Jazz Announces Results of Celator Tender Offer- Jazz Pharmaceuticals (JAZZ) announced the results of its tender offer to purchase all of the outstanding shares of common stock of Celator Pharmaceuticals (CPXX) at $30.25 per share. The tender offer is being effected by Jazz Pharmaceuticals' indirect wholly-owned subsidiary, Plex Merger Sub. A total of 36.5M shares of Celator common stock had been validly tendered, representing ~81.13% of its outstanding shares. Additionally Notices of Guaranteed Delivery have been delivered with respect to 2M additional shares, representing another 4.48%.
Asterias Completes Enrollment and Dosing in SCiSTAR Study- Asterias Biotherapeutics (AST) announced that it has completed enrollment and dosing of five subjects in the first efficacy cohort of its Phase 1/2a study, SCiSTAR, evaluating the activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). Each patient was administered 10M AST-OPC1 cells, a dose high enough to show efficacy based on preclinical studies. Top-line six-month data are expected in January 2017. The primary endpoint is safety.
InVivo Provides Update on INSPIRE Study- InVivo Therapeutics (NVIV) announced hat the 9th and 10th subjects have been implanted in its 20-subject Phase 3 clinical trial, INSPIRE. The study is evaluating he Neuro-Spinal Scaffold in patients with acute spinal cord injury. The 10th patient died from a stroke several days post-implantation. The cause of death was determined to be unrelated to the Neuro-Spinal Scaffold. The primary endpoint is the proportion of patients who achieve an improvement of at least one AIS grade level at month 6. The study is expected to be completed in June 2017.
The Medicines Company Gets Favorable Ruling in Angiomax Patent Dispute- The Medicines Company (MDCO) announced that the .S. Court of Appeals for the Federal Circuit unanimously affirmed an earlier district court ruling that patents covering the company’s anticoagulant Angiomax (bivalirudin) are not invalid under "on sale" bar (a concept that says that a product that is sold for at least one year before the patent application is submitted is not patentable). The original intent for enacting the rule was to prevent inventors from extending their monopoly beyond the patent period.
MyoKardia Shares Soar on Update for Lead Product Candidate- MyoKardia (MYOK) shares closed more than 30% higher on Tuesday after the company provided an update on its lead product candidate MYK-461, under development for the treatment of hypertrophic cardiomyopathy (HCM), a common heart disorder in which the muscle cells enlarge and cause the wall of the ventricles to thicken resulting in restricted blood flow. The company said that data from two recently completed Phase 1 studies showed favorable tolerability of single doses of MYK-461 in healthy volunteers and HCM patients. Repeat doses of MYK-461 were well tolerated for up to 28 days in healthy volunteers across a range of pharmacologically active doses with reductions in cardiac contractility sustained throughout. The data suggest a dose-dependent reduction in contractility consistent with the magnitude of reduction that confers a meaningful clinical benefit, according to the literature.
Exact Sciences Rallies on Takeover Rumors- Exact Sciences (EXAS) shares rose sharply on Tuesday amid takeover rumors. According to reports, Illumina (ILMN) is interested in acquiring EXAS.
Teva Raises Q2 Guidance- Teva Pharmaceutical Industries (TEVA) has raised its second-quarter earnings and revenue guidance to $1.19 - 1.22/$4.9B - 5.0B from $1.16 - 1.20/$4.8B - 4.9B. It expects lower cash flow from operations, though, easing its guidance to $1.0B - 1.1B from $1.2B - 1.3B. The consensus forecast is for earnings of $1.17 per share on revenue of $4.81 billion.
Juno Rallies as FDA Removes Clinical Hold on Mid-Stage Study of JCAR015- Juno Therapeutics (JUNO) shares have surged in pre-market trading today after the FDA removed its clinical hold on the company’s Phase 2 clinical trial, ROCKET, evaluating its lead CAR-T candidate JCAR015 for the treatment of adult patients with relapsed/refractory B cell acute lymphoblastic leukemia. The clinical hold was placed recently after two patients died after receiving the preconditioning regimen of cyclophosphamide + fludarabine. Going forward, the study participants will be preconditioned with cyclophosphamide only.