BioShares Biotechnology Clinical Trials (BBC): $22.94, +$0.26, +24.6% YTD

BioShares Biotechnology Products (BBP): $37.73, +$0.03, +15.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed on uncertainty over the feasibility of a proposed business tax cut. U.S. President Donald Trump’s plans to slash company tax rates to 15 percent from the current 35 percent and 39.6 percent for small firms offered no details on how they would be paid for. Alphabet, Amazon, Microsoft and Intel are some of the major companies scheduled to report quarterly results after markets close. On economic front, investors will look forward to data on durable goods, jobless claims and pending home sales index. Financials and commodity-related stocks weighed on European markets, while Asian stocks recorded a mixed trading day. The dollar held its gains against the Japanese yen and gold was little changed.

 

 

MARKET HIGHLIGHTS

 

Vaccinex announced that a pre-planned analysis of data from Cohort A of the SIGNAL trial was completed. In June 2015, Vaccinex, the Huntington Study Group, and the University of Rochester’s Clinical Trials Coordination Center launched SIGNAL, the first clinical trial to investigate a monoclonal antibody as a potential treatment for Huntington’s disease (HD).

 

TxCell SA reported its cash position and its revenues for the first quarter of 2017.  As of March 31st, 2017, the cash and cash equivalents amounted to €11.3 million.  TxCell did not generate revenues during the first quarter 2017.

 

Onxeo S.A. announced its consolidated revenues and cash position at March 31, 2017.  Revenues increased by 55% to €1,211,000 in the first quarter of 2017 and consisted of: €914,000 in recurring revenue resulting from the sale of products to ONXEO’s commercial partners and royalties on sales. This represents a 21% increase notably due to Beleodaq® sales in the United States by Spectrum Pharmaceuticals.  €297,000 in non-recurring revenue (compared with €27,000 in the first quarter of 2016), corresponding essentially to the phased IFRS recognition of the initial payment associated with the exclusive license agreement signed with Pint Pharma in 2016. At March 31, 2017, the Company had a consolidated cash position of €21.7 million, excluding the €4 million reimbursement of 2016 Research Tax Credit expected in 2017. These resources give Onxeo financial visibility until the beginning of 2018.

 

As previously announced, PharmAthene and Altimmune have signed a definitive agreement for the merger of PharmAthene and Altimmune in an all-stock transaction.  After the close yesterday, the companies announced that, pending approval of the merger between the two companies by PharmAthene’s stockholders at a special meeting of PharmAthene’s stockholders scheduled for May 4, 2017, the combined company has been approved for listing on the Nasdaq Global Market under the symbol “ALT.”  If the merger is approved by PharmAthene’s stockholders and subsequently completed, trading of the combined company’s common stock on the Nasdaq Global Market is expected to commence on May 5, 2017, the day after the anticipated completion of the merger.  PharmAthene’s common stock will continue to trade on the NYSE MKT until the completion of the merger, and, if the merger is not completed, PharmAthene’s common stock will continue to trade on the NYSE MKT.

 

Prothena Corporation will present and participate in the Deutsche Bank 42nd Annual Health Care Conference on May 3rd at 8:40 AM ET in Boston, MA.

 

Minerva Neurosciences will release financial results and business updates for the first quarter of 2017 on Thursday, May 4, 2017.  The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates.

 

DelMar Pharmaceuticals will present a poster at the Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, IL from June 2nd to June 6th, 2017.

 

Rockwell Medical announced today that a poster and oral presentation for Triferic (ferric pyrophosphate citrate) have been selected by the International BioIron Society (IBIS) and will be presented at their 7th International Congress in Los Angeles, at UCLA, at the Luskin Conference Center, on May 7 – 11, 2017. Triferic is the only FDA approved therapy indicated to replace iron and maintain hemoglobin in chronic kidney disease patients receiving hemodialysis.

 

STRATA Skin Sciences announced the launch of the Nordlys device at the American Society for Lasers in Medicine and Surgery (ASLMS) which took place in San Diego from April 5-9, 2017.  STRATA is also announcing its expectations for revenue and earnings contributions from the sale of Nordlys products for the balance of 2017. STRATA is the exclusive United States distributor of the Nordlys laser manufactured by Ellipse Global A/S.

 

STRATA Skin Sciences will release first quarter financial results on Thursday, May 11, after the market close. STRATA Skin Sciences President and Chief Executive Officer, Frank J. McCaney, and Christina Allgeier, Chief Financial Officer, will host a conference call at 4:30 pm Eastern Time to review the Company’s progress and answer questions.

 

Zogenix announced that the last patient has been randomized into the treatment period of Study 1, its first Phase 3 clinical trial evaluating ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.

 

Zogenix will report its financial results for the first quarter ended March 31, 2017, after the market close, and will host a corporate update conference call and webcast on Thursday, May 4th, at 4:30 PM Eastern Time.

 

Advaxis was named to NJBIZ’s “2017 Best Places to Work” in New Jersey list, as compiled and ranked by the Best Companies Group (BCG). Advaxis, which has grown from about 10 employees to more than 100 in the last three years, was among the honorees at an awards reception and ceremony on Wednesday, April 26.

 

Albireo Pharma announced that clinical data from a Phase 2 study of elobixibat in chronic constipation conducted by EA Pharma Co., Ltd. in Japan is scheduled to be presented at Digestive Disease Week (DDW) 2017.

 

Foamix Pharmaceuticals will present a corporate overview and business update at the 42nd Annual Deutsche Bank Health Care Conference, being held on May 3-4, 2017 at The InterContinental Boston Hotel, Boston, MA.

 

Onconova Therapeutics announced the closing of its previously announced public offering of 2,476,190 shares of its common stock at a price to the public of $2.10 per share. The gross proceeds from the offering are approximately $5.20 million, before underwriting discounts and commissions and estimated offering costs.

 

Arrowhead Pharmaceuticals announced that it will host a webcast and conference call on Wednesday, May 3, 2017, at 4:30 p.m. EDT to discuss its financial results for the fiscal 2017 second quarter ended March 31, 2017.

 

Vermillion will report its first quarter 2017 financial results on Thursday, May 11, 2017, followed by an investor conference call and webcast at 8:30 a.m. Eastern Time.

 

Mateon Therapeutics announced that four presentations regarding the company’s preclinical drug development programs will be presented at the Tumor Microenvironment Workshop being held from April 27-29, 2017 at the Palms Hotel in Miami, Florida.

 

After yesterday’s close, Amgen reported 1Q17 non-GAAP EPS of $3.15, which compares to $2.90 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $3.00. Total revenue for 1Q17 was $5.46 billion, which compares to $5.53 billion for the same period a year ago. This compares to a mean estimate of $5.60 billion. Following earnings, Leerink analyst Geoffrey Porges decreased his price target t0 $160 from $163; Goldman analyst Terence Flynn decreased his price target to $202 from $204; Barclays analyst Geoff Meacham decreased his price target to $180 from $185; UBS analyst Carter Gould decreased his price target to $175 from $185; BMO analyst Ian Somaiya decreased his price target to $200 from $212; Bank of America Merrill Lynch analyst Ying Huang decreased his price target to $190 from $192.

 

Celgene reported 1Q17 non-GAAP EPS of $1.68, which compares to $1.32 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $1.63. Total revenue for 1Q17 was $2.96 billion, which compares to $2.51 billion for the same period a year ago. This compares to a mean estimate of $3.04 billion.

 

Alexion reported 1Q17 non-GAAP EPS of $1.38, which compares to $0.99 for the same period a year ago. The company beat the non-GAAP EPS mean estimate of $1.23. Total revenue for 1Q17 was $870.0 million, which compares to $701.0 million for the same period a year ago. This compares to a mean estimate of $826.6 million.

 

Alkermes reported 1Q17 non-GAAP EPS loss of $0.18, which compares to a loss of $0.12 for the same period a year ago. The company missed the non-GAAP EPS mean estimate loss of $0.09. Total revenue for 1Q17 was $191.8 million, which compares to $156.8 million for the same period a year ago. This compares to a mean estimate of $195.2 million.

 

Reuters reported that Bristol-Myers Squibb posted better-than-expected first-quarter earnings, helped by growth from cancer drugs Opdivo and Yervoy and blood thinner Eliquis. Bristol-Myers reported profit of $1.57 billion, or 94 cents a share, in the quarter, up from $1.20 billion, or 71 cents a share, a year earlier. Excluding one-time items, Bristol-Myers said it earned 84 cents a share. Wall Street analysts, on average, had expected the company to earn 74 cents a share. Revenue rose 12 percent to $4.93 billion, which was also higher than the average analyst estimate of $4.74 billion. The company increased its forecast for 2017 earnings to a range of $2.85 a share to $3 a share, up from its previous forecast range of $2.70 a share to $2.90 a share.

 

Reuters reported that AbbVie‘s quarterly profit and revenue beat analysts’ estimates, helped by demand for its top-selling treatment, Humira. Net profit rose to $1.71 billion, or $1.06 per share, in the first quarter ended March 31, from $1.35 billion, or 83 cents per share, a year earlier. Excluding items, the company earned $1.28, beating the average analyst estimate by 2 cents, according to Thomson Reuters I/B/E/S. Net revenue rose 9.7 percent to $6.54 billion, coming in just ahead of the average estimate of $6.48 billion.The company maintained its 2017 adjusted profit forecast.

 

Reuters reported that AstraZeneca reported another quarter of falling drug sales as it awaits pivotal clinical trial data that may revive its fortunes. Despite income from disposals and external deals, first-quarter revenue fell 12 percent to $5.4 billion, although core earnings per share (EPS) rose 4 percent in dollar terms to 99 cents. Industry analysts, on average, had forecast revenue of $5.4 billion and earnings of 82 cents, according to Thomson Reuters data. AstraZeneca reiterated its expectation that full-year revenue would fall at a low to mid single-digit percentage rate, with core EPS dropping by a low to mid-teens percentage.

 

Acceleron Pharma announced updates on the luspatercept clinical programs under its collaboration with Celgene. Luspatercept is an investigational compound being evaluated in two pivotal Phase III trials for the treatment of myelodysplastic syndromes (MDS) and beta-thalassemia.

 

Aldeyra Therapeutics announced that it has enrolled the first patient in a Phase III clinical trial of topical ocular ADX-102 for the treatment of noninfectious anterior uveitis (NAU).

 

Pfizer announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the FDA for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK inhibitors.

 

Teva Pharmaceutical Industries announced the publication of results from the Phase II/III study ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) in Neurology, the medical journal of the American Academy of Neurology. The ARM-TD study evaluated the safety and efficacy of the investigational use of deutetrabenazine (SD-809) compared to placebo in the treatment of moderate to severe tardive dyskinesia (TD).

 

Daiichi Sankyo announced it is making an initial 15 billion yen investment to optimize and enhance its manufacturing capabilities to support its growing antibody drug conjugate (ADC) pipeline.

 

Eisai announced the presentation of results from a new meta-analysis of published clinical trials showing that the effect of adjunctive antiepileptic drug (AED) treatment versus placebo on primary generalized tonic-clonic (PGTC) seizures appears similar between adults and children (greater than or equal to four years old) living with epilepsy. The results were presented at the American Academy of Neurology (AAN) Annual Meeting in Boston, and were selected by AAN to be included in a "Best Of" epilepsy session. It is important that prescribers consult prescribing information for each of the three products included in the meta-analysis for specific information regarding approved age groups, and dosing and administration.

 

TESARO announced that following the recent identification of a fixed dose and patient-centric dosing schedule, the ongoing clinical trial of TSR-042 has been expanded to enroll patients with metastatic microsatellite instability high (MSI-H) endometrial cancer who have progressed following one or two prior chemotherapy treatments. During the first 12 weeks of treatment, TSR-042 is administered once every three weeks, followed by a single dose administration every six weeks until disease progression. The intent of this study is to support a request for accelerated approval and BLA submission to the FDA. The primary endpoints of this trial are overall response rate (ORR) and duration of response, and secondary endpoints include disease control rate, progression free survival (PFS), and overall survival (OS). The addition of cohorts for patients with other tumor types is also planned. This is the first clinical development program within a broader plan that includes potential label expansion trials of TSR-042 in multiple cancers in combination with ZEJULA, TSR-022, TESARO’s anti-TIM-3 antibody, and TSR-033, TESARO’s anti-LAG-3 antibody.

 

Ultragenyx Pharmaceutical announced the initiation of the Phase III study of UX007 for the treatment of Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS) patients experiencing disabling paroxysmal movement disorders.

 

VistaGen Therapeutics announced the peer-reviewed publication of nonclinical studies of the effects of AV-101 (4-Cl-KYN), its CNS prodrug candidate, in four well-established nonclinical models of pain.

 

Novan announced that data from two preclinical studies with SB414, a nitric oxide-releasing cream in development for the treatment of inflammatory skin diseases such as psoriasis and atopic dermatitis, will be presented at the 76(th) Annual Meeting of the Society for Investigative Dermatology in Portland, Oregon. In a psoriasis mouse model, SB414 significantly (p <0.05) reduced composite psoriasis scores and also inhibited the production of pro-inflammatory cytokines, including interleukin-17, or IL-17a and IL-17f. Additionally, in two in vivo models that assess critical components of atopic dermatitis disease pathology, SB414 displayed potent anti-staphylococcal activity and dose-dependent inhibition of inflammation comparable to betamethasone, a mid-potency corticosteroid used to treat eczema patients.

 

InSphero AG entered into an agreement with Pfizer to develop a novel predictive toxicology assay using InSphero 3D InSight Human Liver Microtissues. This novel mechanistic in vitro assay will aim to leverage the enhanced sensitivity and longevity of InSphero 3D liver models, which may allow for the multiplexing of several endpoints to help detect and predict mechanisms of drug toxicity.

 

ChromaDex announced that it has entered into a securities purchase agreement for the sale of up to $25 million of its common stock in a private placement led by Hong Kong business leader Mr. Li Ka-shing.

 

Akari Therapeutics released a statement that Edison Investment Research Ltd. has withdrawn its report issued yesterday titled  “Akari’s Coversin matches Soliris in Phase II” (the “Edison Report”) because it contains material inaccuracies, including without limitation, with respect to Akari’s recently announced interim analysis of its ongoing Phase II PNH trial of Coversin. Investors should not rely upon any information contained in the Edison Report and instead should refer to Akari’s press release issued on April 24, 2017 that discusses the interim analysis of its ongoing Phase II PNH trial and other matters.

 

Sage Therapeutics announced it has initiated a Phase I single ascending dose (SAD) trial of SAGE-718 in healthy volunteers. Top-line results from the SAD study are expected in the second half of 2017.

 

Takeda Pharmaceutical and Harrington Discovery Institute at University Hospitals in Cleveland, Ohio have announced a multi-year collaboration to accelerate breakthrough therapeutic discoveries in rare diseases.

 

Syndax Pharmaceuticals announced the expansion of ENCORE 601/KEYNOTE 142, the ongoing Phase II clinical collaboration with a subsidiary of Merck to include a cohort of patients with microsatellite stable colorectal cancer. This trial is designed to evaluate the safety, tolerability and efficacy of Syndax’s entinostat, an oral, small molecule that targets immune regulatory cells, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy.

 

MacroGenics announced that it has entered into a definitive agreement with an institutional healthcare investor to purchase 1,100,000 shares of its Common Stock at a purchase price of $21.50 per share in a registered direct offering. Gross proceeds to MacroGenics, before deducting estimated offering expenses, will be $23,650,000.  The shares were offered pursuant to the company’s shelf registration and the offering is expected to close on or about May 2, 2017, subject to customary closing conditions. No underwriter or agent was used.

 

ProQR Therapeutics announced that the Company can start the Phase I/II trial for QR-110, named PQ-110-001, in Leber’s congenital amaurosis Type 10 (LCA 10) patients. QR-110 is a novel investigational RNA therapeutic targeting LCA 10 due to the p.Cys998X mutation, a severe genetic rare disease that causes children to lose sight in the first years of life. LCA 10 is one of the most prevalent forms of gene-related blindness in children worldwide and currently there are no therapies commercially available.

 

Myriad Genetics and Clovis Oncology announced a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis’ PARP inhibitor, Rubraca.  Financial terms of the deal were not disclosed.

 

Agios Pharmaceuticals and Aurigene Discovery Technologies announced a global license agreement to research, develop and commercialize small molecule inhibitors of an undisclosed cancer metabolism target.

 

Rigel Pharmaceuticals announced that the FDA has conditionally accepted the proprietary name Tavalisse for the company’s investigational product candidate, fostamatinib disodium, an oral spleen tyrosine kinase (SYK) inhibitor. In addition, Rigel has applied to the U.S. Patent and Trademark Office to obtain federal registration of the Tavalisse mark.

 

Impax Laboratories announced it has received final FDA approval for a generic version of Vytorin (ezetimibe/simvastatin tablets), 10/10, 10/20, 10/40 and 10/80 mg, and immediately initiated commercialization activities of this first-to-market opportunity.

 

Teva Pharmaceutical announced the launch of generic Vytorin (ezetimibe and simvastatin) tablets in the U.S. Ezetimibe and simvastatin tablets are a prescription medicine that contains two (2) cholesterol lowering medicines, ezetimibe and simvastatin, which are used along with diet to: Lower the level of “bad” cholesterol (low density lipoprotein cholesterol or LDL); Increase the level of “good” cholesterol (high density lipoprotein cholesterol or HDL) & Lower the level of fat in blood (triglycerides).

 

Jazz Pharmaceuticals announced positive efficacy results from the global multicenter study of JZP-110 in adult patients with excessive sleepiness associated with narcolepsy.  Based on the preliminary safety analysis, the most commonly reported adverse events (AEs) in this study were generally consistent with those previously observed in the Phase II clinical studies evaluating JZP-110 in narcolepsy.

 

Syros Pharmaceuticals announced that it has closed a previously announced private financing with a select group of existing and new institutional investors. At the closing, the Company issued 2,592,591 shares of common stock at a price of $13.50 per share, yielding gross proceeds of approximately $35 million. The purchase price for the shares represents an 8.8% discount to the average closing price of the Company’s common stock over the 30 trading days prior to April 20, 2017, the date on which the stock purchase agreement for the financing was executed. Net proceeds from this offering are expected to be used to advance the Company’s research and development programs, including the clinical development of SY-1425 in genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and the planned Phase I clinical trial of SY-1365 in patients with advanced solid tumors.

 

Neurocrine Biosciences announced the pricing of its offering of $450.0 million aggregate principal amount of 2.25% convertible senior notes due 2024. The notes will be sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The sale of the notes is expected to close on May 2, 2017, subject to customary closing conditions. Neurocrine also granted the initial purchasers of the notes a 30-day option to purchase up to an additional $67.5 million aggregate principal amount of notes.

 

Flexion Therapeutics announced the pricing of $175.0 million aggregate principal amount of 3.375% convertible senior notes due 2024 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The size of the offering was increased by $50 million from the previously announced offering size of $125 million. In connection with the offering, Flexion has granted the initial purchasers of the Notes a 30-day option to purchase up to an additional $26.25 million aggregate principal amount of the Notes, solely to cover over-allotments, if any. The sale of the Notes is expected to close on May 2, 2017, subject to customary closing conditions. Flexion estimates that the net proceeds from the Notes offering will be approximately $169.5 million, or $195.0 million if the initial purchasers exercise their option to purchase additional Notes in full, after deducting the initial purchasers’ discount and estimated offering expenses. Flexion intends to use the net proceeds from the Notes offering for the commercialization and manufacture of Zilretta (also known as FX006), if approved, product pipeline development, as well as working capital and general corporate purposes. Flexion may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses, technologies, products or assets.

 

Verona Pharma announced the pricing of its global offering of an aggregate of 47,399,001 new ordinary shares, comprising 5,768,000 ADSs at a price of $13.50 per ADS and 1,255,001 ordinary shares at a price of £1.32 per ordinary share, for aggregate proceeds of approximately $80.0 million before deducting underwriting discounts and commissions. Each ADS offered represents eight ordinary shares of Verona Pharma. The ADSs are being offered in a registered public offering in the U.S and the ordinary shares are being offered in a concurrent private placement in Europe and other countries outside of the U.S and Canada. In addition, Verona Pharma has granted the underwriters a 30-day option to purchase up to an additional 865,200 ADSs on the same terms and conditions.

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Ed Arce increased his price target of Akebia Therapeutics to $21 from $18, citing the expansion of its collaboration with Otsuka Pharmaceuticals to develop and commercialize vadadustat in Europe, China, and other territories.

 

Rodman & Renshaw analyst Raghuram Selvaraju initiated coverage of Alimera Sciences with a “buy” rating and $4 price target, citing the company’s commercialized product, Iluvien (fluocinolone acetonide intravitreal implant), is differentiated from other corticosteroid treatment options for diabetic macular edema (DME) in that it is the only approved drug therapy that can deliver consistent daily therapeutic levels for multiple years and mitigate the typical corticosteroid-related side effects.

 

JMP analyst Liisa Bayko established a $145 price target on Incyte, citing maturation of pipeline and leverage of Jakafi into new indications underpin the increased valuation.

 

BTIG analyst Dane Leone increased his price target of bluebird bio to $122 from $83, citing a positive outlook for the bb2121 update at ASCO, favorable comps for LentiGlobin pricing, and higher conviction in overall corporate strategy.