Premarket Biotech Digest – PFE Receives EU Approval, ALKS Announces Positive Results, SRNE Receives FDA Approval

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.

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