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5 Biotech Stocks To Watch In The Coming Weeks (ALBO, ALNY, OTLK, MESO, CRBP)

biotech aug17 lt

The clinical trial results are one of the two major catalysts that affect the stock price of a biotech company, and more so if it is a small/mid-cap stock.

In this article, we will discuss the anticipated near-term milestones of 5 stocks - Albireo Pharma Inc. (ALBO), Alnylam Pharmaceuticals Inc. (ALNY), Corbus Pharmaceuticals Holdings Inc. (CRBP), Mesoblast Limited (MESO) and Outlook Therapeutics Inc. (OTLK).

Read on...

1. Albireo Pharma Inc. (ALBO)

Albireo is a clinical-stage biopharmaceutical company developing novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders.

The most advanced drug candidate in the pipeline is Odevixibat, a selective inhibitor of the ileal bile acid transporter (IBAT). The IBAT is said to play a role in mediating the uptake of bile acids from the small intestine to the liver.

Odevixibat is under a phase III trial in progressive familial intrahepatic cholestasis, a rare genetic liver disease.

The phase III trial, called PEDFIC1, has completed enrollment with 62 patients with progressive familial intrahepatic cholestasis of subtypes 1 or 2, ages 6 months to 18 years, at sites in the United States, Canada, Europe, the Middle East, and Australia.

Given the fact that the topline data from the PEDFIC1 trial is due mid-2020, the results can be reported in the coming weeks.

Cash Position:

The company's cash and cash equivalents were $152.0 million on June 30, 2020.

ALBO has traded in a range of $11.26 to $31.50 in the last 1 year. The stock closed Friday's trading at $25.32, up 7.20%.

2. Alnylam Pharmaceuticals Inc. (ALNY)

Alnylam Pharma is a commercial-stage RNAi therapeutics company, which currently markets ONPATTRO, for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis, and GIVLAARI, for the treatment of adults with acute hepatic porphyria.

The lead investigational drug Lumasiran, proposed for primary hyperoxaluria type 1 in children and adults, is under review by the FDA and European Medicines Agency. The FDA decision on Lumasiran is anticipated on Dec.3, 2020.

Lumasiran is also being studied in a phase III trial in primary hyperoxaluria type 1 patients less than 6 years of age, dubbed ILLUMINATE-B. The topline data from this study are due mid-2020.

Cash Position:

Cash, cash equivalents, marketable debt, and equity securities, and restricted investments as of June 30, 2020, totaled $1.95 billion.

ALNY has traded in a range of $73.32 to $167.33 in the last 1 year. The stock closed Friday's trading at $136.14, down 0.94%.

3. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Corbus Pharma is a clinical-stage drug development company developing medicines for inflammatory and fibrotic diseases.

The company's lead drug candidate is Lenabasum, an oral, selective cannabinoid receptor type 2 (CB2) agonist, being developed as a potential treatment for systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

Lenabasum is under a phase III study in systemic sclerosis, dubbed RESOLVE-1, and in a phase III study in dermatomyositis, known as DETERMINE. A phase IIb study of Lenabasum for cystic fibrosis and a phase IIb study for systemic lupus erythematosus are also ongoing.

The company expects to report topline results from the phase III RESOLVE-1 trial and phase IIb cystic fibrosis trial this quarter.

Cash Position:

The company had cash and cash equivalents of roughly $101 million on July 28, 2020. Corbus Pharma received an aggregate of $71 million in gross proceeds from its at-the-market ("ATM") offering on July 29, and also executed a $50 million debt financing facility with K2 Health Ventures that same day.

CRBP has traded in a range of $3.29 to $8.78 in the last 1 year. The stock closed Friday's trading at $6.97, down 4.98%.

4. Mesoblast Limited (MESO)

Mesoblast, which won the FDA panel backing for its lead asset Ryoncil, proposed for pediatric steroid-refractory acute graft versus host disease, on August 13, has an immediate clinical trial catalyst to keep an eye on.

Another advanced off-the-shelf mesenchymal lineage cell product candidate in the pipeline is MPC-06-ID for the treatment of chronic low back pain due to degenerative disc disease.

MPC-06-ID is under a phase III trial, with data readout due in mid-2020.

Mesoblast has a collaboration with Germany-based Grünenthal to develop and commercialize MPC-06-ID in Europe and Latin America.

Meanwhile, the final decision of the FDA on Ryoncil is expected on September 30, 2020.

Cash Position:

Cash on hand at the end of June 30, 2020, was $129.3 million.

MESO has traded in a range of $3.12 to $20.57 in the last 1 year. The stock closed Friday's trading at $17.88, up 51.40%.

5. Outlook Therapeutics Inc. (OTLK)

Outlook Therapeutics is a late clinical-stage biopharmaceutical company developing ONS-5010, a monoclonal antibody, for various ophthalmic indications.

ONS-5010 is under two phase III studies in wet age-related macular degeneration, or wet AMD, dubbed NORSE 1 and NORSE 2.

The NORSE 1 trial has enrolled a total of 61 treatment-naïve and previously treated patients diagnosed with wet AMD at nine sites in Australia, with topline safety and efficacy data expected later this month.

The NORSE 2 clinical trial has enrolled a total of 227 patients at 39 clinical trial sites in the United States, and pivotal safety and efficacy data are anticipated in the third calendar quarter of 2021.

An open-label safety study of ONS-5010, named NORSE 3, is expected to be initiated next quarter (Q4, 2020).

Cash Position:

The company had cash and cash equivalents of $24.0 million at the end of June 30, 2020.

OTLK has traded in a range of $0.49 to $2.06 in the last 1 year. The stock closed Friday's trading at $1.40, up 4.48%.

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