3 Reasons These Stocks Will Be Better Alzheimer's Investments Than Biogen

 When the Food and Drug Administration (FDA) approved Biogen's (NASDAQ:BIIB) aducanumab -- now marketed as Aduhelm -- for treating Alzheimer's Disease, it marked the end of a long drought. There hadn't been a therapy approved for the disease since 2003. The drug will still have to prove its impact in a follow up study, but that could take years.

No matter how that turns out, the low bar for approval set by the FDA is likely to open the floodgates for Alzheimer's treatments. It has investors in Cassava Sciences (NASDAQ:SAVA) and Annovis Bio (NYSEMKT:ANVS) excited about their candidates, which are currently in clinical trials. Here are three reasons those biotech stocks might offer better gains in the years ahead than Biogen. 

1. Potential risk versus reward 

The first reason is simple. Biogen jumped almost 50% after Aduhelm was approved. It makes sense. The FDA's approval was a broad brush green light even for types of patients who did not participate in the clinical trials. That 50% gain translates to an additional $20 billion in market capitalization. That's even though it's unlikely insurers will cover the diagnostics, treatment, and monitoring for a cohort that the drug hasn't even been tested in. If the market thinks that's what an Alzheimer's drug is worth, there are better risk-reward propositions.

Cassava and Annovis Bio might not have an approved Alzheimer's drug, but they are well on their way. Neither of their candidates have even begun phase 3 trials, but the $2.65 billion and $511 million dollar market caps, respectively, would seem to offer a lot more upside if they get approved. To realize the potential gains, investors will have to wait. Cassava plans to initiate its phase 3 studies later this year and Annovis is still completing its phase 2 trial.

2. The efficacy data is clear

Few diseases offer a winner-take-all market no matter how well a drug performs. That said, efficacy does matter. In that category, the two smaller biotechs both appear to have the upper hand on the larger Biogen.

Biogen initially scrapped its two aducanumab phase 3 studies in early 2019, then decided to file for regulatory approval later that year after analyzing a larger data set. It turned out, one of the two identical trials met its objective for lessening cognitive and functional decline. The data showed a 6.3% improvement on the Alzheimer's Disease Assessment Scale related to cognition after a year of treatment.

Wall Street was skeptical, and at least one analyst assigned a 0% likelihood that management's plan of pushing for approval would work. Never say never. The decision to approve the drug was so controversial that two members of the FDA committee that reviewed it have since quit. That's an indication that it won't be too difficult to beat Biogen's performance.

So far, Cassava and Annovis Bio have both demonstrated better results in a shorter amount of time. Patients taking Cassava's simufilam improved their scores on the same cognitive test by 10% in a mere six months. For Annovis Bio, the improvement was 30% in only 25 days. If the results hold up, one of the two drugs may overtake Biogen's despite the recent approval. Cassava plans to initiate two phase 3 studies later this year and Annovis Bio should conclude its phase 2 in the fall.

3. Factors investors might miss

Sometimes, investors can focus so hard on the results of one drug and one disease they can miss what else a small biotech has going on. Sometimes what gets missed is just as important. For Cassava and Annovis Bio, the method of administration and potential other revenue streams make each a better investment than Biogen at this point.

First, each of their Alzheimer's drugs are orally administered. Compare that to Aduhelm's once a month infusion and it's easy to see why they have a leg up in treating patients with cognitive and behavioral issues related to the disease. As for other revenue, the two definitely have optionality -- the potential for a new business to grow out of the existing one. 

For Annovis Bio, that comes from ANVS401's ability to help patients with other neurocognitive diseases like Parkinson's. The drug clears toxins from the brain to prevent cell death. That can be applicable to multiple diseases beyond Alzheimer's. For Cassava, the optionality comes in the form of a diagnostic test. Specifically, its SavaDx blood test. It would detect Alzheimer's before symptoms like memory loss are even present. If successful, the stock might be a huge winner even if its drug isn't the blockbuster shareholders hope.

The floodgates are open

Whether Biogen is able to prove the efficacy of Aduhelm in its continuing study or another Alzheimer's drug becomes the darling of Wall Street, one thing is clear. A new era is upon us. Companies are beginning to cross the finish line and bring hope to the millions of patients and family members dealing with the disease. As human beings, we should hope they are all successful. As investors, we have to look for the best opportunities. After a big jump in shares of Biogen, the smaller companies with better results and an easier method of administration look like better stocks to buy for market-beating returns.

https://www.fool.com/investing/2021/06/11/ignore-biogen-3-reasons-these-stocks-will-be-bette/

Novan SB206 Can Potentially Shorten Duration Of Contagious Skin Disease

 

• Novan Inc (NASDAQ: NOVN) has announced positive topline efficacy and safety results from the B-SIMPLE4 Phase 3 trial evaluating SB206, a topical antiviral gel, for the treatment of molluscum contagiosum.

• Molluscum is a common, contagious skin infection caused by the molluscipoxvirus.

• The trial met its primary endpoint with 32.4% of the patients in the SB206 arm (n=444) achieving complete clearance of all lesions at Week 12, versus 19.7 in the vehicle arm (n=447).

• Secondary endpoints - 43.5% achieved a lesion count of 0 or 1 at week 12 versus 24.6% in the vehicle arm; 43% exhibited more than 90% clearance of lesions at Week 12, compared to 23.9%.

• 19.6% showed complete clearance of all lesions at Week 8 against 11.6% in the vehicle group.

• The Company hosted a video webcast today at 8:00 a.m. ET.

https://finance.yahoo.com/news/novans-stock-surges-sb206-potentially-112321588.html

Congress wants to make more changes to the U.S. retirement system

 Less than two years after the Secure Act ushered in significant changes to the nation’s retirement system, more modifications may be on the horizon.

Two similar, bipartisan bills — one each in the House and Senate — aim to build on that 2019 legislation as a way to bolster the ranks of savers and increase retirement security. While the measures are in the early stages of the legislative process, observers expect there to be some movement on them in the coming months.

“The outlook is positive,” said Timothy Lynch, senior director at the law firm of Morgan Lewis. “There’s bipartisan support, so there’s likely to be action sooner rather than later.”

However, he said, the differences between the bills would need to get worked out. And, exactly how to offset any resulting revenue losses could be a sticking point.

“The House bill has some ‘pay-fors,’” said Paul Richman, chief government and political affairs officer at the Insured Retirement Institute. “The Senate bill has none at all, but that could change.”

Called the Securing a Strong Retirement Act — and nicknamed “Secure 2.0” — the House bill received unanimous approval last month from the Ways and Means Committee. Its sponsors are the panel’s chairman, Richard Neal, D-Mass., and ranking member Kevin Brady, R-Texas.

The Senate bill — called the Retirement Security and Savings Act and sponsored by Sens. Ben Cardin, D-Md., and Rob Portman, R-Ohio — has not yet received committee attention but is expected to next month, according to a person familiar with the bill’s path forward.

Here are some of the main provisions in the two measures, with their differences noted, that would impact retirement savers and retirees.

Student loan debt and retirement savings

Most companies that offer 401(k) plans will match your contributions up to a certain amount — e.g., a 100% match for the first 3% you contribute, with a 50% match for the next 2%. For workers whose student loan debt keeps them from putting money into their retirement accounts, it means missing out on that company money.

Both the House and Senate measures would enable employers to make contributions to 401(k) plans (and similar workplace plans) on behalf of employees who are making student loan payments instead of contributing to their retirement plan.

“The larger issue of how to address student loan debt doesn’t have a lot of bipartisan agreement,” Lynch said. “This would be one step to try to help.”

Catch-up contributions

Current law allows retirement savers age 50 or older to make so-called catch-up contributions to their retirement savings. On top of the standard annual contribution limits — $19,500 for 401(k) plans and $6,000 for individual retirement accounts in 2021 — those who qualify can put an extra $6,500 in their 401(k) or $1,000 in their IRA.

Both the House and Senate bills aim to expand those amounts, although the specifics differ a bit.

The House bill would adjust annual catch-up amounts based on inflation, and would expand the 401(k) catch-up to $10,000 for individuals who are age 62, 63 or 64. Workers enrolled in so-called SIMPLE plans would be allowed $5,000 in catch-up contributions, up from the current $3,000.

The Senate bill also would index the IRA amount to inflation, but is more generous with the 401(k) catch-up contribution of $10,000: It would apply to people age 60 or older.

The House bill also would change the tax aspect of catch-up amounts as a way to offset any revenue losses from other provisions.

That is, all catch-up contributions to 401(k) plans and the like would be treated as Roth contributions — i.e., after tax — starting next year. Current law allows workers to choose whether to make those contributions on a pretax or Roth basis (assuming their company gives them the choice). 

Additionally, matching contributions from employers currently can only be made to pretax accounts. A provision in the House bill would allow them to be post-tax (Roth) contributions if the employee wanted to go that route.

Required minimum distributions

The Secure Act already changed when required minimum distributions, or RMDs, from retirement accounts must begin to age 72, from 70½. Under the new House bill, those mandated annual withdrawals wouldn’t have to start until age 73 in 2022, and then age 74 in 2029 and age 75 by 2032.

Similarly, the Senate bill would raise the RMD age to 75 by 2032. It also would waive RMDs for individuals with less than $100,000 in aggregate retirement savings, as well as reduce the penalty for failing to take RMDs to 25% from the current 50%.

Annuity changes

One option to provide an income stream later in life is a qualified longevity annuity contract, or QLAC. Once you purchase the annuity, you specify when you want the income to start.

However, the maximum that can go into a QLAC is either $135,000 or 25% of the value of your retirement accounts, whichever is less.

Both bills would remove the 25% cap. The Senate measure would also increase the maximum amount allowed in a QLAC to $200,000.

“That would let people save more in a tax-deferred environment [for use] later in their retirement years,” Richman said.

Additionally, both bills would direct the Treasury Department to create regulations allowing exchange-traded funds, or ETFs, to be investment options in variable annuity contracts. Right now, it’s not an option due to regulations that were written before ETFs were created, Richman said.

“It would allow an ETF-structured annuity, which would provide consumers with a lower-cost investment option,” he said.

ETFs generally cost less than mutual funds, which are the typical investment offering in variable annuities.

Auto-enrollment in 401(k) plans

The House bill would require employers to automatically enroll employees in their 401(k) plan at a rate of at least 3% and then increase it each year until the worker is contributing 10% of their pay. Businesses with 10 or fewer employees and new companies (under 3 years old) are among those that would be excluded from the mandate.

The Senate bill does not require auto-enrollment, although it includes incentives to encourage companies to implement that feature.

Other items

Both measures would create a national online lost-and-found database for retirement plans that workers may lose track of after they leave a job.

Additionally, while the House bill pushes for greater public awareness of the so-called saver’s credit — a tax credit available to retirement savers at the lower end of the income spectrum — the Senate bill would boost the income limit for individuals claiming the credit and would allow it to be refundable into a retirement account.

Also, under both bills, part-time employees who work at least 500 hours for two consecutive years would be eligible to participate in their company’s 401(k) plan.

https://www.cnbc.com/2021/06/09/congress-wants-to-make-more-changes-to-the-us-retirement-system.html

Autolus Presents New Data on obe-cel in r/r Indolent B Cell Lymphomas at heamatology meet

 Obe-cel achieves 100% complete remission rate in a cohort of indolent B Cell Non-Hodgkin lymphoma patients with excellent CAR T engraftment, expansion, and persistence

No ICANS or high grade Cytokine Release Syndrome observed

Durability of response in ALL patients continues to support potential for transformational therapy in adult ALL

Conference Call to be held on Friday, June 11, 2021 at 8:30 am ET / 1:30 pm BST

Conference Call
Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST to discuss the data presented at EHA. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 3697562. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 3697562.

https://finance.yahoo.com/news/autolus-therapeutics-presents-data-obe-110000390.html

Sanofi builds case for rare disease drug sutimlimab after FDA rejection

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end.

The results of the 42-subject CADENZA study – reported at the ongoing European Haematology Association (EHA) – showed that sutimlimab was able to reduce the destruction of red blood cells (haemolysis) seen in patients with CAD within one week of starting treatment.

In CAD, an autoimmune reaction causes the body to attack health red blood cells, leading to severe anaemia, fatigue and acute haemolytic crises – when large numbers of cells are destroyed within a short period of time. In some cases patients can develop life-threatening blood clotting complications.

Sutimlimab, which Sanofi acquired via its $11.6 takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD.

It has the potential to become the first-ever approved therapy for the CAD, and picked up a breakthrough designation from the FDA last year. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs.

In CADENZA, the antibody met its combined objective of improving haemoglobin levels in the blood by at least 1.5 g/dl, preventing blood transfusions between weeks five and 26, and avoiding the need for other CAD therapies. That was achieved in 73% of patients, compared to 15% of the placebo group.

Looking at secondary measures, sutimlimab improved average haemoglobin levels by 2.6 g/dl compared to placebo over the six-month follow-up, and also improved fatigue scores whilst cutting levels of bilirubin and LDH, two biomarkers for haemolysis.

The FDA turned down Sanofi’s initial attempt to secure marketing approval for sutimlimab last November, based on the results of the earlier phase 3 CARDINAL trial in 24 patients – although that rejection stemmed from deficiencies identified at a third-party manufacturer of the drug.

Sutimlimab is also being developed for other indications including immune thrombocytopenic purpura, and was billed a one of the most promising assets in Bioverativ’s pipeline when the company was acquired by Sanofi.

“Based on the robust clinical evidence we have to-date, sutimlimab significantly inhibits haemolysis and has the potential to be an important new treatment for CAD,” said Karin Knobe, head of development, rare, and rare blood disorders at Sanofi.

The drug is part of a renaissance in the French drugmaker’s pipeline, which had been looking depleted for a number of years, along with other candidates like immunology blockbuster Dupixent (dupilumab), haemophilia candidates fitusiran and BIVV001, BTK inhibitor SAR442168 for multiple sclerosis, breast cancer candidate amcenestrant and nirsevimab for respiratory syncytial virus (RSV).

https://pharmaphorum.com/news/eha21-sanofi-builds-case-for-rare-disease-drug-sutimlimab-after-fda-rejection/ 

Bristol Myerrs, Acceleron: Phase 2 Study of Reblozyl in Beta Thalassemia

 Results showed treatment with Reblozyl plus best supportive care improved anemia in 77% of patients compared to placebo

Reblozyl was generally well tolerated and improvements in hemoglobin correlated with improved patient-reported outcomes over a continuous 12-week interval

In the study, 89.6% of patients treated with Reblozyl remained transfusion free vs. 67.3% of patients in the placebo arm at weeks 1-24

Results featured in Presidential Symposium of European Hematology Association’s Virtual Congress as one of top six abstracts submitted

https://www.businesswire.com/news/home/20210611005039/en/Bristol-Myers-Squibb-and-Acceleron-Present-First-Results-from-Phase-2-BEYOND-Study-of-Reblozyl%C2%AE-luspatercept-aamt-in-Adults-with-Non-Transfusion-Dependent-NTD-Beta-Thalassemia

Janux Therapeutics Prices IPO

 Janux Therapeutics, Inc. (Janux), a biopharmaceutical company developing novel T cell engager immunotherapies, today announced the pricing of its initial public offering of 11,400,000 shares of its common stock at a price to the public of $17.00 per share. The gross proceeds to Janux from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $193.8 million. All of the shares are being offered by Janux. In addition, Janux has granted the underwriters a 30-day option to purchase up to an additional 1,710,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Market on June 11, 2021, under the ticker symbol "JANX." The offering is expected to close on June 15, 2021, subject to the satisfaction of customary closing conditions.

BofA Securities, Cowen and Evercore ISI are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

https://www.benzinga.com/pressreleases/21/06/b21523761/janux-therapeutics-announces-pricing-of-initial-public-offering