Mon, Aug. 24, 8:47 AM
- Peregrine Pharmaceuticals (NASDAQ:PPHM) and AstraZeneca (NYSE:AZN) announce plans for a cancer immunotherapy clinical trial collaboration to evaluate PPHM's investigational phosphatidylserine-signaling pathway inhibitor, bavituximab, in combination with AZN's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab.
- The companies say they will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors.
- PPHM +5.2%, AZN -1.2% premarket.
Wed, Jul. 22, 8:16 AM
- A Phase 3 clinical trial (SUMIT) assessing AstraZeneca's (NYSE:AZN) Orphan Drug-tagged selumetinib in combination with dacarbazine for the treatment of uveal melanoma failed to achieve its primary endpoint of progression-free survival (PFS). The full analysis of the data is ongoing.
- Selumetinib, licensed from Array BioPharma (NASDAQ:ARRY) in 2003, is under development for the second-line treatment, in combination with docetaxel, of KRAS-positive advanced non-small cell lung cancer, differentiated thyroid cancer and neurofibromatosis Type 1. It inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from growing.
- Uveal melanoma (UM), comprising 5% of all melanoma cases, occurs when cancer cells grow in the tissues of the eye. No effective treatments for advanced UM exist.
- AZN shares are off a fraction premarket on light volume. ARRY is off 15% premarket on higher-than-normal volume.
Tue, Jun. 23, 9:04 AM
- Thinly traded micro cap BIND Therapeutics (NASDAQ:BIND) is up 4% premarket on increased volume in response to its announcement that the FDA approved AstraZeneca's (NYSE:AZN) IND for its Accurin AZD2811, an Aurora B Kinase inhibitor that has shown promising activity in solid and blood cancers.
- The companies inked a collaboration deal in April 2013 to develop BIND's Accurins in cancer. The dosing of the first patient in a Phase 1 trial, expected in Q4, will trigger a $4M milestone payment to BIND.
- Previously: AstraZeneca (AZN +0.5%) is the latest major pharmaceutical company to license Bind Therapeutics'... (April 22, 2013)
Tue, Jun. 16, 2:12 PM
- Receptos (NASDAQ:RCPT) has jumped, +4.4%, to $182.35 on chatter that Wedbush has raised its price target on the stock to $348 and says a takeover is coming.
- The company has been subject to takeover speculation, including suitors like AstraZeneca (NYSE:AZN) talking about a $200/share bid, as well as Teva (NYSE:TEVA) and Gilead (NASDAQ:GILD) discussing $280/share bids.
Tue, May 26, 4:56 AM
- AstraZeneca's (NYSE:AZN) goal of topping $45B in revenue by 2023 has been dealt a severe blow by a problem with an experimental psoriasis drug that the company had viewed as a potential billion-dollar plus seller.
- Amgen (NASDAQ:AMGN), its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal thoughts were observed in patients taking the medicine.
- AZN -1.6%; AMGN -0.8% premarket
Wed, May 6, 8:35 AM
- Thinly-traded micro cap Ardelyx (NASDAQ:ARDX) is down 26% premarket on light turnover in response to its announcement that a Phase 2a clinical trial evaluating its lead product candidate tenapanor in patients with Stage 3 chronic kidney disease (CKD) who also had type 2 diabetes and albuminuria (excess protein in the urine) failed to achieve its primary efficacy endpoint of decreasing the urinary albumin-creatinine ratio compared to placebo.
- The specific endpoint of the 154-subject study was a statistically significant decrease in the albumin-creatinine ratio from baseline to Week 12 versus placebo. The test group showed a 16% reduction compared to 11% for control.
- The company entered into a collaboration agreement with AstraZeneca (NYSE:AZN) in October 2012 to develop and commercialize tenapanor. AstraZeneca is currently reviewing the data from this trial along with results from other studies to determine a path forward. It is obligated to inform Ardelyx no later than June 29 if it decides to cease development of tenapanor. If it decides to pursue only the irritable bowel syndrome with constipation (IBS-C) indication, Ardelyx will be entitled to a $10M milestone payment. If it decides to pursue additional indications, it will be entitled to a $20M milestone.
- Ardelyx President & CEO Mike Raab says, "Should AstraZeneca decide to return the program to us, we seek to be in a position to initiate a Phase 3 clinical program for tenapanor in IBS-C in the fourth quarter of 2015. Additionally, we intend to be prepared to continue the development of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis."
Tue, Apr. 7, 7:51 PM
- Small cap Regulus Therapeutics (NASDAQ:RGLS) jumps 11% after hours on robust volume in response to its announcement that AstraZeneca (NYSE:AZN) will proceed with the clinical development of RG-125 for the treatment of nonalcoholic steatohepatitis (NASH) in type 2 diabetics. This is the first product candidate to be advanced through clinical trials under the companies' 2012 strategic alliance. Under the terms of the agreement, AstraZeneca's will assume responsibility for the development of RG-125 as well as pay Regulus a $2.5M milestone fee. A Phase 1 trial should commence by year-end. Both firms will submit preclinical data on the RG-125 program to be presented at a future scientific meeting.
- RA-125 is a GalNAc (N-Acetylgalactosamine) -conjugated anti-miR targeting microRNA-103/107 (miR-103/107). MicroRNAs are small non-coding RNAs that regulate gene expression. miR-103/107 plays a key role in insulin sensitivity. Inhibiting miR-103/107 leads to a sustained reduction in fasting glucose and fasting insulin levels and decreases liver triglycerides and steatosis.
- GalNAc-conjugation is the most effective way to deliver a subcutaneous dose of an RNA-based therapeutic.
- Previously: Regulus Therapeutics enters into a strategic alliance with AstraZeneca (AZN) to discover,... (Aug. 14, 2012)
Tue, Mar. 10, 1:13 PM
- H.C. Wainwright maintains Buy rating on Acadia Pharmaceuticals (NASDAQ:ACAD) with $50 price target. Implied upside 19%.
- "Based on the clear beneficial safety profile for Nuplazid for PD+P over available atypical antipsychotics, we reiterate our bullish view regarding the PD+P indication and that the PD market alone (given the significant unmet need) is sufficient to support our $50 PT. We continue to see AD+P as a high risk, free call option potentially providing additional upside for investors," firm says.
- SA author Investing Healthcare calls ACAD "the biggest goldmine for acquirers in 2015." Potential buyers include AstraZeneca (NYSE:AZN), AbbVie (NYSE:ABBV), and Otsuka Pharmaceuticals.
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%)
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