Focus Ticker: Galectin Therapeutics

Galectin Therapeutics $GALT announced on Thursday that it observed positive results from its Phase 2a clinical trial, evaluating lead product candidate GR-MD-02 for the treatment of moderate-to-severe plaque psoriasis. All five subjects, who took the treatment with 8 mg/kg of GR-MD-02 administered every other week showed clinical improvement as measured by a scale called PASI (Psoriasis Area and Severity Index), with an average of 52%. The subject with the most severe disease saw a 72% improvement after 13 infusions over 24 weeks. The complete results will be presented at a future scientific conference.

Sector News

Accelerated Pharma all-set for IPO- Westport, CT-based Accelerated Pharma $ACCP (pending) is all set for an IPO of 1,888, 889 shares of common stock at $8-$10. The company is a clinical-stage biopharmaceutical firm, using its genomic technology to enhance the development of pre-existing pharmaceutical products for the treatment of a range of cancers and to prospectively detect patients who may be the best respondents to therapy.

Pfizer pondering selling consumer health business: Reuters- Pfizer $PFE is considering a potential sale or spinoff of its consumer health unit that could value the business as much as $14 billion, according to Reuters’ report. Divesting this division, which includes Advil and Chapstick, would be one the company biggest ever corporate moves since cancelling a $160 billion deal to acquire Allergan earlier this year.

Anthera Pharma’s blisibimod fails Phase 3 lupus study- Anthera Pharmaceuticals’ $ANTH fell sharply amid heavy trading volume in response to its announcement that a Phase study, labeled CHABLIS-SC1, evaluating blisibimod for the treatment of patients with active systemic lupus erythematosus (SLE) failed to achieve its primary endpoint.

Allergan launches TAYTULLA, an oral contraceptive-Allergan $AGN announced the launch of TAYTULLA ( (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20 mcg, an oral contraceptive in a softgel capsule for the prevention of pregnancy, the only oral contraceptive available in this formulation.

FDA designates Seattle Genetics’ ADCETRIS a Breakthrough Therapy-The FDA designated Seattle Genetics’ $SGEN ADCETRIS (brentuximab vedotin) a Breakthrough Therapy for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic late cell lymphoma (pcALCL), who have received one prior line therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma, accounting for more than 75% of cases. A Breakthrough Therapy status helps a company to receive intensive guidance from the FDA review team, including the involvement of more senior agency personnel and a rolling review of the New Drug Application.

Deals and Collaborations

Halozyme Therapeutics $HALO and Roche’s $RHHBY Genentech will jointly conduct studies evaluating the combination of Tecentriq (atezolizumab) and Halozyme’s PEGPH20 in up to eight tumor types from early next year. The first clinical trial will be an open-label Phase 1b/2 led by Genentech that will assess the combination in six tumor types, with initial emphasis on gastrointestinal malignancies, including pancreatic and gastric cancers, some of who suffer from high levels of hyaluronan (HA). Halozyme’s will be taking care of supplies during the development. Then, Halozyme will lead a clinical trial, which is an open-label Phase 1b evaluating the combination along with chemo in patients with advanced/metastatic biliary and gallbladder cancers. Patients with high HA levels will get enrolled for the trials.

Amgen $AMGN and Janssen Pharmaceuticals $JNJ will jointly conduct multiple clinical trials evaluating the combination of KYPROLIS (carfilzomib) and DARZALEX (daratumumab) in patients with multiple myeloma (MM). As per the agreement, each company will supply its product and divide development related costs on a study-specific basis.

Bristol-Myers Squibb $BMY signed a global licensing agreement with Japanese firm Nitto Denko $NDEKF for the development and commercialization of Nitto’s siRNA molecules targeting heat shock protein 47 (HSP47) formulations containing vitamin A. The agreement includes Nitto’s lead product candidate, Phase 1b-stage ND-L02-s0201, for the treatment of advanced liver fibrosis and grants BMY the option for secure exclusive licenses for HSP47 sirRNAs in vitamin A formulation for the treatment of lung fibrosis and other organ fibrosis.

Approvals

The FDA approved Gilead Sciences’ $GILD Vemlidy (Vemlidy (tenofovir alafenamide)(TAF) 25 mg for the treatment of adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. The agency's action date (PDUFA) was scheduled on November 11.TAF has similar efficacy to TDF [Viread (tenofovir disoproxil fumarate)] but at 1/10 the dose as a result it is less stressful on the kidneys and bones.

Earnings

AmpliPhi Biosciences $APHB reported Q3 EPS of -$0.32, beating the guidance by $0.09. Revenue was $0.03 million, a drop of 78.6%, Y-o-Y.

Tonix Pharmaceuticals $TNXP reported Q3 EPS of -$0.29, beating the guidance by $0.05. Cash and cash equivalents were at $26.73 million.

AstraZeneca $AZN reported Q3 EPS of $1.32, beating the guidance by $0.58. Revenue was $5.7 billion, a drop of 4.2$, Y-o-Y, and missing the estimate by $250 million.

Tenax Therapeutics $TENX posted Q3 EPS of -$0.15, beating the guidance by $0.02.
Evotec AG $EVOTF posted Q3 EPS of €0.07. Revenue for the quarter was €45.17M, a growth of 35.9%, Y-o-Y.

Dimension Therapeutics $DMTX reported Q3 EPS of -$0.58, missing the guidance by $0.03. Revenue was $2.76 million, a growth of 34%, Y-o-Y, and beating the estimate by $0.6 million.