Despite Confusion, Palatin's Phase II Data Solid [View article]
About 2 years ago a German Company ( Boerenger) had a similar like drug proposed for female lack of sexual desire which was turned down down by the FDA despite good data. PTN 's drug was also called Melanotan II at one time. Which has a tanning effect. The PTN drug has been around for last 10 + years. Acts on Melanocortin brain receptors 3 and 4 which also control appetite and sexual desire. I believe Brem is injectable. This is a problem. I have followed PTN for over 15 some years. They tried to get it approved for male sexual interest also. The BPAX T patch has had it's problems with the FDA. They had to prove no increase in Breast Cancer and other adverse events. They are still in limbo with T patch-gel, best I know. Biggest side effect of Brem is nausea, vomiting. I doubt that lack of female sexual interest therapy with Brem would pass the FDA advisory committee. However, it is a good idea since there are no centrally acting sexual interest stimulating drugs. I treat low libido daily. It would be great to have a drug like bremelanotide in the Rx " tool kit" for low libido. Just doubt PTN drug will pass. Karlis Ullis, MD Santa Monica , CA 90405 kullismd@gmail.com http://bit.ly/16psqGk
Exelixis (EXEL) initiates a Phase 3 pivotal trial of cabozantinib (the tyrosine kinases inhibitor that is FDA approved for the treatment of metastatic medullary thyroid cancer) in patients with metastatic renal cell carcinoma. (PR) [View news story]
Caboz has 3 mechanisms of action to stop tumor growth. EXEL has a big future. Karlis Ullis, MD
Credit Suisse stresses a more defensive posture in MLPs, focusing attention on large, relatively liquid, investment-grade MLPs or affiliates with exposure to the coming crude oil production boom in North America. Its eight favorite MLPs to buy now: WMB, QRE, LNG, TRGP, CQP, XTEX, ACMP, GEL. [View news story]
Shares of Spherix (SPEX +33.8%) are notably sweeter after the company signs a MOU with ChromaDex (CDXC.OB +1%) to "optimize a more efficient scalable process for the production of tagatose," a natural sweetener with the same bulk and sweetness as sugar that suffers from a high cost of production. Notable personnel info: CDXC's Troy Rhonemus, previously "the product line lead manager at Cargill Health responsible for managing the operations and supply chain of Truvia," will oversee the effort. ( PR ) [View news story]
Are they talking about Stevia or another sweetner? Karlis Ullis, MD kullismd@gmail.com
Cancer-focused biotech GTx (GTXI +7.1%) moves higher on double its 10-day average volume after Stifel Nicolaus initiates coverage with a Buy rating citing "a potentially significant value-creating event … with the pending Enobosarm Phase 3 data." Price target is $7, representing a 40% upside from the stock's current price.[View news story]
Embosarm is an important advance in medicine. SARM's are novel to the anabolic market. Likely will advance quickly. I am behind it. Karlis Ullis, MD kullismd@gmail.com http://bit.ly/ZeKX1x
More on CVR Partners (UAN) Q4 earnings: Removing the biennial turnaround at the Coffeyville plant brings adjusted EBITDA/share to $0.37, 76% higher than the headline number. Average gate price for ammonia of $676/ton, up from $606 a year ago. UAN price of $274/ton, down from $334 a year ago. 2013 distribution guidance of $2.15-$2.45/share ($1.81 in 2012), includes a favorable settlement in property tax dispute with Montg. Co., Kansas. Shares +2.8% AH. (PR) [View news story]
The dividend yield is down to about 3%? Supposed to be about $2+ per share? What gives? Karlis Ullis
Repros Therapeutics (RPRX) +33.1% premarket on news its Androxal Phase 3 program has been given a receipt of written guidance from the FDA, effectively a notice that the FDA has accepted its study plans. Androxal is a treatment to normalize testosterone and luteinizing hormone levels in men. [View news story]
This of no surprise. I have used Clomid the mixed isomer form for many years with my patients. Clomid works, but the Trans isomer form (Androxal) is most effective isomer! Analogy is Celexa (mixed isomer form and less effective) vs Lexapro (pure form). I have followed RPRX since it was 50 cents/share. Will buy more on some dips. I think as an andrology (male hormone) endocrinologist Androxal (IMHO) will likely be approved in 2014-5. Email me for any questions. BTW: Of concern is the negative mood-libido effect I see with Clomid. Would like to see some libido mood studies done by Repros. Need to look for this data. Karlis Ullis, MD kullismd@gmail.com http://bit.ly/JdtaAH
GTx's CEO Hosts Analyst Day Conference (Transcript) [View article]
GTXI now is armed with a SARM and and Estrogen Alpha receptor antagonist ( or agonist) both novel new medical-medicinal categories and multi therapeutic possibilities. I saw some of their data at the last Endocrine Society meeting in Houston. Great presentation. Thanks Mr Steiner. Karlis Ullis, MD kullismd@gmail.com http://bit.ly/JdtaAH
Repros Therapeutics (RPRX +2.5%) moves up after saying that it's conducting a 6-month 500 subject open label study as part of an FDA requirement for Androxal, and it's sent a "request for guidance" letter to the agency regarding two other pivotal studies on the drug as well. Additionally, the company also says its requested an end of Phase 2 meeting before the end of April for its vaginal Proellex program for the treatment of uterine fibroids. [View news story]
The biggest problem with clomophene citrate (Clomid) is that the cis-isomer form has negative mood effects and lowers libido. Whether the trans isomer (Androxal) does that I have not seen such in the studies so far. What I have seen are the Testosterone (T) values and sperm counts. If anyone has any mood-libido data on Androxal please contact me. I have treated over 300 men with Clomid to determine functionality of pituitary and as a T replacement. About 65% report negative mood-libido despite elevated T levels which some describe as an Estrogenic-like feeling. Let me know. Karlis Ullis, MD kullismd@gmail.com http://bit.ly/JdtaAH
The opportunity for CreXus (CXS) from sitting on Annaly's (NLY) far-larger balance sheet should be "exponential" says Annaly CEO Denahan on the earnings call. Annaly is also receiving large principal pay downs each month - money that used to go to new MBS purchases, or (lately) share buybacks, but now can go to the higher-yielding commercial space (the acquisition is not yet a done deal). [View news story]
This is confusing. What benefit will NLY get? Karlis Ullis
Isis Pharmaceuticals' CEO Discusses Update on FDA Approval of KYNAMRO Conference Call (Transcript) [View article]
Big Milestone for ISIS. I have followed this company for about 8 years. They have an amazing patent library. They should be a buy out target. Dyslipidemia therapy is in it's infancy. Statins are like Penicillin in the history of antimicrobial therapy. The new targets of lipid therapy will be the small dense LDL particles which Statins to not affect well. Also reverse cholesterol transport and vessel inflammation. More needs to be done with with those people who have the Genotypes - ApoE 3/4 and 4/4 which are somewhat statin resistant and many other therapies. They are at greater CV risk. Hope we see more newer and better therapies. Karlis Ullis, MD Kullismd@gamil.com http://bit.ly/JdtaAH
Vanguard Natural Resources (VNR) -4.9% AH after announcing a public offering of 8M common units. VNR intends to use net proceeds to pay down debt from its senior secured revolving credit facility, which was incurred in part to fund recent acquisitions. [View news story]
Despite Confusion, Palatin's Phase II Data Solid [View article]
Biggest side effect of Brem is nausea, vomiting.
I doubt that lack of female sexual interest therapy with Brem would pass the FDA advisory committee. However, it is a good idea since there are no centrally acting sexual interest stimulating drugs.
I treat low libido daily. It would be great to have a drug like bremelanotide in the Rx " tool kit" for low libido. Just doubt PTN drug will pass.
Karlis Ullis, MD
Santa Monica , CA 90405
kullismd@gmail.com
http://bit.ly/16psqGk
Exelixis (EXEL) initiates a Phase 3 pivotal trial of cabozantinib (the tyrosine kinases inhibitor that is FDA approved for the treatment of metastatic medullary thyroid cancer) in patients with metastatic renal cell carcinoma. (PR) [View news story]
Karlis Ullis, MD
Credit Suisse stresses a more defensive posture in MLPs, focusing attention on large, relatively liquid, investment-grade MLPs or affiliates with exposure to the coming crude oil production boom in North America. Its eight favorite MLPs to buy now: WMB, QRE, LNG, TRGP, CQP, XTEX, ACMP, GEL. [View news story]
Shares of Spherix (SPEX +33.8%) are notably sweeter after the company signs a MOU with ChromaDex (CDXC.OB +1%) to "optimize a more efficient scalable process for the production of tagatose," a natural sweetener with the same bulk and sweetness as sugar that suffers from a high cost of production. Notable personnel info: CDXC's Troy Rhonemus, previously "the product line lead manager at Cargill Health responsible for managing the operations and supply chain of Truvia," will oversee the effort. ( PR ) [View news story]
Karlis Ullis, MD
kullismd@gmail.com
Cancer-focused biotech GTx (GTXI +7.1%) moves higher on double its 10-day average volume after Stifel Nicolaus initiates coverage with a Buy rating citing "a potentially significant value-creating event … with the pending Enobosarm Phase 3 data." Price target is $7, representing a 40% upside from the stock's current price. [View news story]
the anabolic market. Likely will advance quickly.
I am behind it.
Karlis Ullis, MD
kullismd@gmail.com
http://bit.ly/ZeKX1x
More on CVR Partners (UAN) Q4 earnings: Removing the biennial turnaround at the Coffeyville plant brings adjusted EBITDA/share to $0.37, 76% higher than the headline number. Average gate price for ammonia of $676/ton, up from $606 a year ago. UAN price of $274/ton, down from $334 a year ago. 2013 distribution guidance of $2.15-$2.45/share ($1.81 in 2012), includes a favorable settlement in property tax dispute with Montg. Co., Kansas. Shares +2.8% AH. (PR) [View news story]
What gives?
Karlis Ullis
Bullish Catalysts Make GTx Top Biotech Buy For Q1 2013 [View article]
Karlis Ullis, MD
Kullismd@gmail.com
Repros Therapeutics (RPRX) +33.1% premarket on news its Androxal Phase 3 program has been given a receipt of written guidance from the FDA, effectively a notice that the FDA has accepted its study plans. Androxal is a treatment to normalize testosterone and luteinizing hormone levels in men. [View news story]
I have followed RPRX since it was 50 cents/share. Will buy more on some dips. I think as an andrology (male hormone) endocrinologist Androxal (IMHO) will likely be approved in 2014-5.
Email me for any questions.
BTW: Of concern is the negative mood-libido effect I see with Clomid. Would like to see some libido mood studies done by Repros. Need to look for this data.
Karlis Ullis, MD
kullismd@gmail.com
http://bit.ly/JdtaAH
Enerplus: An Attractive Investment For 2013 [View article]
KU
GTx's CEO Hosts Analyst Day Conference (Transcript) [View article]
antagonist ( or agonist) both novel new medical-medicinal categories and multi therapeutic possibilities. I saw some of their data at the last Endocrine Society meeting in Houston.
Great presentation. Thanks Mr Steiner.
Karlis Ullis, MD
kullismd@gmail.com
http://bit.ly/JdtaAH
Repros Therapeutics (RPRX +2.5%) moves up after saying that it's conducting a 6-month 500 subject open label study as part of an FDA requirement for Androxal, and it's sent a "request for guidance" letter to the agency regarding two other pivotal studies on the drug as well. Additionally, the company also says its requested an end of Phase 2 meeting before the end of April for its vaginal Proellex program for the treatment of uterine fibroids. [View news story]
Let me know.
Karlis Ullis, MD
kullismd@gmail.com
http://bit.ly/JdtaAH
The opportunity for CreXus (CXS) from sitting on Annaly's (NLY) far-larger balance sheet should be "exponential" says Annaly CEO Denahan on the earnings call. Annaly is also receiving large principal pay downs each month - money that used to go to new MBS purchases, or (lately) share buybacks, but now can go to the higher-yielding commercial space (the acquisition is not yet a done deal). [View news story]
Karlis Ullis
Isis Pharmaceuticals' CEO Discusses Update on FDA Approval of KYNAMRO Conference Call (Transcript) [View article]
They should be a buy out target. Dyslipidemia therapy is in it's infancy. Statins are like Penicillin in the history of antimicrobial therapy. The new targets of lipid therapy will be the small dense LDL particles which Statins to not affect well. Also reverse cholesterol transport and vessel inflammation. More needs to be done with with those people who have the Genotypes - ApoE 3/4 and 4/4 which are somewhat statin resistant and many other therapies. They are at greater CV risk.
Hope we see more newer and better therapies.
Karlis Ullis, MD
Kullismd@gamil.com
http://bit.ly/JdtaAH
Vanguard Natural Resources (VNR) -4.9% AH after announcing a public offering of 8M common units. VNR intends to use net proceeds to pay down debt from its senior secured revolving credit facility, which was incurred in part to fund recent acquisitions. [View news story]
Karlis Ullis
Enerplus: An Attractive Investment For 2013 [View article]
Thank you,
Karlis Ullis, MD