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LifeSci Launches LifeSci Public Relations

LifeSci Public Relations offers expert public and media relations support and strategic corporate communications counsel. The firm is led by an expert team with a long track record of successfully implementing public relations programs for public and private healthcare companies across multiple industry sectors. LifeSci PR will provide its clients with a unique opportunity to build corporate, clinical, product and disease awareness by fostering relationships with prominent industry influencers and by communicating through traditional and other innovative media platforms. LifeSci Public Relations’ offering will integrate with that of LifeSci’s broader investor relations and capital markets offerings, providing significant communications synergy and value to the firm’s clients.  For more information see our news release here, visit www.lifescipublicrelations.com or contact us at info@lifescipublicrelations.com.

 

 

MARKET COMMENTARY

 

Hopes of business-friendly tax cuts in the United States coupled with upbeat Chinese trade data boosted riskier assets, pushing global stock markets higher. U.S. stock index futures and the dollar gained, while gold retreated further from this week’s three-month high. The day’s economic calendar carries import and export prices, U-Mich sentiment and federal budget. OPEC-led production cuts pushed the oil up.

 

 

MARKET HIGHLIGHTS

 

BioTime announced the pricing of an underwritten public offering of 6,481,482 shares of its common stock at a public offering price of $2.70 per share. The gross proceeds to BioTime, Inc. from this offering are expected to be approximately $17.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioTime, Inc. The offering is expected to close on or about February 15, 2017, subject to customary closing conditions. BioTime, Inc. has also granted to the underwriters a 30-day option to purchase from it up to an additional 972,222 shares of its common stock, to cover over allotments, if any. BioTime, Inc. intends to use the net proceeds from this offering for general corporate purposes, including, without limitation, to fund clinical trials, research and development activities and for general working capital. Raymond James is acting as sole book-running manager for the offering. Ladenburg Thalmann, Chardan and LifeSci Capital are acting as co-managers.

 

Catalyst Biosciences announced a reverse stock split of its shares of common stock at a ratio of one-for-fifteen. The reverse stock split will be effective at 5:00 p.m. Eastern Time on February 10, 2017. At the opening of trading on February 13, 2017, Catalyst’s common stock will begin trading on a split-adjusted basis and the number of shares of Catalyst’s common stock outstanding will decrease from approximately 13.0 million pre-split shares to approximately 868,000 post-split shares.

 

Santhera Pharmaceuticals announced the successful placement of CHF 60 million senior unsecured convertible bonds due 2022.  Santhera has successfully placed CHF 60 million senior unsecured convertible bonds (the "Convertible Bonds") due 2022. The Company intends to use the net proceeds from this placement primarily to fund the commercialization of Raxone® in the currently approved indication, to prepare the market entry and commercial launch in subsequent indications, for investment into further clinical trials with Raxone and for other corporate purposes.

 

TRACON Pharmaceuticals reported top-line results from a randomized Phase 2 clinical trial of TRC105 in recurrent glioblastoma (GBM) funded and conducted by the Clinical Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).  In the trial, TRC105 combined with Avastin® (bevacizumab) was compared to single agent Avastin in a total of 101 patients with recurrent GBM following chemoradiation.  The trial was designed to detect a three-month improvement in progression free survival (PFS), the primary endpoint, from the expected value of 3.45 months with single agent Avastin. Top-line data indicate that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed data and the associated correlative analyses are expected to be presented at an oncology conference later this year.

 

Achaogen will be participating in the Leerink Partners 6th Annual Global Healthcare Conference at 2:30 p.m. Eastern Time on Thursday, February 16th, 2017.

 

After yesterday’s close, Seattle Genetics reported 4Q16 GAAP EPS loss of $0.39, which compares to a loss of $0.18 for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $0.35. Total revenue for 4Q16 was $105.3 million, which compares to $93.5 million for the same period a year ago. This compares to a mean estimate of $105.0 million. Following earnings, Piper Jaffray analyst Edward Tenthoff increased his price target to $55 from $42; SunTrust analyst Yatin Suneja increased his price target to $50 from $45; Cowen analyst Boris Peaker increased his price target to $53 from $47; Morgan Stanley analyst Andrew Berens decreased his price target to $70 from $72; Leerink analyst Michael Schmidt decreased his price target to $70 from $72; Goldman Sachs analyst Salveen Richter decreased her price target to $48 from $49; Bank of America/Merrill Lynch analyst Tazeen Ahmad downgraded the company to “underperform” from “neutral” and decreased her price target to $56 from $58.

 

Seattle Genetics announced a development and license agreement with Immunomedics under which Seattle Genetics would receive exclusive worldwide rights to develop, manufacture and commercialize sacituzumab govitecan (IMMU-132). Sacituzumab govitecan is an antibody-drug conjugate (ADC) targeted to TROP-2, which is expressed in several solid tumors including cancers of the breast, lung and bladder. Sacituzumab govitecan is in a phase I/II trial for patients with triple negative breast cancer (TNBC), as well as multiple other solid tumors. It received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with TNBC who have failed prior therapies for metastatic disease. Data from the phase I/II trial are intended to serve as the basis for a planned BLA submission under the FDA’s accelerated approval regulations.

 

Marathon Pharmaceuticals announced that the FDA has granted approval of EMFLAZA (deflazacort) for the treatment of Duchenne muscular dystrophy in patients 5 years and older.

 

Neurocrine Biosciences and BIAL announced that they have entered into an exclusive licensing agreement for the development and commercialization of opicapone in North America. ONGENTYS (opicapone) is a once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor) that was approved in June 2016 by the European Commission as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.

 

Syros Pharmaceuticals announced the publication of a paper in a special cancer-focused issue of the scientific journal Cell that highlights gene control as an important area for cancer drug discovery and development, underscoring the promise of Syros’ pioneering approach to advance a new wave of medicines that control the expression of disease-driving genes.

 

AVEO Oncology announced clinical and regulatory updates for its lead drug candidate, tivozanib, an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). The Company announced today that its pivotal, Phase III TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), is enrolling substantially ahead of schedule. The Company now expects TIVO-3 to complete enrollment in June 2017, ahead of its prior guidance of August 2017. Because the study is event driven the Company is not revising the anticipated time to topline data at this time, which is currently expected in the first quarter of 2018. TIVO-3 is expected to undergo a pre-planned futility analysis around midyear. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support first and third line indications for tivozanib in the U.S.

 

Cellceutix announced that the Company has initiated its main clinical site for the start of its Phase IIa clinical trial of the p53 drug candidate Kevetrin in the treatment of platinum-resistant/refractory ovarian cancer.

 

Biostage announced the pricing of a public offering with expected total gross proceeds of approximately $8.0 million.  The offering is expected to close on or about February 15, 2017, subject to satisfaction of customary closing conditions.

 

On February 8, 2017, Acorda Therapeutics entered into a settlement agreement with Apotex Corporation and Apotex Inc. to resolve pending patent litigation brought by the Company against Apotex involving Ampyra (dalfampridine) Extended- Release Tablets. The pending patent litigation was filed by the Company in the U.S. District Court for the District of Delaware in response to Apotex’s submission of an ANDA to the FDA, seeking marketing approval for a generic version of Ampyra. As a result of the settlement agreement, Apotex will be permitted to market a generic version of Ampyra in the United States at a specified date in 2025, or potentially earlier under certain circumstances. The parties will request that the Court enter a Consent Order, in which it will dismiss the Company’s litigation against Apotex referred to above. Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The settlement with Apotex does not resolve pending patent litigation brought by the Company against other parties who have submitted ANDAs to the FDA seeking marketing approval for generic versions of Ampyra. The expiration date for the Company’s latest expiring Ampyra patent listed in the FDA’s Orange Book is May 2027.

 

Immunomedics announced it has postponed the Company’s 2016 Annual Meeting of Stockholders previously scheduled for February 16, 2017. The Annual Meeting has been postponed to March 3, 2017 at 10:00 a.m. Eastern Time and will be held at the Executive Offices of Immunomedics, Inc., located at 300 The American Road, Morris Plains, New Jersey 07950. The record date of January 24, 2017 has not changed.

 

Crescita Therapeutics announced that Ms. Muneerah Kanji, MBA, CPA, CA, Crescita’s Corporate Controller, has assumed the role of Interim Chief Financial Officer replacing Mr. Mario Laflamme who has resigned for health-related family reasons. Crescita has commenced a formal search process for a new Chief Financial Officer.

 

ITUS is changing the Record Date for its current stock rights offering. The new Record Date will be Wednesday, March 1, 2017. For new shareholders to be eligible for the rights offering, shareholders will need to purchase ITUS common stock by Friday, February 24, 2017.

 

 

ANALYST RECOMMENDATIONS

 

Jefferies analyst Matthew Andrews assumed coverage of Spectrum with a “buy” rating and $7.50, citing SPPI is undervalued based on Rolontis’ LT promise in chemotherapy-induced neutropenia.

 

Deutsche Bank analyst Andrew Peters increased his price target of Neurocrine to $63 from $62, citing the deal appears to be a smart way to leverage the commercial infrastructure with a late-stage asset.

 

Leerink analyst Seamus Fernandez downgraded Tesaro to “market perform” from “outperform,” and increased his price target to $186 from $152, citing downgrade is based on price.

 

Mizuho analyst Irina Koffler downgraded Teva to “underperform” from “neutral” and decreased her price target to $27 from $40, citing there could be additional downside to the stock from an at-risk Copaxone launch any time in 2017;  Teva’s interim CEO may further reduce the 2017 outlook on Monday’s earnings call and there could be additional mgmt. departures; because of the back-loaded timing of its anticipated exclusive generics launches and uncertain execution across 40-60 smaller generic launches in a stressed organization, Teva may be forced to sell off assets or cut its dividend earlier in the year to meet aggressive debt repayment targets within 18 months after closing the Actavis deal; we are not expecting an influx of new shareholders in front of Allergan’s planned sale of over 100M Teva shares after its August lock-up period expires.

 

Following Array BioPharma’s earnings, Cowen analyst Chris Shibutani increased his price target to $15 from $10.

 

Stifel analyst Stephen Willey increased his price target of Innoviva to $14 from $13, citing the growth trajectories of each respiratory franchise (particularly Breo) and each successive quarter of operating performance provides validation of management’s original strategic initiative for delivering shareholder value through the formation of Innoviva.

 

Following Regeneron’s earnings, Raymond James analyst decreased his price target to $420 from $441; BMO analyst Matthew Luchini decreased his price target to $408 from $419; Bernstein analyst Aaron Gal decreased his price target to $410 from $420; Leerink analyst Geoffrey Porges decreased his price target to $448 from $487; Goldman analyst Terence Flynn decreased his price target to $417 from $446; Canaccord analyst John Newman decreased his price target to $375 from $450; JP Morgan analyst Cory Kasimov decreased his price target to $437 from $440.

 

Cantor Fitzgerald analyst Elemer Piros initiated coverage of Ocular with an “overweight” rating and $35 price target, citing Ocular’s portfolio of sustained release therapies have the potential to treat an array of ophthalmic conditions with significant unmet need.