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An Ear To The Pharma: 11 Stocks To Watch This Week

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Another week has rolled by, and as usual, the biotech sector saw some stocks soaring to the moon and some hitting the skids.

Daxor Corp. (DXR) was in the news for all the right reasons, climbing as much as 240% last week as a pioneering study indicated that the Company's precision blood volume analysis (BVA) reduced heart failure readmissions by 56% and mortality by over 80%.

On the contrary, Solid Biosciences Inc. (SLDB) plunged nearly 68% last week, following the full clinical hold imposed by the FDA on its phase I/II trial of SGT-001 for Duchenne Muscular Dystrophy after a patient experienced an unexpected adverse reaction. The study has been under partial clinical hold since last November due to safety concerns.

Let's take a look at the pharma stocks and upcoming events to keep an ear out for in the coming week.

1. SELLAS Life Sciences Group Inc. (SLS)

SELLAS is a development-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications.

The Company's lead product candidate is Galinpepimut-S (GPS), licensed from Memorial Sloan Kettering Cancer Center.

A phase II study of GPS in Multiple Myeloma, and a phase I/II study of GPS in combination with Opdivo in Ovarian Cancer are underway. Also in the pipeline is NEUVAX, under phase II testing in combination with Herceptin, for HER2 1+/2+ breast cancers.

Watch out for...

--- The updated data from the II study of GPS in Multiple Myeloma are expected to be presented on March 19, 2018, at the European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting.
--- Interim data from GPS /Opdivo combination trial in ovarian cancer is expected in the first half of this year.
--- Interim data analysis of the phase II study of NEUVAX is scheduled for the first half of this year.

SLS closed Friday's (Mar.16) trading at $4.79, down 1.44%.

2. Cellectis S.A. (CLLS)

Cellectis is a clinical-stage biopharmaceutical company developing immunotherapies based on gene-edited CAR T-cells (UCART).

The Company has two product candidates in clinical testing - UCART19 & UCART123.

UCART19 is under two phase I trials in acute lymphoblastic leukemia, dubbed CALM and PALL. The other drug candidate UCART123 is under two phase I trials - one in acute myeloid leukemia (AML) and the other in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Intermediary data from the CALM and PALL trials were presented at ASH in December 2017. The data showed an 83% complete remission rate across the adult and pediatric patient populations at day 28 post CAR T-cell infusion.

Watch out for...

Additional results from the two phase I clinical trials with UCART19 will be presented on March 21, 2018.

CLLS closed Friday's trading at $33.65, down 4.10%.

3. ImmunoGen Inc. (IMGN)

ImmunoGen is a pioneer in the field of antibody-drug conjugates or ADCs.

The Company's lead product candidate is Mirvetuximab soravtansine, an ADC, 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.

In the FORWARD II trial, Mirvetuximab soravtansine is evaluated in combination with Avastin, carboplatin, Doxil or Keytruda.

Initial safety and preliminary efficacy data from the FORWARD II trial that were presented last May were promising.

Watch out for...

-- The interim futility analysis of the FORWARD I trial will be conducted this month.
--- The updated dose-escalation findings from the Mirvetuximab soravtansine plus Keytruda combination cohort in the FORWARD II trial will be presented at the Society of Gynecologic Oncology annual meeting this month.

IMGN closed Friday's trading at $12.22, up 3.30%.

4. Altimmune Inc. (ALT)

Altimmune is a clinical-stage immunotherapeutics company having two product candidates in its pipeline - NasoVAX, a phase II seasonal influenza vaccine candidate, and HepTcell, a phase I immunotherapeutic candidate for the potential cure of chronic hepatitis B.

Watch out for...

-- Initial data from the phase II study of NasoVAX are due this quarter (period ending March 30, 2018).

The Company had reported positive initial data from its HepTcell phase I study in December 2017. HepTcell was well tolerated, and the preliminary data showed evidence of dose dependent increases in cellular immune response to HBV antigens.

-- The full analysis of all data through the post-dosing period in the phase I study is also expected this quarter.

ALT closed Friday's trading at $1.63, down 4.68%.

5. AnaptysBio Inc. (ANAB)

AnaptysBio is a clinical-stage antibody development company focused on unmet medical needs in inflammation.

The Company's lead drug candidate is ANB020, an inhibitor of interleukin-33 cytokine, or IL-33, which has a role to play in various infectious and inflammatory diseases.
ANB020 is under phase IIa testing in the indications of moderate-to-severe adult atopic dermatitis, severe adult peanut allergy, and severe adult eosinophilic asthma.

Watch out for...

-- Top-line data from the ongoing phase IIa trial assessing the tolerance of oral food challenge before and after administration of a single dose of ANB020 or placebo in a total of 20 adult patients with severe peanut allergy are expected this month.

ANAB closed Friday's trading at $112.54, up 0.43%.

6. Arena Pharmaceuticals Inc. (ARNA)

Arena Pharmaceuticals markets the obesity drug Belviq, and has three investigational clinical drug candidates - Ralinepag, a phase III-ready compound, for the potential treatment of pulmonary arterial hypertension; Etrasimod, which is under phase II study for ulcerative colitis, and APD371, also under phase II study, for the potential treatment of visceral pain, specifically pain associated with Crohn's disease.

Watch out for...

-- Data from phase II trial of Etrasimod in ulcerative colitis is anticipated this month.

ARNA closed Friday's trading at $31.51, down 4.54%.

7. Biohaven Pharmaceutical Holding Co. Ltd. (BHVN)

Biohaven Pharma is a clinical-stage biopharmaceutical company developing drugs for neurological diseases, including rare disorders.

The Company's lead drug candidate is Rimegepant (BHV-3000) for acute treatment of Migraine, which is under phase III development.

The Company initiated two pivotal phase III trials of orally-dosed 75 mg Rimegepant for the acute treatment of migraine last July. The two trials have together enrolled approximately 3,000 subjects.

Watch out for...

-- Top-line results from two pivotal phase III trials of orally-dosed 75 mg Rimegepant for the acute treatment of migraine are expected this month.

BHVN closed Friday's trading at $27.22, down 0.11%.

8. Cidara Therapeutics Inc. (CDTX)

Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives.

The Company's lead drug candidate is Rezafungin, which is under a phase II international trial in the treatment of candidemia and invasive candidiasis called STRIVE.

Watch out for...

-- The topline data from STRIVE are expected by the end of the first quarter (March 2018).

CDTX closed Friday's trading at $7.90, down 3.07%.

9. Flex Pharma Inc. (FLKS)

Flex Pharma is engaged in developing innovative and proprietary treatments for cramps and spasticity associated with the severe neurological diseases of amyotrophic lateral sclerosis, multiple sclerosis and peripheral neuropathies such as Charcot-Marie-Tooth (CMT).

The Company's lead drug candidate is FLX-787.

Watch out for...

-- Top-line results from a phase II placebo-controlled, cross-over study testing FLX-787 in patients who suffer from spasticity, cramps, and spasms as a consequence of multiple sclerosis, which is ongoing in Australia, are due in late Q1, 2018. (March, 2018).

FLKS closed Friday's trading at $7.60, up 3.26%.

10. Protagonist Therapeutics Inc. (PTGX)

Protagonist is a clinical-stage biopharmaceutical company developing peptide-based innovative medicines.

The Company has three clinical-stage product candidates, PTG-100, PTG-200, and PTG-300.

PTG-100 is currently in a Phase 2b clinical trial for moderate-to-severe ulcerative colitis; PTG-200 is currently being studied in Phase 1 clinical trial in healthy volunteers to support further development in Crohn's disease, and PTG-300 recently completed a Phase 1 clinical trial.

PTG-300 is being developed for the treatment of anemia related to rare blood diseases with an initial focus on beta-thalassemia.

Watch out for...

-- An interim futility analysis of the phase 2b clinical trial of PTG-100 for moderate-to-severe ulcerative colitis is due this quarter.

PTGX closed Friday's trading at $20.30, down 1.41%.

11. TESARO Inc. (TSRO)

TESARO is an oncology-focused biopharmaceutical company. The lead drug candidate is Niraparib, an orally active and potent PARP inhibitor being developed for the treatment of ovarian and breast cancer.

Watch out for...

-- Top-line results from a phase II study of Niraparib in patients with Ovarian Cancer who have received three or four previous chemotherapy regimens, dubbed QUADRA, are due this quarter (i.e., period ending March 2018).

TSRO closed Friday's trading at $61.81, down 3.99%.

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