AstraZeneca (AZN) Receives CRL on ZS-9

BTIG Remains Bullish on Relypsa (RLYP) Following 'Surprise' CRL for AstaZeneca's (AZN) ZS-9

BTIG is joining in on the slew of analyst coverage for Relypsa (Nasdaq: RLYP) today.

Analyst Timothy Chiang commented today: This morning, AstraZeneca (NYSE: AZN) announced that it had received a... More

Relypsa (RLYP) to Trade Toward Takeover Valuation After Competitor Delay - Mizuho

Mizuho analyst Irina Koffler is re-evaluating her Underperform rating and $12 PT on Relypsa (NASDAQ: RLYP) after AZN... More

AstraZeneca's (AZN) Phase III FALCON Trial of Fulvestrant vs. Anastrozole Met Primary Endpoint

AstraZeneca (NYSE: AZN) announced positive results from the Phase III FALCON trial comparing fulvestrant 500mg to anastrozole 1mg for the treatment of locally-advanced or metastatic breast cancer, in postmenopausal women who have not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer.1

Fulvestrant 500mg demonstrated superiority compared with anastrozole 1mg in FALCON, and met its primary endpoint of extended progression-free-survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines.1

Sean Bohen, Executive Vice President, Global Medicines Development... More

AstraZeneca's CRL on ZS-9 Reduces Near Term Commercial Risk for Veltassa and Relypsa (RLYP) - Wedbush

Wedbush analyst Liana Moussatos reiterated an Outperform rating and $51 price target on Relypsa, Inc. (NASDAQ: RLYP) after AstraZeneca announced receipt of a complete response letter (CRL) from the FDA for ZS-9 instead of approval. Moussatos notes the press release cited a failed manufacturing inspection and receipt of new data for review: The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to... More

Relypsa (RLYP) Surges Higher After AstraZeneca's ZS-9 Receives CRL from FDA

Relypsa (NASDAQ: RLYP) is surging 39% in pre-open trade after rival AstraZeneca (NYSE: AZN) received a CRL from the FDA on competing drug ZS-9, the investigational medicine being developed for the treatment of hyperkalaemia, made by ZS Pharma, a wholly-owned... More