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Stock Market & Financial Investment News

News Breaks
July 22, 2014
16:18 EDTPFE, PBYIPuma Biotech now responsible for R&D expenses associated with legacy trials
Puma Biotechnology (PBYI) announced an amendment to its licensing agreement with Pfizer (PFE) for Puma's investigational drug PB272, or neratinib. The amendment to the license agreement provides that Puma will now be solely responsible for the expenses associated with the ongoing legacy clinical trials. Puma anticipates that this will result in an increase in research and development, or R&D, expenses, which will total approximately $30M. Puma further anticipates that a significant percentage of this approximately $30M will occur in FY14 and will decrease over time until the trials are completed. In addition, according to the terms of the original license agreement, upon commercialization of neratinib, Puma is obligated to pay Pfizer incremental annual royalties ranging between 10%-20% of net sales of neratinib. Under the terms of the amendment to the license agreement, upon commercialization of neratinib, Puma will be obligated to pay Pfizer annual royalties on net sales of neratinib at a fixed rate in the low- to mid- teens.
News For PBYI;PFE From The Last 14 Days
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May 14, 2015
12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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10:09 EDTPBYIIncreasing equity options volume on open
Increasing equity options volume on open: ONTY CBRL PBYI GWW AXLL IEV KSS EXPR UEC JACK
09:22 EDTPBYIOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Perry Ellis (PERY), up 11.5%... Ctrip.com (CTRP), up 13.4%. ALSO HIGHER: AcelRx (ACRX), up 10.3% after being awarded contract worth up to $17M from Defense Dept to advance ARX-04... Oncothyreon (ONTY), up 16.9% after ASCO presentation data released... CYREN (CYRN), up 14.6% after announcing agreement with Dell.... Discovery Laboratories (DSCO), up 5.2% after Aerosurf shows positive Phase 2a data... Kate Spade (KATE), up 3.9% after being initiated with an Outperform at Wedbush. DOWN AFTER EARNINGS: Digital Ally (DGLY), down 16.4%... Kohl's (KSS), down 10.2%... VOXX (VOXX), down 8.1%... Cosi (COSI), down 7.3%. ALSO LOWER: Biotechnology (PBYI), down 15.1%% after Neratinib data published in ASCO abstract... Gevo (GEVO), down 10.7% after 4.3M share Spot Secondary priced at $4.00.
09:20 EDTPBYIPuma Biotechnology data look strong, says Leerink
Leerink says that after close examination, the data in Puma Biotechnology's ASCO abstract for neratinib's adjuvant study ExteNET look strong. The firm notes that unlike the HERA trial for Herceptin which enrolled only centrally confirmed HER2-positive breast cancer patients, approximately 80% of Puma's ExteNET patients were confirmed to be HER2+ upon central testing. When focusing on these patients, the magnitude of benefit for neratinib improved, Leerink says. It estimates disease free survival including ductal carcinoma in situ difference at two years to be 4.5%. The firm keeps an Outperform rating on Puma amid today's selloff.
08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:09 EDTPBYIPuma Biotechnology volatility elevated into release of four abstracts
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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07:52 EDTPBYIPuma Biotechnology data positive, says RBC Capital
RBC Capital believes that the data on Puma's neratinib drug indicates that it has strong efficacy, and additional benefits compared with prior trials. The firm expects investors and medical professionals to have a greater appreciation of the drug's benefits once all of the data on the drug is presented at ASCO. RBC keeps a $285 price target and Outperform rating on the shares.
07:11 EDTPBYIOptions expected to be active
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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19:12 EDTPBYIOn The Fly: After Hours Movers
UP AFTER EARNINGS: Paragon Offshore (PGN), up 10.3%... Shake Shack (SHAK), up 10%... Vipshop Holdings (VIPS), up 6.7%. ALSO HIGHER: Vascular Biogenics (VBLT), up 12.8% and Oncothyreon (ONTY), up 15.5% after release of ASCO presentation data. DOWN AFTER EARNINGS: Identiv (INVE), down 10.3%... Sphere 3D (ANY), down 11.3%... VOXX International (VOXX), down 8.1%. ALSO LOWER: Puma Biotechnology (PBYI), down 21.8% after Neratinib data published in ASCO abstract... Karyopharm Therapeutics (KPTI), down 1.2% after ASCO presentation data released... Gevo (GEVO), down 11.4% after filing to sell common stock and warrants.
18:37 EDTPBYIBiopharmaceutical stocks volatile after release of ASCO presentation data
After the market close, the American Society of Clinical Oncology, or ASCO, provided public access to 5,000 cancer drug trial research abstracts ahead of the society's 51st annual meeting from May 29 to June 2 in Chicago, Illinois. In after-hours trading, a number of biopharmaceutical stocks were active, including Vascular Biogenics (VBLT) and Oncothyreon (ONTY), which rose 13% and 14.9%, respectively, and Puma Biotechnology (PBYI) and Karyopharm Therapeutics (KPTI), which fell 23.9% and 14.8%, respectively.
17:47 EDTPBYIPuma Biotechnology down 24% after Neratinib data published in ASCO abstract
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17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
07:31 EDTPFEHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
May 11, 2015
17:36 EDTPFEAthersys down 10.1% after Pfizer notified that it will terminate agreement
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17:34 EDTPFEAthersys receives notification that Pfizer will terminate agreement
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17:02 EDTPBYIPuma Biotechnology reports Q1 EPS ($1.02), consensus ($1.35)
Net cash used in operating activities for the first quarter of 2015 was $50.0 million. At March 31, 2015, Puma had cash and cash equivalents of $155.5 million and marketable securities of $154.9 million, compared to cash and cash equivalents of $38.5 million and marketable securities of $102.8 million at December 31, 2014. Puma's current level of cash and cash equivalents and marketable securities includes net proceeds of approximately $205.0 million from a public offering of the Company's common stock, which was completed in January 2015.
16:33 EDTPFEPfizer takes minority interest in AM-Pharma, secures option to acquire company
AM-Pharma and Pfizer announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, Pfizer has made an upfront payment of $87.5M for the minority equity interest and exclusive option, with additional potential payments of up to $512.5M upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed. “Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”
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