Gainers & Losers Of Aug.21: CHRS, GTHX, OTIC, APEN, PETS...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 22, 2017.

GAINERS

1. Coherus Biosciences Inc. (CHRS)

Gained 22.07% to close Monday's (Aug.21) trading at $13.55.

News: The Company has secured private placement from Temasek, an investment company headquartered in Singapore.

Temasek plans to invest up to $150 million in Coherus over two tranches. The first tranche of $75 million in aggregate gross proceeds will be completed and funded by August 31, 2017 with 6.55 million shares of common stock to be issued at an offering price of $11.44 per share.

The second tranche is projected to be funded following receipt of the FDA approval for the CHS-1701 pegfilgrastim biosimilar product candidate.

Coherus' CHS-1701 was turned down by the FDA in June of this year - with the Company being asked to conduct a reanalysis of a subset of subject samples with a revised immunogenicity assay, and submit certain additional manufacturing related process information.

2. G1 Therapeutics Inc. (GTHX)

Gained 11.61% to close Monday's trading at $17.88.

News: No news

The Company made its debut on the NASDAQ on May 17, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.

Trilaciclib is under four Phase 2 clinical trials - three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer. G1T38 is under a phase 1b/2a study for the treatment of ER+, HER2- breast cancer. G1T48 is currently in IND-enabling studies, and is on track for Phase 1 clinical development in the fourth quarter of 2017.

Near-term catalysts:

-- Investigational New Drug application filing for G1T38 in non-small cell lung cancer is expected in the fourth quarter of 2017. -- IND filing for G1T48 in ER+, HER2- breast cancer is expected in the fourth quarter of 2017. -- Top-line data from a phase 2a study of Trilaciclib in first-line small-cell lung cancer are expected in the first quarter of 2018. -- Enrollment for the phase 2a trial of Trilaciclib in second/third-line small-cell lung cancer is expected in the second quarter of 2018. -- Preliminary Phase 1b data for G1T38 plus Faslodex in ER+ breast cancer are anticipated in the second quarter of 2018.

3. Intellia Therapeutics Inc. (NTLA)

Intellia is a genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system.

Gained 10.49% to close Monday's trading at $16.75.

News: No news

4. Otonomy Inc. (OTIC)

Gained 8% to close Monday's trading at $20.25.

News: No news

Near-term catalysts:

-- The top line data from a phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-1, are expected to be announced in September. -- The top line data from its second phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-2, are anticipated by the end of 2017. -- A phase II study of OTO-311 for the treatment of patients with tinnitus is expected to be initiated by the end of 2017. -- The supplemental New Drug Application for the approval of OTIPRIO as a treatment for patients with Acute Otitis Externa is under FDA review - with a decision date set for March 2, 2018. OTIPRIO was approved by the FDA for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement in December 2015.

5. Sucampo Pharmaceuticals Inc. (SCMP)

Gained 7.80% to close Monday's trading at $11.05.

News: No news

Recent event:

On August 2, 2017, the Company reported Q2, 2017 financial results.

Adjusted net income for the recent second quarter rose to $16.5 million or $0.28 per share, on revenue of $59.9 million. This compared with an adjusted net income of $10.3 million or $0.24 per share and revenue of $51.95 million in the year-ago quarter.

Near-term clinical trial catalysts:

-- A phase III trial of CPP-1X/sulindac to treat Familial Adenomatous Polyposis, a predominately genetic disease is underway. Sucampo has exclusive option for North America. The NDA filing of CPP-1X/sulindac is expected in 2018. -- Filed an sNDA in July with the FDA for the approval of AMITIZA (lubiprostone) for pediatric functional constipation in 10-17 year old patients. AMITIZA is already approved for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women. -- A phase III study evaluating the bioequivalence of sprinkle and capsule formulations of Lubiprostone compared to placebo, when administered orally in subjects with Chronic Idiopathic Constipation is ongoing. -- A pivotal phase IIb/III trial.VTS-270 for the treatment of Niemann-Pick Disease Type C is underway. The trial is fully enrolled and pivotal data are expected in mid-2018.

6. MyoKardia Inc. (MYOK)

Gained 7.12% to close Monday's trading at $43.25.

News: No news

Recent events:

-- On August 14, 2017, the Company announced the closing of its previously announced underwritten public offering of 4.02 million shares of common stock, at the public offering price of $35.50 per share, including full exercise by the underwriters of their option to purchase additional shares. -- On August 7, 2017, the Company reported positive topline data from the first patient cohort of its phase II study of Mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy patients, dubbed PIONEER-HCM. The news sent the stock soaring over 83% that day.

MYOK was trading around $12.50 when we alerted our premium subscribers to the stock on April 5, 2017.

For more details about MYOK, please visit RTTNews' Emerging Biostocks page.

7. Immunomedics Inc. (IMMU)

Gained 7.01% to close Monday's trading at $9.01.

News: The Company's investigational drug Labetuzumab govitecan (IMMU-130) produced encouraging survival results in a phase II study in heavily-pretreated patients with metastatic colorectal cancer (mCRC).

To know more about IMMU, visit our Company Spotlight column.

LOSERS

1. Apollo Endosurgery Inc. (APEN)

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

Lost 8.39% to close Monday's trading at $3.93.

News: No news

Recent event:

On August 10, 2017, the FDA alerted alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery.

The following are the clarifications provided by the Company today pertaining to the FDA's alert.

ORBERA, which assists adult patients suffering from obesity with a body mass index of 30 to 40 in losing and maintaining weight, was approved by the FDA in August of 2015. "Since its approval, there have been 5 reported deaths of patients who had received the ORBERA intragastric balloon in four different countries, and they were all self reported by the Company. The incident rate remains less than 0.01% and there have been no product liability-related claims in connection with the five cases".

2. Harvard Bioscience Inc. (HBIO)

Lost 6.67% to close Monday's trading at $2.80.

News: No news

Recent event:

On July 27, 2017, the Company reported Q2, 2017 financial results.

On a non-GAAP basis, net income was $0.9 million or $0.03 per share for the recent second quarter compared to $1 million or $0.03 per share in the year-ago quarter. Revenues for the second quarter of 2017 dropped to $25.2 million from $26.1 million in the comparable year-ago period.

Looking ahead to full year 2017, the Company expects revenues to be flat compared to 2016 revenues, and non-GAAP earnings per share of $0.13 to $0.15.

3. PetMed Express Inc. (PETS)

Lost 5.78% to close Monday's trading at $41.73. The stock, which touched a new 52-week high of $50.65 on July 26, 2017, has retraced some of its gains.

News: No news

Recent event:

On July 24, 2017, the Company reported stellar financial results for the fiscal first quarter ended June 30, 2017.

Net income rose to $9.3 million or $0.45 per share for the recent fiscal first quarter on net sales of $79.7 million. This compared with a net income of $6.6 million or $0.32 per share and net sales of $72.5 million for the quarter ended June 30, 2016.

The analysts polled by Thomson Reuters expected the Company to earn $0.38 per share on net sales of $77.33 million.