BioShares Biotechnology Clinical Trials (BBC): $19.71, +$0.09, +7.1% YTD

BioShares Biotechnology Products (BBP): $34.64, +$0.34, +5.8% YTD

 

 

MARKET COMMENTARY

 

U.S. stock futures were little changed and the dollar rose against a basket of currencies as investors wait to parse non-farm payrolls data for clues on the pace of Federal Reserve rate hikes this year. November trade deficit and factory orders data are also on the economic calendar. European stocks were lower, while Asian markets ended on mixed. Oil gained as Saudi Arabia and Abu Dhabi stared promised supply cuts. Gold edged lower after hitting a one-month high in the previous session.

 

 

MARKET HIGHLIGHTS

 

VBL Therapeutics announced today that it has completed enrollment in the GLOBE Phase 3 study evaluating the efficacy of its lead candidate ofranergene obadenovec (VB-111) in patients with recurrent glioblastoma (rGBM). Enrollment in the study, 256 patients in total, has been completed five months ahead of schedule.

 

Zogenix announced that due to the Company’s ongoing relocation of all corporate functions, including finance, from San Diego, CA, to Emeryville, CA, Ann D. Rhoads, Executive Vice President, Chief Financial Officer, Treasurer and Secretary, will depart Zogenix following a transition period. Michael P. Smith, most recently Chief Financial Officer at Raptor Pharmaceutical Corp., has been appointed to fill the position, effective January 16, 2017.  Ms. Rhoads will continue to serve as Zogenix’s Chief Financial Officer through January 16, 2017, and thereafter has agreed to provide consulting services to the Company in connection with the transition of duties to Mr. Smith, the completion of the 2016 year-end audit and related filings for the calendar year ended December 31, 2016.

 

NEOVACS announced that it will be participating in the LifeSci Advisors Corporate Access Event, hosting one-on-one meetings with investors January 9-11 at the Sir Francis Drake Hotel in San Francisco, CA. This event is being held around the 35th Annual J.P Morgan Healthcare Conference.  Neovacs will present a corporate overview at the Biomed Event – 2nd edition – on January 26 at the Salon Hoche in Paris, France.

 

Aradigm Corporation will present an overview of the Company at the 9th Annual Biotech Showcase Conference on Monday, January 9, 2017, at 5:00 p.m. Pacific time.

 

The MEDICREA Group will host one-on-one investor meetings during the 35th Annual J.P. Morgan Healthcare Conference as part of the LifeSci Advisors Corporate Access Event at the Sir Francis Drake Hotel in San Francisco, CA.

 

OncoGenex Pharmaceuticals and Achieve Life Science announced that they have entered into a definitive merger agreement under which OncoGenex will acquire Achieve in an all-stock transaction. Upon completion of the proposed merger, Achieve’s equity holders are expected to own 75% of the combined company’s outstanding shares and current stockholders of OncoGenex are expected to own the remaining 25% of the combined company’s outstanding shares.  Following completion of the merger, OncoGenex Pharmaceuticals will be renamed Achieve Life Sciences. In addition, prior to the completion of the proposed merger, OncoGenex is expected to distribute to its stockholders contingent value rights (CVRs) for 80% of any net proceeds of certain payments arising from a future sale, transfer, license or similar transaction involving OncoGenex’s apatorsen oncology product candidate.

 

Stemline Therapeutics announced an agreement with the FDA on the registration pathway for SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN). To support the filing of a BLA for full approval in first-line BPDCN, Stemline is currently enrolling an additional small cohort, planned for 8-12 first-line BPDCN patients, into its ongoing Phase II trial. To date, approximately half of these new patients are enrolled into the study, with full enrollment expected this quarter. Stemline intends to file a BLA in 2H17, which is anticipated to undergo an expedited review given SL-401’s Breakthrough Therapy Designation. If successful, Stemline projects a commercial launch of SL-401 in 2018.

 

Ionis Pharmaceuticals and Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals, announced an exclusive, worldwide option and collaboration agreement with Novartis to develop and commercialize AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx). Ionis and Akcea are eligible to receive $225 million in near-term payments, including an immediate $75 million up-front option payment and a $100 million equity investment in Ionis, which equates to 1,631,435 shares at $61.30 per share. Ionis and Akcea are also eligible to receive a license fee as well as development, regulatory and commercial milestone payments as each drug advances. In addition, Ionis and Akcea are eligible to receive tiered royalties in the mid-teens to low twenty percent range on net sales of each drug.

 

Regeneron Pharmaceuticals and Sanofi announced that they will appeal the injunction granted by the U.S. District Court for the District of Delaware preventing the marketing, selling or manufacturing of Praluent in the U.S. during the term of two Amgen patents. The companies believe Amgen’s asserted patent claims are invalid and will also appeal a prior jury verdict upholding the validity of those patents. The court has delayed imposition of the injunction for 30 days to allow Sanofi and Regeneron to file a motion for a suspension (stay) of this injunction during the appeal process. Praluent continues to be available to patients at this time. Following the news, Baird analyst Brian Skorney increased his price target of Amgen to $165 from $157; Goldman analyst Terence Flynn increased his price target of Amgen to $218 from $202. Goldman analyst Terence Flynn decreased his price target of Regeneron to $448 from $514; Baird analyst Brian Skorney decreased his price target of Regeneron to $369 from $379; SunTrust analyst Yatin Suneja decreased his price target of Regeneron to $375 from $410; RBC analyst Adnan Butt decreased his price target of Regeneron to $598 from $626; Jefferies analyst Biren Amin decreased his price target of Regeneron to $349 from $394.

 

Neurocrine Biosciences announced that the FDA, after further review of the INGREZZA (valbenazine) NDA, has decided to cancel the Psychopharmacologic Drugs Advisory Committee meeting which was originally scheduled for February 16, 2017. The FDA informed the Company that the Priority Review of the NDA of INGREZZA for the treatment of tardive dyskinesia is continuing as planned with the previously announced PDUFA target action date of April 11, 2017. The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials along with the results from another 18 clinical trials; extensive preclinical testing and drug manufacturing data were included in the NDA submission. The FDA granted Breakthrough Therapy Designation to INGREZZA for tardive dyskinesia in 2014.

 

Dow Jones reported that Teva Pharmaceutical Industries released a downbeat earnings forecast for fiscal 2017. Teva expects revenue of $23.8 billion to $24.5 billion and adjusted earnings per share of $4.90 to $5.30. Analysts from Thomson Reuters had expected $25.32 billion in revenue and earnings per share of $5.82.

 

Genentech, a member of the Roche Group, announced that the FDA has approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.  This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with Lucentis were more than 12 letters, compared to 1.4 letters for those treated with vPDT.

 

Roche announced that it received clearance from FDA via Direct de novo decision on their Anti-Müllerian (AMH) assay, making it the first approved fully automated AMH test available in the U.S to doctors looking to help women who are planning to become pregnant or struggling with infertility.

 

PTC Therapeutics announced that the FDA has granted orphan drug designation (ODD) to RG7916 for the treatment of patients with Spinal Muscular Atrophy (SMA). RG7916 is part of PTC’s joint development program in SMA with Roche and the SMA Foundation (SMAF).

 

Acceleron Pharma announced its major corporate research and development goals and priorities for 2017.

 

ContraFect provided an update on its clinical development timeline for CF-301. The company now expects to initiate the Phase II study of CF-301 in patients with Staphylococcus aureus (Staph aureus) bacteremia in mid-2017, as an investigational drug product lot did not meet manufacturing release specifications.

 

Xenetic Biosciences announced that Xenetic received a $3 million milestone payment from Shire related to Shire’s advancing the Phase I/IIa clinical study for the PSA-Recombinant SHP656 or Factor VIII ("FVIII") being developed as a long-acting therapeutic for the treatment of hemophilia. The stated goal of Shire is to introduce an innovative FVIII protein that can significantly prolong the circulating half-life of the FVIII protein, with the objective of providing a once weekly treatment or reaching higher trough activity levels for greater efficacy.

 

Momenta Pharmaceuticals and CSL Limited announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize Fc multimer proteins, including Momenta’s M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic in 2017. Momenta will receive a $50 million upfront license fee from CSL and is eligible to receive future milestone and royalty payments for M230. In addition to advancing M230, CSL and Momenta intend to enter into a research collaboration to develop additional Fc multimer proteins that may originate from Momenta’s or CSL’s research.

 

Chimerix announced the appointments of Randall Lanier, PhD, as Chief Science Officer and Roy W. Ware, PhD, MBA, as Chief Manufacturing and Technology Officer. Dr. Lanier will continue to oversee preclinical screening programs, biology and virology. Dr. Ware will oversee manufacturing, clinical trial material sourcing, medicinal and process chemistry, and analytical and pharmaceutical development. Together they will lead the Chimerix Discovery effort.

 

Mirati Therapeutics announced data from two ongoing clinical programs, including the Phase Ib and Phase II trials of glesatinib, a spectrum selective kinase inhibitor for the treatment of non-small cell lung cancer (NSCLC) patients with genetic alterations of MET, and the Phase Ib trial of sitravatinib, a receptor tyrosine kinase inhibitor for the treatment of genetically-selected NSCLC and other solid tumors.

 

Revance Therapeutics defined key 2017 clinical milestones for DaxibotulinumtoxinA for Injection (RT002) and provided its financial outlook for 2017. The company also announced its unaudited December 31, 2016 cash and investments balance was $185 million and now expects its cash and investments to fund the company into the third quarter of 2018.

 

MacroGenics announced that the FDA has granted orphan drug designation to MGD006 (also known as S80880), a DART molecule that recognizes both CD123 and CD3, for the investigational treatment of acute myeloid leukemia (AML). MGD006 is currently being evaluated in the U.S. and Europe in a Phase I dose-escalation study designed to assess the safety and tolerability of the molecule in patients with relapsed/refractory AML or myelodysplastic syndrome (MDS). MacroGenics retains full development and commercialization rights to MGD006 in the U.S., Canada, Mexico, Japan, South Korea and India. Servier participates in the development and has rights to MGD006 in all other countries.

 

Clearside Biomedical announced it has received a NOA from the USPTO for U.S. Patent Application Number 15/086,485 entitled, “Methods and Devices for the Treatment of Ocular Diseases in Human Subjects.”

 

Intellipharmaceutics International announced that its United States ("U.S.") marketing partner, Par Pharmaceutical, has launched the 25 and 35 mg strengths of its generic Focalin XR (dexmethylphenidate hydrochloride extended-release) capsules in the U.S. The FDAhas granted final approval to Par’s ANDA for its generic Focalin XR capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. The Company is unable to state or estimate an actual launch date of any remaining strengths, but currently intends to provide an update once it is advised by Par of the launch of any additional strengths of its generic Focalin XR.

 

Chimerix announced preliminary data from an ongoing Phase I study to investigate the safety, tolerability and plasma/intracellular concentration of intravenous (IV) brincidofovir (BCV) following single escalating doses in healthy adult subjects.

 

Juniper Pharmaceuticals announced plans for 2017 that are expected to enable the company to submit IND applications for its hormone-delivery intravaginal ring (IVR) candidates in the first half of 2018.

 

RedHill Biopharma announced the presentation of an abstract relating to YELIVA, the Company’s proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, at the 2017 Cholangiocarcinoma Foundation Annual Conference, on February 2, 2017, in Salt Lake City, UT.

 

Adaptive Biotechnologies announced it has entered into an agreement with Amgen to further develop and commercialize Adaptive’s NGS-based clonoSEQ Assay to assess minimal residual disease (MRD) in patients with Acute Lymphoblastic Leukemia (ALL).

 

Orexigen Therapeutics announced that results of its IGNITE study were published online by Obesity, the peer-reviewed journal of The Obesity Society. The IGNITE study was an open-label randomized Phase IIIb study designed to evaluate the use of Contrave in combination with a commercially-available comprehensive lifestyle intervention program compared with usual care in a real-world weight-loss setting. Study results showed that treatment with Contrave, when used in a manner consistent with prescribing information in the U.S. and EU, resulted in a significant decrease in body weight compared with usual care.

 

Puma Biotechnology expanded the fourth cohort from its Phase II SUMMIT clinical trial of its lead drug candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation (basket trial). The cohort that has been expanded is the cohort that includes patients with metastatic cervical cancer and whose tumors have a HER2 mutation.

 

China Biologic Products announced that its majority-owned subsidiary Shandong Taibang Biological Products Co. Ltd. received two approvals from the Shandong Provincial Health and Family Planning Commission on December 30, 2016 to build a new plasma collection station and a new branch collection facility, respectively, in Shandong Province.

 

Tyme Technologies announced the appointment of Shabnam Stanicky as COO.

 

Neurocrine Biosciences announced that David-Alexandre "DA" Gros M.D. has joined the executive management team as President and COO.

 

Impax Laboratories confirmed that it has filed an ANDA with the FDA containing a paragraph IV certification for a generic version of Aubagio (teriflunomide) tablets, 14 mg.

 

Foundation Medicine announced that, as part of the succession of its executive leadership, the Board of Directors has appointed Troy Cox as CEO to succeed Michael Pellini, M.D. Dr. Pellini, who has served as CEO of the company since 2011, has been appointed chairman of the company’s Board of Directors. Alexis Borisy, founding CEO and current chairman of the board for Foundation Medicine, will continue to serve on the Board of Directors. Mr. Cox will also join the Board of Directors. All of these changes will become effective by February 6, 2017.

 

REGENXBIO provided a year-end 2016 corporate update.

 

Adamas Pharmaceuticals announced that the FDA has accepted for review the NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The ADS-5102 application has been given a PDUFA target action date of August 24, 2017.

 

TARIS Biomedical announced that it has closed initial enrollment in its Phase Ib clinical trial of TAR-200 (GemRIS) following highly positive results. TAR-200, a drug-device combination product utilizing the TARIS System, is designed to release gemcitabine continuously into the bladder over 7 days. This open-label study assessed the safety and tolerability of TAR-200 when used in patients with MIBC following initial diagnosis and prior to radical cystectomy. In addition, the study evaluated anti-tumor activity at Day 28 of the study. The treatment regimen employed in this study included two system deployments separated by a 14-day rest period.

 

BioAtla and F1 Oncology announced a global license agreement to combine BioAtla’s CAB technology with F1 Oncology’s proprietary technologies to develop and commercialize chimeric antigen receptor T-cell (CAR-T) therapies and other ACTs for the treatment of cancer. 

 

Alexion Pharmaceuticals announced that the FDA has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).

 

Bristol-Myers Squibb and GeneCentric Diagnostics announced a biomarker research collaboration to explore whether the application of GeneCentric’s Cancer Subtype Platform (CSP) might be able to identify translational biomarkers for Opdivo (nivolumab), which may help inform future clinical trials. Additionally, GeneCentric announced it has secured equity funding from Bristol-Myers Squibb that will support the clinical development of GeneCentric’s CSP and build-out of GeneCentric’s new laboratory in Research Triangle Park.

 

Myriad Genetics announced that multiple Blue Cross Blue Shield (BCBS) affiliate plans have issued positive coverage determinations for EndoPredict, including Independence Blue Cross, Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of Kansas City, Horizon Blue Cross Blue Shield of New Jersey and BlueCross BlueShield of South Carolina. These five BCBS plans provide coverage for an additional 12 million patients in the United States. EndoPredict is a second-generation, multigene test that is designed to predict disease recurrence in patients diagnosed with breast cancer.

 

Dermira provided an update on its clinical development programs and recent leadership additions.

 

Pacira Pharmaceuticals reported preliminary unaudited total revenues and EXPAREL (bupivacaine liposome injectable suspension) net product sales for the fourth quarter and full-year 2016.

 

Mirati Therapeutics announced the pricing of an underwritten public offering of 4,350,176 shares of its common stock at a price to the public of $5.60 per share. In addition, and in lieu of common stock, Mirati is offering to funds affiliated with Boxer Capital pre-funded warrants to purchase up to an aggregate of 7,258,263 shares of common stock at a purchase price of $5.599 per warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds from this offering are expected to be approximately $65.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati. The offering is expected to close on or about January 11, 2017, subject to customary closing conditions. Mirati has granted the underwriters a 30-day option to purchase up to an additional 652,526 shares of common stock in connection with the public offering. All of the securities are being offered by Mirati. Mirati expects to use the net proceeds from this offering for general corporate purposes, including for clinical development of glesatinib, sitravatinib and mocetinostat, as well as for development of preclinical programs and working capital. Leerink Partners is acting as sole book-running manager in the offering.

 

 

ANALYST RECOMMENDATIONS

 

BTIG analyst Robert Hazlett initiated coverage of Nektar Therapeutics with a “buy” rating and $22 price target, citing Nektar is advancing polymer conjugation to new heights, enhancing and broadening the once standard technology for biological applications to small molecules and cytokines.

 

BTIG analyst Dane Leone initiated coverage of Loxo Oncology with a “buy” rating and $52 price target, citing LOXO-101 data to date looks best in class for the NTRK inhibitors, and the LOXO-195 strategy provides a durable advantage for the NTRK franchise; positive expectations for the read-out of the pivotal NAVIGATE study during late 3Q17; and concerns regarding a commercial launch of LOXO-101 are misplaced as the key target indications such as Non-Small Cell Lung Cancer (NSCLC), already have well engrained processes for genomic profiling.

 

JMP analyst Jason Butler upgraded Zafgen to “market outperform” from “market perform,” citing expectations of positive Phase 1 results for ZGN-1061.

 

Jefferies analyst Gena Wang initiated coverage of Abeona with a “buy” rating and $11 price target, citing ABEO uses validated AAV9 vectors to develop gene therapies in lysosomal storage diseases with brain manifestations.  

 

Credit Suisse analyst Kennen MacKay made price target changes to the following companies: Acceleron Pharma to $46 from $42; FibroGen to $44 from $39; Five Prime Therapeutics to $64 from $54; OvaScience to $1 from $2; Prothena to $69 from $63; Puma Biotechnology to $107 from $111; Seattle Genetics to $62 from $60; UltraGenyx Pharmaceutical to $90 from $104.

 

SunTrust analyst John Boris increased his price target of Revance Therapeutics to $32 from $22, citing a catalyst-rich year drives value.

 

Roth Capital analyst Scott Henry initiated coverage of BioPharmX with a “buy” rating and $3 price target, citing potential of its novel topical acne treatment BPX-01.

 

BMO analyst Do Kim revised his price target of the following companies: Aeglea Bio Therapeutics increased to $21 from $19; Alexion increased to $170 from $165; Amgen increased to $197 from $186; Biogen increased to $336 from $328; Biomarin decreased to $115 from $119; Celgene increased to $144 from $142; Intercept decreased to $198 from $204; Myokardia increased to $28 from $27; Vertex decreased to $78 from $88.

 

Citi analyst Joel Beatty downgraded Halozyme Therapeutics to “neutral” from “buy,” citing the stock price now fairly reflects the value of PEGPH20 after it traded higher yesterday, and a lack of major catalysts over the next 12 months.