Week Ahead In Pharma: COVID-19 Data Readout, FDA Decisions, CTAD Presentation

In the healthcare sector, two stocks recorded triple-digit gains in the past week – Scholar Rock Holding Corp.(SRRK) with 175% and Miragen Therapeutics Inc. (MGEN) with 167%.

While Scholar Rock rallied on the back of promising six-month results of a phase II study of SRK-015 in the treatment of patients with spinal muscular atrophy, reported on October 27, Miragen picked up steam following the acquisition of Viridian Therapeutics Inc., a privately held biotechnology company, on October 28.

Let’s take a look at some of the pharma/biotech stocks that merit attention in the coming week.

1. Dynavax Technologies Corp. (DVAX)

Dynavax is a commercial-stage biopharmaceutical company whose marketed product is HEPLISAV-B, which was approved by the FDA in 2017, for the prevention of hepatitis B virus (HBV) infection in adults ages 18 and older.

The company is also developing CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships.

Watch out for…

A phase I clinical trial evaluating Canadian firm Medicago’s plant-derived vaccine candidate adjuvanted with Dynavax’s CpG 1018 to prevent COVID-19 is underway. Preliminary safety and immunogenicity results from the phase I study, due in October, are awaited.

DVAX has traded in a range of $1.80 to $12.44 in the last 52 weeks. The stock closed Friday’s trading at $3.73, down 4.36%.

2. vTv Therapeutics Inc. (VTVT)

vTv Therapeutics is a clinical-stage biopharmaceutical company with a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease, diabetes, and inflammatory disorders.

The company’s lead drug candidate is Azeliragon, which antagonizes the Receptor for Advanced Glycation Endproducts (RAGE).

Azeliragon in a phase III study in people with Alzheimer’s disease, dubbed STEADFAST, failed to meet the key goals in April 2018. The study neither demonstrated any improvement in cognitive nor functional outcomes as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).

However, with results of post-hoc subgroup analyses of the STEADFAST Study demonstrating positive benefit in a population of mild Alzheimer’s disease patients with type 2 diabetes, vTv Therapeutics initiated the Elevage study last June. Patient enrollment in the Elevage Study was completed in September 2020.

Watch out for…

The company will provide a general study update and data on the baseline characteristics of patients enrolled in the ongoing phase II Elevage Study on November 4.

The topline results from the Elevage study are expected in December 2020.

VTVT has traded in a range of $1.34 to $4.23 in the last 1 year. The stock closed Friday’s trading at $1.70, down 2.30%.

3. Bellerophon Therapeutics Inc. (BLPH)

Bellerophon Therapeutics is a clinical-stage biotherapeutics company developing innovative therapies in the treatment of cardiopulmonary and infectious diseases.

The company reported positive top-line results from its phase II clinical study of INOpulse for the treatment of Pulmonary Hypertension associated with Pulmonary Fibrosis, dubbed iNO-PF, in February this year.

Event:

Data from the phase II iNO-PF study will be presented at the American Thoracic Society Interstitial Lung Disease Mini Symposia and the 2020 Pulmonary Fibrosis Foundation Meeting on November 5.

BLPH has traded in a range of $3.19 to $26.00 in the last 1 year. The stock closed Friday’s trading at $8.43, up 2.06%. A 1-for-15 reverse stock split was implemented on February 10, 2020.

4. Biogen Inc. (BIIB)

Biogen’s Biologics License Application for Aducanumab is slated to be scrutinized by the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA on November 6.

Aducanumab is proposed for the treatment of Alzheimer’s disease. Biogen licensed Aducanumab from Neurimmune in 2007. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of Aducanumab globally.

The FDA’s final decision on Aducanumab is expected on March 7, 2021.

BIIB has traded in a range of $243.25 to $374.9 in the last 1 year. The stock closed Friday’s trading at $252.07, up 2.68%.

5. Cassava Sciences Inc. (SAVA)

Cassava Sciences is a clinical-stage biopharmaceutical company whose initial focus is on developing Sumifilam, a proprietary, investigational drug to treat Alzheimer’s disease, and SavaDx, a blood-based diagnostic to detect Alzheimer’s disease.

In 2019, the company reported positive results from its phase IIa study of Sumifilam in Alzheimer’s disease. Last month, final results of a phase IIb study of Sumifilam 50 mg or 100 mg twice daily for 28 days in patients with Alzheimer’s disease were announced, wherein the treatment group showed statistically significant improvements in biomarkers of the Alzheimer’s disease compared to the placebo group. This study is funded by the National Institutes of Health.

Event:

The clinical results of the phase IIb study of Sumifilam, funded by the National Institutes of Health, are scheduled to be presented at the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD) on November 7.

SAVA has thus far hit a 52-week low of $1.21 and a 52-week high of $12.68. The stock closed Friday’s trading at $8.21, down 5.96%.

6. Supernus Pharmaceuticals Inc. (SUPN)

Supernus awaits the FDA decision on its drug candidate SPN-812, proposed for the treatment of children and adolescents with attention deficit hyperactivity disorder, which is slated for November 8.

SPN-812 is a novel non-stimulant and its active ingredient is Viloxazine hydrochloride which was previously marketed in Europe for many years as an antidepressant.

If approved, SPN-812 will compete with Eli Lilly’s (LLY) Strattera, the first non-stimulant treatment for ADHD. Strattera, which was approved in 2002, went generic in May 2017, when several generic versions of the drug secured the FDA nod simultaneously.

While stimulant drugs are the most commonly prescribed medications for the treatment of ADHD and are considered first-line treatments, non-stimulant drugs are usually considered second-line or third-line treatments and they provide a useful alternative for children who do not tolerate stimulants well.

SUPN has traded in a range of $13.12 to $29.36 in the last 1 year. The stock closed Friday’s trading at $18.36, up 0.05%.

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