Miragen Therapeutics shares soar on leukemia data

Miragen Therapeutics announces data from Phase 1 trial of cobomarsen

Miragen Therapeutics (MGEN) announced new efficacy and safety data from the ATLL arm of its ongoing Phase 1 clinical trial of cobomarsen, which will be presented at the 12th Annual T-Cell Lymphoma Forum in La Jolla, CA, which is taking place from January 30th to February 1st.

Miragen shares soar on its test data, Stockwinners

Of note are the data from the subtype of aggressive ATLL patients (Adult T-Cell Leukemia Lymphoma (ATLL)) who at study entry had persistent residual disease after chemotherapy or other therapy.

In the trial, six patients of this subtype had an MST of 26 months with three patients still on treatment at the time of data analysis.

Adult T-Cell Leukemia Lymphoma does not have a cure, Stockwinners

The Company was most encouraged, however, by the observed biomarker activity showing that disease stabilization is marked by a decrease in biomarkers of tumor cells activation and proliferation, providing evidence of the biological mechanism effect of cobomarsen on disease stabilization.

The Company is evaluating cobomarsen in an ongoing Phase 1 basket trial of cancers where the disease process appears to be correlated with an increase in miR-155 levels, including ATLL, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Today’s announcement includes results for the first 15 patients with aggressive subtypes of ATLL who were treated with three doses of cobomarsen by intravenous infusion, including 600, 900 and 1200 mg doses.

The preliminary results from this first-in-human Phase 1 clinical trial of the miR-155 inhibitor, cobomarsen, in patients with ATLL was observed to improve disease stabilization and reduce biomarker expression associated with ATLL cellular proliferation and activation in patients with persistent residual disease after chemotherapy and other therapies.

Of the 15 ATLL patients treated with cobomarsen, nine were actively relapsing at the time of screening, and six had residual nodal or circulating leukemic disease after chemotherapy or other systemic therapies.

For these six patients, the duration of cobomarsen treatment ranged from 4.5 to 23.7 months, with three patients still on study as of October 17, 2019.

MST of these patients was 26 months, compared with the 7.4 months MST from a retrospective external historical cohort based on a literature search of peer-reviewed papers. The Company compiled a historical external control which includes a series of studies with ATLL patients treated with standard of care over the past 10 years.

These studies included more than 6,000 ATLL patients. The Company calculated an MST from diagnosis of 7.4 months for patients with the aggressive ATLL subtypes, regardless of the type of therapy or number of therapies administered.

Five of these six patients treated with cobomarsen were alive as of the October 17, 2019 data analysis. In the trial, disease stabilization was marked by an observed decrease in Ki-67, a biomarker of cell proliferation, as well as other biomarkers of cell activation on circulating tumor cells, providing evidence of the biological mechanism effect of cobomarsen on disease stabilization.

For the clinical trial, the Company established a retrospective external historical cohort based on a literature search of peer-reviewed papers which reported MST from diagnosis and PFS on large cohorts of ATLL patients over the last decade.

A total of 16 papers describing unique cohorts of patients from Japan, the United States, South America and Europe were included in the MST retrospective analysis, of which 12 included data regarding MST for combined aggressive subtypes and eight reported MST for both acute and lymphomatous sub-types separately but not for the combined aggressive subtypes.

The number of patients included in each publication varied from 54 to 1,792, for a total of 6,440 patients.

Chronic administration of cobomarsen has been generally safe and well tolerated with a favorable safety profile over one year of dosing on a weekly basis.

There were 196 total reported adverse events as of October 17, 2019, with only 22% of the total AEs considered possibly related to study drug, and 86% of the total AEs considered mild or moderate. 14% of the total AEs were Grade 3 or 4 and most resolved within 11 days.

With no drug related deaths and only two serious adverse events occurring in the same patient and deemed possibly related to the study drug, the observed safety profile of cobomarsen in ATLL through October 17, 2019 appears to be benign and well tolerated with chronic dosing.

MGEN closed at $1.69, last traded at $2.80.

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BeiGene announces acceptance of supplemental NDA in China for REVLIMID

BeiGene announces acceptance of supplemental NDA in China for REVLIMID for the treatment of lymphoma

BeiGene (BGNE) announced that the China National Medical Products Administration has accepted a supplemental new drug application for #REVLIMID, in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma.

BeiGene shares have been active lately, Stockwinners

REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma who are not eligible for transplant.

REVLIMID used for the treatment of multiple myeloma, Stockwinners

It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb (BMY) company.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control data package, including the results from the pivotal Phase 3 AUGMENT study sponsored and conducted by Bristol-Myers Squibb.

Bristol-Myers treatment for colorectal cancer approved, Stockwinners
Bristol-Myers purchased Celgene and REVLIMID awhile back, Stockwinners

AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab or rituximab and placebo.

With a median follow-up of 28.3 months, R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival, evaluated by an independent review committee, relative to the control arm with a 54% reduction in the risk of progression or death.

The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate, a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC.

Duration of response was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively.

Bristol Meyers Comments on Celgene purchase, Stockwinners
Bristol Meyers Comments on Celgene purchase, Stockwinners

The most frequent adverse event in the R2 arm was neutropenia, vs. 22% in the control arm.

Additional commonly observed AEs in more than 20% of patients included diarrhea, constipation, cough, and fatigue. Adverse events that were reported at a higher rate in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

BMY closed at $63.51. BGNE closed at $173.14.

See our other blogs about BeiGene.

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ArQule sold for $2.7 billion

Merck to acquire ArQule for $20 per share

Merck (MRK) and ArQule (ARQL) announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7B.

Merck buys ArQule for $2.7B, Stockwinners

ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase, or BTK, inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies.

BTK inhibition has been shown to prevent B-cell receptor signaling that is critical for the survival and proliferation of leukemic cells in many B-cell malignancies.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
Merck buys ArQule, Stockwinners

ARQ 531 is a selective, reversible inhibitor that blocks both wild-type BTK and the C481S mutant form of the enzyme that is commonly associated with resistance to other BTK inhibitors.

In early clinical trials, ARQ 531 demonstrated a manageable safety profile and early signs of anti-tumor activity for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, and Richter’s Transformation.

ArQule lead investigative drug is ARQ531

Final data from the Phase 1 study of ARQ 531 will be presented on December 9 at the 61st American Society of Hematology, or ASH.

Under the terms of the acquisition agreement announced, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of ArQule.

The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of ArQule’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Upon the successful completion of the tender offer, Merck’s acquisition subsidiary will be merged into ArQule, and any remaining shares of common stock of ArQule will be canceled and converted into the right to receive the same $20 per share price payable in the tender offer.

The transaction is expected to close early in Q1 of 2020.

ARQL closed at $9.66, last traded at $19.90.

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Audentes Therapeutics sold for $3 billion

Astellas to acquire Audentes for $60 per share in cash

Astellas Pharma (ALPMY) and Audentes Therapeutics (BOLD) announced that they have entered into a definitive agreement for Astellas to acquire Audentes at a price of $60.00 per share in cash, representing a total equity value of approximately $3B.

Under the agreement, which has been unanimously approved by the boards of directors of both Astellas and Audentes, Astellas will acquire Audentes through Asilomar Acquisition Corp., a wholly-owned subsidiary of Astellas US Holding, Inc.

Gene Therapy pays off nicely for Audentes Therapeutics, Stockwinners

Asilomar will commence a tender offer for all outstanding shares of common stock of Audentes, for a price of $60.00 per share in cash.

Promptly upon successful completion of the Tender Offer, Asilomar will be merged into Audentes, and any remaining shares of common stock of Audentes will be canceled and converted into the right to receive the same $60.00 per share price.

Astellas pays $3 billion for Audentes Therapeutics, Stockwinners

The board of directors of Audentes has resolved to recommend that Audentes stockholders tender their shares to Astellas. Consummation of the transaction is subject to customary closing conditions, including US antitrust clearance and the tender of a majority of Audentes’ outstanding shares of common stock.

The offer price represents a premium of 110% to Audentes’ closing share price of $28.61 on December 2, 2019.

The all-cash transaction is valued at approximately $3B including the purchase of all common shares, options, restricted stock units and other securities.

The Tender Offer period is expected to commence in the next few weeks and to expire 20 business days after its commencement, unless otherwise extended.

If the Tender Offer conditions are not satisfied, Astellas may be required to extend the Tender Offer under certain circumstances. Astellas is still reviewing the impact of a consummation of the transaction on its financial results for the fiscal year ending March 31, 2020.

Audentes Therapeutics, Inc. focuses on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases caused by single gene defects.

The company is developing AT132, which is in Phase I/II clinical studies for the treatment of X-linked myotubular myopathy (XLMTM); AT342 that is in Phase I/II clinical studies to treat crigler-najjar syndrome; AT845, which is in preclinical studies for the treatment of pompe disease; and AT307 to treat CASQ2 subtype of catecholaminergic polymorphic ventricular tachycardia. 

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MorphoSys higher on lymphoma data

MorphoSys says tafasitamab B-MIND study successfully passed futility analysis

MorphoSys (MOR) announced that the ongoing tafasitamab phase 3 B-MIND study has successfully passed the pre-planned, event-driven interim analysis for futility.

MorphoSys higher on lymphoma data, Stockwinners

An independent data monitoring committee reviewed the data and recommended to increase the number of patients from currently 330 to 450.

B-MIND compares the efficacy of the CD19 antibody tafasitamab plus bendamustine with rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma, or r/r DLBCL.

Tafasitamab (MOR208) is a humanized monoclonal antibody , Stockwinners

“Within the interim analysis for futility, data were assessed by the IDMC for the probability of a positive study at primary completion.

The IDMC assessed efficacy data in both the overall patient population as well as in the biomarker-positive subpopulation. The biomarker, described as patients with a low natural killer cell count at baseline, was implemented as a co-primary endpoint in an amendment of B-MIND in the first quarter 2019.

The recommendation to enroll more patients aims to increase statistical power of the study in the biomarker-described patient subpopulation as well as the overall patient population. Data of the analysis were not shared with MorphoSys.

As a continuation of the B-MIND study protocol, enrollment will proceed according to the original inclusion and exclusion criteria to allow for ongoing comparison of the efficacy in the overall and biomarker positive patient population.

Top line results are expected to be available in Q1 2022,” the company stated.

Piper Jaffray Comments

Piper Jaffray analyst Danielle Brill said news that MOR208 successfully passed the B-MIND trial futility analysis is “a positive clearing event for investors” that de-risks the stock, even though enrollment will be expanded from 300 to 450 patients and it is unclear how strong the efficacy signal was in the overall population.

She continues to expect FDA and EMA approval for MOR208 based on L-MIND data by mid-2020 and keeps an Overweight rating on MorphoSys shares.

MOR +$1.98 to $28.09.

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BeiGene drug wins FDA approval for rare form of lymphoma

The FDA granted accelerated approval to the capsules for treatment of adult patients with mantle cell lymphoma, who have received at least one prior therapy.

The U.S. Food and Drug Administration approved BeiGene Ltd’s lymphoma drug, accepting the Chinese drugmaker’s strategy of largely using data from trials held outside the United States to file for approval.

FDA granted accelerated approval to the capsules for treatment of adult patients with mantle cell lymphoma
FDA granted approval to the capsules for treatment of aduls with mantle cell lymphoma, Stockwinners

The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21% Caucasian, and between 10% to 15% were from the United States, BeiGene said.

The FDA granted accelerated approval to the capsules for treatment of adult patients with mantle cell lymphoma, who have received at least one prior therapy.

Mantle cell lymphoma is a rare, aggressive form of non-Hodgkin lymphoma, a blood cancer that most often affects men aged over 60. The company estimates between 3,000 and 4,000 new patients were diagnosed in the United States in 2015.

Last month, BeiGene (BGNE) and Amgen (AMGN) announced a global strategic oncology collaboration for the commercialization and development in China of Amgen’s XGEVA, KYPROLIS, and BLINCYTO, and the joint global development of 20 oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.

In connection with the collaboration, Amgen said it will purchase a 20.5% stake in BeiGene for approximately $2.7B in cash at $174.85 per American Depositary Share, or ADS.

BGNE closed at $196.40.

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Nektar Therapeutics is in focus

Nektar presents new clinical, preclinical data from immuno-oncology pipeline

Nektar Therapeutics (NKTR) announced the presentation of five clinical and preclinical data abstracts focused on its immuno-oncology portfolio at the 2019 Society for Immunotherapy of Cancer Annual Meeting.

Stockwinners offers winning stock and option picks since 1998
Nektar Therapeutics is in focus, Stockwinners

New clinical results from the PIVOT-02 Phase 1/2 study were shared in an oral presentation titled, “Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the Phase 1/2 PIVOT-02 Study” during the Combination Phase 1-2 Clinical Trials Session on Saturday, November 9th.

Additional preclinical data presented at the annual meeting highlighted NKTR-255, an IL-15 agonist discovered by Nektar.

The presentations demonstrated that NKTR-255 enhanced activity of antibody-dependent cellular cytotoxicity against tumor cells in vitro, and that it also enhanced in vivo efficacy of ADCC-inducing antibodies in models of human solid tumors.

NKTR-255 is designed to engage the IL-15 pathway to stimulate and expand natural killer cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells.

Nektar product pipeline, Stockwinners

NKTR-255 is currently being evaluated in a Phase 1/2 clinical trial in patients with either relapsed or refractory Non-Hodgkin’s lymphoma or multiple myeloma.

“The data presented at this year’s SITC meeting continue to showcase the potential of our I-O portfolio, most notably our key IL-2 pathway program, bempeg, and our new IL-15 pathway program, NKTR-255,” said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar.

“The 18-month follow-up data presentation for the Stage IV melanoma patients in our PIVOT-02 study reinforces the promise of BEMPEG and NIVO to work synergistically to achieve a deepening of response over time, while maintaining a favorable safety and tolerability profile. We’re pleased that at this 18 month timepoint, 85% of patients who achieved responses have ongoing responses and median PFS has not yet been reached.”

Separately, Nektar Therapeutics (NKTR) announced updated results from the first-in-human Phase 1a study of NKTR-358, a novel T regulatory cell stimulator in development for the treatment of autoimmune and other chronic inflammatory conditions.

Nektar reports new data, Stockwinners

The data, which were presented at the 2019 Annual Meeting of the American College of Rheumatology in Atlanta, show that treatment with NKTR-358 led to a marked and selective dose-dependent expansion in the numbers and proliferative capacity of FoxP3+CD25bright Treg cells, and a measurable activation of Treg cells.

These data are a continuation of initial results reported at 2019 Annual European Congress of Rheumatology in June 2019.

NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune-regulating Treg cells.

NKTR-358 works by targeting the interleukin-2 receptor complex to stimulate the proliferation and activation of Treg cells.

NKTR-358 was discovered by Nektar and is being co-developed and commercialized in partnership with Eli Lilly (LLY).

Eli Lilly announces Alimta label expanded by FDA, Stockwinners
Eli Lilly and Nektar report new data, Stockwinners

“We’re pleased to report that final results from our first-in-human Phase 1a study continue to support the positive safety and tolerability profile of NKTR-358, while reinforcing its selective and measurable impact on the numbers, expansion and activation of regulatory T cells or Tregs,” said Brian Kotzin, M.D., senior VP, Clinical Development and NKTR-358 Program Lead at Nektar.

“Autoimmune and inflammatory diseases are marked by an imbalance in the body’s self-tolerance and self-regulatory immune pathways, and the ability of NKTR-358 to expand functional Tregs could help restore normal balance.

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BeiGene shares soar on Amgen stake

Amgen to buy 20.5% stake in BeiGene for $2.7B at $174.85 per ADS

BeiGene (BGNE) and Amgen (AMGN) announced a global strategic oncology collaboration for the commercialization and development in China of Amgen’s XGEVA, KYPROLIS, and BLINCYTO, and the joint global development of 20 oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China.

Amgen takes 20% stake in BeiGene, Stockwinners

In connection with the collaboration, Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7B in cash at $174.85 per American Depositary Share, or ADS.

Amgen will receive one seat on BeiGene’s Board of Directors.

Under the agreement, BeiGene will commercialize XGEVA, KYPROLIS and BLINCYTO in China for five or seven years, during which time the parties will equally share profits and losses.

Amgen enters Chinese market by taking stake in BeiGene, Stockwinners

Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained; and XGEVA was approved in China in 2019 for patients with giant cell tumor of the bone and is in development for prevention of skeletal-related events in cancer patients with bone metastases.

Blincyto is indicated for acute lymphoblastic leukemia, Stockwinners

KYPROLIS is in late-stage development in China for patients with multiple myeloma, and BLINCYTO is in late-stage development in China as a treatment for adult patients with relapsed or refractory acute lymphoblastic leukemia.

Kyprolis is indicated for multiple myeloma , Stockwinners

BeiGene has agreed to jointly develop 20 Amgen oncology pipeline assets globally, which include targeted small-molecule agents such as AMG 510, a first-in-class investigational KRAS G12C inhibitor, as well as BiTE antibodies, for solid and hematologic malignancies; Amgen and BeiGene will co-fund global development costs, with BeiGene contributing up to $1.25B worth of development services and cash over the term of the collaboration.

BeiGene is entitled to receive royalties from global sales of each product outside of China, with the exception of AMG 510; For each pipeline asset that is approved in China, BeiGene will receive commercial rights for seven years from approval, during which time the parties will share equally in profits and losses.

BeiGene is also entitled to receive royalties from sales in China for five years after the seven-year commercial term; and BeiGene will also have the right to retain approximately one of every three approved pipeline assets, up to a total of six, other than AMG 510, for commercialization in China, during which time the parties will share in profits and losses.

The transactions have been approved by the boards of directors of both companies and are expected to close in the first quarter of 2020, subject to approval by a majority vote of BeiGene’s shareholders pursuant to the listing rules of the Hong Kong Stock Exchange, the expiration or termination of applicable waiting periods under applicable antitrust laws, and satisfaction of other customary closing conditions.

BeiGene has already received commitments from shareholders holding approximately 40% of its outstanding shares to vote in favor of the transactions.

BGNE closed at $138.34, last traded at $174.58.

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Sarepta reports positive results for muscular dystrophy Type 2E treatment

Sarepta announces results from gene therapy trial for beta sarcoglycanopathy

Sarepta Therapeutics (SPRT) announced the nine-month functional results from three Limb-girdle muscular dystrophy Type 2E ,LGMD2E, clinical trial participants who received SRP-9003. SRP-9003 is an investigational gene therapy intended to transduce skeletal and cardiac muscle with a gene that codes for the full-length, native beta-sarcoglycan protein, the lack of which is the sole cause of LGMD2E.

Sarepta drops after U.K. trial halt,
Sarepta rises on muscular dystrophy data, Stockwinners

In Cohort 1 of the SRP-9003 study, three participants ages 4-13 were treated with an infusion of SRP-9003 at a dose of 5x1013vg/kg.

Improvements in functional outcomes were observed at day 270 for all three participants.

“We have now observed consistent functional improvements, in addition to high levels of expression of the missing protein of interest and strong results in related biomarkers, in both of our first cohorts for Duchenne muscular dystrophy and LGMD2E. We intend to test one higher dose of SRP-9003 in LGMD2E participants, select our clinical dose and then advance our SRP-9003 program, along with our other five LGMD programs, as rapidly as possible,” said Doug Ingram, Sarepta’s president and chief executive officer.

“With the results of our first LGMD2E cohort, Sarepta continues to build its gene therapy engine, an enduring model created to design, develop and bring to the medical and patient community transformative therapies for those living with, and too often dying from, rare genetic disease.”

No new safety signals were observed and the safety profile seen to date supports the ability to dose escalate in the next cohort of the study. As previously disclosed, two participants in the study had elevated liver enzymes, one of which was designated a serious adverse event (SAE), as the participant had associated transient increase in bilirubin. Both events occurred when the participants were tapered off oral steroids and, in both instances, elevated liver enzymes returned to baseline and symptoms resolved following supplemental steroid treatment.

SPRT is up $5.52 to $86.86.

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Karyopharm Therapeutics shares jump on FDA decision

Karyopharm announces FDA approval of XPOVIO-dexamethasone combination for multiple myeloma

Karyopharm Therapeutics shares soar on FDA approval, Stockwinners

Karyopharm Therapeutics Inc. (KPTI) announced that the U.S. Food and Drug Administration has approved oral XPOVIO, a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

XPOVIO to become commercially available in the U.S. on or before July 10, 2019, Stockwinners

The ongoing, randomized Phase 3 BOSTON study evaluating selinexor in combination with Velcade and low-dose dexamethasone will serve as the confirmatory trial.

The FDA’s Accelerated Approval Program was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need.

Karyopharm expects XPOVIO to become commercially available in the U.S. on or before July 10, 2019.

A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency.

The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Xpovio.

Women who are pregnant or breastfeeding should not take Xpovio because it may cause harm to a developing fetus or newborn baby. Xpovio must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

The FDA granted this application Fast Track designation. Xpovio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Executive Changes

In a regulatory filing, Karyopharm disclosed that on July 2, Karyopharm Therapeutics promoted Perry Monaco to Senior Vice President, Sales responsible for the company’s sales function under the direction of Michael Kauffman, Chief Executive Officer of the company.

On July 2, following the buildout of the company’s commercial organization and development of the company’s product launch strategy, Anand Varadan resigned as Executive Vice President, Chief Commercial Officer of the company, effective July 5.

KPTI last traded at $8.15.

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