Thu, Feb. 5, 4:32 AM
- AstraZeneca (NYSE:AZN) reported a fourth-quarter loss this morning, but stressed that it was on track to return to growth by 2017.
- The company's fourth-quarter net loss came in at $321M, down 38% from $524M a year earlier, while sales for the last three months of the year fell 2% to $6.68B.
- Actavis (NYSE:ACT) also confirmed that AstraZeneca would buy its branded respiratory business in the U.S. and Canada for an initial $600M.
- ACT -1.7% premarket
Mon, Feb. 2, 11:41 AM
- Thinly-traded relatively-recent IPO Ardelyx (ARDX -30.9%) heads south on a 4x surge in volume albeit on turnover of only 325K shares. The company reported results from a Phase 2b clinical trial sponsored by development partner AstraZeneca (AZN -1%) that assessed tenapanor in hyperphosphatemic patients with chronic kidney disease on hemodialysis.
- The study met its primary efficacy endpoint of a statistically significant dose-related decrease in serum phosphate levels in patients treated with tenapanor compared to placebo (p=0.012). The overall safety profile did not change, but the rate of diarrhea, the most frequent adverse side effect, was much higher than expected.
- Ardelyx intends to evaluate the future development plans for tenapanor with AstraZeneca for this indication as well as irritable bowel syndrome. The study results will be presented in a future peer-reviewed forum.
- Previously: Tenapanor successful in Phase 2 trial (Oct. 1, 2014)
Dec. 22, 2014, 12:58 PM
- Thinly-traded nano cap Advaxis (ADXS +29.8%) zooms ahead on a 7x surge in volume. Shares have rocketed up 80% from the close of $3.78 on December 12. On December 15, the FDA cleared the company's IND to conduct a Phase 1/2 trial of ADXS-HPV alone or in combination with MedImmune's (AZN +0.7%) investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of HPV-associated cervical cancer and HPV-associated head and neck cancer.
- A week earlier, the agency cleared its IND for the start of a Phase 1/2 trial of ADXS-PSA in combination with Merck's Keytruda (pembrolizumab) for the treatment of prostate cancer.
- Separately, the company completed securities purchase agreements with two institutional investors for the sale of ~3.9M shares of common stock at $4.25 per share. Proceeds will fund the continued clinical development of its cancer immunotherapy pipeline.
- Previously: Advaxis submits IND for HPV-associated cancers (Nov. 12, 2014)
- Previously: Advaxis files IND for prostate cancer therapy candidate (Nov. 5, 2014)
Dec. 11, 2014, 10:38 AM
- Today is shaping up to be another session of positive money flow into AstraZeneca (AZN +0.5%). Shares are up a fraction on turnover of 3M compared to the average daily volume of 2.1M. Yesterday, shares rose 2.2% on a 3x surge in volume.
- Investors appear to like the potential of Moventig (naloxegol) in Europe.
- Previously: Moventig cleared in Europe for OIC (Dec. 9, 2014)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Nov. 18, 2014, 4:35 AM
- Ahead of a six-hour investor meeting later today, AstraZeneca (NYSE:AZN) has reiterated that it expects annual sales to rise by three quarters and exceed $45B by 2023, a forecast it first gave after seeing off a $118B bid from Pfizer in May.
- "We have more than doubled the number of potential medicines in our late-stage pipeline since 2012 and we are on track to return to growth by 2017," says Chief Executive Pascal Soriot.
- AZN -1.1% premarket
Nov. 6, 2014, 4:54 AM
- AstraZeneca (NYSE:AZN) raised its 2014 sales forecast for the second quarter in a row, as the delayed arrival of Nexium generics in the U.S. kept cash flowing from the heartburn and ulcer pill.
- The company said full-year revenue was now expected to increase in low single-digits, compared with previous guidance for sales to be in line with 2013.
- However, profit excluding certain items fell during the quarter, declining 13% Y/Y to $1.77B from $2.03B.
- AstraZeneca also announced a $325M upfront payment from Aegerion Pharmaceuticals, after agreeing to sell its rare disease drug Myalept.
- AZN -1.4% PM
Sep. 29, 2014, 6:07 PM
- Following a successful Phase 3 trial, the FDA has approved Relistor for "the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain."
- Salix (NASDAQ:SLXP) will sell Relistor under a license from developer Progenics (NASDAQ:PGNX). Many expected FDA approval to arrive following a favorable July ruling.
- PGNX +3.4% AH.
- Related tickers: (AZN)(CBST +0.9%)(SGYP -3.4%)(NKTR -0.9%)
Sep. 23, 2014, 9:10 AM
Jun. 12, 2014, 6:48 PM
- Nektar Therapeutics (NKTR) +9.2% AH after a long trading halt, as an FDA advisory panel recommended against requiring cardiovascular outcome trials for a certain class of drugs - including NKTR's Movantik - in the treatment of constipation caused by opioid medicines (earlier).
- The drug treatment, being developed by NKTR partner AstraZeneca (AZN), also is being reviewed by health agencies in the European Union and Canada.
- The FDA is expected to make a decision on Movantik by Sept. 16.
May. 19, 2014, 12:45 PM
May. 19, 2014, 9:13 AM
May. 19, 2014, 7:08 AM
- Leading AstraZeneca (AZN) shareholders aren't happy about the company's rebuffing of Pfizer's latest £69B ($117B) offer.
- Jupiter Fund Management, a top-30 shareholder in the U.K. pharmaceuticals provider, is "disappointed" that the rejection was so categorical. "They should have at least engaged in a constructive conversation...to assess the opportunities that a combined entity could bring," Jupiter says.
- A fund manager at a top 10 investor says: "We do not think the Astra management have done a good job on behalf of shareholders."
- AstraZeneca's shares are -12% premarket.
- Previous coverage
May. 19, 2014, 3:27 AM
- As tipped, AstraZeneca (AZN) has rejected Pfizer's (PFE) final proposal of £55 a share, or £69B ($117B), saying that the bid "falls short of AstraZeneca’s value as an independent science-led company."
- AstraZeneca told Pfizer on Friday that any offer would have to be over 10% above the latter's previous bid of £53.50.
- The U.K. company said that while Pfizer's pursuit has been driven by cost and tax savings, it "has failed to make a compelling strategic, business or value case."
- Pfizer's final proposal "would present significant risks for shareholders, while also having serious consequences for the company, our employees and the life-sciences sector in the U.K., Sweden and the U.S.," AstraZeneca said.
- AstraZeneca's shares are -13.2% at £41.87 in London. (PR)
May. 18, 2014, 9:13 PM
- "They can either accept or reject it," says Pfizer (PFE) CEO Ian Read of his company's "final" offer for AstraZeneca (AZN) valued at about $120B. "They have until the 26th of May," under U.K. takeover rules.
- The new offer increases the cash component of the deal to 45% of the total price, values AstraZeneca shares at £55 ($92.48) each, and comes after some back and forth between the companies that started on Thursday with Pfizer offering £53.50. AstraZeneca, according to Read, said £53.50 substantially undervalues the company. "If that is what you believe, I really cannot find a way to close a substantial gap," Read says he told AZN at the close of a Sunday phone call.
Apr. 28, 2014, 12:48 PM
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