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An Ear To The Pharma: 12 Stocks To Watch (AIMT, TXMD, MDGL…)

may may25 lt

Another busy week just rolled by - with many of the FDA-related actions and a couple of clinical trial announcements making headlines.

The new drug approvals of the just concluded week include BioMarin Pharmaceutical Inc.'s (BMRN) Palynziq, the first enzyme therapy to treat phenylketonuria, and Dova Pharmaceuticals Inc.'s (DOVA) Doptelet for thrombocytopenia, while Recro Pharma Inc.'s (REPH) IV Meloxicam for the management of moderate to severe pain failed to get the regulatory blessing.

In terms of clinical trial results, Avenue Therapeutics Inc. (ATXI), Reata Pharmaceuticals Inc. (RETA) and AbbVie (ABBV) reported positive data from their respective studies during the week while Genmab A/S (GMXAY.OB) failed to make its mark.

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


1. Aimmune Therapeutics Inc. (AIMT)

Aimmune Therapeutics is a biopharmaceutical company developing treatments for life-threatening food allergies.

The Company's lead investigational drug is AR101, being developed for desensitization of patients with peanut allergy.

The positive results from a pivotal phase III efficacy trial of AR101 in patients with peanut allergy, dubbed PALISADE, were reported in February of this year. The trial met the primary endpoint - with 67.2% of AR101 patients ages 4-17 tolerating at least a 600-mg dose of peanut protein in the exit food challenge, compared to 4.0% of placebo patients.

Watch out for…

Additional data from the PALISADE trial are expected to be reported at the European Academy of Allergy and Clinical Immunology (EAACI) Congress on May 28, 2018.

AIMT closed Friday's trading at $32.65, down 1.66%.

2. TherapeuticsMD Inc. (TXMD)

TherapeuticsMD's TX-004HR, an applicator-free vaginal estradiol softgel, is at the FDA altar again, awaiting the final word on May 29, 2018.

TX-004HR is proposed for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women.

The FDA had turned down TX-004HR last May, citing lack of long-term endometrial safety data. Addressing the concerns raised by the regulatory agency, the Company resubmitted the amended TX-004HR NDA in November 2017, which was deemed complete.

TXMD closed Friday's trading at $6.40, up 5.09%.

3. Madrigal Pharmaceuticals Inc. (MDGL)

Madrigal Pharma is a clinical-stage biopharmaceutical company focused on developing treatments for NASH and HeFH.

The Company's lead drug candidate is MGL-3196, under phase II development.

Last December, the Company reported that there was statistically significant improvement in the relative decrease in liver fat in patients with NASH treated with MGL-3196 compared with placebo, at 12-weeks, the primary end point in the phase II proof-of-concept trial.

In February of this year, the Company reported positive results from a multi-center, 12-week phase II clinical trial of MGL-3196 in patients with heterozygous familial hypercholesterolemia (HeFH).

Watch out for…

The final 36-week data from the phase II study of MGL-3196 in NASH patients is expected to be announced by the end of May.

MDGL closed Friday's trading at $114.88, down 6.33%.

4. Kitov Pharma Ltd (KTOV)

The FDA decision on Kitov Pharma's (KTOV) Consensi, previously known as KIT-302, is expected on May 31, 2018.

The Company is seeking approval of Consensi to simultaneously treat pain caused by osteoarthritis, as well as hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain.

Consensi is comprised of two FDA approved drugs, Celebrex, a COX-2 inhibitor, for the treatment of pain caused by osteoarthritis, and Norvasc, a calcium channel blocker for lowering blood pressure.

KTOV closed Friday's trading at $2.05, up 0.99%.

5. bluebird bio Inc. (BLUE)

bluebird bio is a gene therapy company, with a focus on developing a one-time treatment option for patients with severe genetic and rare diseases and cancer.

The Company's lead drug candidate is LentiGlobin, which is under a phase III study in patients with transfusion-dependent ß-thalassemia (TDT) with the ß0/ß0 genotype, dubbed Northstar-3; a phase III study in patients with TDT and non-ß0/ß0 genotypes, known as Northstar-2; a phase I/II study in patients with TDT and all genotypes, dubbed Northstar; a phase I study in patients with TDT and severe sickle cell disease, dubbed HGB-205, and a phase I study in patients with sickle cell disease, known as HGB-206.

Also in the pipeline is bb2121, under phase II study in subjects with relapsed and refractory multiple myeloma, and bb21217, under phase I study in adults with relapsed/refractory multiple myeloma.

Watch out for…

Updated interim data from the ongoing phase 1 study of bb2121 in patients with late stage relapsed/refractory multiple myeloma are expected to be presented at the ASCO Annual Meeting on June 1, 2018.

The presentation will include safety and efficacy data from 21 patients treated in dose-escalation phase and early data from patients treated in dose-expansion phase.

BLUE closed Friday's trading at $188.15, up 0.61%.

6. Agios Pharmaceuticals Inc. (AGIO)

Agios Pharma is a biopharmaceutical company developing novel investigational medicines to treat cancer and rare genetic diseases.

The most advanced drug candidate in the pipeline is Ivosidenib, under phase III testing in combination with VIDAZA in frontline acute myeloid leukemia, and under phase III trial in previously treated advanced Cholangiocarcinoma patients with IDH1 mutations (ClarIDHy).

Ivosidenib is also under phase I testing in relapsed or refractory acute myeloid leukemia (RR-AML); phase I frontline combo study testing Ivosidenib plus induction and consolidation therapy in patients with newly diagnosed AML; phase I/II frontline combo trial of Ivosidenib with VIDAZA in newly diagnosed AML patients, and phase I study in subjects with advanced solid tumors, including Glioma, with an IDH1 mutation.

The other clinical drug candidates are AG-881, under phase I study in patients with advanced solid tumors, including gliomas, with an IDH1 and/or IDH2 mutation; AG-270, under phase I study in subjects with advanced solid tumors or lymphoma with MTAP loss; and AG-348 under phase II study in adult patients with Pyruvate Kinase Deficiency.

Watch out for…

The first data from the phase I study of AG-881 in patients with advanced solid tumors, including gliomas, with an IDH1 and/or IDH2 mutation will be presented on June 1, 2018, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Updated data from the phase I trial of Ivosidenib in relapsed or refractory acute myeloid leukemia (RR-AML) are expected to be presented on June 2, 2018 at the ASCO Annual Meeting.

AGIO closed Friday's trading at $89.36, up 0.84%.

7. Endocyte Inc. (ECYT)

Endocyte is a biopharmaceutical company developing targeted therapies for the personalized treatment of cancer.

The Company's lead investigational clinical program is 177Lu-PSMA-617, which is entering phase III testing for metastatic castration-resistant prostate cancer (mCRPC).

Watch out for…

Updated data from a phase II study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC), including data from an additional 20 patient expansion cohort, will be presented at the 2018 ASCO Annual Meeting on Saturday, June 2, 2018.

The Company recently reported median overall survival of 13.5 months for the first cohort of 30 patients enrolled.

ECYT closed Friday's trading at $13.33, down 5.19%.

8. Loxo Oncology Inc. (LOXO)

Loxo Oncology is focused on developing highly selective medicines for patients with genetically defined cancers.

The Company's lead product candidate is Larotrectinib. It is currently being evaluated in a phase I study in adult subjects with advanced solid tumors, phase II 'basket' trial in adult/adolescent patients with solid tumors harboring TRK fusions, and phase I/II trial in pediatric patients with advanced solid or primary CNS tumors.

The other clinical programs in the pipeline are LOXO-292, which is under a phase I trial in patients with advanced solid tumors, and LOXO-195, which is under a phase 1/2 trial in patients with TRK fusion cancers who have progressed while receiving another TRK inhibitor or are intolerant to another TRK inhibitor.

Watch out for…

Interim data from the ongoing phase I clinical trial for LOXO-292 in patients with advanced solid tumors will be presented on June 2, 2018 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

LOXO closed Friday's trading at $165.71, down 1.08%.

9. Seattle Genetics Inc. (SGEN)

Seattle Genetics is a biotechnology company developing drugs based on antibody-drug conjugate (ADC) technology.

The Company has one marketed product Adcetris, and a robust pipeline of novel therapies for solid tumors and blood-related cancers.

Adcetris is a CD30-directed antibody-drug conjugate, indicated for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

Watch out for…

Updated data from a phase 1 study of Enfortumab vedotin for patients with metastatic urothelial cancer will be presented on June 3, 2018 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

SGEN closed Friday's trading at $55.79, up 0.76%.

10. Odonate Therapeutics Inc. (ODT)

Odonate is a pharmaceutical company focused on developing therapeutics that improve and extend the lives of patients with cancer.

The Company's lead drug candidate is Tesetaxel, which is under phase III trial in patients with locally advanced or metastatic breast cancer, dubbed CONTESSA.

Watch out for…

Poster presentations on Tesetaxel will be made at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1st and June 2nd, 2018.

ODT closed Friday's trading at $23.20, down 0.56%.

11. Jounce Therapeutics Inc. (JNCE)

Jounce Therapeutics is a clinical stage company developing novel cancer immunotherapies.

The Company's lead product candidate is JTX-2011 that is currently in phase II portion of Phase 1/2 trial in patients with solid tumors in both monotherapy and combination settings, dubbed ICONIC.

Watch out for…

Updated results, including preliminary efficacy data on all evaluable patients in the trial across four solid tumor types: gastric cancer, triple negative breast cancer (TNBC), head and neck squamous cell cancer (HNSCC) and non-small cell lung cancer (NSCLC), will be presented on June 2, 2018, at the ASCO.

JNCE closed Friday's trading at $11.39, up 2.52%.

12. Stemline Therapeutics Inc. (STML)

Stemline is a clinical stage biopharmaceutical company developing novel oncology therapeutics that target difficult to treat cancers.

The Company's pipeline includes SL-401, which has successfully completed a phase II pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and in phase I/II trials in acute myeloid leukemia (AML) in remission with minimal residual disease (MRD), high-risk myeloproliferative neoplasms (MPN) of unmet medical need, and relapsed/refractory multiple myeloma (in combination with pomalidomide); SL-701, under a phase II study in adult patients with second-line glioblastoma multiforme (GBM), and SL-801, under a phase I trial in patients with advanced solid tumors.

The Company initiated a rolling Biologics License Application submission for SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm last month.

Watch out for…

Data from the phase II trial of SL-701 in patients with second-line glioblastoma will be presented on June 2, 2018 at the ASCO.

Interim results from the phase I trial of SL-801 in patients with advanced solid tumors will be presented on June 4, 2018 at the ASCO.

STML closed Friday's trading at $19.15, down 2.54%.

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