Caladrius Biosciences tumbles on disappointing results

Caladrius says no improvement in primary endpoint in T-Rex study results

Caladrius tumbles on results, Stockwinners
Caladrius tumbles on results, Stockwinners

Caladrius (CLBS) announced top-line results from the Sanford Project: T-Rex study, a prospective, randomized, placebo-controlled, double-blind Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of the company’s CLBS03 as a treatment for recent-onset type 1 diabetes, or T1D, in adolescents.

The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study, however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at one year was observed at the group level.

As with many Phase 2a trials, the database from this study is large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03.

In addition, the data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.

Different factors, including genetics and some viruses, may contribute to type 1 diabetes. Although type 1 diabetes usually appears during childhood or adolescence, it can develop in adults.

Despite active research, type 1 diabetes has no cure. Treatment focuses on managing blood sugar levels with insulin, diet and lifestyle to prevent complications.

CLBS is down $1.26 to $4.08.

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Nektar receives $1.85 billion from Bristol-Myers

Bristol-Myers to pay Nektar $1.85B in cash, stock as part of collaboration pact

 

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Bristol-Myers to pay Nektar $1.85B in cash

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) announced the companies have executed a global strategic development and commercialization collaboration for Nektar’s lead immuno-oncology program, NKTR-214.

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Bristol-Myers to pay Nektar $1.85B in cash

Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb’s Opdivo and Opdivo plus Yervoy in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.

NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.

Bristol-Myers Squibb and Nektar have agreed to a joint clinical development plan to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in registration-enabling clinical trials in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.

Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront cash payment of $1.0B and an equity investment of $850M, or 8,284,600 shares of Nektar’s common stock at $102.60 per share.

Bristol-Myers Squibb has agreed to certain lock-up, standstill and voting provisions on its share ownership for a period of five years subject to certain specified exceptions.

Nektar is also eligible to receive an additional $1.78B in milestones, of which $1.43B are development and regulatory milestones and the remainder are sales milestones.

Nektar will book revenue for worldwide sales of NKTR-214 and the companies will split global profits for NKTR-214 with Nektar receiving 65% and Bristol-Myers Squibb 35%.

Bristol-Myers Squibb will retain 100% of product revenues for its own medicines.

The parties also will share development costs relative to their ownership interest of medicines included in the trials. For trials in the joint clinical development plan that include NKTR-214 with Opdivo only, the parties will share development costs with 67.5% allocated to Bristol-Myers Squibb and 32.5% allocated to Nektar.

For trials in the joint clinical development plan that include NKTR-214 with Opdivo and Yervoy, the parties will share development costs with 78% allocated to Bristol-Myers Squibb and 22% allocated to Nektar.

Both Bristol-Myers Squibb and Nektar have agreed for a specified period of time to not commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan.

The parties are otherwise free to develop NKTR-214 with their own pipeline assets and/or any other third party compounds. Both parties have agreed to initiate registration-enabling studies in the joint clinical development plan within 14 months of the effective date of the agreement, subject to allowable delays.

Both parties will jointly commercialize NKTR-214 on a global basis. Bristol-Myers Squibb will lead global commercialization activities for NKTR-214 combinations with Bristol-Myers Squibb medicines and Nektar will co-commercialize such combinations in the US, major EU markets and Japan.

Nektar will lead global commercialization activities for NKTR-214 combinations with either Nektar medicines and/or other third-party medicines.

For Bristol-Myers Squibb, the transactions are expected to be dilutive in 2018 and 2019 to the company’s non-GAAP EPS by 2c and 10c, respectively.

Nektar and Bristol-Myers Squibb currently expect to complete the transaction during the second quarter of 2018, subject to the expiration or termination of applicable waiting periods under all applicable US antitrust laws and the satisfaction of other usual and customary closing conditions.

Further details of the agreement can be found in Nektar’s Form 8-K filed today with the Securities and Exchange Commission. Nektar and Bristol-Myers Squibb entered into a clinical collaboration in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care.

The Phase 1/2 PIVOT clinical study is ongoing in over 350 patients with melanoma, kidney, non-small cell lung cancer, bladder, and triple-negative breast cancers.

NKTR closed at $75.66, it last traded at $69.97. BMY closed at $63.87. It last traded at $62.51.


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Corcept sinks after Teva submits application to sell Korlym

Corcept sinks after Teva submits application to sell Korlym in U.S. 

Corcept sinks after Teva submits application to sell Korlym. Stockwinners.com
Corcept sinks after Teva submits application to sell Korlym

Corcept Therapeutics (CORT) announced in a regulatory filing that it received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals (TEVA) submitted an Abbreviated New Drug Application to the FDA seeking authorization to manufacture, use or sell a generic version of Korlym in the United States.

KORLYM is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.

Korlym is a glucocorticoid receptor antagonist that is indicated to control hyperglycemia associated with Cushing’s syndrome, a rare, debilitating endocrine disorder. Cushing’s syndrome is caused by prolonged exposure to elevated levels of glucocorticoids (hypercortisolism). The potent metabolic effects of excess cortisol influence many tissues and body systems, and patients often have many problems, including diabetes, obesity, muscle wasting, depression, cognitive difficulties, and psychosis.

The Notice Letter contains Paragraph IV certifications against certain of Corcept’s patents related to Korlym, the company points out. The Notice Letter also alleges that the Korlym patents, the ‘348 patent with an expiration date in August 2028 and the ‘495 patent with an expiration date in August 2036, will not be infringed by Teva’s proposed product, are invalid and/or are unenforceable.

“The Company intends to vigorously defend its extensive intellectual property rights related to Korlym,” Corcept stated.


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Dexcom tumbles after Abbott receives Medicare approval for Libre

Dexcom falls after Abbott receives Medicare approval for Libre

Dexcom tumbles on Bigfoot news. See Stockwinners.com Market Radar
Dexcom falls after Abbott receives Medicare approval for Libre

Shares of Dexcom (DXCM) are sinking after Abbott (ABT) announced that FreeStyle Libre, its new continuous glucose monitoring system, is now available to Medicare patients.

ABBOTT ANNOUNCES MEDICARE COVERAGE

This morning, Abbott announced that the FreeStyle Libre System, the company’s new continuous glucose monitoring system, is now available to Medicare patients, having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services.

Coverage includes all Medicare patients with diabetes who use insulin and who meet the eligibility criteria.

Abbott said that the factory-calibrated FreeStyle Libre system is the only CGM system recognized by Medicare that requires no user calibration whatsoever and also does not require the need for routine fingersticks.

BUYING OPPORTUNITY

Following Abbott’s announcement, Piper Jaffray analyst JP #McKim said he believes Abbott’s Medicare approval for #Libre is “more market-expanding than share-taking” for Dexcom, and maintained an Overweight rating on Dexcom shares, seeing the pullback as a buying opportunity for longer-term investors.

The analyst believes the sooner-than-expected Medicare coverage minimizes upside potential for Medicare revenue in 2018, but added that CGM adoption is expected to accelerate and he thinks “the superior product” of Dexcom will win more Medicare patients.

NORTHLAND DOWNGRADES

Northland analyst Suraj #Kalia downgraded Dexcom to Underperform from Market Perform after Abbott announced Medicare coverage for the Libre FGM.

The analyst believes it undercuts Dexcom’s competitive advantages, and contends that there is additional headline risk vis-a-vis Medtronic’s (MDT) Guardian Connect CGM approval in the pipeline.

Further, #Kalia believes Dexcom’s stock is bound to be under pressure over the next 12-18 months. The analyst added that Dexcom does have the best in class sensor and the company has an “excellent” pipeline but argued that the Libre FGM may be “good enough” for a large chunk of patients, especially as its about one-tenth the cost of Dexcom’s upfront price.

OTHER ANALYST COMMENTARY

Cowen analyst Doug Schenkel believes shares of Dexcom are down too much following Abbott’s announcement and that a 10% sellof “appears disproportionate” on a three month timing swing on an expected event. Baird analyst Jeff Johnson said he believes today’s news may not be create as much near-term risk to Dexcom numbers as investors believe.

PRICE ACTION

In Thursday’s trading, Dexcom is down 10.8%, or $6.29, to $51.79.


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Biotech stocks to watch in January

Ten biotech names to watch in January 

Biogen says BAN2401 did not meet primary endpoint. Stockwinners.com

In a research note to investors, Jefferies analyst Michael #Yee identified what he sees as ten potential disclosures or announcements that could come in the next two weeks to start 2018.

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Among the names that may see stock-moving events as the new year begins are Celgene (CELG), Biogen (BIIB) and Vertex (VRTX).

TURNING THE PAGE TO 2018

Jefferies’ Yee told investors that “turning the page to 2018 and into a January conference,” he is modestly optimistic that large-cap biotech picks up a bit given the recent pullback, tax reform and low investor expectations.

He reiterated that the big biotech names are working toward a much bigger 2018 product cycle and late-stage data read out period.

Celgene tumbles

Thinking outside of the box, the analyst pointed out that the key upside “wild-card” is whether “big consolidation” actually occurs in the large caps based on pharmaceutical companies buying pharma or “big biotech” companies.

STOCK-MOVING ANNOUNCEMENTS

Other than surprise M&A deals that could swing sentiment in biotech, Jefferies’ Yee sees the potential for at least ten stock-moving announcements within his coverage going into a major industry conference in two weeks.

The analyst told investors that #Celgene is likely to pre-announce results for its fourth quarter and provide new 2018 guidance, though investors should assume that outlook could be conservative.

#Biogen could also disclose color around Spinraza patient numbers and update on aducanumab Alzheimer’s enrollment, he contended.

Yee argued that #Vertex could pre-announce on its fourth quarter but may not provide 2018 Cystic Fibrosis guidance until its ‘661 combo is approved in February. The company could also disclose Phase 3 triple plans and update on Phase 2 data.

Regarding #Alnylam Pharmaceuticals (ALNY), the analyst highlighted the company may discuss the path forward for ALN-TTRsc02, update on the ALN-GO1 phase 1 program, or announce a new program in the near-term.

#AveXis (AVXS) may provide FDA meeting updates and next steps post recent regulatory discussions; Intercept Pharmaceuticals (ICPT) may pre-announce fourth quarter Ocaliva sales or announced the initiation of a Phase 3 cirrhosis study, or give color on upcoming FDA label change; and Assembly Biosciences (ASMB) could announce Phase 1b HBV data on viral knockdown, he contended.

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Lastly, Yee pointed out that Axovant Sciences (AXON) may report Phase 2B data for intepiridine in dementia with Lewy bodies and nelotansersin in visual hallucinations, while Acorda Therapeutics (ACOR) is likely to pre-announce 2017 Ampyra net sales and provide 2018 financial guidance, and FibroGen (FGEN) could disclose HRCT imaging IPF data or Phase 2 pancreatic cancer data for pamrevlumab.


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FDA approves drugs for adults with type 2 diabetes

Merck announces FDA approval for STEGLATRO, STEGLUJAN 

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FDA approves drug for Type 2 diabetes

Merck (MRK) and Pfizer (PFE) announced that the U.S. Food and Drug Administration has approved STEGLATROTM tablets, an oral sodium-glucose cotransporter 2 inhibitor, and the fixed-dose combination STEGLUJAN tablets.

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FDA approves drug for Type 2 diabetes

STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

STEGLATRO and STEGLUJAN are not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

STEGLUJAN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.

STEGLATRO and STEGLUJAN are contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, or with a history of a serious hypersensitivity reaction to ertugliflozin.

STEGLUJAN is also contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin.

These FDA approvals are supported by seven Phase 3 studies of approximately 4,800 patients.

STEGLATRO was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment.


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