Canadian Solar receives go-private offer

Canadian Solar announces receipt of ‘go-private’ offer of $18.47 per share

canadian-solar receives going private offer. Stockwinners.com
Canadian Solar receives going private offer

Canadian Solar (CSIQ) announced that its board has received a preliminary, non-binding proposal letter, dated December 9, from its Chairman, President and CEO Shawn Qu, to acquire all of the outstanding common shares of the company not already beneficially owned by Dr. Qu and his wife, Hanbing Zhang, in a “going-private” transaction for cash consideration of $18.47 per common share.

The board has formed a special committee of independent and disinterested directors to consider the proposed transaction.

The company expects that the Special Committee will retain independent advisors, including independent legal and financial advisors, to assist it in this process.

“The Board cautions the Company’s shareholders and others considering trading in the Company’s securities that the Board has just received the Proposal Letter and has not had an opportunity to carefully review and evaluate the Proposed Transaction or make any decision with respect to the Company’s response to the Proposal Letter.

The Board also cautions that there can be no assurance that any definitive offer relating to the Proposed Transaction or any other transaction will be made by Dr. Qu or any other person, that any definitive agreement with respect to the Proposed Transaction or any other transaction will be executed or that the Proposed Transaction or any other transaction will be approved or consummated,” the company stated.

ANALYST COMMENTS

Coker Palmer analyst Brad Meikle believes the offer to take Canadian Solar private by its CEO and Founder “puts in a floor value for the company.” The analyst, however, believes Canadian Solar’s fair value is “significantly higher” than the $18.47 per share offer. If the company does end up going private, it will be at a “significantly” higher price than today’s offer, Meikle tells investors. The analyst notes his fair value estimate for Canadian Solar is $32 per share and his upside target is $45 per share.

CSIQ closed at $18.20.


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bluebird bio sharply higher on its sickle cell drug

bluebird bio presents updated data from HGB-205 study of LentiGlobin

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bluebird bio presents updated data from HGB-205 study of LentiGlobin

bluebird bio (BLUE) announced updated data from the ongoing HGB-205 clinical study of its LentiGlobin gene therapy product candidate in patients with severe sickle cell disease and transfusion-dependent beta-thalassemia.

HGB-205 is an ongoing, open-label, single-center Phase 1/2 study designed to evaluate the safety and efficacy of LentiGlobin drug product in the treatment of patients with severe SCD and TDT.

The study enrolled three patients with severe SCD and four patients with TDT, who have undergone infusion with LentiGlobin DP. Results as of September 20 include: SCD: All three treated patients showed rising HbAT87Q levels in the first six months.

Patient 1204 was 13 years old at study enrollment. At last follow-up, this patient had a total hemoglobin of 12.4 g/dL, of which 6.1 g/dL was HbAT87Q. HbAT87Q concentration in this patient has remained stable since approximately nine months post-infusion.

The patient continues to show marked clinical improvement.

Patient 1207 was 16 years old at study enrollment. At last follow-up, this patient had a total hemoglobin of 10.0 g/dl, of which 0.7 g/dl was HbAT87Q.

This patient had a pre-treatment history of frequent episodes of vaso-occlusive crisis and acute chest syndrome despite hydroxyurea prior to beginning regular transfusions.

Patient 1207 had episodes of ACS and hospitalization at six and eight months post-treatment, and received three transfusions. Patient 1208 was 21 years old at study enrollment.

At last follow-up, this patient had a total hemoglobin of 10.6 g/dL, of which 2.7 g/dL was HbAT87Q.

This patient had a pre-treatment history of frequent episodes of VOCs and ACS prior to beginning regular transfusions, and was still symptomatic while receiving regular transfusions.

Following LentiGlobin treatment, Patient 1208 has had no episodes of VOCs or ACS. TDT: All four patients with TDT have remained free of chronic transfusions since shortly after receiving LentiGlobin DP. Patient 1201 has been free of transfusions for 45.2 months with total hemoglobin of 10.1 g/dL, of which 6.7 g/dL was HbAT87Q. Patient 1202 has been free of transfusions for 40.1 months with total hemoglobin of 12.9 g/dL, of which 10.1 g/dL was HbAT87Q.

Patient 1206 has been free of transfusions for 23.8 months with total hemoglobin of 11.1 g/dL, of which 8.0 g/dL was HbAT87Q. Patient 1203, who is homozygous for the severe beta+ mutation IVS1-110, has been free of transfusions for 20.9 months with total hemoglobin of 8.7 g/dL, of which 6.7 g/dL was HbAT87Q.

Three of four patients were able to begin therapeutic phlebotomy. Patient 1202 subsequently discontinued iron chelation and phlebotomy. The safety profile of LentiGlobin DP continues to be consistent with myeloablative conditioning with single-agent busulfan.

No DP-related adverse events have been observed, and there is no evidence of clonal dominance.

BLUE closed at $171.15. It last traded at $223.40.


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FDA approves Intersect ENT’s sinus implant

Intersect ENT announces FDA approval for SINUVA sinus implant

Intersect ENT announces FDA approval for SINUVA sinus implant. Stockwinners.com
Intersect ENT announces FDA approval for SINUVA sinus implant.

Intersect ENT (XENT) announced that it has received approval from the U.S. Food and Drug Administration for the SINUVA Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery.

Placed during a routine physician office visit, SINUVA expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days.

Results from a randomized clinical trial demonstrated a 63% relative reduction in bilateral polyp grade for patients treated with SINUVA, compared to control.

The FDA submission for the SINUVA Implant was supported by the results of clinical studies of 400 patients, including the landmark RESOLVE II pivotal study.

RESOLVE II met its co-primary efficacy endpoints, which included a statistically significant reduction from baseline in bilateral polyp grade and a reduction from baseline Nasal Obstruction/Congestion score.

Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal congestion and percent ethmoid sinus obstruction.

The FDA did not require any post-approval clinical trials.

XENT closed at $28.60.


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Spark Therapeutics tumbles on data

Spark Therapeutics, Pfizer announce longer-term data in SPK-900 Phase 1/2 trial

Spark Therapeutics (ONCE) and Pfizer (PFE) announced that, with a cumulative follow-up of more than 13 patient years of observation, all 11 participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for the treatment of patients with hemophilia B had discontinued routine infusions of factor IX concentrates and shown sustained steady-state factor IX activity levels with no serious adverse events, thrombotic events or factor IX inhibitors observed.

Based on individual participant history for the year prior to the study, the overall annualized bleeding rate (ABR) was reduced by 97 percent (calculated based on data after week four; 95 percent based on data after infusion) to a mean of 0.3 annual bleeds, compared to a mean of 10.5 bleeds annually before SPK-9001 administration.

Overall annualized infusion rate (AIR) was reduced 99 percent (calculated based on data after week four; 97 percent based on data after infusion) to a mean of 0.8 (1.7) annual infusions, compared to a mean of 62.5 infusions per year before SPK-9001 administration.

Data on all 11 participants were presented today by Lindsey A. George, M.D., attending physician in the Division of Hematology at Children’s Hospital of Philadelphia and principal investigator of the trial, at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta.

ONCE closed at $73.38. It last traded at $58.00.


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uniQure reports positive hemophilia B data

uniQure announce long-term data from Phase I/II trial of AMT-060

uniQure announce long-term data from Phase I/II trial of AMT-060. Stockwinners.com
uniQure announce long-term data from Phase I/II trial of AMT-060

uniQure (QURE) announced updated results from its ongoing, dose-ranging Phase I/II trial of AMT-060, its investigational gene therapy in patients with severe hemophilia B.

The data includes up to two years of follow-up from the low-dose cohort and up to 18 months of follow-up from the second, higher-dose cohort.

The AAV5-based AMT-060 remains safe and well-tolerated with up to two years of follow-up, with no new serious adverse events and no development of inhibitors.

No patient in the study has had any loss of Factor IX activity or capsid-specific, T-cell-mediated immune response.

Eighteen-month follow-up data from the second-dose cohort continue to show stable FIX activity with substantial improvement in disease state in all five patients, including the discontinuation of routine prophylactic FIX infusions in all patients that previously required chronic replacement therapy.

The annualized spontaneous bleeding rate for the second dose cohort declined 89% to a mean of 0.3 bleeds after gene transfer. In the last year of follow-up, no patient in the second cohort has reported any spontaneous bleeds.

These clinical data were presented this morning in an oral presentation at the 58th American Society of Hematology Annual Meeting taking place in Atlanta, Georgia.

QURE closed at $17.82. It last traded at $18.50.


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Juno Therapeutics and Celgene higher on lymphoma data

Juno Therapeutics, Celgene report additional data from TRANSCEND study

Juno Therapeutics (JUNO) and Celgene Corporation (CELG) released additional data from the TRANSCEND study of JCAR017 in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Celgene tumbles following Phase III failure of GED-003. See Stockwinners.com for stocks to buy, stocks to watch, stocks to trade

TRANSCEND is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.

As with previous readouts, the TRANSCEND data were presented for both the core and full groups.

The core group includes 29 patients who received dose level two, 34 patients who received dose level one, and 4 patients who received dose level one twice, approximately 14 days apart.

The core group includes patients with DLBCL who are ECOG Performance Status 0-1. These patients represent a high-risk patient population, with approximately 90% of treated patients having one or more predictors of poor survival, including double or triple hit lymphoma, being chemorefractory to front-line or subsequent therapies, never reaching a complete remission with prior treatments, or never having undergone an autologous transplant.

Enrollment of the pivotal cohort is ongoing with the core group at DL2. The full analysis group represents evaluable r/r patients in the DLBCL cohort, which includes an additional 24 patients with poor performance status or with niche subtypes of aggressive NHL.

In both analysis groups all efficacy data are based on at least one month of follow-up with a 28-day restaging scan and all safety evaluable data are based on having received JCAR017 with at least one month of follow-up. Product was available for 98% of patients apheresed in the DLBCL cohort.

Topline data from the presentation as of the October 9 data cutoff date included: Responses in core group: At DL2, the data showed a 3 month overall response rate of 74% and a 3 month complete response rate of 68%. Of patients that have reached 6 months of follow-up, 50% were in CR.

Across doses, 80% of patients with CR at 3 months stayed in CR at 6 months, and 92% of patients in response at 6 months remain in response as of data cutoff.

Across doses, median duration of response was 9.2 months and median durability of CR was not reached. Tolerability in core group:1% experienced severe cytokine release syndrome and 15% experienced severe neurotoxicity. 36% had any grade CRS and 21% had any grade NT. 58% had no CRS or NT of any grade.

At dose level 1, 3% experienced severe CRS and 21% experienced severe NT. At dose level 2, 0% experienced severe CRS and 7% experienced severe NT. 13% received tocilizumab and 18% received corticosteroids. Tolerability across doses in full group:1% experienced severe CRS and 12% experienced severe NT. 35% had any grade CRS and 19% had any grade NT. 60% had no CRS or NT of any grade.

The most common treatment-emergent adverse events other than CRS and NT that occurred at greater than or equal to 25% included neutropenia, anemia, fatigue, thrombocytopenia, nausea, and diarrhea. The most common TEAEs were similar between core and full groups.

CELG closed at $106.09. JUNO closed at $58.65


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