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

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

May 27, 2016 8:50 AM EDT

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

May 27, 2016 7:22 AM EDT

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

May 27, 2016 7:08 AM EDT

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

May 27, 2016 6:34 AM EDT

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

AstraZeneca (AZN) Receives CRL on ZS-9

May 27, 2016 6:14 AM EDT

AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium... More

Relypsa (RLYP) volatility elevated ahead of FDA decision on AstraZeneca (AZN) competing drug

May 27, 2016 6:04 AM EDT

Relypsa (NASDAQ: RLYP) June weekly call option implied volatility is at 243, June is at 184, July is at 167; compared to its 52-week range of 43 to 176 ahead of the imminent decision from the FDA on AstraZeneca (AZN) competing drug LOKELMA (ZS-9).

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Relypsa (RLYP) Ticks Higher Ahead of FDA on ZS-9

May 26, 2016 4:38 PM EDT

Traders closely watching Relypsa (NASDAQ: RLYP) ahead of the imminent decision from the FDA on AstraZeneca (NYSE: AZN) competing drug LOKELMA (ZS-9), which some see as a binary event for the stock. After gaining 2.5% intra-day, shares tick 0.9%... More

Relypsa (RLYP) Gains Ahead of Binary Event

May 25, 2016 11:04 AM EDT

Relypsa (NASDAQ: RLYP) will be on watch today ahead of tomorrow's PFUDA for AstraZeneca (NYSE: AZN) competing drug LOKELMA (ZS-9), which some see as a binary event for the stock.

The most... More