Harriet Lefton

About the Author Harriet Lefton

Harriet originates from the UK where she worked as a journalist specializing in the metal markets. She graduated from the University of Cambridge before becoming a qualified UK lawyer.

Tuesday’s Biotech Insights: Aldeyra Therapeutics Inc (ALDX) and SAGE Therapeutics Inc (SAGE), Aethlon Medical, Inc. (AEMD)

A glimpse into three biotech movers: ALDX, SAGE, AEMD.

Aldeyra Therapeutics Inc (NASDAQ:ALDX) shares are exploding in Tuesday’s trading. Shares are currently up by 55% and are now trading at $6.55. The move comes on the long-awaited Phase 2a trial results of ALDX’s dry eye disease treatment. Topical ocular ADX-102 was found to show improvement across multiple signs and symptoms, both statistically and clinically.

Out of the three formulations tested (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) 0.1% was found to be the most effective and tolerable and will now be advanced to the Phase 2b clinical trial, which is set to take place in the first half of 2018.

“ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide,” says John Sheppard, a Professor of Ophthalmology at Eastern Virginia Medical School. “The evidence of rapid-onset activity and the tolerability profile demonstrated in the Phase 2a clinical trial suggests that ADX-102 could provide important patient benefits relative to existing therapies.”

Specifically, the drug was tested in 51 patients for 28 days. Aldeyra say improvements were evident within a week. According to Aldeyra, there is a sizeable opportunity for an effective treatment of dry eye disease. This is because the current treatments, which are generally perceived to be inadequate, nonetheless still accounted for approximately $1.8 billion in prescription sales in the US in 2016.

ALDX has a Strong Buy analyst consensus rating according to TipRanks. In the last three months, three analysts have published buy ratings on the stock. These analysts have an average 12-month price target of $13 which stands at a massive 209% upside from the current share price.

SAGE Therapeutics Inc (NASDAQ:SAGE) shares are sinking by 16% in Tuesday’s trading. The Cambridge-based company has just announced that its treatment of super-refractory status epilepticus (SRSE) did not meet the primary endpoint of a phase 3 trial. SRSE- for which there are currently no FDA-approved treatments- refers to life-threatening seizures that last for longer than five minutes.

Following the news, top Leerink Swann analyst Paul Matteis nonetheless reiterated his buy rating on the stock. He says he would be very surprised if Sage continued clinical development in this context, and expects the company to focus on developing the same Brexanolone drug but for mood disorders. In the context of postpartum depression (PPD), he believes the drug has a 75% chance of success- and that this has fueled the stock’s recent share climb:

“We believe the vast majority of SAGE’s outperformance in 2017 was driven by indications other than SRSE. We still think that PPD … should stand on its own merits given that the phase II data are placebo controlled, show a large signal (and) are published” says Matteis.

Overall, SAGE has a Strong Buy analyst consensus rating. In the last three months, eight out of nine analyst ratings are bullish on the stock. Meanwhile the average analyst price target of $97.29 suggests that SAGE has close to 26% upside potential from the current share price.

Aethlon Medical, Inc. (NASDAQ:AEMD) shares are spiking by an incredible 73% in Tuesday’s trading. The stock, currently up by $1.36, is now trading at $3.20. The company, which creates immunotherapeutic devices to combat infectious disease and cancer, has just received positive news from the United States Food and Drug Administration (FDA).

The FDA has given an Expedited Access Pathway (EAP) designation to Aethlon’s Hemopurifier for the treatment of life-threatening viruses. To boost the body’s natural immune defenses, the Hemopurifier eliminates life-threatening disease targets that are shielded from the immune system and not well addressed by traditional drug therapies. To date, Hemopurifier therapy has been used for the Ebola virus, Hepatitis C virus and HIV. Aethlon says that the Ebola response was so remarkable response with just a single administration of Hemopurifier therapy that Time Magazine called it one of the “Eleven Most Remarkable Advances in Healthcare.”

The EAP designation is designed to enable more rapid patient access to breakthrough technologies for life threatening disease conditions where no approved or cleared treatment alternatives exist. With the EAP, the FDA will collaborate with Aethlon to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA (pre-market application) standard of reasonable assurance of safety and effectiveness.

“We are honored to have our Hemopurifier® designated to the Expedited Access Pathway and additionally are pleased that FDA has also allowed our proposed “indication for use,” which provides the possibility of treating a wide-range of life-threatening viruses versus a single disease condition,” says AEMD CEO Jim Joyce.


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