam, in early October. The news followed a positive 12-month study in which patients' cognition improved by 3.2 points on a 70-point scale. Most patients show declines. Even Biogen's (BIIB) approved Alzheimer's drug, Aduhelm, only slows the cognitive decline in mild-to-moderate Alzheimer's patients.

Critics of SAVA stock note the study was open-label. That means patients knew they were receiving the experimental drug. The Phase 3 study, however, will test simufilam against a placebo.

-=Cassava Sciences (SAVA) : Alzheimer's drug trial results

 

Cassava Sciences announces results of an interim analysis from an open-label study of simufilam, its lead drug candidate for the treatment of Alzheimer's disease

• Patients' cognition improved 1.6 Points on ADAS-Cog11.
• Patients' behavior improved 1.3 Points on NPI.
• Improvements maintained at 6 months.
• Results support advancing simufilam into Phase 3 clinical program.

Pain Therapeutics (PTIE) to change name to Cassava Sciences (SAVA)

• Update Sep 26, 2024 — The Securities and Exchange Commission today filed charges against Cassava Sciences, Inc., its founder and former CEO, Remi Barbier.

Headquarters: Austin, TX

Founded: 1998

 

Pain Therapeutics Inc. (PTIE) said Wednesday it's changing its name and ticker to better reflect its focus on developing drugs for neurodegenerative diseases such as Alzheimer's. The company will be named Cassava Sciences Inc. with immediate effect. From March 28, it will start trading on Nasdaq under the new ticker symbol "SAVA." The company is currently in a phase 2 testing of a drug candidate aimed at treating Alzheimer's, that does not seek to clear amyloid from the brain, but rather to stabilize a critical protein in the brain. It is also working to develop a biomarker/diagnostic to detect Alzheimer's using a simple blood test. Shares rose 1.7% in premarket trade, but have fallen 82.2% in the last 12 months, while the S&P 500 SPX, -0.02% has gained 7.9%.