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Week Ahead In Pharmaceuticals: 7 Stocks To Watch (AIMT, LXRX, TXG…)

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The week ending September 14, 2019, witnessed a string of disappointments on the Alzheimer's drug development front.

On September 9, 2019, Neurotrope Inc. (NTRP) announced that its confirmatory phase II study of Bryostatin-1 in moderate to severe Alzheimer's did not meet the primary endpoint. NTRP lost 80% of its value, following the news.

On September 13, 2019, Eisai Co. Ltd. and Biogen Inc. (BIIB) pulled the plug on two phase III clinical studies on their investigational Alzheimer's drug Elenbecestat due to unfavorable risk-benefit ratio. Elenbecestat is the second phase III Alzheimer's drug of the two companies to bite the dust. In March of this year, Eisai and Biogen discontinued two late-stage trials of their experimental Alzheimer's disease drug Aducanumab after disappointing results of a futility analysis.

Another late-stage clinical trial failure reported in the week was that of Tocagen Inc. (TOCA), a clinical-stage, cancer-selective gene therapy company. On September 12, 2019, the Company announced that its phase III clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high-grade glioma (HGG) undergoing resection, dubbed Toca 5, missed the primary endpoint of overall survival compared to standard of care treatment. TOCA lost over 67% of its value in the week.

However, it was not all gloom and doom on the clinical trial front in the week.

ACADIA Pharmaceuticals Inc. (ACAD) gained nearly 70% in the week, following promising results from its phase III study evaluating Pimavanserin for the treatment of dementia-related psychosis, dubbed HARMONY, which were reported on September 9, 2019.

Now, here are some of the pharma/biotech stocks to watch out for in the week starting September 15.

1. Aimmune Therapeutics Inc. (AIMT)

Friday the 13th is generally considered an unlucky day, but was not so for Aimmune Therapeutics.

The Company's peanut allergy treatment AR101, whose proposed trade name is Palforzia, has won the FDA panel nod.

On September 13, 2019, the FDA's Allergenic Products Advisory Committee, or APAC, voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of Palforzia.

Palforzia is a powder made from shelled, dry roasted peanut, proposed as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.

The final FDA decision on the drug is expected by January 2020. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, Palforzia will be the first medicine for peanut allergy. The market opportunity for Palforzia is estimated to be in excess of $1 billion peak sales in the U.S. alone.

Trading of Aimmune stock was halted on Friday. AIMT closed Thursday's trading at $24.67.

2. Kodiak Sciences Inc. (KOD)

Kodiak Sciences is a clinical-stage biopharmaceutical company developing biologics-based medicines to treat retinal diseases.

The Company's lead drug candidate is KSI-301, which is under a phase Ib open-label multiple-dose study in patients with anti-VEGF treatment naïve neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema due to retinal vein occlusion (RVO).

Watch out for…

The first durability data from the phase Ib trial of KSI-301 in treatment-naïve patients with macular degeneration, diabetic macular edema, and retinal vein occlusion are slated to be presented on September 15, 2019, at The Retina Society Annual Meeting in London, U.K.

KOD closed Friday's trading at $14.99, up 6.69%.

3. 10x Genomics Inc. (TXG)

10x Genomics is a life science technology company developing single-cell sequencing lab hardware and software.

The Company launched its IPO on September 12, 2019, pricing its shares at $39 each. The stock opened the first day of trading at $54 and closed at $52.75.

The IPO is expected to close on September 16, 2019, subject to the satisfaction of customary closing conditions.

The Company generates revenue from the sale of its Chromium solutions and in particular its Single Cell Gene Expression solutions. These products have enabled researchers to make fundamental discoveries across multiple areas of biology, including oncology, immunology, and neuroscience.

On September 11, 2019, Bio-Rad filed a suit against 10x Genomics in the District of Delaware alleging that 10x Genomics' Next GEM products infringe certain claims of U.S. Patent No. 8,871,444. 10x Genomics believes that the '444 patent is invalid and not infringed, and intends to defend itself vigorously.

TXG closed Friday's trading at $52.27, down 0.91%.

4. Lexicon Pharmaceuticals Inc. (LXRX)

Lexicon Pharma is a bbiopharmaceutical company developing precise medicines for people with serious, chronic conditions.

The Company has two approved drugs Xermelo, indicated for carcinoid syndrome diarrhea, approved in the U.S. and Europe in 2017, and diabetes medicine Zynquista, approved in Europe in April of 2019. The drug was rejected by the FDA in March of this year.

Watch out for…

New analyses from pivotal studies of Zynquista in type 1 diabetes will be presented on September 17, 2019, at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD).

Last week, Lexicon announced the termination of its alliance with Sanofi for the development and commercialization of Zynquista and the settlement of its related disputes with Sanofi.

Following the termination of the alliance, Lexicon has regained all rights to Zynquista and assumes full responsibility for the worldwide development and commercialization of Zynquista in both type 1 and type 2 diabetes.

LXRX closed Friday's trading at $2.34, down 3.31%.

5. bluebird bio Inc. (BLUE)

bluebird bio is focused on developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies. The Company has one approved gene therapy Zynteglo, which is approved in Europe, for patients ages 12 years and over with transfusion-dependent ß-thalassemia who do not have the ß0/ß0 genotype.

The investigational gene therapies in the Company's pipeline include LentiGlobin for the treatment of transfusion-dependent ß-thalassemia and sickle cell disease; bb2121, under a phase II pivotal study in adults with relapsed/refractory multiple myeloma, dubbed KarMMa, and Lenti-D, under a Phase 2/3 study for treating boys with a rare metabolic disorder called cerebral adrenoleukodystrophy, dubbed Starbeam study.

Watch out for…

Updated clinical data from the Starbeam study in patients with cerebral ALD will be presented on September 18, 2019, at the 13th European Pediatric Neurology Society (EPNS) Congress.

Initial interim data from the Starbeam study were reported in April 2016, after which the Company has been providing periodic updates on the trial.

Cerebral adrenoleukodystrophy (CALD) is a potentially fatal form of adrenoleukodystrophy that affects the nervous system of boys. CALD involves a breakdown of the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control.

Currently, the only effective treatment option for patients with CALD is allogeneic hematopoietic stem cell transplant (HSCT).

Near-term Catalysts:

** Initiation of a rolling Biologics Licensing Application submission to the U.S. FDA for Zynteglo in patients with TDT and non-ß0/ß0 genotypes is expected by the end of 2019.
** Initiation of Phase 3 HGB-210 study of LentiGlobin in patients with sickle cell disease is anticipated by the end of 2019.

BLUE closed Friday's trading at $104.85, up 1.69%.

6. 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 clinical drug candidates include Azeliragon, a potential treatment of mild Alzheimer's disease in patients with type 2 diabetes, under phase II trial, and TTP399, an add-on to insulin therapy for patients with type 1 diabetes, in a phase II study.

Watch out for…

Additional results from Part 1 of the Simplici-T1 Study will be presented on September 18, 2019 at the 55th Annual Meeting of the European Association for the Study of Diabetes in Barcelona Spain.

Simplici-T1 Study is a phase II trial evaluating TTP399 as an add-on to insulin therapy for patients with type 1 diabetes. The study consists of two parts - Part 1 and Part 2.

In June 2019, the Company announced positive topline results from Part 1 of the Simplici-T1 Study.

Near-term Catalysts:

** The Part 2 confirmatory phase of the Simplici-T1 Study began enrolling patients in May of this year, and results for this portion of the study are expected in the latter part of the first quarter of 2020.
** The topline results from the phase II proof of concept study of Azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes are anticipated by the end of the fourth quarter of 2020.

VTVT closed Friday's trading at $1.61, up 0.94%.

7. Leap Therapeutics Inc. (LPTX)

Leap Therapeutics is developing targeted and immuno-oncology therapeutics. The Company's most advanced clinical candidate is DKN-01 in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers.

Also in the pipeline is TRX518 that is in advanced solid tumor studies.

Watch out for…

Additional response and biomarker data from a phase II study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced Epithelial Endometrial Cancer, Epithelial Ovarian Cancer, or Carcinosarcoma is slated to be presented at the Annual Global Meeting of the International Gynecologic Cancer Society that is going to be held between Sep 19 and Sep.21, 2019.

DKN-01 as a monotherapy and in combination with paclitaxel has generated partial responses and durable clinical benefit in heavily pre-treated patients, according to the Company.

LPTX closed Friday's trading at $1.77, up 2.31%.

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