02.10.2018 02:52:30

OGEN Abuzz, NTGN Glows, NEPT On A High, TLRY Back In News

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. Oragenics Inc. (OGEN)

Gained 39.13% to close Monday's (Oct.1) trading at $1.60.

News: The Company is scheduled to make a presentation at the Ladenburg Thalmann 2018 Healthcare Conference on October 2, 2018, at 1:00 PM ET.

Clinical Trial & Near-term Catalyst:

In August of this year, the Company resumed its phase II clinical trial of AG013, a live biotherapeutic product for the potential treatment of oral mucositis following a positive review by an independent Data Safety Monitoring Board (DSMB).

The study is expected to be completed next year.

2. Neon Therapeutics Inc. (NTGN)

Gained 35.25% to close Monday's trading at $11.55.

News: James Allison, one of the Company's scientific founders has been awarded the 2018 Nobel Prize in Physiology or Medicine for his work in the discovery of cancer therapy by inhibition of negative immune regulation.

He shares the Prize with Tasuku Honjo of Japan, a professor at Kyoto University.

Recent event:

-- The Company's shares debuted on The Nasdaq Global Select Market on June 27, 2018, at an offering price of $16.00 each.

Near-term Catalysts:

Neon is a clinical-stage immuno-oncology company developing neoantigen-targeted therapies.

-- A phase 1b clinical trial of NEO-PV-01 in the metastatic setting, dubbed NT-001, has completed enrollment, with updated data expected to be presented in October 2018 at ESMO, and 52-week data expected in the first half of 2019. -- Initiation of phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations, dubbed NT-003, is expected in the second half of 2018. -- The 52-week data from a phase Ib trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer, dubbed NT-002, is expected in the second half of 2019. -- Submission of a European Clinical Trial Application (CTA) for NEO-PTC-01, a personal neoantigen T-cell therapy, in the first half of 2019. -- Submission of an Investigational New Drug (IND) application for NEO-SV-01 in subset of ER+ breast cancer to the FDA in the first half of 2019.

3. Acasti Pharma Inc. (ACST)

Gained 21.71% to close Monday's trading at $1.57.

News: No news

Clinical Trials & Near-term Catalyst:

Enrollment in the Company's TRILOGY program is slated to be completed this year, with topline results to be reported before the end of 2019.

TRILOGY is a two-trial phase III clinical program designed to evaluate the safety and efficacy of lead drug candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia.

In after-hours, the Company announced its election to issue common shares to the holders of its outstanding convertible debentures in satisfaction of interest payable.

4. Neptune Wellness Solutions Inc. (NEPT) (NEPT.TO)

Gained 18.56% to close Monday's trading at $4.60.

News: The Company made an investor presentation today.

The Company develops turnkey nutrition product solutions available in various unique delivery forms, offers specialty ingredients such as MaxSimil, a patented ingredient that enhances the absorption of lipid-based nutraceuticals, and a variety of other marine and seed oils. Leveraging its scientific, technological and innovative expertise, Neptune is preparing to commence production of products for legal cannabis markets.

Recreational marijuana is all set to become officially become legal in Canada on October 17, 2018. The first country to have legalized recreational marijuana is Uruguay, and that was in December 2013.

5. Tilray Inc. (TLRY)

Gained 14.87% to close Monday's trading at $164.98.

News: High Park Farms Ltd., a subsidiary of Tilray, has received its sales license from Health Canada to sell cannabis under the Access to Cannabis for Medical Purposes Regulations (ACMPR).

The license will allow High Park Farms to supply and sell finished cannabis products within the ACMPR as well as sales in anticipation of the launch of the adult-use market in Canada upon its legalization on October 17, 2018.

6. Altimmune Inc. (ALT)

Gained 13.18% to close Monday's trading at $4.98.

News: No news

Pipeline:

Altimmune is a clinical-stage immunotherapeutics company having three clinical product candidates in its pipeline namely, NasoVAX, a phase II seasonal influenza vaccine candidate, HepTcell, a phase I immunotherapeutic candidate for the potential cure of chronic hepatitis B, SPARVAX-L, a phase II Anthrax vaccine, and NasoShield, a next generation Anthrax vaccine, under phase I study.

Recent events:

-- On September 28, the Company priced an underwritten public offering of common units and pre-funded units for a combined total of 2,400,000 units at $5.00 each.

Each unit consists of a share of its common stock and a warrant to purchase one share of common stock at an exercise price of $6.00. The gross proceeds from the offering are expected to be approximately $12 million.

The offering is expected to close on or about October 2, 2018, subject to customary closing conditions.

-- On September 14, the Company effected a 1 for 30 reverse stock split. -- On September 4, the Company announced additional positive data from a Phase 2a study of its NasoVAX intranasal influenza vaccine candidate. The results demonstrated a statistically superior mucosal immune response providing a first line of defense against infection; a durable serum immune response at six months compared to over 50% decline with Fluzone, a licensed injectable influenza vaccine, and a continued clean safety profile.

Near-term Catalyst:

Immunogenicity data for two-dose cohort from the phase I study of NasoShield under investigation as a potential vaccine against anthrax is expected to be available in the fourth quarter of this year.

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