Top Pick of the Day: MYOV

Myovant Sciences Ltd (MYOV) announced initiating  a Phase 3 clinical program consisting of two international clinical trials, SPIRIT 1 and SPIRIT 2. The trials will evaluate the efficacy and safety of relugolix in women with endometriosis-associated pain. SPIRIT 1 and SPIRIT 2 are randomized, double-blind, placebo-controlled, Phase 3 clinical trials. Each trial targets to enroll approximately 600 women aged 18 to 50 years. The company will also assess safety outcomes such as bone mineral density changes, measured by dual-energy x-ray absorptiometry.
The company stock gained nearly 3 percent in its previous trading session. It is up 2 percent on Year to Date basis while it lost over 3 percent of its value in the past 12 months.

Focus Ticker: PFE

Pfizer Inc. (PFE) announced receiving the European Commission’s approval for Besponsa treatment for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. The goal of treatment in relapsed or refractory (resistant) ALL is to achieve complete remission without excessive toxicity so patients may proceed to additional therapeutic intervention. The European Commission’s approval of BESPONSA is supported by results from the Phase 3 INO-VATE ALL trial, in which 326 adult patients with relapsed or refractory B-cell precursor ALL were enrolled and which compared BESPONSA to standard of care chemotherapy.
The company stock has gained over 3 percent this year so far while its 12 months decline stands at 1 percent.

Sector News

Alkermes (ALKS) reported positive results from a Phase 3 clinical trial, ENLIGHTEN-1, assessing ALKS 3831 for the treatment of schizophrenia. The study showed treatment with ALKS 3831 produced a statistically significantly greater reduction in symptoms compared to placebo (p<0.001), the primary endpoint. 

CytomX Therapeutics (CTMX) announced advancing its CD71-targeting Probody drug conjugate CX-2029 into toxicology studies. The event triggered a $15 million  milestone payment from collaboration partner AbbVie. CytomX plans to file an IND in 2018.

Approvals

Sorrento Therapeutics (SRNE) announced receiving the FDA approval for its Investigational New Drug Application (IND) for resiniferatoxin, a non-opioid TRPV1 agonist for the potential treatment of chronic pain. Preliminary results from a Phase 1 study at NIH showed clinically meaningful reductions in pain and a reduced dependence on opioids.
LivaNova (LIVN) announced the FDA approval for its Vagus Nerve Stimulation Therapy system to treat epilepsy patients as young as four years old. The company claimed that it is the first VNS therapy approved for this population of pediatric patients.

Deals and Collaborations

Eiger BioPharmaceuticals (EIGR) announced inking a new deal with Theragene Pharmaceuticals to sell Mydicar (rAAV1-SERCA2a) for $3.1 million. Eiger will be eligible to receive milestones up to $15 million and royalties on net sales. Mydicar is a cardiovascular gene therapy product that uses an adeno-associated virus (AAV) to deliver a certain protein to cardiac cells. 

Walgreens (WBA) announced its new collaboration with LabCorp (LH) for eveloping and operating patient service centers within certain Walgreens stores this year. Seven sites including five in Denver, CO, one in Morrisville, NC and one in Deerfield, IL. will begin seeing patients this year.