ATOS Catches Eyes, PTIE Gains, CNCE Hits Right Notes, SMMT Keeps Sliding

Oct24 102417

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 24, 2017.


1. Atossa Genetics Inc. (ATOS)

Gained 96.77% to close Tuesday's (Oct.24) trading at $1.22.

News: The Company is going to host a conference call on October 25, 2017 at 10 am EDT to discuss preliminary results from its Phase 1 dose escalation study of its proprietary oral Endoxifen.

Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high risk patients.

2. Pain Therapeutics Inc. (PTIE)

Gained 27.27% to close Tuesday's trading at $4.76.

News: The Company announced it has successfully completed a Phase I clinical study for PTI-125, a new experimental drug therapy to treat Alzheimer's disease.

The study investigated the safety, dosing and pharmacokinetic profile of PTI-125 in healthy human volunteers. The study was conducted with support from a $1.7 million research grant award from the National Institute on Aging, part of the National Institutes of Health.

Near-term catalysts:

-- Top line results from abuse potential study via the nasal route of abuse with REMOXY ER expected by year-end 2017.
-- Resubmission of the New Drug Application for REMOXY ER in Q1 2018. REMOXY ER was issued a Complete Response Letter by the FDA last September.

REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."

3. CymaBay Therapeutics Inc. (CBAY)

Gained 10.79% to close Tuesday's trading at $8.73.

News: The Company will provide an update on results from its phase II study of Seladelpar in patients with primary biliary cholangitis during a Key Opinion Leader (KOL) meeting on Wednesday, October 25, 2017.

4. Concert Pharmaceuticals Inc. (CNCE)

Gained 10.54% to close Tuesday's trading at $17.41.

News: No news

Recent event:

-- On October 19, 2017, the Patent Trials and Appeal Board of the U.S. Patent and Trademark Office denied Incyte Corp.'s (INCY)'s petition challenging the Patent No. 9,249,149 covering Concert's CTP-543, an investigational compound for the treatment of alopecia areata.

The patent 9,249,149 claims that CTP-543 is a novel composition of matter. In April 2017, Incyte had filed an Inter Partes Review Petition (IPR) against Concert seeking to invalidate that patent.

CTP-543 is under a phase 2a clinical trial for alopecia areata. The Company expects the trial to be completed in the second half of 2018.

5. Novan Inc. (NOVN)

Gained 8.02% to close Tuesday's trading at $5.79.

News: No news


The Company's internal development pipeline includes:

-- SB206, which is under phase II trial for genital warts; under phase I study for Molluscum and under phase I study for HPV -associated STIs.
-- NVN3100, which is under pre-clinical testing for anal neoplasia and cervical neoplasia.
-- SB414, which is under phase I study for psoriasis, and under preclinical testing for atopic dermatitis.
-- SB204, under late-stage development for acne, and under phase II study for Onychomycosis Tinea Pedis.

6. Urogen Pharma Ltd. (URGN)

Gained 7.72% to close Tuesday's trading at $29.45.

News: No news

The Company made its debut on the NASDAQ on May 4, 2017, offering its shares at a price of $13.00 each.

The lead drug candidate of Urogen is MitoGel, a novel sustained release formulation of Mitomycin C, for the treatment of non-muscle invasive, low-grade upper tract urothelial carcinoma (UTUC).

A phase III trial of MitoGel for the treatment of low-grade upper tract urothelial carcinoma, dubbed OLYMPUS, is underway.

Recent event:

-- On August 29, 2017, the FDA granted Fast Track designation for MitoGel.

7. T2 Biosystems Inc. (TTOO)

Gained 5.79% to close Tuesday's trading at $4.02.

News: No news

Recent event:

-- On September 11, 2017, the Company announced that it has filed a 510(k) premarket submission for the T2Bacteria Panel with the FDA.

The T2Bacteria Panel is designed to run on the FDA-cleared T2Dx Instrument. The T2Bacteria Panel, once FDA cleared, combined with the commercially available T2Candida Panel is designed to be the first comprehensive rapid diagnostic solution on the market that identifies pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within 8 hours of blood draw.

Near-term catalyst:

-- The Company is slated to release its 2017 third quarter financial and operational results after the market closes on Thursday, November 2, 2017.

8. Ocular Therapeutix Inc. (OCUL)

Gained 5.73% to close Tuesday's trading at $5.90.

News: No news

Recent event:

-- In July of this year, the Company's DEXTENZA, proposed for the treatment of post-surgical ocular inflammation and pain, was issued a Complete Response Letter by the FDA.

The CRL from the FDA referred to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production. Ocular Therapeutix plans to produce additional commercial batches of DEXTENZA and submit data from these batches to the FDA with the resubmission of its NDA.

Near-term catalysts:

-- A phase III clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension is underway - with topline efficacy data expected in the second half of 2018.
-- A second phase III trial with OTX-TP for the treatment of glaucoma and ocular hypertension is expected to be initiated this year.
-- A pilot human clinical trial with an intracameral product candidate, OTX-TIC, which is a bioresorbable travoprost-containing hydrogel depot delivered via a fine-gauge needle injection for patients who have moderate to severe glaucoma is expected to be initiated in 2017.
-- Advance OTX-TKI into phase I testing by the end of 2017.


1. Immune Design Corp. (IMDZ)

Lost 16.35% to close Tuesday's trading at $4.35.

News: The Company has priced an underwritten public offering of 19.5 million shares of its common stock at a price to the public of $4.10 each.

Proceeds to Immune Design from this offering are expected to be approximately $80.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. The offering is expected to close on October 27, 2017.

2. Ionis Pharmaceuticals Inc. (IONS)

Lost 12.40% to close Tuesday's trading at $55.01.

News: No news

Near-term catalyst:

-- The Company is slated to discuss its third quarter 2017 financial results and report on pipeline and business progress on Tuesday, November 7, 2017.

3. PetMed Express Inc. (PETS)

Lost 11.61% to close Tuesday's trading at $38.37.

Recent event:

-- On October 23, 2017, the Company reported better-than-expected Q3, 2017 financial results, sending the stock up 18% that day.

Net income for the quarter ended September 30, 2017 was $8.8 million or $0.43 per share, on net sales of $66.7 million. Analysts polled by Thomson Reuters expected the Company to earn $0.30 per share on revenue of $63.36 million.

The Company posted a net income of $4.9 million or $0.24 per share and revenue of $60.8 million for the quarter ended September 30, 2016.

The Board of Directors declared a quarterly dividend of $0.20 per share on the Company's common stock. The dividend will be payable on November 17, 2017, to shareholders of record at the close of business on November 6, 2017.

4. Omeros Corporation (OMER)

Lost 11.49% to close Tuesday's trading at $15.72.

News: No news

Near-term catalyst:

The Company is scheduled to report Q3, 2017 financial results on any day between Nov 7, 2017 and Nov 13, 2017.

5. Summit Therapeutics plc (SMMT)

Lost 10.73% to close Tuesday's trading at $9.73.

News: No news

Near-term catalysts:

-- Initiate phase III trial of Ridinilazole for treating C. difficile infection in the first half of 2018.
-- Report full 24-week data analysis from a phase II proof of concept clinical trial of Ezutromid in patients with DMD, dubbed PhaseOut DMD, in Q1 2018.
-- Top-line data from the complete 48-week PhaseOut DMD clinical trial are expected in Q3 2018.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT