Ligand Pharma Shares Plummet after Amgen’s Phase 3 Kyprolis Fails-Ligand Pharmaceuticals $LGND felt some selling pressure on Monday as trading volume more than doubled, apparently as a reaction to the failure of Amgen’s $AMGN Phase 3 clinical trial of a combination regimen including KYPROLIS (carfilzomib) intended to treat patients with certain multiple myeloma patients. $LGND gets sales-based royalties of 1.5% to 3% from KYPROLIS. In the last four quarters, Amgen booked $611mn in sales for the drug.
Kitov Pharma’s Lead Product Candidate Shows Bioequivalence to a Reference Drug-Normally thinly traded stock, Kitov Pharmaceuticals ($KTOV), catapulted on Tuesday amid high-volume trading, which was 4x than the normal trading volume, as it announced positive results in another bioequivalence clinical trial on lead product candidate KIT-302 with lower-dose (2.5 mg of amlodipine). It presented the outcome of the previous bioequivalence study with positive results on May 10. At that time the study was performed with 10 mg dose. The company is expected apply for the New Drug (NDA) in the coming quarter.
Stereotaxis Secures $24mn Equity Financing; Shares Surge 30%-The nano-cap stock Stereotaxis $STXS announced on Tuesday that it has secured $24mn in equity financing through the private placement of convertible stock with a conversion price of $0.65. The company will raise $25.8mn, if all the additional warrants are exercised. It has also agreed woth its creditor Healthcare Royalty Partners to satisfy its $18.4mn outstanding debt with a payment of $13mn. It’s a good move because the interest rate the company paid was 16%.
Mylan To Face an Enquiry over EpiPen Data- EpiPen’s overpricing issue is bothering Mylan $MYL. Last week, CEO Heather Bresch, testifying before a congressional committee said that the company’s profit for a two-pack EpiPens was $100, although the list price shows $608. Separately, in a response to questions from the WSJ, Mylan said that the figure included taxes, which it did not convey it to the committee. The drug-maker significantly lowered its profit calculation by applying a corporate tax rate of 37.5%, which is 5x its overall tax rate of last year.
Sage Therapeutics Reports More Positive Data from Phase 2 Study of SAGE-547-Sage Therapeutics $SAGE gave additional positive data from Phase 2 clinical trial of SAGE-547 intended for patients with severe postpartum depression at the Marce Society for Perinatal Mental Health Biennial Scientific Meeting. The candidate was found to be well-tolerated with no severe adverse events reported during treatment and follow-up periods. The topline results from both trials are expected next year. Secondary endpoints demonstrated significant difference in improvement from baseline for SAGE-547 compared to placebo over 3 weeks.
Actinium Commences Mid-Stage Clinical Study of Actimab-A-Actinium Pharmaceuticals $ATNM has initiated Phase 2 clinical trial of Actimab A intended for patients diagnosed with Acute Myeloid Leukemia Over Age 60. A formal presentation evaluating the interim outcome of Phase 2 study is expected in mid-2017 and the topline results are anticipated in the latter half of 2017.
CEL-SCI Asked to Hold Phase 3 Study on Multikline-The FDA asked CEL-SCI Corporation $CVM to put its Multikine (Leukocyte Interleukin Injection), a Phase 3 clinical trial in advanced primary head and neck cancer, on clinical hold. The company expects to get a formal letter in the next 30 days and will work diligently to sort out the matter. The specific reasons for the hold have not been provided. The study, at present, has 926 patients enrolled.
FDA Labels Summit’s ezuytomid as Rare Paediatric Disease Treatment of DMD-Summit Therapeutics $SMMT announced that its Phase 2 study candidate, ezutromid, intended for Duchenne muscular dystrophy (DMD) received a Rare Paediatric Disease designation from the FDA. As an utrophin modulator, ezutromid has the potential of being developed as disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, irrespective of their underlying dystrophin gene mutation.
Novo Nordisk announces DKK3.4B share buyback program-Novo Nordisk $NVO announced that the company will buyback B shares for an amount up to DKK 3.4bn ($510mn) between the period of August 5 to October 26. The decision is a part of the broader repurchase program of up to DKK 14bn, to be completed during 12-month period, starting Feb. 2016.
Bristol-Myers to test Opdivo with Nektar drug for several cancers-Bristol-Myers Squibb $BMY announced on Tuesday that it would assess the use of its blockbuster cancer immunotherapy Opdivo in combination with an experimental drug from Nektar Therapeutics to treat multiple cancers. Opdivo, which competes with Merck & Co's Keytruda, belongs to a costly new class of medicines branded PD-1 checkpoint inhibitors that work by taking the brakes off the immune system. An initial dose-escalation study is in progress. Bristol-Myers Squibb and Nektar will equally divide the costs of the clinical studies. Nektar will however maintain its global commercial rights to NKTR-214.
Idera Pharmaceuticals Announces Encouraging Pre-Clinical Data-Idera $IDRA provided some valuable insights on its ongoing pre-clinical trial. It gave a new pre-clinical data on mechanism of action supporting selective targeting of single point mutations. The data indicates that 3GA could be used to treat diseases that require allele-specificity.