BioShares Biotechnology Clinical Trials (BBC): $18.89, -$0.38, +2.6% YTD
BioShares Biotechnology Products (BBP): $33.82, -$0.50, +3.3% YTD
On the last trading day of the month, U.S. stock index futures pointed to a lower open and the dollar was headed for its worst start to a year since 2008 as uncertainty over U.S. President Donald Trump’s policies weighed on investor sentiment. The market will focus on the earnings from top companies including Apple, Electronic Arts and Anadarko Petroleum scheduled to report after the closing bell. Employment, CaseShiller, Chicago PMI and consumer confidence data are on the economic calendar. European shares traded higher, while Asian stocks closed lower with Japan’s Nikkei index posting the biggest daily decline since November. Oil prices slipped on rising U.S. drilling activity. Gold rose buoyed by safe-haven demand.
TiGenix NV announced that the first patient has been enrolled and treated in its Phase Ib/IIa clinical trial for Cx611 (SEPCELL) in the treatment of severe sepsis in community-acquired pneumonia (CAP).
Santhera Pharmaceuticals announced that its Board of Directors is nominating Elmar Schnee, Philipp Gutzwiller, Patrick Vink, MD, and Thomas Meier, PhD and CEO of Santhera, for election to the Board of Directors at the Annual Shareholders` Meeting to be held on April 4, 2017. Thomas Meier will also be proposed as Delegate of the Board.
Addex Therapeutics announced that The Michael J. Fox Foundation for Parkinson`s Research (MJFF) has awarded the Company an $835,000 grant towards the discovery and development of tyrosine receptor kinase B (TrkB) positive allosteric modulators (PAMs) as potential novel treatments for Parkinson`s disease.
Cellect Biotechnology has appointed Yaron Pereg, Ph.D., as the new Chief Development Officer of the Company filling the role of the recently resigned Dr. Nadir Askenasy, who served as its Chief Technology Officer. Dr. Pereg brings unique experience in large scale biotech projects development from his role as Senior Director of Oncology at BioLineRx.
Tenax Therapeutics announced top-line results from its Phase III LEVO-CTS trial. The study did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days. However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes. Patient visits for data on death through day 90 have not yet been completed. The Company has a meeting scheduled with the FDA to review the preliminary trial data and discuss a path forward to bring this potentially lifesaving treatment to the benefit of patients undergoing serious cardiac surgery.
Dimension Therapeutics announced preliminary topline safety and early efficacy results of Dimension’s multi-center Phase I/II study of DTX101 for the treatment of adult patients with moderate/severe to severe hemophilia B. DTX101, Dimension’s lead AAV candidate, is designed to deliver stable expression of blood clotting Factor IX (FIX) in patients with hemophilia B, a rare genetic bleeding disorder resulting from a deficiency in FIX. Dimension is reporting preliminary topline Phase I/II results from the trial’s first two dose cohorts (Cohort 1: N=3, 1.6 x 1012 GC/kg; Cohort 2: N=3, 5 x 1012 GC/kg). Patients in the two cohorts have been in post-treatment follow-up ranging from 6 to 52 weeks.
Teva Pharmaceutical confirmed the U.S. District Court for the District of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE (glatiramer acetate injection) 40 mg/mL. The patent infringement case involved five of six ANDA filers. Teva plans to appeal the decision.
Momenta Pharmaceuticals announced that the United States District Court for the District of Delaware has found each of Teva Pharmaceutical‘s U.S. Patent Nos. 8,232,250; 8,399,413; 8,969,302; and 9,155,776 invalid as obvious over the prior art.
Aeterna Zentaris announced the occurrence of the 384(th) death in the pivotal Phase III ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with Zoptrex (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, representing the clinical endpoint of the study. The Company currently expects to lock the clinical database and to report top-line results in April 2017. Zoptrex is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the FDA.
Dow Jones reported that Pfizer said revenue declined in its latest quarter, and the company gave an outlook for full-year revenue below Wall Street’s expectations. For the year, Pfizer now expects revenue of $52 billion to $54 billion and adjusted earnings per share of $2.50 to $2.60. Analysts polled by Thomson Reuters had expected revenue of $54.03 billion and $2.56 in per-share earnings. For its latest quarter, Pfizer reported a profit of $775 million, or 13 cents a share, up from a loss of $172 million, or 3 cents a share, a year prior. The previous year’s quarter included charges related to a settlement over allegations that one of its units overcharged government Medicaid health programs and related to devaluations in Venezuela related to the country’s financial crisis. On an adjusted basis, earnings were 47 cents a share, down from 53 cents. Revenue fell 3% to $13.63 billion. Analysts polled by Thomson Reuters had forecast adjusted earnings of 50 cents a share on revenue of $13.63 billion.
Dow Jones reported that Eli Lilly reported higher profit and revenue as new drugs bolstered results. The company reaffirmed its revenue and adjusted earnings per-share guidance for the year. In all for the December quarter, Lilly reported a profit of $771.8 million, or 73 cents a share, up from $478.4 million, or 45 cents a share, a year prior. Excluding other items, earnings per share was 95 cents. Revenue grew 7.2% to $5.76 billion. Analysts projected 98 cents in adjusted per-share profit on $5.55 billion in sales.
AveXis announced that the EMA has granted access into its PRIority MEdicines (PRIME) program for the company’s proprietary gene therapy, AVXS-101, for the treatment of spinal muscular atrophy (SMA) Type 1. The PRIME application was based on data from both preclinical evaluations and the ongoing Phase I clinical trial of AVXS-101 as of September 15, 2016.
Aevi Genomic Medicine announced that the first patient has been dosed in a Phase I/II clinical trial to assess the efficacy of its lead investigational drug, AEVI-001 (NFC-1), in children with 22q11.2 Deletion Syndrome (22q DS), a rare disorder caused by an abnormality found on the 22(nd) chromosome. The trial will evaluate the changes in symptoms associated with three neuropsychiatric disorders — including anxiety, attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) — that are often found in patients affected by 22q DS.
Cellectar Biosciences announced the advance online publication of an article in Nature Reviews Clinical Oncology. In addition, the company anticipates an oral presentation on its drug delivery platform at the Academic Surgical Congress on February 8, 2017, at the Encore Hotel, Las Vegas. Each publication increases our understanding regarding the unique tumor targeting ability of the company’s phospholipid drug conjugates (PDCs) with fluorescent payloads.
Reuters reported that Mylan said U.S. antitrust authorities had launched an investigation into its EpiPen emergency allergy treatment. The FTC had asked the company for information months ago as part of a preliminary investigation, a company spokesperson said in an email. The company did not provide any further details on the investigation but said suggestions it took any inappropriate or unlawful actions to prevent generic competition was "without merit."
Endo International announced that one of its operating companies, Par Pharmaceutical has received final approval from the FDA for its NDA for ephedrine sulfate injection, a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.
Exelixis and Takeda Pharmaceutical announced an exclusive licensing agreement for the commercialization and further clinical development in Japan of cabozantinib, Exelixis’ lead oncology medicine. With the signing of the agreement, Takeda gains exclusive commercial rights for all potential future cabozantinib indications in Japan, including advanced renal cell carcinoma (RCC), for which cabozantinib is marketed in the U.S and EU as CABOMETYX tablets. The two companies will collaborate on the future clinical development of cabozantinib in Japan. Under the terms of the agreement, Exelixis will receive a $50 million upfront payment. Exelixis is eligible to receive development, regulatory, and first-sales milestones of $95 million for the first three planned indications. In addition, Exelixis will be eligible to receive royalties on sales by Takeda.
Motif Bio announced that the last patient has finished the treatment phase in REVIVE-1, the Phase III clinical trial investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
Novartis announced that the EC has approved Votubia (everolimus) dispersible tablets* as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). Votubia is now the first approved pharmacologic therapy in all 28 member states of the EU, plus Iceland and Norway, specifically for the treatment of refractory partial-onset seizures associated with TSC.
GenSight Biologics announced that the FDA has granted orphan drug designation (ODD) to the Company’s product candidate GS030 for the treatment of retinitis pigmentosa.
Indivumed announced that they have signed an agreement providing Regeneron Pharmaceuticals with access to Indivumed’s quality tissue sample and clinical and molecular data collection methods, to support the company’s cancer research programs.
AbCheck s.r.o. announced the achievement of the first clinical milestone in its antibody discovery collaboration with Eli Lilly. The milestone, the commencement of patient enrollment for a Phase I study of an antibody discovered under the collaboration agreement, triggers an undisclosed milestone payment to AbCheck from Lilly. Further details about the study and antibody were not disclosed.
Antibe Therapeutics announced that its subsidiary Citagenix has launched PentOS OI Max for the dental biologics market. PentOS OI Max is the newest member of the PentOS OI family of bone grafts for oral and maxillofacial surgery.
Trillium Therapeutics announced that it has initiated dosing in its second Phase I clinical trial with TTI-621 (SIRPaFc) in patients with relapsed or refractory percutaneously-accessible solid tumors and mycosis fungoides. Trillium is developing TTI-621 as a novel checkpoint inhibitor of the innate immune system, and the drug is currently being evaluated in an ongoing 10-cohort Phase Ib study in patients with relapsed or refractory hematologic malignancies.
Seres Therapeutics reported that it has completed in-depth analyses of the previously reported SER-109 Phase II, eight-week clinical study data in patients with multiply recurrent Clostridium difficile infection. The company also reported the full, 24-week SER-109 Phase II study results and open label extension study data.
Regeneron Pharmaceuticals announced that it has elected Tony Coles, M.D., to its Board of Directors.
MediWound announces final positive results from the Company’s second Phase II clinical trial evaluating EscharEx for debridement of dead or damaged tissue in chronic and other hard-to-heal wounds, which includes data from the follow-up period of six months from last treatment or three months from wound closure.
Bellicum Pharmaceuticals announced the appointment of Rick Fair as President and Chief Executive Officer, and as a member of the Board of Directors, effective immediately. Mr. Fair joins Bellicum from Genentech/Roche, where he was Senior Vice President, Head of Oncology Global Product Strategy, and brings an impressive record of results in global, strategic and operational roles to Bellicum. Mr. Fair succeeds Tom Farrell, who will serve as an advisor to the Company during the transition.
Hematogenix Laboratory Services announced the inclusion by Merck as one of the national reference laboratories offering the FDA-approved PD-L1 companion diagnostic assay PD-L1 IHC 22C3 pharmDx for KEYTRUDA.
Rigel Pharmaceuticals announced the pricing of its previously announced underwritten public offering of 20,000,000 shares of its common stock, offered at a price of $2.00 per share to the public. The gross proceeds to Rigel from this offering are expected to be approximately $40,000,000, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by Rigel. All of the shares in the offering are to be sold by Rigel. The offering is expected to close on or about February 3, 2017, subject to the satisfaction of customary closing conditions. Rigel has granted the underwriters a 30-day option to purchase up to an aggregate of 3,000,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions.
Provectus Biopharmaceuticals announced that it has commenced a rights offering, pursuant to which the Company is issuing subscription rights to purchase units to (i) the Company’s existing common stockholders and to (ii) holders of the Company’s class of warrants with an exercise price of $0.85 per share expiring June 19, 2020 (collectively, the "Holders"). Holders will receive one subscription right for each 20 shares of common stock and each 20 Listed Warrants held as of January 26, 2017. Each Right will entitle Holders to purchase one Unit at a subscription price of $1.00 per Unit. Each Unit consists of four shares of common stock and one-half a share of Series C Convertible Preferred Stock.
Mesoblast announced that its non-executive Director, Dr Eric A. Rose, was awarded the 2017 Earl Bakken Scientific Achievement Award by The Society of Thoracic Surgeons during the organization’s 53rd Annual Meeting held last week in Houston, Texas. This award, established through a grant from Medtronic, honors individuals who have made outstanding scientific contributions that have enhanced the practice of cardiothoracic surgery and patients’ quality of life. Dr Rose is a world renowned cardiovascular surgeon and heart failure expert, who provides Mesoblast with deep insight in the design and conduct of the Company’s cardiovascular clinical programs.
Sonoma Pharmaceuticals announced the appointment of Marc Umscheid as chief strategy and marketing officer. Previously, Umscheid worked at the Clorox Company where he most recently served as senior marketing director and business development team leader.
Versartis announced the promotion of Joshua T. Brumm to COO and Paul Westberg to Chief Business Officer. Mr. Brumm had been serving as CFO and will continue in that role and Mr. Westberg was previously Senior Vice President, Corporate Development.
SunTrust analyst Peter Lawson increased his price target of Incyte to $140 from $115, citing increased pipeline and technology value.
Following Ocera Therapeutics’ announcement the top-line results from OCRX’s long-awaited Phase II program disappointed as IV OCR-002 missed the primary endpoint of reducing time to symptom improvement in acute hepatic encephalopathy, HC Wainwright analyst Ed Arce decreased his price to $4 from $10; JMP analyst Liisa Bayko downgraded the stock to “market perform” from “market outperform. ”
Bank of America Merrill Lynch analyst Sumant Kulkarni upgraded Teva to “buy” from “neutral,” citing now that the Copaxone ruling out of the way, the risk/reward is more appealing.
Mizuho analyst Irina Koffler decreased her price target of Endo International to $15 from $25, citing recent commentary.
BNP Paribas analyst Romain Zana upgraded Qiagen to “neutral” from “underperform,” and increased his price target to EUR26 from EUR18, citing improved visibility with a proven strong momentum on Quantiferon, LS recovery and incremental growth ahead coming from GeneReader.
Leerink analyst Paul Matteis assumed coverage of Dicerna Pharmaceuticals with a “market perform” rating and $4 price target, citing DRNA’s lead asset DCR-PHXC is the first candidate selected out of its GalXC platform and is a dicer substrate siRNA (DsiRNA) that targets HAO1 for the treatment of Primary Hyperoxaluria 1.
Citi analyst Robyn Karnauskas increased her price target of Calithera Biosciences to $8 from $5, citing CALA announced a collaboration with Incyte to develop CB-1158 for hem/onc indications which removes a financing overhang.
Following Momenta’s favorable ruling from a US District Court invalidating four patents for Teva’s Copaxone 40mg, Goldman analyst Stephan Stewart increased his price target to $16 from $14; Barclays analyst Douglas Tsao decreased his price target to $20 from $19; Leerink analyst Jason Gerberry increased his price target to $20 from $19; Stifel analyst Thomas Shrader increased his price target to $30 from $20; JP Morgan analyst Christopher Schott increased his price target to $20 from $18.
JP Morgan analyst Jessica Fye decreased her price target of AMAG Pharmaceuticals to $24 from $33, citing a number of updates at the J.P. Morgan Healthcare conference including the shift in Makena SC strategy, Rekynda in-licensing and 2017 guidance.