- Xenon pharma reported financial results.
- Myovant moves forward with relugolix.
- BMY suffers a setback with its MM drug.
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Xenon Pharmaceuticals Reports Financial Results, Misses EPS
Xenon Pharmaceuticals (XENE) reported its fourth quarter and full-year results. While the results were largely impressive, the company missed reaching its revenue and EPS estimates. The company also provided corporate updates about its various activities. For its full year, the company's revenue was at $6.8 million, in comparison to nil revenue it had reported in the year earlier.
Xenon reported spending $38.8 million on its research and development activities during the entire year while it had registered $23.6 million in research and development expenses for the previous year. The general and administrative expenses for the entire year stood at $10.8 million in comparison to $8.4 million it had spent in the previous year. Xenon reported its other operating expenses at nil while its other incomes for the entire year were at $1.2 million.
Xenon reported that Flexion Therapeutics Inc. (FLXN) has acquired the global rights for developing and commercializing XEN402, which is now known as FX301. Dr. Simon Pimstone, Xenon's Chief Executive Officer, said:
We are focused on developing multiple innovative products for the treatment of epilepsy and believe that Xenon has one of the most exciting epilepsy pipelines currently in development."
The company also provided updates about its ongoing collaboration with Neurocrine Biosciences Inc. (NBIX) for developing treatments for epilepsy.
Xenon is a clinical-stage biopharmaceutical company and is mainly engaged in developing and commercializing treatments for neurological disorders. Its lead drug candidate XEN1101 is a differentiated Kv7 potassium channel modulator for treating epilepsy while its XEN496, a Kv7 potassium channel modulator has been given orphan drug designation for treating KCNQ2 developmental and epileptic encephalopathy. The company filed an Investigational New Drug application pertaining a pharmacokinetic study testing proprietary pediatric formulation of ezogabine (XEN496) in healthy adult volunteers.
Myovant Sciences Goes Ahead with Relugolix Combo Application
Myovant Sciences (MYOV) announced that it has submitted its Marketing Authorization Application to the European Medicines Agency for relugolix combination tablet. The drug candidate is being developed for treating female patients suffering from moderate to severe symptoms associated with uterine fibroids. Myovant seeks to file the NDA for the US approval in April 2020. The drug candidate has the potential to become a one pill, once a day treatment for women suffering from uterine fibroids.
The company has attached safety and efficacy data from the Phase 3 LIBERTY program to support its application. The program comprised two multinational pivotal clinical studies LIBERTY 1 and LIBERTY 2. The company also provided data from a one-year open-label extension study of relugolix combination therapy. The company is looking forward to further collaboration with the EMA and will provide additional regulatory information in the coming months.
Myovant expects the EMA to carry out a technical validation of the application in March 2020 so as to ensure that all required regulatory documentation is included in the application. Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant said:
With this submission, we have achieved a significant milestone and are one step closer to providing a one pill, once-a-day potential new treatment option to women with uterine fibroids."
Phase 3 clinical program tested relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg for 24 weeks.
LIBERTY 1 and 2 met the primary endpoint (p <0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria while the corresponding percentage for women in placebo stood at 18.9 percent and 14.7 percent respectively. On an average, there was 84.3% reduction in menstrual blood loss from baseline in women treated with the combination. The open-label extension study met the primary endpoint by showing an 87.7% response rate at one year, demonstrating the durability of the treatment.
Bristol-Myers Squibb Receives Setback on its MM Study
Bristol-Myers Squibb (NYSE:BMY) reported primary results from its ELOQUENT 1 study designed to evaluate the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd) for treating patients suffering with newly diagnosed and untreated Multiple Myeloma. The trial was a randomized and open-label program and the final analysis showed that the addition of Empliciti did not provide any statistically significant improvement in progression-free survival.
The main purpose of the study was to determine whether adding Empliciti to Revlimid and low-dose dexamethasone would improve Progression-Free Survival, forming the primary endpoint of the study. The secondary endpoints of the study included overall survival and objective response rate. Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol-Myers Squibb said:
While we are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant-ineligible patients, the Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options."
Bristol-Myers Squibb is collaborating with AbbVie (ABBV) for developing the drug candidate while retaining the sole responsibility of commercializing it. Empliciti is, currently, approved along with Rd (the combination of Revlimid and steroid dexamethasone) for treating relapsed or refractory patients. Myeloma market is, currently, dominated by a variety of drugs along with new entrants such as Johnson & Johnson's (JNJ) Darzalex. Bristol-Myers Squibb is working towards boosting its cancer portfolio as it recently added Revlimid and Pomalyst through its buyout of Celgene (CELG). However, the latest setback is expected to make a dent in its plans.
Multiple myeloma is a type of blood cancer that affects plasma cells in the bone marrow. Some of the current treatment regimes for this type of cancer include the use of patient's own stem cells and chemotherapy. With this drug candidate, Bristol-Myers Squibb is looking to tap the market for patients who have not been treated earlier. This is considered to be a lucrative segment as patients tend to remain on treatment for a longer period of time.
Empliciti is a monoclonal antibody and it works by targeting the antigen SLAMF7. The drug recorded $357 million in global revenue in 2019, lagging behind some of its peers including Revlimid which registered $1.3 billion in global sales during the same time period. Johnson & Johnson's Darzalex proved to be a front runner with nearly $3 billion in global sales. Bristol-Myers Squibb is working on multiple therapies for treating multiple myeloma. Its CAR T cell therapy idecabtagene vicleucel works by targeting the antigen BCMA. The company is collaborating with bluebird bio (BLUE) for developing this treatment. However, even this therapy faces a stiff challenge from GlaxoSmithKline's (GSK) balantamab mafodotin, which has now been submitted to the FDA for approval purpose.
Bristol-Myers Squibb stock has shown strong performance as it gained over 18 percent in the past 12 months. The stock continues to be a good candidate for a long-term portfolio with its upcoming catalysts. It is also expected to receive a boost as the company works towards integrating its operations with Celgene.
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