09.06.2017 07:40:35

Gainers & Losers Of June 8: ANAB, INO, SCLN, NLNK, JUNO...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 8, 2017.

GAINERS

1. AnaptysBio Inc. (ANAB)

Gained 17.42% to close Thursday's trading at $22.65.

News: No news

Near-term catalysts:

-- Top-line results from a phase 2a clinical trial for ANB020 in adult patients with severe peanut allergy are anticipated during the second half of 2017. -- Top-line results from a phase 2a clinical trial for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis are anticipated during the second half of 2017. -- Top-line results from a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 is being administered in single and multiple doses, through subcutaneous and intravenous routes of administration are expected during the second half of 2017. AnaptysBio plans to initiate Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, using ANB019 during 2018.

2. OncoMed Pharmaceuticals Inc. (OMED)

Gained 10.90% to close Thursday's trading at $3.56.

News: No news

Recent events:

-- On May 8, 2017, the Company announced that its phase II clinical trial of Demcizumab in combination with carboplatin and pemetrexed in front-line non-squamous non-small cell lung cancer, dubbed DENALI, failed to meet its efficacy endpoints when compared to placebo. -- On April 24, 2017, OncoMed announced that it is reducing its workforce by approximately 50 percent, resulting in 64 remaining full-time employees. -- On April 17, 2017, the Company announced that its phase II trial of Tarextumab in small cell lung cancer failed to meet its endpoints. The same day, the Company announced that is discontinuing enrollment in the Phase 1b clinical trial of brontictuzumab in combination with trifluridine/tipiracil (Lonsurf) in third-line colorectal cancer patients.

3. Inovio Pharmaceuticals Inc. (INO)

Gained 10.83% to close Thursday's trading at $8.19.

News: The FDA has removed the clinical hold on the Company's proposed phase III clinical trial of its investigational immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus.

A clinical hold was imposed on the phase III clinical program for VGX-3100 last October as the FDA required additional data supporting the shelf-life of the Company's immunotherapy delivery device CELLECTRA 5PSP.

Inovio satisfied the FDA's request for information relating to its CELLECTRA 5PSP delivery device, resulting in the FDA removing the clinical hold on the phase III program.

The phase III program of VGX-3100, named REVEAL, will consist of a primary study (REVEAL 1) and confirmatory study (REVEAL 2), which will be conducted in parallel. The studies will each enroll 198 patients in more than 100 study centers globally. Inovio plans to immediately begin recruiting patients for the phase III trial.

4. Coherus Biosciences Inc. (CHRS)

Gained 9.93% to close Thursday's trading at $22.70.

News: No news

Near-term catalyst:

-- If the FDA sticks to its deadline, today (June 9, 2017) we will know whether or not Coherus BioSciences' product candidate CHS-1701 gets the regulatory green light.

CHS-1701 is a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta that was approved in 2002.

Neulasta is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy. The drug generated sales of $4.65 billion in sales for Amgen last year.

5. Ovid Therapeutics Inc. (OVID)

Gained 9.31% to close Thursday's trading at $12.44.

News: No news

Recent event: 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.

The most advanced clinical drug candidate of the Company is OV101, a potential treatment for Angelman syndrome and Fragile X syndrome.

A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, and a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are underway.

6. SciClone Pharmaceuticals Inc. (SCLN)

Gained 7.92% to close Thursday's trading at $10.90.

News: SciClone is all set to be acquired by a consortium led by GL Capital for $11.18 per share, representing a valuation of approximately $605 million.

The acquisition price represents a premium of 11% over SciClone's closing stock price on June 7, 2017 and a premium of 16% over its ten-day volume-weighted average closing stock price. The transaction, which is expected to close this calendar year, is subject to approval by SciClone stockholders and other customary closing conditions.

LOSERS

1. NewLink Genetics Corp. (NLNK)

Lost 41.24% to close Thursday's trading at $6.24.

News: Roche Group's Genentech is terminating its worldwide license agreement with NewLink related to IDO inhibitor Navoximod.

In October 2014, NewLink and Genentech had entered into an exclusive worldwide license agreement for the development of Navoximod (formerly NLG 919, GDC 0919). Under the terms of the deal, NewLink was eligible to receive in excess of $1 billion in milestone payments as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.

Navoximod is under phase I trials in solid tumors.

Now that, Genentech has decided to walk away from the deal, Navoximod will revert to NewLink Genetics when the termination becomes effective.

2. Calithera Biosciences Inc. (CALA)

Lost 7.67% to close Thursday's trading at $15.05.

News: No news

The Company's lead product candidate is CB-839, a selective inhibitor of glutaminase, an enzyme required by cancer cells for growth and survival. In preclinical studies, CB-839 has been shown to halt the growth of or kill cancer cells across a range of tumor types.

CB-839 has been evaluated as a monotherapy and in combination with everolimus and cabozantinib in renal cell carcinoma patients in phase I trials. In the CB-839 phase I monotherapy trial, disease control was achieved in 52% of patients. In the phase I combination with everolimus, disease control was achieved in 93% of patients, and their median progression free survival was 8.5 months.

Near-term catalyst:

-- A phase II trial of CB-839 in combination with Everolimus is planned, and is expected to be initiated in the second half of 2017.

3. Egalet Corporation (EGLT)

Lost 7.03% to close Thursday's trading at $2.38.

News: No news

Recent events:

-- On June 7, 2017, the Company announced that it has partnered with Ascend Therapeutics to co-promote SPRIX Nasal Spray to more than 9,000 women's healthcare practitioners.

SPRIX Nasal Spray is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. (Source: Drugs.com).

On June 6, 2017, the Company announced that one of the largest payers in the United States will provide coverage of its ARYMO ER, which was approved by the FDA in January of this year for treatment of chronic pain.

4. Juno Therapeutics Inc. (JUNO)

Lost 5.77% to close Thursday's trading at $22.36.

News: BTIG analysts have downgraded shares of Juno to "Sell" from "Neutral", and set a price target of $12.

Recent event:

On June 5, 2017, the Company reported high durable response rates in patients with relapsed or refractory CD19+ aggressive non-Hodgkin lymphoma in its phase I trial of JCAR017, dubbed TRANSCEND. But investors were disappointed to learn that 18% (8/44) of patients experienced severe neurotoxicity and 2% (1/44) experienced severe cytokine release syndrome in core analysis group, sending the stock down more than 10% that day.

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Aktien in diesem Artikel

AnaptysBio Inc Registered Shs 23,40 -1,68% AnaptysBio Inc Registered Shs
Coherus BioSciences Inc 1,16 -3,25% Coherus BioSciences Inc
Ovid Therapeutics Inc Registered Shs 1,01 0,00% Ovid Therapeutics Inc Registered Shs