An Ear To The Pharma: 9 Stocks To Watch (CTMX, ZEAL, MRSN...)

(RTTNews) - The week that went by saw major announcements related to non-alcoholic steatohepatitis, Duchenne Muscular Dystrophy and sickle cell disease.

Madrigal Pharmaceuticals Inc. (MDGL) reported positive top-line, 36-week results from its phase II of MGL-3196 in patients with biopsy-proven non-alcoholic steatohepatitis on May 31, 2018, sending the stock soaring over 140% that day.

CRISPR Therapeutics AG (CRSP) on May 30, 2018, revealed the FDA's clinical hold on the planned initiation of a phase I/II trial of CTX001 in the U.S. in adult patients with sickle cell disease. The stock fell as much as 17% in intra-day trading on May 31, 2018. CTX001 is being co-developed by CRISPR Therapeutics and Vertex Pharmaceuticals (VRTX).

Sarepta Therapeutics Inc. (SRPT), on June 1, 2018, announced that EXONDYS for Duchenne Muscular Dystrophy failed to win over the European Medicines Agency's Committee for Medicinal Products for Human Use. EXONDYS was granted accelerated approval in the U.S. for Duchenne muscular dystrophy in September 2016, despite an FDA panel recommending against its approval. The approval of EXONDYS is considered one of the controversial decisions.

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

1. Infinity Pharmaceuticals Inc. (INFI)

Infinity is a biopharmaceutical company focused on developing novel cancer treatments.

The Company's lead drug candidate is IPI-549 that is being evaluated as a monotherapy and in combination with Opdivo in a phase I/Ib study in approximately 200 patients with advanced solid tumors.

The phase I/Ib study includes four parts namely, monotherapy dose escalation, monotherapy expansion, combination dose escalation and combination expansion.

The Company reported encouraging monotherapy dose escalation clinical and translational data from the phase 1/1b study of IPI-549 last November. The data, based on 18 patients evaluable for activity, demonstrated a 44 percent clinical benefit rate, including one partial response in a patient with advanced peritoneal mesothelioma.

Watch out for…

Data from combination dose escalation portion of the phase I/Ib study of IPI-549, updated data from the monotherapy portion of the trial, and initial data from the combination expansion cohort of the study are expected to be presented on June 4, 2018, during the American Society of Clinical Oncology (ASCO) Annual Meeting.

INFI closed Friday's trading at $2.01, down 0.99%.

2. Acceleron Pharma Inc. (XLRN)

Acceleron is a clinical-stage biopharmaceutical company developing therapeutics to treat serious and rare diseases.

The Company's lead product candidate is Luspatercept that is in multiple phase II and phase III trials in myelodysplastic syndromes (MDS) and beta-thalassemia, as well as in a phase II trial in myelofibrosis.

Watch out for…

Updates from the ongoing long-term phase II extension trials in MDS and beta-thalassemia are expected to be presented on June 4, 2018 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

XLRN closed Friday's trading at $35.87, up 0.93%.

3. CytomX Therapeutics Inc. (CTMX)

CytomX is an oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform.

The Company's lead drug candidate is CX-072, which is under a phase I/II clinical trial, dubbed PROCLAIM.

PROCLAIM is evaluating CX-072 as monotherapy and in combination with Yervoy or Zelboraf in patients with advanced or recurrent solid tumors or lymphomas.

Watch out for…

The preliminary clinical results from PROCLAIM-072 are expected to be presented on June 4, 2018 at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

CTMX closed Friday's trading at $25.53, down 0.55%.

4. Zealand Pharma A/S (ZEAL)

Zealand Pharma is a biotechnology company focused on developing drugs for gastrointestinal, metabolic and other specialty diseases.

The Company's Glepaglutide, a long-acting GLP-2 analog in development for the treatment of short bowel syndrome, is a phase III ready compound.

Last June, the Company reported positive phase II results for Glepaglutide, clearly indicating the potential to ultimately offer better treatment to patients with short bowel syndrome.

Watch out for…

New results from the phase II trial of Glepaglutide for the treatment of short bowel syndrome will be presented on June 3, 2018.

ZEAL closed Friday's trading at $15.32, up 3.86%.

5. Protalix BioTherapeutics Inc. (PLX)

Protalix is a biopharmaceutical company developing drugs based on its proprietary ProCellEx system for the treatment of Fabry disease, cystic fibrosis, and immune and inflammatory diseases.

One of the clinical drug candidates of the Company is OPRX-106 for the treatment of ulcerative colitis, under phase II testing.

The positive interim results from the phase IIa clinical trial of OPRX-106 for the treatment of ulcerative colitis, reported in March of this year, showed that 67% of patients experienced a clinical response, and 28% of patients experienced a clinical remission.

Watch out for…

New clinical data from the phase IIa clinical trial of OPRX-106 for the treatment of ulcerative colitis will be presented on June 4, 2018.

PLX closed Friday's trading at $0.47, down 3.25%.

6. Portola Pharmaceuticals Inc. (PTLA)

Portola is a commercial-stage biopharmaceutical company focused developing therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases.

The Company's lead clinical asset is Cerdulatinib, being developed to treat patients with follicular lymphoma (FL), peripheral T-cell lymphoma, and other hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies.

A phase IIa study evaluating the safety and efficacy of Cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies is underway.

Interim results from the study were initially reported in June 2017.

Watch out for…

New interim results from the ongoing phase IIa study of Cerdulatinib in patients with Non-Hodgkin Lymphoma (NHL), including B-cell NHL and relapsed/refractory peripheral T-cell lymphoma (PTCL), will be presented on June 4, 2018, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

PTLA closed Friday's trading at $40.77, up 1.54%.

7. MEI Pharma Inc. (MEIP)

MEI Pharma is a pharmaceutical company focused on developing new therapies for cancer.

One of the clinical drug candidates of the Company is ME-401, under a phase Ib, open-label, dose-escalation study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma.

Early safety and efficacy data from the phase Ib study of ME-401 in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma were reported last May.

Watch out for…

Updated results from the phase 1b study evaluating ME-401 in relapsed/refractory indolent B-cell malignancies will be presented on June 4, 2018 at the ASCO Annual Meeting.

MEIP closed Friday's trading at $3.43, up 3.31%.

8. Mersana Therapeutics Inc. (MRSN)

Mersana is a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) for the treatment of cancers.

The Company's lead product candidate is XMT-1522, under phase I clinical trials in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC) and gastric cancer patients.

Watch out for…

Interim data from the ongoing Phase 1 dose-escalation and expansion study evaluating XMT-1522 in patients with HER2-expressing breast, lung and gastric tumors will be presented on June 4, 2018, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

MRSN closed Friday's trading at $20.70, down 1.10%.

9. TESARO Inc. (TSRO)

TESARO is an oncology-focused biopharmaceutical company.

The Company's marketed drug ZEJULA (niraparib) is approved for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

In April of this year, the Company announced positive results from QUADRA, a phase II study of ZEJULA in patients with ovarian cancer who have received three or four previous chemotherapy regimens.

According to the trial results, ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line homologous recombination deficiency (HRD) positive patients who were PARP inhibitor naïve, and platinum sensitive, with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months.

Watch out for…

Additional QUADRA data will be presented on June 4, 2018 at the ASCO Annual Meeting.

TSRO closed Friday's trading at $46.89, up 2.45%.