TXMD To Resubmit TX-004HR NDA Soon, FLGT Optimistic, MLAB Disappoints

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 6, 2017.

GAINERS

1. TherapeuticsMD Inc. (TXMD)

Gained 31.65% to close Monday's (Nov.6) trading at $5.74.

News: The Company announced third-quarter financial results and business update.

Net loss for the third quarter of 2017 narrowed to $14.7 million or $0.07 per share from $25.0 million or $0.13 per share for the third quarter of 2016. Net revenue for the recent third quarter declined to $4.4 million from $5.5 million in the comparable year-ago quarter due to price drop of its products and a slight decrease in the number of units sold.

Near-term catalysts:

-- Resubmission of New Drug Application for TX-004HR, also known as Yuvvexy, in the coming weeks.

TX-004HR is an applicator-free vaginal estradiol softgel for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

The FDA had turned down the Company's request to approve TX-004HR in May of this year, citing lack of long-term endometrial safety data for the product candidate beyond the 12-weeks studied in the pivotal phase III study.

-- Submission of NDA for TX-001HR expected in December 2017. TX-001HR is a bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

2. Fulgent Genetics Inc. (FLGT)

Gained 14.12% to close Monday's trading at $3.96. The stock touched a new 52-week low of $3.40 today before closing the day higher.

News: The Company reported Q3, 2017 financial results and provided guidance for the fourth quarter.

GAAP loss for the third quarter of 2017 was $1.1 million or $0.06 per share, and non-GAAP loss, which excludes equity-based compensation expenses and equity loss in investee, and uses a corporate tax rate of 36% for the quarter, was $442,000, or $0.02 per share.

Revenue for the recent third quarter was $4.5 million, a decrease of 10% year over year from $5.0 million in the third quarter of 2016.

Looking ahead to the fourth quarter, the Company expects revenue to increase to $5 million.

3. Kala Pharmaceuticals Inc. (KALA)

Gained 14.58% to close Monday's trading at $18.70.

News: No news:

Recent event:

-- On October 25, 2017, the Company submitted a New Drug Application to the FDA for INVELTYS (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery.

Near-term catalyst:

-- A phase III trial evaluating KPI-121 0.25% in patients with dry eye disease is underway, and top-line results are expected by the end of 2017.

4. Ovid Therapeutics Inc. (OVID)

Gained 14.21% to close Monday's trading at $8.84.

News: No news

The Company made its debut on the NASDAQ Global Select Market on May 5, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's pipeline includes OV101, a potential treatment for Angelman syndrome and Fragile X syndrome, and TAK-935/OV935 for treatment of adults with rare epilepsies.

A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome, and a phase 1b/2a clinical trial of TAK-935/OV935 in adults with rare epilepsies are underway.

Near-term catalysts:

-- The top line data from the phase I trial evaluating OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are expected to be available in the coming months. -- The topline data from phase II OV101 STARS trial are expected in 2018. -- Data from the phase 1b/2a clinical trial of TAK-935/OV935 are also expected next year.

5. Aptevo Therapeutics Inc. (APVO)

Gained 11.87% to close Monday's trading at $3.11.

News: No news

You can find more about APVO in our premium stock report.

6. Marinus Pharmaceuticals Inc. (MRNS)

Gained 11.15% to close Monday's trading at $6.88.

News: No news

Recent events:

-- Initiated a phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis. Data from this study is expected in 2018. -- Initiated a phase II study of Ganaxolone IV in patients with status epilepticus. Data from this study is also expected next year.

7. China Biologic Products Holdings Inc. (CBPO)

Gained 9.54% to close Monday's trading at $84.96.

News: No news

Recent event:

-- On November 1, 2017, the Company reported third-quarter financial results.

On a non-GAAP basis, adjusted net income attributable to the Company increased to $39.4 million or $1.38 per share from $34.3 million or $1.22 per share in the same quarter of 2016. Total sales in the third quarter of 2017 increased by 15.1% to $99.6 million from $86.5 million in the comparable year-ago quarter.

The Company reiterated its full year 2017 forecast of non-GAAP adjusted net income growth of 18% to 20% in RMB terms over 2016 financial results and lowered its total sales growth outlook to 9%-10% in RMB terms from its previous estimates of 13%-15%.

LOSERS

1. Tivity Health Inc. (TVTY)

Lost 34.24% to close Monday's trading at $31.60.

News: The Company has an 18-year relationship with UnitedHealthcare offering its SilverSneakers Fitness Program to their Medicare Advantage members throughout the U.S. Today, UnitedHealthcare announced that beginning in 2018, it will provide its own new fitness benefit program in nine states for members enrolled in eligible UnitedHealthcare Medicare Advantage Plans. This program has been previously available in two states.

However, UnitedHealthcare noted that it will continue to offer the SilverSneakers Fitness Program for their Group Medicare Advantage members in all 50 states.

2. Neos Therapeutics Inc. (NEOS)

Lost 16.09% to close Monday's trading at $10.82.

News: No news

Recent event:

-- On October 30, 2017, the Company rejected the October 26th unsolicited proposal from PDL BioPharma Inc. (PDLI) to acquire all of the outstanding shares of Neos for $10.25 per share in cash.

Near-term catalyst:

-- The Company is slated to report its third quarter 2017 financial results prior to the opening of U.S. financial markets on Wednesday, November 8, 2017.

3. Mesa Laboratories Inc. (MLAB)

Lost 12.35% to close Monday's trading at $138.41.

News: The Company reported lackluster Q2, 2017 financial results.

Net income for the second quarter declined to $2.353 million or $0.60 per share on revenue of $22.95 million. This compared with a net income of $2.358 million or $0.62 per share and revenue of $24.4 million in the year-ago quarter.

Analysts polled by Thomson Reuters expected the Company to earn $0.64 per share on revenue of $25.75 million.

4. Novan Inc. (NOVN)

Lost 9.95% to close Monday's trading at $5.70.

News: No news

Pipeline:

The Company's 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 sexually transmitted infections. -- 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 -- SB208, under phase II study for Onychomycosis Tinea Pedis.

5. ACADIA Pharmaceuticals Inc. (ACAD)

Lost 9.21% to close Monday's trading at $32.55.

News: No news

Near-term catalyst:

-- The Company is slated to report its financial results for the third quarter ended September 30, 2017 on Tuesday, November 7, 2017, after the U.S. financial markets close.

6. GlycoMimetics Inc. (GLYC)

Lost 7.90% to close Monday's trading at $11.08.

News: No news

Near-term catalyst:

-- The Company is slated to report its third-quarter 2017 financial results on Wednesday, November 8, 2017, at 8:30 a.m. ET.