Celgene’s Revlimid fails in lymphoma patients

Celgene’s Revlimid in follicular lymphoma shows no superiority vs. standard

Celgene tumbles
Celgene’s Revlimid fails in lymphoma patients

Celgene (CELG) and the Lymphoma Academic Research Organisation reported results from a phase III, randomized, open-label, international clinical study evaluating Revlimid plus rituximab – R2 – followed by R2 maintenance compared to the standard of care with rituximab plus chemotherapy followed by rituximab maintenance in patients with previously untreated follicular lymphoma.

The R2 treatment arm did not achieve superiority in the co-primary endpoints of complete response or unconfirmed complete response at 120 weeks and progression-free survival during the pre-planned analysis. Neither arm was superior for either of the co-primary endpoints.

The safety findings were consistent with the known profiles of the regimens investigated. Additional analyses are ongoing and planned.

ANALYST  REACTION

Piper cuts Celgene target to $100 on second Revlimid failure in lymphoma – Piper Jaffray analyst Christopher Raymond lowered his price target for Celgene to $100 from $109 after the Phase 3 Relevance trial evaluating Revlimid plus Rituximab in front line follicular lymphoma failed to show superior efficacy versus standard-of-care.

This is the second Revlimid failure in lymphoma following last year’s disappointment in diffuse large B-cell lymphoma,

#Raymond tells investors in a research note. This latest failure could have a near-term negative impact on Revlimid’s revenue trajectory since a “decent chunk” of off-label use in the U.S. likely stems from lymphoma, the analyst contends. He sees a “new element of uncertainty” and keeps a Neutral rating on Celgene.

Jefferies analyst Michael Yee says the failed Phase III Relevance study announced tonight by Celgene is irrelevant. The study had somewhat low expectations and it also makes Revlimid “less big,” which isn’t necessarily a bad problem, Yee tells investors in a research note.

The analyst says his thesis on the stock is unchanged and keeps a Buy rating on Celgene with a $125 price target.

The stock in after-hours trading is down 4% to $103.76. It has a 52-week trading range of $94.55 – $147.17.

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Insys Therapeutics sued by N. Carolina

N. Carolina AG Stein files lawsuit against Insys Therapeutics over Subsys

N. Carolina files lawsuit against Insys. Stockwinners.com
N. Carolina files lawsuit against Insys Therapeutics 

North Carolina Attorney General Josh Stein filed a lawsuit against drug manufacturer Insys Therapeutics (INSY) alleging an extensive scheme involving kickbacks, deception and fraud in marketing its drug #Subsys.

Subsys is a spray form of the synthetic opioid fentanyl, which is approximately 50 times stronger than heroin and 100 times more potent than morphine.

Subsys is approved only for adult cancer patients who are already on round-the-clock opioids for pain, but experience additional, breakthrough pain and for whom no other pain medications are effective.

The lawsuit alleges that Insys gave illegal kickbacks to doctors for promoting and prescribing Subsys for non-cancer patients, including through a multi-million dollar speaker program that rewarded physicians who wrote prescriptions for the drug.

Insys employees also allegedly pushed doctors to switch patients who were being prescribed non-equivalent fentanyl prescriptions to Subsys, and often at a starting dose of up to twelve or sixteen times larger than the label directed.

Finally, the suit alleges that Insys deceived health insurers into covering Subsys prescription claiming Insys employees often posed as prescribers or their staff and invented medical histories for patients to ensure the drug would be covered.

Only about 10% of prescriptions for which Insys sought prior authorization from insurers were for patients with breakthrough cancer pain, the only use the FDA had approved.

INSY is down 18 cents to $7.02.


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Long Island Iced Tea to rebrand as ‘Long Blockchain Corp.’

Long Island Iced Tea to rebrand as ‘Long Blockchain Corp.’

Long Island Iced Tea to rebrand as 'Long Blockchain Corp.' Stockwinners.com
Long Island Iced Tea to rebrand as ‘Long Blockchain Corp.’

Long Island Iced Tea Corp. (LTEA) announced that the parent company is shifting its primary corporate focus towards the exploration of and investment in opportunities that leverage the benefits of blockchain technology.

In connection with the shift in strategic direction, the company has approved changing its name from “Long Island Iced Tea Corp.” to “Long Blockchain Corp.” and has reserved the web domain www.longblockchain.com.

The company intends to request Nasdaq to change its trading symbol in connection with the name change.

The company will continue to operate Long Island Brand Beverages, LLC as a wholly-owned subsidiary and maintain the focus of this business on the ready-to-drink segment of the beverage industry, specifically, premium, ‘better-for-you’ brands marketed at an affordable price.

In conjunction with the shift in business strategy, the company has submitted a request to the SEC to withdraw its previously filed S-1 registration statement relating to a proposed underwritten public offering, which was filed on November 11, Long Island noted.

LTEA closed at $2.44. It last traded at $12.05 in pre-market trading. This seems to be the bubble mentality at its worse!


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Biogen’s BAN2401 fails to achieve results

 Biogen’s BAN2401 did not meet primary endpoint in Phase II clinical study

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

Eisai and Biogen (BIIB) announced that an Independent Data Monitoring Committee has determined that BAN2401, an anti-amyloid beta protofibril antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase II clinical study.

Following the predefined study protocol, the blinded study will continue and a comprehensive final analysis will be conducted at 18 months seeking to demonstrate clinically significant results.

The results of the final analysis are expected to be obtained during the second half of 2018.

Study 201 is a placebo-controlled, double-blind, parallel-group, randomized study in patients with prodromal or mild Alzheimer’s disease and with positive biomarkers for brain amyloid pathology.

The study design included 16 interim analyses that assessed potential for futility or stopping for safety. Neither of these conditions was met and the study continues to a full analysis at 18 months.

The efficacy of five dose groups of BAN2401 was evaluated at 12 months based on Eisai’s in-house developed novel endpoint Alzheimer’s disease Composite Score.

According to the Bayesian analysis at 12 months, success was judged as an 80% or higher probability of achieving a Clinically Significant Difference. In the final analysis at 18 months, a comprehensive evaluation which includes assessing changes from baseline in the clinical evaluation indicators ADCOMS and Clinical Dementia Rating Sum of Boxes, as well as changes in biomarkers such as brain amyloid levels as measured by amyloid PET and total hippocampal volume using vMRI, will be assessed. BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between Eisai and BioArctic.

Since March 2014, Eisai and Biogen have been jointly developing BAN2401.

BIIB closed at $333.47. It last traded at $319.94.


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