After back-to-back clinical disasters pushed Eleven Biotherapeutics ($EBIO) into penny stock territory, Nasdaq says it's time to get squared away or move off the exchange. The Cambridge, MA-based biotech addressed the delisting notice from Nasdaq in an SEC filing, noting that its stock is trading under $1 a share and that stockholders' equity did not comply with the minimum stockholders' equity requirement of $5,000,000. The biotech now has 180 days to regain compliance with Nasdaq rules. SEC filing
@FierceBiotech: Eyeing the U.S. market, TiGenix touts 52-wk data from PhIII stem cell trial. Story | Follow @FierceBiotech
@JohnCFierce: I have a gut feeling that UC and The Broad are going to settle up on CRISPR. Excellent summary from @sxbegle. STAT story | Follow @JohnCFierce
> Shares of Omeros ($OMER) were buoyed on Tuesday after the biotech reported that it had won orphan drug status and launched a late-stage program for its kidney therapy. Story
> Rigel Pharmaceuticals ($RIGL) named Anne-Marie Duliege to the role of chief medical officer, replacing Elliott Grossbard, who is retiring after 14 years with the company. Release
> Epizyme ($EPZM) outlined plans for the next 5 years of its business, looking to transition into a commercial operation and prepare for the potential approval of its lead cancer drug. More
> Sterop, a Belgian drugmaker, is accused of supplying ephedrine to Mexican drug cartels to be used in the production of methamphetamine. Story
> AstraZeneca's ($AZN) in-development cancer therapy MEDI-551 picked up the FDA's orphan drug designation for its potential in neuromyelitis optica, a rare autoimmune disorder. News
Medical Device News
@FierceMedDev: ICYMI yesterday: J&J's Ethicon to buy NeuWave for soft-tissue, microwave ablation for cancer. Article | Follow @FierceMedDev
@VarunSaxena2: Toyota developing wearable device to improve mobility for the blind. Report | Follow @VarunSaxena2
@EmilyWFierce: Duke University teams with NC State for new cancer drug development project in canines. FierceAnimalHealth story | Follow @EmilyWFierce
> BD forms $500M JV with private equity firm Apax to house ailing respiratory biz. Report
> Agilent to lay down $80M for large stake in sequencing company Lasergen. Story
> Canon in exclusive negotiations to acquire Toshiba Medical Systems, likely for around $6B. Article
Pharma News
@FiercePharma: South Korea's Green Cross to supply Americas with flu vaccine in $32M deal. FierceVaccines item | Follow @FiercePharma
@EricPFierce: More biologics manufacturing capacity comes online in the U.S. FiercePharmaManufacturing article | Follow @EricPFierce
@CarlyHFierce: ICYMI yesterday: Amgen is eyeing heftier deals, but so are its biggest rivals. Story | Follow @CarlyHFierce
> Orexigen takes another body blow from ill-fated Contrave trial. More
> With FDA settlement, tiny Amarin creates opening for pharma in off-label marketing. Story
> Surprise proposal: Medicare wants to jump on the value-based pricing bandwagon. Article
Pharma Marketing News
> Allergan rolls out third round of Linzess ads, targeting patients fed up with OTC meds. Report
> Fake smiles star in Otsuka and Lundbeck's DTC push for Rexulti in depression. Story
> Ill-fated Contrave trial piles more hurt on Orexigen. Item
> AbbVie's Humira, Pfizer's Lyrica kick off 2016 with hefty TV ad spend. Article
> Blind Pfizer sales rep gets her chance to argue for a car and driver in court. More
Biotech Research News
> MIT team spotlights role of amino acids in building tumor cells. Item
> Single gene mutation linked with significantly reduced heart attack risk. Report
> Mouse, tissue tests confirm a new pathway for insulin resistance in diabetes. Story
> Karolinska: Nanoparticle tech opens up new drug, vaccine targets. More
> Mount Sinai: CDK4/ARK5 inhibitor could offer new treatment for multiple myeloma. Article
Vaccines News
> Sanofi digs into details on hastened Zika effort. Story
> Vaxart, Immunovaccine, Mayo Clinic jump onto Zika vaccine bandwagon. More
> South Korea's Green Cross to supply Americas with flu vaccine in $32M deal. Item
> Duke, NIAID track HIV evolution with eyes on creating a vaccine. Article