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An Ear To The Pharma: 8 Stocks To Watch (CMRX, CRBP, KPTI, VRX…)

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The week that went by saw a number of companies present updated results on their clinical trials at the American Society of Clinical Oncology (ASCO), the world's largest clinical cancer research meeting.

While Deciphera Pharmaceuticals Inc. (DCPH) soared nearly 48% on encouraging updated data from its ongoing Phase 1 clinical trial of DCC-2618 in patients with gastrointestinal stromal tumors, Nektar Therapeutics (NKTR) disappointed investors as its shares tumbled nearly 42% on a decline in response rate in its PIVOT-02 study.

The PIVOT-02 is a phase 1/2 trial evaluating a combination of NKTR-214 and Opdivo in patients with locally advanced or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, or triple-negative breast cancer.

Now, here are some of the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.

1. Chimerix Inc. (CMRX)

Chimerix (CMRX) is a biopharmaceutical company developing novel antivirals to address unmet medical needs.

The Company's lead product candidate is oral Brincidofovir in late-stage development for the treatment of smallpox. Brincidofovir is also under phase II testing for adenovirus. Also in the pipeline is IV BCV under phase II development for multi-viral prevention, and CMX521 for norovirus in Phase 1 testing.

Watch out for…

The first oral presentation on CMX521 will be made at the International Conference on Antiviral Research (ICAR) that will be held June 11 - June 15.

CMRX closed Friday's trading at $4.43, down 3.90%.

2. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Corbus Pharma is a late-stage pharmaceutical company focused on developing novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases.

The Company's lead product candidate is Lenabasum, currently being evaluated in clinical studies in systemic sclerosis, cystic fibrosis, dermatomyositis and systemic lupus erythematosus.

Watch out for…

Safety and efficacy data of Lenabasum (JBT-101) in diffuse cutaneous systemic sclerosis subjects treated for one year in an open-label extension to phase II trial of Lenabasum will be presented on June 13, 2018.

In November 2016, the Company reported positive top line data from its phase II trial of Lenabasum in systemic sclerosis.

CRBP closed Friday's trading at $5.75, down 2.54%.

3. Karyopharm Therapeutics Inc. (KPTI)

Karyopharm Therapeutics is a clinical-stage pharmaceutical company developing drugs for the treatment of cancer and other major diseases.

The Company's lead drug candidate is Selinexor (KPT-330), being evaluated in multiple phase II/III clinical trials in patients with relapsed and/or refractory hematological and solid tumor malignancies.

On April 30, 2018, the Company announced promising top-line results from its phase IIb study of Selinexor in heavily pretreated patients with refractory multiple myeloma, dubbed STORM. According to the trial results, oral Selinexor achieved 25.4% overall response rate and median duration of response of 4.4 months in patients with penta-refractory myeloma.

A phase 1b/2 study evaluating Selinexor in combination with existing therapies for the treatment of patients with heavily pretreated multiple myeloma, dubbed STOMP, is ongoing. Positive data from the STOMP study were presented last December.

Watch out for…

Updated results from the Phase 1b/2 STOMP study evaluating Selinexor and Dexamethasone in combination with Velcade, Pomalyst, or Darzalex in relapsed or refractory multiple myeloma will be presented at the European Hematology Association on June 15, 2018.

KPTI closed Friday's trading at $17.59, up 1.56%.

4. Blueprint Medicines Corp. (BPMC)

Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined diseases.

Avapritinib (BLU-285), BLU-554 and BLU-667 are the Company's clinical drug candidates, all of which are under phase I testing.

BLU-285 is being explored in the indications of advanced gastrointestinal stromal tumors and advanced systemic mastocytosis. BLU-554 for the treatment of advanced hepatocellular carcinoma, and BLU-667, a potent and selective inhibitor of RET mutations, fusions, and predicted resistant mutants, is being explored in RET-altered cancers.

Last December, Blueprint Medicines presented updated data from the dose escalation portion of its ongoing Phase 1 clinical trial of Avapritinib in patients with advanced systemic mastocytosis, dubbed the Explorer trial. The data showed an overall response rate of 72 percent and a disease control rate of 100 percent in patients evaluable for response.

Watch out for…

Updated data from the Explorer trial will be presented on June 15, 2018, at the European Hematology Association.

BPMC closed Friday's trading at $66.87, down 1.66%.

5. Affimed N.V. (AFMD)

Affimed is a clinical-stage biopharmaceutical company focused on developing highly targeted cancer immunotherapies.

The Company's pipeline product candidates are AFM11, AFM13, AFM24 and AFM26.

In February of this year, the Company announced encouraging data from a phase 1b study of the combination of AFM13 with anti-PD-1 antibody Keytruda in relapsed/refractory Hodgkin lymphoma, and a phase 1b/2a trial of AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma.

In a phase 1b study of the combination of AFM13 with anti-PD-1 antibody Keytruda in relapsed/refractory Hodgkin lymphoma, the objective response rate (ORR) was 89%. That compared favorably to the historical ORR of Keytruda's 58-63% as monotherapy in a similar patient population.

The Complete Response (CR) Rate was 44% for the combination, and it represented a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).

Watch out for…

The 3-month response data from the dose-escalation and extension cohorts of the phase 1b study of the combination of AFM13 with Keytruda in relapsed/refractory Hodgkin lymphoma is expected to be presented on June 15, 2018 at the 23rd Annual Congress of the European Hematology Association (EHA).

AFMD closed Friday's trading at $2.15, unchanged from the previous day's close.

6. Global Blood Therapeutics Inc. (GBT)

Global Blood Therapeutics is a clinical-stage biopharmaceutical company, developing its lead product candidate, Voxelotor, as an oral, once-daily therapy for sickle cell disease.

A phase III study evaluating Voxelotor in adults and adolescents with SCD is known as HOPE Study. This trial consists of two parts - Part A and Part B.

Voxelotor is also being studied in a phase IIa trial in patients 6-17 years of age, known as HOPE-KIDS 1 Study.

The HOPE-KIDS 1 Study also consists of 2 parts - single-dose Part A portion, and multiple-dose Part B portion (doses of 900 mg per day and 1500 mg per day).

Watch out for…

24-week data on patients treated with the 900 mg dose of Voxelotor in Part B of the HOPE-KIDS 1 Study will be presented on June 15, 2018 at the European Hematology Association (EHA) Congress.

GBT closed Friday's trading at $46.15, down 3.95%.

7. ArQule Inc. (ARQL)

ArQule is a biopharmaceutical company developing targeted therapeutics to treat cancers and rare diseases.

The Company's clinical drug candidates are:

-- ARQ 087 (Derazantinib), under phase III trial in Intrahepatic Cholangiocarcinoma (iCCA).
-- ARQ 531, under phase I dose escalation study in selected subjects with relapsed or refractory hematologic malignancies.
-- Miransertib (ARQ 092) under phase I/II trial for Proteus syndrome, and phase Ib trial in combination with Carboplatin plus Paclitaxel, in combination with Paclitaxel, or in combination with Anastrozole in subjects with selected solid tumors.
-- ARQ 751, under phase I dose escalation study in subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations.

Watch out for…

Clinical data from the phase I dose escalation study of ARQ 531 in subjects with relapsed or refractory hematologic malignancies will be presented on June 15, 2018 at the EHA Congress in Stockholm, Sweden.

ARQL closed Friday's trading at $5.33, down 7.79%.

8. Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO)

Valeant Pharma awaits the FDA approval for IDP-118 lotion, proposed as a topical treatment for plaque psoriasis, on June 18, 2018.

IDP-118 is a fixed combination of Halobetasol, a corticosteroid, and Tazarotene, a retinoid, formulated as a once-daily lotion.

If approved, IDP-118 will be the first and only topical lotion that contains the unique combination of Halobetasol and Tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.

VRX closed Friday's trading at $25.79, up 3.37%.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

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