Wed, Jan. 7, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Dec. 18, 2014, 11:41 AM
- Thinly-traded nano cap Agenus (AGEN +11.3%) jumps on triple normal volume in response to the successful outcome of the Phase 3 clinical trial of GlaxoSmithKline's (GSK +2.4%) shingles vaccine candidate, HZ/su. One of the key components of the vaccine's adjuvant system, AS01B, is Agenus' QS-21 Stimulon adjuvant.
- Previously: Glaxo shingles vaccine candidate successful in Phase 3 study (Dec. 18, 2014)
Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
Oct. 22, 2014, 7:57 AM
Sep. 30, 2014, 5:07 PM
Aug. 27, 2014, 6:17 PM
- Tekmira Pharma (NASDAQ:TKMR) +4.2% AH following a Daily Mail story suggesting it is a takeover candidate, after shares have nearly doubled in the past month thanks to attention over its experimental treatment for the deadly ebola virus.
- Rumors suggest interested parties could include Shire (NASDAQ:SHPG) and GlaxoSmithKline (NYSE:GSK); the report suggests the recent premium paid for InterMune could put a valuation of at least $40/share on TKMR.
Aug. 26, 2014, 10:23 AM
- Shares of nano cap Genetic Technologies (GENE +42.9%) jump on an 11x surge in volume in response to the report of a North Carolina district court order denying a motion by GlaxoSmithKline (GSK +0.5%) to dismiss Genetic Tech's primary non-coding DNA patent infringement lawsuit.
- Genetic Tech filed the suit in 2011. On June 27, 2014 GSK moved to have Genetic Tech's complaint dismissed, arguing that the patent covers natural phenomena (laws of nature) that are not entitled to patent protection. The court issued its denial order on August 22.
- The Northern California District Court denied a similar motion by Agilent (A -0.1%) on March 12, 2014.
Jul. 23, 2014, 9:11 AM
Jul. 14, 2014, 6:19 PM
- Codexis (NASDAQ:CDXS) +84.4% AH on news it granted a license to GlaxoSmithKline (NYSE:GSK) to use its CodeEvolver platform technology to develop enzymes for use in pharmaceutical and health care products.
- CDXS says it is eligible to receive up to $25M over a period of about two years, and could receive additional milestone payments of up to $38.5M per project, depending on successful application of the technology.
Apr. 2, 2014, 7:25 AM
- GlaxoSmithKline (GSK) has ended Phase III testing of its MAGE-A3 lung-cancer vaccine after failing to find a sub-group of patients who could benefit from the therapy.
- GSK's move comes less than two weeks after MAGE-A3 failed in the overall trial, which tested the drug for non-small cell lung cancer.
- GSK will continue to research the benefits of MAGE-A3 for melanoma in sub-populations after the drug failed in an overall study of subjects with this type of cancer.
- MAGE-A3 was designed to help the immune systems of cancer patients prevent the return of the disease after surgery.
- GSK's stock is -0.5%.
- Shares in Agenus (AGEN), whose QS-21 Stimulon adjuvant, or booster, is used in MAGE-A3, are -9.4%. (PR)
Feb. 25, 2014, 2:14 PM
- InterMune's (ITMN +162.8%) spectacular gains after reporting positive ASCEND data (I, II) may have further to go, Baird analyst Brian Skorney believes, viewing ITMN as an ideal acquisition target for a big pharma company.
- A substantial unmet need in idiopathic pulmonary fibrosis provides a blockbuster market opportunity, Baird says, with a number of companies with the capability to sell ITMN's drug with their current salesforce, most notably GlaxoSmithKline (GSK), Gilead (GILD) and Novartis (NVS); Skorney sees a potential acquisition price into the 60s.
- Even without an acquisition, Skorney thinks ITMN should reach $44, with clinical risk is now in the rear-view mirror and potential for greater penetration and higher pricing in the U.S.
Jan. 7, 2014, 8:02 AM
- Epizyme (EPZM) rallies 32% (low volume) in premarket action.
- Monday evening, the company reported that it has achieved the "POC milestone in the EPZ-5676 DOT1L inhibitor clinical program," an event which triggers a $25M payment from partner Celgene (CELG).
- Objective responses in patients with translocations of the MLL-r observed in the fourth dose cohort of an ongoing Phase 1 study were the triggering event.
- Additionally, the company says "a development candidate milestone has been achieved for one of the three HMT targets included" in the GlaxoSmithKline (GSK) partnership, triggering another $4M milestone payment.
- 2013 end-of-year cash now seen at $145M versus $115M previous. (PR)
Jan. 6, 2014, 2:26 PM
- Shares of Prosensa (RNA +6.4%) are higher on the session.
- Investors may be reacting to Adam Feuerstein's mention of the company in his article regarding the FDA's stance on DMD drugs.
- "Chew's letter, suggests some wiggle room for the possibility that FDA would... might... possibly... be willing to review [Sarepta's] eteplirsen based on the existing phase II data," Feuerstein writes, before saying that "the same could be said for [RNA] and GSK's drisapersen, if the companies decide to submit data from the failed Phase 3 study."
Nov. 26, 2013, 8:10 AM
- Isis Pharmaceuticals (ISIS) starts a Phase 1 study of ISIS-GSK3 in "a therapeutic area where there is a significant need for better therapies."
- The investigational drug "is designed to inhibit the production of an undisclosed target." (PR)
- The initiation of the study earns ISIS a $3M milestone payment from GlaxoSmithKline (GSK).
- ISIS +2.8% premarket
Nov. 12, 2013, 7:08 AM
- GSK's (GSK) darapladib treatment failed to reduce the risk of heart attack or stroke among chronic-heart-disease patients in the first of two Phase III trials.
- GSK acquired the rights to darapladib when it bought Human Genome Sciences for $3B in 2012.
- In the study of over 1,500 patients, darapladib was no better than a placebo in cutting the time prior to a heart attack, stroke or death.
- However, darapladib did bring about a reduction in some coronary events, although GSK didn't provide details.
- Analyst Savvas Neophytou expects GSK to take a writedown of £150M ($239M) in Q4 because of the failure of darapladib.
- Shares are -2.2% premarket. (PR)
Oct. 21, 2013, 7:40 AM
- Threshold Pharmaceuticals' (THLD) TH-302 performed well in combination with antiangiogenic agents, which inhibit the growth of new blood vessels, in two Phase I studies.
- In one trial, TH-302 was used with GSK's (GSK) Votrient for treating advanced solid tumors, achieving a clinical benefit rate of 76% (partial response rate of 12% plus a stable disease rate of 64%).
- In another study, TH-302 brought partial responses when used with Pfizer's (PFE) Sutent in patients with renal cell carcinoma (kidney cancer) and gastrointestinal stromal tumors.
- All tumors eventually become resistant to antiangiogenics, says Dr Hebert Hurwitz of Duke Cancer Institute. "Co-targeting tumor angiogenesis and tumor hypoxia, which is believed to be a key driver of treatment resistance, is one approach to potentially prevent or reverse this mechanism of resistance."
- Threshold's shares are +9.7%. (PR)
GSK vs. ETF Alternatives
GlaxoSmithKline PLC incorporated in United Kingdom. The Company creates, discoveres, develops, manufactures and markets pharmaceutical products including vaccines, over-the-counter (OTC) medicines and health-related consumer products.
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