Analyst Comments, FDA
May 23, 2016 11:41 AM EDT
Lerink Partners analyst, Michael Schmidt, believes Cabo beating Sutent in the 1L RCC study is the best possible case scenario for Exelixis (NASDAQ: EXEL). The company announced positive "CABOSUN" Phase II top-line data" for EXEL's Cabometyx (Cabo) in first line renal cell carcinoma (RCC) this morning. The Outperform rating on shares of EXEL is based on the analyst's thesis that recently FDA approved Cabo is well positioned to capture significant market share in 2nd/3rd line treatment of RCC.
The approved Cabo data and label are impressive and the stock's current valuation only reflects a modest opportunity for the product in RCC. Today's news on Cabo further supports this theses. The positive Ph II results reported could justify potential NCCN listing (and hence reimbursed use) in treatment of intermediate/high risk 1L RCC and solidify Cabo as agent of choice in 2L and 3L even in a theoretical future scenario where more immuno-oncology (IO) agents are being used in 1L.
Cabo superior vs. Sutent in randomized Phase II trial in treatment- naïve advanced RCC patients. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Cabo compared with Sutent in patients with advanced intermediate- or poor-risk RCC. This represents the first time that an agent has shown superiority over Sutent in 1L RCC. Full results will be submitted for presentation at a future medical conference. The "CABOSUN" trial is part of EXEL's collaboration with the NCI (CTEP program).
The firm maintained an Outperform rating and price target of $8 on EXEL.
This dolt has posted every five minutes since the open and might have 100 message posts today.
Sunday, 15 May 2016 05:10 AM
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What we’re hoping is that CEO Sedor can build off the company’s foundation and continue expanding the Pernix Prescriptions Direct (PPD) program. As of Q1, over 10,000 patients have enrolled in the program since inception. PPD currently represents 11% of Treximet and 6% of Silenor weekly total prescriptions.
In terms of financial engineering, he needs to reduce interest expense and SG&A expenses. Selling, general and administrative expense (SG&A) in the first quarter 2016 increased by $5.5 million, or 27%, to $26.0 million as compared to $20.5 million in the first quarter of 2015. The increase was driven primarily by selling and marketing costs for Zohydro ER with BeadTek, which was acquired in April 2015. Interest expense for the three months ended March 31, 2016 was $9.0 million compared to $9.4 million last year. As of March 31, 2016, the company had total liquidity of $47.4 million, consisting of $36.6 million of cash and approximately $10.8 million available to draw under its $50.0 million revolving credit facility. Total principal amount of debt outstanding at the end of the quarter was $339.1 million and net debt was $302.5 million. The total principal amount of debt consists of $195.1 million of 12% Senior Secured notes, $130.0 million of 4.25% convertible notes and $14.0 million under its revolving credit facility. The company added:
Pernix continues to pursue a number of actions to improve its financial flexibility and strengthen its balance sheet. These actions include improving the Company’s operating cash flow generation by optimizing its product portfolio, continuing to examine its cost structure, engaging with lenders to constructively restructure existing debt and exploring strategic partnerships and collaborations. While Pernix is committed to actively pursuing these activities, there can be no assurance that these initiatives will result in any transacti
“Back up the truck, my friends.”
I never imagined that I would see the day that a medicine developed by a pharmaceutical company would be referred to as controversial, when compared to using marijuana as an alternative.
You would think that the headline was a misprint and should read as follows:
The Drug That Could Be Better at Controlling Seizures in Epilepsy Patients Than Controversial Marijuana
This is manipulative window dressing and purposeful reissued old news of something that took place in October, November or December in the fourth quarter of last year, which was a half of a year ago.
13G Filing Shows Pernix Therapeutics Holder Morgan Stanley Holds 8.6% Stake
Paul Quintaro , Benzinga Staff Writer
December 31, 2015 1:47pm
Considering that earnings are being reported in a few days I would be inclined to wait to buy, but instead on a hunch I just picked up some shares.
Wynn suffers from an eye disease, retinitis pigmentosa, which affects his peripheral vision and therefore, occasionally, his interaction with proximate objects, and, without realizing it, he backed up a step or two as he talked. “So then I made a gesture with my right hand,” Wynn said, “and my right elbow hit the picture. It punctured the picture.”