01.12.2017 03:46:30

BEAT Upbeat, SYRS Gearing Up For ASH, Catalyst-Rich Year Ahead For ARGX

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 29, 2017.

GAINERS

1. Verastem Inc. (VSTM)

Gained 15.03% to close Thursday's (Nov.30) trading at $4.21.

News: No news

The Company's lead product candidate is Duvelisib.

Near-term catalysts:

-- Initiation of a phase II study of Duvelisib in patients with relapsed or refractory *PTCL is expected by year end. -- Submit NDA for Duvelisib during the first quarter of 2018, requesting full approval for it for the treatment of patients with relapsed or refractory *CLL/SLL and accelerated approval for the treatment of patients with relapsed or refractory FL.

* Peripheral T-cell lymphoma (PTCL); Chronic lymphocytic leukemia (CLL); Small lymphocytic lymphoma (SLL); Follicular lymphoma (FL).

2. argenx SE (ARGX)

Gained 14.32% to close Thursday's trading at $32.02.

News: No news

Pipeline:

The Company's most advanced product candidate is ARGX-113. Three phase II trials with an intravenous formulation of ARGX-113 are underway - one in patients with myasthenia gravis, another in patients with primary immune thrombocytopenia, and the third in patients with pemphigus vulgaris.

We had alerted our premium subscribers to ARGX on November 23, 2017.

3. Syros Pharmaceuticals Inc. (SYRS)

Gained 12.59% to close Thursday's trading at $14.85.

News: No news

Pipeline:

The Company's drug candidates are SY-1425, in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, in a Phase 1 clinical trial for patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

Near-term catalysts:

-- Initial clinical data from phase II clinical trial of SY-1425 are expected to be reported on December 10, 2017. -- Preliminary clinical data from phase I clinical trial of SY-1365 is expected in 2018.

4. Sangamo Therapeutics Inc. (SGMO)

Gained 12.11% to close Thursday's trading at $16.20.

News: No news

The company's proprietary technology is "zinc-finger protein", or ZFP, technology, which is designed to edit DNA, say by turning off or turning on genes for treating a disease. Zinc finger proteins are a class of naturally-occurring DNA binding proteins, and they are so named because they resemble a finger-like shape and include a zinc ion.

Recent event:

-- On November 15th, the Company reached an important milestone - i.e., the dosing of the first patient in its CHAMPIONS trial as this is for the first time that a genome editing therapy is being tested inside a patient's body.

The CHAMPIONS trial is a phase 1/2 clinical trial evaluating ascending doses of SB-913, and is designed to enroll 9 adults with Mucopolysaccharidosis II (MPS II).

Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is a progressively debilitating disorder. This condition occurs in about 1 in 100,000 to 1 in 170,000 males (Source: NIH).

5. Melinta Therapeutics Inc. (MLNT)

Gained 11.84% to close Thursday's trading at $17.00.

News: The Company has agreed to acquire infectious disease business from The Medicines Co. (MDCO)

This acquisition will add three marketed products to Melinta's portfolio namely, recently approved and launched Vabomere, and established commercial products Orbactiv and Minocin IV.

Melinta already has 1 approved drug Baxdela. It was recently approved by the FDA for the treatment of patients with ABSSSI, and will be launched in Q1 2018. The peak sales potential of Melinta's product portfolio post-closure exceeds $1 billion.

Recent event:

-- Melinta began trading on the NASDAQ on November 6, 2017, following its reverse merger with Cempra Inc.

6. XOMA Corp. (XOMA)

Gained 11.44% to close Thursday's trading at $25.52.

News: No news

Recent events:

-- On November 6, 2017, the Company reported better-than-expected third quarter 2017 financial results. --On October 4, 2017, the Company inked license agreements with three different companies, Tizona Therapeutics, Inc., Torch Biosciences, Inc., and LakePharma, for use of XOMA's proprietary phage display libraries for antibody discovery. --On August 25, 2017, the Company licensed the global commercial rights to Gevokizumab to Novartis. In a separate agreement, XOMA granted Novartis a license to its intellectual property covering the use of IL-1 beta targeting antibodies in the treatment of cardiovascular disease.

Gevokizumab is under phase II trials in acne vulgaris; acute coronary syndromes; diabetic nephropathies; giant cell arteritis; labyrinthitis; myositis; osteoarthritis; schnitzler syndrome and scleritis.

The licensing agreements eliminate almost half of XOMA's outstanding debt, more than double its cash position, and generate potential recurring revenues through royalties, according to XOMA.

7. Achaogen Inc. (AKAO)

Gained 9.32% to close Thursday's trading at $11.96.

News: No news

Recent event:

-- On October 26, 2017, the Company submitted a New Drug Application to the FDA, seeking approval of Plazomicin for the treatment of complicated urinary tract infections and bloodstream infections.

Clinical trials & Near-term catalyst:

-- A phase I study of C-Scape, an oral antibiotic in the treatment of complicated urinary tract infections, is underway, and top-line results are expected by this year end.

8. Zealand Pharma A/S (ZEAL)

Gained 9.01% to close Thursday's trading at $11.96.

News: No news

Clinical trials & Near-term catalysts:

-- On June 19, 2017, the Company reported positive results from a phase II trial of Glepaglutide in adult patients with short bowel syndrome. -- On July 3, 2017, the Company announced the initiation of a multinational phase III clinical trial of Dasiglucagon, a potential first-in-class glucagon analog suitable for a ready-to-use rescue pen to treat severe hypoglycemia, in four countries (Austria, Germany, Canada and the U.S.). -- On October 12, 2017, the Company announced the initiation of a phase I trial to evaluate the pharmacokinetic profile of Glepaglutide after a single intravenous injection and after multiple subcutaneous injections in healthy subjects. Results from this trial are expected in Q1 2018.

9. BioCryst Pharmaceuticals Inc. (BCRX)

Gained 8.55% to close Thursday's trading at $5.08.

News: No news

Clinical trials & Near-term catalyst:

-- On September 5, 2017, the Company reported positive results from APeX-1, its phase II trial of orally administered once-daily BCX7353 in hereditary angioedema (HAE). -- A phase III trial of BCX7353 as a preventative treatment to reduce the frequency of attacks in HAE patients, dubbed APeX-2, is expected to be initiated in Q1 2018.

10. ImmunoGen Inc. (IMGN)

Gained 8.36% to close Thursday's trading at $6.35.

News: No news

Pipeline:

The Company's lead product candidate is Mirvetuximab soravtansine, under a phase III trial as a single agent for the treatment of platinum-resistant ovarian cancer, dubbed FORWARD I, and under a phase 1b/2 study as combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer, known as FORWARD II.

Also in the pipeline are IMGN779 and IMGN632.

IMGN779 is under a phase I trial in adult patients with relapsed/refractory CD33-positive Acute Myeloid Leukemia while IMGN632, being developed for hematologic malignancies.

Near-term catalysts:

-- Report updated Phase 1 clinical data for IMGN779 in adult patients with relapsed or refractory AML, IMGN779 preclinical combination data, and IMGN632 preclinical data at ASH annual meeting. -- Initiate a phase I study for IMGN632 before year-end. -- Activate more than 100 sites globally for the FORWARD I trial by year-end. -- Report updated dose escalation findings from the FORWARD II trial in the first half of 2018.

11. BioTelemetry Inc. (BEAT)

Gained 8.01% to close Thursday's trading at $29.00.

News: The Company announced it is participating in Apple Heart Study. This study is being conducted by Apple (AAPL) and Stanford Medicine to improve the technology used to identify irregular heart rhythms.

As part of the study, Apple has launched "Apple Heart Study app" that uses data from Apple Watch to identify irregular heart rhythms, and notify users who may be experiencing atrial fibrillation (AFib).

The Apple Heart Study app is available in the US App Store to customers who are 22 years or older and have an Apple Watch Series 1 or later.

LOSER

1. Spero Therapeutics Inc. (SPRO)

Lost 6.49% to close Thursday's trading at $11.95.

News: No news

Recent events:

-- The Company's stock made its debut on The Nasdaq Global Select Market on November 2, 2017, at an offering price of $14.00 per share. -- On October 20, 2017, the Company initiated a phase I safety, tolerability, and pharmacokinetics study of ORAL SPR994 in healthy subjects.

Near term catalyst:

-- If the phase I study results are positive, a pivotal phase III clinical trial of ORAL SPR994 in patients with complicated urinary tract infections (cUTI) is planned for second half of 2018.

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Aktien in diesem Artikel

Apple Inc. 221,50 1,19% Apple Inc.
arGEN-X SE (spons. ADRs) 570,00 0,00% arGEN-X SE (spons. ADRs)
BioCryst Pharmaceuticals 6,87 -1,86% BioCryst Pharmaceuticals
Sangamo Therapeutics Inc 1,83 1,48% Sangamo Therapeutics Inc
Spero Therapeutics Inc Registered Shs 1,07 -1,10% Spero Therapeutics Inc Registered Shs
Xoma Corp Registered Shs 29,20 3,55% Xoma Corp Registered Shs