Novartis is disputing a report from Democratic senators that said it made misleading comments about its $1.2M contract with former attorney for President Donald Trump, Michael Cohen, according to Reuters.The group of senators concluded that Novartis’ relationship with Cohen was longer and more detailed than reported
Friday, July 13, 2018
MEI started at buy by SunTrust
MEI Pharma initiated with a Buy at SunTrust. SunTrust analyst Yatin Suneja initiated MEI Pharma with a Buy rating and $12 price target.
Galmed started at buy by Stifel
Galmed initiated with a Buy at Stifel. Stifel analyst Adam Walsh initiated Galmed with a Buy rating and $35 price target, calling it a “legitimate late-stage NASH play” after Aramchol recently proved itself in a Phase 2 trial as a clearly active and “very safe” compound for treating NASH.
Catalyst started at buy by Oppco
Catalyst Pharmaceuticals initiated with an Outperform at Oppenheimer. Oppenheimer analyst Leland Gershell initiated Catalyst Pharmaceuticals with an Outperform rating and $6 price target, telling investors that he sees “smooth FDA sailing” for Firdapse following a surprise setback in 2016, and says Firdapse should start generating revenue for Catalyst by early 2019. Looking ahead, Gershell sees label expansion to congenital myasthenic syndromes in 2020, and clinical data reveals in other ultra-orphan conditions over the next 12-18 months that could catalyse upward revisions to his model.
Atossa starts Phase 2 of breast cancer med study
Atossa Genetics announced that it has opened a Phase 2 study of its proprietary oral Endoxifen to treat breast cancer in the “window of opportunity” setting, which is the period between diagnosis of breast cancer and surgery. The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with Estrogen Receptor Positive and HER2 negative stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The U.S. FDA has provided a guidance document on “window of opportunity” or neoadjuvant studies entitled “Guidance for Industry Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.” The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored.
Array cancer combo gets updated recommendation from guideline body
Array BioPharma Inc. (NASDAQ: ARRY) today announced that the National Comprehensive Cancer Network (NCCN) has updated the Clinical Practice Guidelines in Oncology for Melanoma to include BRAFTOVI™ in combination with MEKTOVI® as a Category 1 first-line and second-line treatment option for patients with BRAFV600E or BRAFV600K-mutant metastatic or unresectable melanoma.
The U.S. Food and Drug Administration (FDA) approved BRAFTOVI in combination with MEKTOVI on June 27, 2018 for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test based on data from the pivotal Phase 3 COLUMBUS trial, which demonstrated the combination doubled median progression-free survival (mPFS) compared to vemurafenib alone (14.9 months versus 7.3 months, respectively [hazard ratio (HR) (0.54), (95% CI 0.41-0.71), p<0.0001]. In the trial, only 5% of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.
“We greatly appreciate the NCCN’s rapid evaluation and recommendation for BRAFTOVI + MEKTOVI as a Category 1 treatment option for patients with advanced BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer. “These products represent a new standard of care for patients with this deadly type of skin cancer.”
A Category 1 recommendation indicates that, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Acceleron cut to neutral by Morgan Stanley
Acceleron downgraded to Equal Weight after data-driven rally at Morgan Stanley. As previously reported, Morgan Stanley analyst Matthew Harrison downgraded Acceleron to Equal Weight from Overweight, stating that he believes the risk/reward is now more balanced with both of its Phase 3 readouts being reflected in valuation with the stock’s recent move higher. He expects limited upside for the shares until management presents greater detail on the magnitude of the efficacy response and safety, which he thinks likely will come at the ASH meeting. Harrison keeps a $50 price target on Acceleron shares.
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