BioShares Biotechnology Clinical Trials (BBC): $22.15, +$0.49, +20.3% YTD

BioShares Biotechnology Products (BBP): $37.05, +$0.60, +13.1% YTD

 

 

MARKET COMMENTARY

 

Wall Street was set for a higher start as investors shrugged off concerns over U.S. President Donald Trump’s political future. European shares recovered from heavy losses suffered this week, while Asian shares ended broadly higher. The dollar fell against a basket of currencies and was on track to record its worst week since August. Oil prices rose on growing expectations that big crude exporters will extend output cuts to curb a persistent glut in inventories and gold edged up.

 

 

MARKET HIGHLIGHTS

 

Santhera Pharmaceuticals announced an updated timeline for the ongoing assessment by the Committee for Medicinal Products for Human Use (CHMP) of its extension application for Raxone® (idebenone) in Duchenne muscular dystrophy (DMD).  "Santhera is in ongoing, constructive discussions with the CHMP, and we are now expecting to receive a request for supplementary information to further support the clinical relevance of our data. We are working closely with the CHMP to conclude the application process and anticipate an opinion in Q3 2017," said Thomas Meier, PhD, CEO of Santhera.

 

DelMar Pharmaceuticals announced its financial results for the quarter ending March 31, 2017, the third quarter of the Company’s 2017 fiscal year.  For the three months ended March 31, 2017 the Company reported a net loss of $1,868,460 or $0.18 per share, compared to a net loss of $1,140,401, or $0.10 per share for the three months ended March 31, 2016.

 

OSE Immunotherapeutics announced today that the Company will present at the upcoming “Annual Sachs Immuno-Oncology: BD&L and Investment Forum” being held on June 2, 2017, in Chicago, Illinois, in parallel to the international annual American Society of Clinical Oncology (ASCO) meeting.

 

Amicus Therapeutics has completed the analysis plan for the primary endpoints in the blinded ongoing Phase III clinical study (ESSENCE) of the novel topical medicine SD-101 for epidermolysis bullosa (EB). SD-101 was one of the first treatments to receive the FDA’s Breakthrough Therapy designation. ESSENCE is a double-blind, placebo-controlled registration study that completed enrollment of more than 160 patients who have a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.

 

Merck announced that the FDA has approved two new indications for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In the second-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

 

Merck announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ISENTRESS (raltegravir) 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. In adults and pediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.

 

Revance Therapeutics announced duration of effect of at least 24 weeks in its U.S. Phase II open-label, dose-escalating clinical study of DaxibotulinumtoxinA Injectable (RT002) to treat moderate-to-severe isolated cervical dystonia, a movement disorder of the neck, in adults. The company also announced additional positive efficacy results and that RT002 was generally safe and well-tolerated. Following the news, Aegis analyst Difei Yang increased her price target to $36 from $28.

 

Atossa Genetics announced that it completed enrollment in the topical arm of its Phase I dose escalation study of Atossa’s proprietary Endoxifen. Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is used to treat breast cancer and for breast cancer prevention in high risk patients.

 

Avenue Therapeutics, a Fortress Biotech Company, announced that Notice of Allowance has now been received from the USPTO for a new patent application (U.S. Application No. 15/163,111), entitled "Intravenous Administration of Tramadol.”  The patent application describes and claims a dosing regimen of intravenous (IV) 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every 6 hours at steady state.

 

Lion Biotechnologies announced that the first patient was dosed in the second cohort of its ongoing Phase II trial of LN-144 for the treatment of patients with metastatic melanoma. This cohort utilizes the company’s generation 2 manufacturing process which includes cryopreservation of the outbound products.

 

Bristol-Myers Squibb announced that the EMA validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib) to treat children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) and to include the powder for oral suspension. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

 

Propanc Biopharma announced that fresh new insights have emerged into how cancer stem cells (CSCs) are able to resist standard treatments, become more aggressive and spread rapidly. Published in Oncogene, by researchers from the Bellvitge Biomedical Research Institute south of Barcelona, Spain, the findings have significant implications for Propanc Biopharma’s lead product PRP, which reprograms CSCs so that they are no longer malignant and a threat to the patient. PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.

 

AVEO Oncology announced its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the CHMP, the scientific committee of the EMA, as part of the MAA review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting.

 

Neurocrine Biosciences announced the upcoming presentation at the American Psychiatric Association (APA) Annual Meeting of pharmacokinetic data, as well as long-term data from the KINECT 3 Phase III extension study of INGREZZA (valbenazine) capsules for the treatment of adults with TD.

 

Halozyme Therapeutics announced the pricing of its previously announced underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $12.50 per share. The gross proceeds from this offering are expected to be approximately $125 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Halozyme. In addition, Halozyme has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less the underwriting discounts and commissions, in connection with the offering. Wells Fargo Securities and Deutsche Bank Securities are acting as joint book-running managers for the offering.Barclays and JMP Securities are acting as co-managers for the offering. Halozyme intends to use the net proceeds from this offering to fund continued development of its PEGPH20 oncology program and for other general corporate purposes.

 

 

ANALYST RECOMMENDATIONS

 

BTIG analyst Robert Hazlett initiated coverage of Prothena with a “buy” rating and $80 price target, citing material potential for the programs in amyloidosis, Parkinson’s, and inflammatory diseases.

 

Leerink analyst Joseph Schwartz initiated coverage of Arena with an “outperform” rating and $5 price target, citing a strategic reorganization led by a new management team, there are multiple opportunities for the company to generate significant shareholder value by developing potential best-in-class agents targeting blockbuster opportunities.

 

Following Endologix’s announcement of its second, year-plus Nellix US approval delay since November 2016, RBC analyst Glenn Novarro decreased his price target to $5 from $8.

 

BTIG analyst Robert Hazlett initiated coverage of Axsome with a “buy” rating and $14 price target, citing Axsome Therapeutics has two material assets in pivotal clinical studies: AXS-05 and AXS-02. AXS-05, a fixed dose combination of dextromethorphan and bupropion, is in pivotal trials for treatment-resistant depression, and will soon begin Phase 3 for agitation in Alzheimer’s disease; Fast Track designation has been granted for both indications. AXS-02, an oral version of zoledronate, has been granted Fast Track for complex regional pain syndrome (CRPS) and knee osteoarthritis (OA) with bone marrow lesions, and is being developed for chronic low back pain (CLBP) with Modic changes.

 

Cantor analyst Bryan Brokmeier initiated coverage of Thermo Fisher with an “overweight” rating and $194 price target, citing the industry remains highly-fragmented, creating significant opportunity for organic growth at the expense of weaker competitors, as well as M&A, which TMO has demonstrated is a valuable tool for deploying strong FCF.

 

JMP analyst Liisa Bayko initiated coverage of Spring Bank Pharmaceuticals with a “market perform” rating and $20 price target, citing SBPH is a biopharmaceutical company developing novel therapeutics generated from its proprietary small molecule nucleic acid hybrid (SMNH) chemistry platform.

 

Raymond James analyst Laura Chico initiated coverage of the following companies:Paratek Pharmaceuticals with a “buy” rating and $36 price target; Vital Therapies with an “outperform” rating and $6 price target. 

 

Wedbush analyst David Nierengarten increased his price target of Epizyme to $24 from $22, citing EPZM management provided additional color today around Ph 2 solid tumor data reported in ASCO abstracts, which showed four confirmed PRs in 31 evaluable patients.