At the beginning of the year, Cassava Sciences (NASDAQ:SAVA) stock was a lowly micro-cap. Today it boasts a market capitalization of over $3.8 billion.
SAVA stock has grown by a dumbfounding 1,313% since the beginning of the year and is arguably the hottest biotech of the year.
Cassava is developing a drug to treat Alzheimer’s disease and has so far proven to improve patient outcomes across a range of biomarkers.
It appears that it has developed the first genuine disease-modifying Alzheimer’s drug, which has a massive growth runway ahead.
Cassava’s Alzheimer’s drug simufilam recently completed its phase 2 trials, and its results are remarkable. The placebo-controlled study had a positive impact on a range of biomarkers.
SAVA stock has been progressing in the right direction and has gained a healthy 50% in the past couple of months. Cassava could pursue multiple paths for the drug’s approval with stellar biotech data and a clean tolerability profile. Therefore, SAVA stock is an attractive long-term investment.
SAVA Stock and the Path To Approval
Cassava plans to conduct two phase 3 clinical trials before the conclusion of this year in testing simufilam’s efficacy. Both trials will compare the drug to placebos.
The first will look at a couple of cognitive benchmarks in testing the patient’s ability to care for themselves. The second trial will assess the drug’s effectiveness in slowing down the progression of the disease.
Apart from those studies, the company would need to reproduce its recently reported results.
The phase 2 trials showed that simufilam was effective across a wide range of biomarkers and slowed down the progression of the disease. However, Cassava might not have to undergo such intense scrutiny given how Biogen (NASDAQ:BIIB) got its drug Aduhelm approved.
Biogen didn’t have substantial biomarker data to show that its drug improved cognitive benchmarks for Alzheimer’s patients.
Cassava does have evidence that simufilam improves cognitive benchmarks and can slow down the progression of the disease. Therefore, the compelling body of data from over a decade of studies and the relatively low bar set by the FDA strengthens simufilam’s case significantly.
Cassava recently released its 9-month data from its ongoing study of simufilam. The results from the patients involved in the study were outstanding and unprecedented.
It is the first Alzheimer’s drug to have shown cognitive improvement after nine months.
Simufilm showcased an 18% average improvement from the baseline on the ADAS-Cog11 scale. Its 3.0 point benefit was up considerably from the 1.6 points benefit in month 6.
Patients are getting better as 90% of those involved in the study saw a benefit. Moreover, 66% of them saw an absolute improvement from the baseline, which was spectacular.
The drug’s data is currently unrivaled and highly consistent. Cognitive benefits can be traced way back to pre-clinical studies.
Additionally, the drug has an incredible safety profile with no serious adverse events, and the dropout rate was lower than 10%. Cassava showed biomarker data from 25 of the participants in the study. Simufilam improved a whole panel of biomarkers, including neurodegeneration and neuroinflammation.
Final Word on SAVA Stock
Alzheimer’s and other dementias are expected to cost the U.S. upwards of $355 billion in 2021 and reach $1.1 trillion by 2050.
Cassava Sciences and other biotechs involved in developing a novel Alzheimer’s drug are looking at a huge addressable market.
Cassava appears to have a solid case at this point and is on the verge of validating simufilam as a miracle drug. If that happens, there is a tremendous upside potential left in the stock.
On the date of publication, Muslim Farooque did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.