Pharmaceutical companies Nektar Therapeutics and  Bristol-Myers Squibb have expanded their collaboration to develop an anti-cancer treatment. The treatment comprises Nektar’s bempegaldesleukin (bempeg) and Bristol-Myers' Opdivo (nivolumab).  The expansion would go beyond the three pivotal studies in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) - to include additional trials in adjuvant melanoma and in muscle-invasive bladder cancer.  Nektar and Bristol-Myers will also begin phase 1/2 dose escalation studies in first-line RCC.  The two companies began the partnership in 2016.The cost-sharing conditions won’t change in the expanded accord. Bristol-Myers will  also fund a Phase 1/2 dose optimization and expansion trial assessing the combo in first-line non-small cell lung cancer. Nektar will be able to receive up to $125 million total once the fi

Incyte Corporation shares took a hit late trading Thursday, after news of disappointing results on one of its clinical trials. The pharmaceutical  company revealed that one of its drugs fell short of meeting its primary endpoint in a phase 3 trial.That is, it did not meet the primary endpoint of a statistically significant improvement in overall response rate (ORR) at Day 28 compared to placebo plus corticosteroids; also, no difference was found in non-relapse mortality at month 6, which is a crucial secondary endpoint. The above-mentioned disease is often seen in patients undergoing bone marrow or organ transplants.

Biotech company Wave Life Sciences’ shares plummeted , after clinical test results on a anti-Huntington disease drug turned out to be a bit disappointing. The trial, which compared the results from oligonucleotide therapeutic WVE-120102 with a placebo, showed a statistically significant 12.4% reduction in a disease-causing mutant huntingtin protein, at the highest doses tested ( as indicated in the Wave Life’s statement).However,  “there was no difference" in total huntingtin protein compared with placebo, the company said. The drug was generally safe and “well tolerated among patients receiving doses up to 16 mg in both single and multidose portions of the study,” according to Wave Life. Wave Life conducted a Phase 1b/2a Precision-HD2 trial.

Nektar Therapeutics (Nasdaq: NKTR) is a biopharmaceutical company that drugs for cancer, autoimmune diseases, and chronic pain.The company’s fundamental indicators are all over the place, but the stock has been trending lower since September. If we connect the closing high from September with intraday high from February, it creates a trend line that the stock just hit in the last few days.

Regeneron Pharmaceuticals’ first-quarter earnings came in lower  than what analysts expected. Regeneron raked in adjusted earnings of $4.45 per share, missing Wall Street's expectation of $5.52.Revenue of $1.71 billion also was lower than analysts' $1.76 billion expectations.  CEO Leonard Schleifer emphasized that the company is optimistic about the potential of its  product Dupixent, which is now FDA-approved in atopic dermatitis and asthma in both adults and adolescents and is currently under Priority Review by the FDA for chronic rhinosinusitis with nasal polyps.

Celgene Corporation says that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for label expansions of its oncology drug, Revlimid and Imnovid. The CHMP recommended approval of the triplet regimen of Revlimid as combination therapy with Velcade and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.The committee is expected to make its final decision in approximately two months. 

Durham, NC-based biotech Precision Biosciences has filed a prospectus for a $100 million IPO. Next year, the company should launch a Phase 1/2a clinical trial evaluating a gene-edited allogeneic CAR T candidate targeting CD18 in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) patients.The company believes that this is the first allogeneic CAR T for NHL.

Biotech firm Exelixis (Nasdaq: EXEL) has been trending sharply higher since the end of October and a trend channel has formed that defines the up and down cycles within the overall upward trend.The stock has been grinding sideways with a slight downward bias since mid-January and that has allowed the lower rail of the channel to catch up to the stock price. With the stock hitting the lower rail it looks as if the next upward cycle is underway.

Epizyme, Inc. incurred loss of 29 cents per share in the fourth quarter of 2018, narrower than the Zacks Consensus Estimate of loss of 49 cents and the year-ago loss of 52 cents. Read more...

Roche is buying U.S.-based gene therapy specialist Spark Therapeutics for $4.3 billion after developments in this area convinced the Swiss drugmaker to “step up”, Chief Executive Severin Schwan said on Monday. Roche will pay $114.50 per share for Spark for a portfolio that includes a blindness treatment that has U.S. and European approval and other projects for hemophilia and neurodegenerative disorders like Huntington’s disease. Philadelphia-based Spark’s shares are up about 30 percent this year.The U.S.-company’s stock tumbled last year after two of 12 patients showed an unfavorable immune response when treated with a higher dose of Spark’s haemophilia therapy SPK-8011.

Halozyme Therapeutics came out with a quarterly loss of $0.01 per share versus Wall Street's estimate of a loss of $0.02.Last quarter, it was expected that this biopharmaceutical company would post a loss of $0.23 per share when it actually produced a loss of $0.19. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Halozyme posted revenue of $60.23 million for the quarter ended December 2018.

This compares to loss of $1.81 per share a year ago.  Earnings showed surprise growth of 4.24%.A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.69 per share when it actually produced a loss of $1.63, delivering a surprise of 3.55% growth.

Prothena Corporation had mixed results for Q4 2018.The company reported a loss of $0.56 per share, narrower than the Street's estimate loss of $0.96 cents and the year-ago loss of $1.24. “In 2018, we continued to advance our neuroscience pipeline of novel investigational therapeutics towards key milestones,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. The company’s shares have lost 12.1% in the past six months compared with the industry's decline of 11.8%.

Exelixis, Inc. delivered better-than-expected results for fourth-quarter 2018, wherein both earnings and revenues beat estimates on strong performance by Cabometyx.  Read more...

Biotech firm Exelixis (Nasdaq: EXEL) has been trending higher since the end of October.That pattern looks similar to what we saw at the end of December. Tickeron’s A.I.

Shares of Incyte Corporationdeclined 1.9% after the FDA extended the review period of the supplemental New Drug Application (sNDA) for Jakafi to treat patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. Read  more...

Proteostasis Therapeutics (PTI) is a small-cap company developing small molecule therapeutics to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing.Recently, the company announced positive preliminary results from its ongoing Phase 1 study of combination therapies for CF. Cystic fibrosis (CF) is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe.

Novavax, Inc.’s stock price jumped +7.6% in the latest trading session.This follows the biotech company's recent announcement of the initiation of phase 2 clinical trial of its flu vaccine NanoFlu in older adults. What's more,Novavax's current ratio - a metric of how well a company can meet its short-term obligations - is at 4.50x, which is higher than some of its peers GlaxoSmithKline (0.90x) Novartis (1.10x) and Sanofi (1.20x) as suggested by a Market Realist report.