Tuesday, September 25, 2018
Verastem price target raised to $15 from $10 at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth raised his price target for Verastem to $15 after the FDA approved the company’s lead product, Copiktra , for the treatment of third-line chronic lympocytic leukemia, small lympocytic leukemia, and follicular lymphoma. Not unexpectedly, the FDA has included a boxed warning highlighting the increased risk of serious infections, diarrhea, and colitis with Copiktra, the analyst adds. He expects Copiktra to generate revenues of $178M for these three indications by 2025 and keeps a Buy rating on Verastem.
https://thefly.com/landingPageNews.php?id=2794987
Cidara Therapeutics: Cidara granted FDA QIDP, Fast Track Designations
Cidara Therapeutics announced that the FDA has granted both Qualified Infectious Disease Product, or QIDP, and Fast Track designations for the company’s prophylaxis development program for lead antifungal product candidate, rezafungin for injection. Specifically, the QIDP designation is for the development of rezafungin for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Cidara previously announced QIDP designation for rezafungin for the treatment of invasive fungal infections caused by Candida.
https://thefly.com/landingPageNews.php?id=2795025
Nemaura Medical’s sugarBEAT could be used without finger stick
Nemaura Medical announced data indicating sugarBEAT could potentially be used as an adjunctive CGM without the need for finger-stick calibration. Nemaura retrospectively evaluated a portion of previously completed clinical data for 75 patients, using a refined factory calibration constant, based upon newly developed algorithms. 66% of patches worn by 92% of the patients generating 9,863 paired data points were evaluated, with 58% of these paired data points giving a MARD of 13.61%. Nemaura further noted 73% of these paired data points gave a MARD of 17.83%. Nemaura is currently undertaking additional data analysis, to potentially allow sugarBEAT to be used with zero or reduced frequency finger-stick calibration. SugarBEAT is anticipated to launch in the UK in the coming months, and is intended to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics.
https://thefly.com/landingPageNews.php?id=2795063
Jefferies boosts Amarin target to $15, sees ‘meaningful potential’ for buyout
Jefferies analyst Roger Song raised his price target for Amarin to $15 saying the 25% MACE reduction in the REDUCE-IT “clearly gives” the company an opportunity to grow sales to $2B-$3B. His model now assumes peak adjusted sales of $3B and he keeps a Buy rating on Amarin. Song thinks the shares “have room to climb higher” after yesterday’s 300% rally. The analyst also sees “meaningful potential” for a takeover event since Amarin is now “significantly de-risked.”
https://thefly.com/landingPageNews.php?id=2795083
Galapagos starts global Phase 2 for osteoarthritis med
Galapagos NV (Euronext & NASDAQ:GLPG) reports first dosing in the global ROCCELLA Phase 2 trial with GLPG1972/S201086 in knee osteoarthritis patients. Galapagos receives a 9 million milestone payment from its collaboration partner Servierfor this achievement.
ROCCELLA is a multiregional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily doses of GLPG1972/S201086 in patients with knee osteoarthritis (OA). ROCCELLA is planned to recruit approximately 850 patients in countries in Europe, Asia, North America and South America. Galapagos is responsible for ROCCELLA in the United States, where 300 patients are targeted to be recruited. Servier will run the trial in all other countries.
The primary objective of ROCCELLA is to demonstrate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo in reducing cartilage loss after 52 weeks of treatment. This cartilage loss will be measured precisely by magnetic resonance imaging (MRI). Secondary objectives include safety and tolerability, several additional measures of structural progression, improvement in pain, function, stiffness, and patient global assessment.
GLPG1972/S201086 is a disease-modifying osteoarthritis drug (DMOAD) candidate that, in two animal models, has been shown to efficiently target a cartilage degrading enzyme called ADAMTS-5. A Phase 1 trial in healthy volunteers met all of its safety and pharmacokinetic targets and also demonstrated that GLPG1972/S201086 reduced the blood level of the ARGS neoepitope by approximately 50% within two weeks. ARGS neoepitope is a biomarker for ADAMTS-5 activity and, as such, serves as a reflection of cartilage breakdown. In a more recent Phase 1b trial in OA patients in the United States, similar findings were seen over a four-week period. Specifically, GLPG1972/S201086 was well tolerated and reduced ARGS neoepitope blood levels by up to 50%.
OA is a highly prevalent and disabling pathology. There are no treatments available today that counteract disease progression. Patients are left with only symptomatic treatments. As a result, OA represents an important unmet medical need. Galapagos developed investigational molecule GLPG1972/S201086 with the potential of becoming a first-in-class DMOAD as part of a collaboration with Servier that began in 2010. Galapagos has full U.S. commercial rights to GLPG1972/S201086 and is eligible to receive development, regulatory and other milestone payments plus royalties from Servier upon commercialization outside the United States.
Reata Has Positive Phase 2 Data for Nephropathy, Kidney Disease Med
Statistically Significant Improvement in Kidney Function Observed in Both Diseases After 12 Weeks of Treatment
Conference Call with Management Scheduled for Today at 8:00 am ET
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced positive, final results from the IgA nephropathy and type 1 diabetic chronic kidney disease (T1D CKD) cohorts of PHOENIX, a Phase 2 study of bardoxolone methyl (bardoxolone) in patients with rare forms of CKD. Compared to baseline, bardoxolone significantly improved kidney function as measured by patients’ estimated glomerular filtration rate (eGFR) at Week 12 in both cohorts, which was the primary endpoint of the PHOENIX study.
In the IgA nephropathy cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 8.0 mL/min/1.73 m2 (n=26; p<0.0001) at Week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated that these patients’ kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m2 prior to study entry. The observed 8.0 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately six years of average eGFR loss.
In the T1D CKD cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m2 (n=28; p=0.02) at Week 12 compared to baseline. Reata collected historical eGFR data for 22 of these patients, which demonstrated that these patients’ kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m2 prior to study entry. The observed 5.5 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately three years of average eGFR loss.
With respect to safety, no treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity.
“With these data, bardoxolone has improved kidney function in multiple rare forms of CKD, including Alport syndrome, autosomal dominant polycystic kidney disease, IgA nephropathy, and type 1 diabetic CKD,” said Colin Meyer, M.D., Reata’s Chief Medical Officer. “The absence of drug-related serious adverse events and the eGFR improvements observed in the rare forms of CKD that we have studied suggest that bardoxolone has the potential to become an effective therapy for multiple rare forms of CKD.”
Reata management will host a call to discuss these results today, September 25th, 2018 at 8:00 a.m. ET.
| CONFERENCE CALL INFORMATION | |
| Date: | Tuesday, September 25th, 2018 |
| Time: | 8:00 a.m. ET |
| Audience Dial-in (toll-free): | (844) 348-3946 |
| Audience Dial-in (international): | (213) 358-0892 |
| Passcode: | 9899458 |
| Webcast Link: | https://edge.media-server.com/m6/p/qos423s5 |
Cerecor to acquire Ichorion Therapeutics in $26.6M transaction
Cerecor announced that it has agreed to acquire Ichorion Therapeutics. Ichorion is a privately-held biopharmaceutical company focused on developing treatments and increasing awareness of inherited metabolic disorders known as Inborn Errors of Metabolism. The terms of the agreement include the issuance of approximately 5,800,000 shares of Cerecor common stock at closing, subject to an end of 2019 lock-up, and development milestones worth up to an additional $15M, payable either in Cerecor stock or in cash in certain circumstances. The transaction was unanimously approved by the Board of Directors of both Cerecor and Ichorion and is expected to close later today.
https://thefly.com/landingPageNews.php?id=2794871
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