BioShares Biotechnology Clinical Trials (BBC): $22.31, -$0.56, +21.2% YTD

BioShares Biotechnology Products (BBP): $37.72, -$0.66, +15.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were slightly lower ahead of a crucial jobs report that could bolster expectations of a U.S. interest rate hike next week. The ADP national employment report, labor costs, productivity and wholesale inventory data are on the economic calendar. European shares traded lower as EDF plunged to a fresh all-time low after the French government stake sale, while Asian stocks closed lower mostly. Gold slipped as the dollar strengthened. Oil prices fell as data showed growing U.S. crude stockpiles.

 

MARKET HIGHLIGHTS

 

Catalyst Biosciences announced financial results for the fourth quarter and full year ended December 31, 2016.  Net loss for the three months ended December 31, 2016 was $3.7 million, or ($4.68) per basic and diluted share, compared to $5.1 million, or ($6.73) per basic and diluted share, for the prior year period. Net loss for the years ended December 31, 2016 and 2015 was $16.9 million, or ($21.75) basic and diluted share, compared to $14.8 million, or ($49.99) per basic and diluted share, for the prior year.

Cash, cash equivalents and short-term investments as of December 31, 2016 and 2015 were $17.1 million and $32.5 million, respectively. The Company believes that its existing capital resources will be sufficient to meet its projected operating requirements for at least the next 12 months.

 

Kitov Pharmaceuticals Holdings announced that the Company has signed a definitive License Agreement for its lead product candidate, KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension, for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd., a leading South Korea-based pharmaceutical company.  Upon receipt of marketing authorization in South Korea, Kuhnil will have the exclusive right and license to manufacture, distribute and sell KIT-302 in South Korea.  Kuhnil will be responsible for seeking regulatory approval for KIT-302 in South Korea.

 

Mateon Therapeutics will present a company overview at the 29th Annual ROTH Conference on Wednesday, March 15th.

 

AzurRx BioPharma today announced the appointment of Charles J “Chuck” Casamento to the Board of Directors effective March 3, 2017.

 

Heat Biologics announced that the company has entered into a definitive agreement with the holders of 75.5% of the outstanding capital stock of Pelican Therapeutics to acquire an 80% controlling interest in Pelican. Headquartered in Austin, Texas, Pelican is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a highly differentiated and potentially “best-in-class” T cell costimulatory receptor.

 

Intellia Therapeutics reported updated data showing increased levels of genome editing efficiency in vivo and durability results with its CRISPR/Cas9 technology, following a single administration. Using its lipid nanoparticle (LNP) technology, Intellia achieved approximately a 97 percent reduction in serum transthyretin (TTR) protein driven by 70 percent gene editing efficiency in the mouse liver.

 

Teligent announced it has received approval of the Company’s ANDA from the FDA of Clobetasol Propionate Gel, 0.05%.  This is Teligent’s second approval for 2017, and its thirteenth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

 

Keryx Biopharmaceuticals announced that the FDA has accepted for review the sNDA for Auryxia (ferric citrate) tablets. The sNDA acceptance by the FDA indicates that the application is sufficiently complete to permit a substantive review. The PDUFA target action date for completion of the FDA’s review is November 6, 2017.

 

OPKO Health, through its subsidiaries, Eirgen Pharma Limited, Ireland and OPKO Pharmaceuticals LLC, has received notification from the European Commission designating OPKO’s oligonucleotide-based AntagoNAT (CUR-1916) an orphan medicinal product under Regulation (EC) No 141/2000 for the treatment of Dravet Syndrome.  An Orphan Drug Application is under review by the FDA. There is currently no approved treatment for Dravet Syndrome in the U.S.

 

Cellectar Biosciences announced it has entered into a licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property rights covering the method of use (MOU) for the company’s lead PDC compound, CLR 131, in multiple myeloma.

 

Sucampo Pharmaceuticals reported consolidated financial results for the fourth quarter and full year ended December 31, 2016.

 

Flex Pharma reported financial results for the year ended December 31, 2016 and provided an update on its clinical development and corporate activities. Total revenue for the three months ended December 31, 2016, was approximately $299,000, including approximately $291,000 of net product revenue and approximately $8,000 of other revenue. Net loss for the three months ended December 31, 2016 was ($7.9) million, or ($0.48) per share and included $1.2 million of stock compensation expense.

 

Allergan announced that the FDA has accepted for filing the company’s sNDA for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating VRAYLAR for the maintenance of efficacy in adults with schizophrenia to the current product label.

 

Matinas BioPharma Holdings announced positive efficacy results from the study of MAT2501 in an in vitro preclinical model of Mycobacterium abscessus. This study was conducted in collaboration between Matinas BioPharma and Colorado State University (CSU), supported, in part, through a contract from the Division of Microbiology and Infectious Diseases, NIAID, National Institutes of Health.

 

Ocera Therapeutics announced it will report additional encouraging results from its Phase IIb STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy (HE) at the Cowen and Company 37(th) Annual Healthcare Conference.

 

Abeona Therapeutics announced that the EMA Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Abeona’s EB-101 gene therapy program for patients with recessive dystrophic epidermolysis bullosa (RDEB), a devastating, life-threatening genetic skin disorder that is characterized by skin blisters and erosions all over the body.

 

Celyad announced that the U.S. FDA authorized the initiation of the THINK trial in the U.S. THINK evaluates NKR-2 CAR-T cells in seven indications, five solid cancers and two hematological malignancies.

 

Innovus Pharmaceuticals announced that it received the CPNP notification number required to commercialize Sensum+ in all 28 member countries of the European Union.

 

Creative Medical Technology Holdings announced the appointment of Dr. Thomas Ichim to the position of Chief Scientific Officer.  Dr. Ichim will lead development of the Company’s clinical stage CaverStem personalized stem cell therapy for erectile dysfunction, as well as advance preclinical and eventually clinical studies on the Company’s universal donor AmnioStem stem cell therapy for post-stroke recovery.

 

Alexion Pharmaceuticals announced that the FDA has accepted for review the Company’s sBLA to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The sBLA submission is supported by comprehensive data from the Phase III REGAIN study. The FDA set a PDUFA date of October 23, 2017.

 

BerGenBio ASA announced it has entered into a collaborative agreement with Merck through a subsidiary, focused on the clinical evaluation of BGB324 with KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

 

Cellceutix announced interim results in the first two cohorts of its ongoing Phase IIa clinical trial of Brilacidin for the induction of remission of mild-to-moderate Ulcerative Colitis. Patient recruitment to the third cohort (highest dose) is currently underway. Patients include those with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).

 

Valeant Pharmaceuticals has commenced an offer to purchase for cash up to $600,000,000 aggregate principal amount of the Company’s outstanding 6.75% Senior Notes Due 2018 upon terms and subject to the conditions set forth in the Offer to Purchase, dated March 7, 2017, and a related Letter of Transmittal.

 

Pacira Pharmaceuticals announced the pricing of $300 million aggregate principal amount of convertible senior notes due 2022 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Pacira also granted the initial purchasers of the notes a 30-day option to purchase up to an additional $45 million aggregate principal amount of notes.  The sale of the notes to the initial purchasers is expected to settle on March 13, 2017, subject to customary closing conditions, and is expected to result in approximately $290 million of net proceeds to Pacira after deducting fees and estimated offering expenses payable by Pacira (assuming no exercise of the initial purchasers’ option to purchase additional notes).

 

Dermira announced that it has closed its previously announced public offering of 5,750,000 shares of its common stock, including 750,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock, at a price to the public of $33.70 per share. The aggregate gross proceeds to Dermira from the offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $193.8 million. Leerink Partners, Evercore Group and Guggenheim Securities acted as joint book-running managers for the offering. Needham & Company acted as co-manager.

 

Kite Pharma announced the closing of its previously announced underwritten public offering of 4,750,000 shares of its common stock at a price to the public of $75.00 per share, as well as the exercise in full of the underwriters’ option to purchase 712,500 additional shares. Including the option exercise, the total gross proceeds to Kite from the offering are expected to be approximately $409.7 million, before deducting the underwriting discounts and commissions and estimated offering expenses. The closing of the option exercise is expected to occur on or about March 10, 2017, subject to customary closing conditions. Jefferies LLC acted as sole book-running manager for the offering. Cowen and Company, LLC, RBC Capital Markets, LLC and Guggenheim Securities, LLC acted as co-managers.

 

 

ANALYST RECOMMENDATIONS

 

Following Aerie Pharmaceuticals’ earnings, Cantor analyst Elemer Piros increased his price target to $56 from $50; Needham analyst Serge Belanger increased his price target to $58 from $52; JMP analyst Donald Ellis increased his price target to $57 from $49; Canaccord analyst Dewey Steadman increased his price target to $56 from $50; RBC analyst Adnan Butt increased his price target to $55 from $54.

 

Susquehanna analyst Andrew Finkelstein downgraded Impax Labs to “neutral” from “positive” and decreased his price target to $10 from $18, citing a lack of compelling risk/reward on a quick takeout deal vs. a challenging near-term outlook and lingering downside risks.

 

Deutsche Bank analyst Gregg Gilbert upgraded Impax Labs to “buy” from “hold,” citing stand-alone assumptions as well as potential M&A.

 

SunTrust analyst Peter Lawson increased his price target of Incyte to $160 from $140, citing Incyte is well positioned heading into 2017 with data readouts from multiple IO combination trials with epacadostat.

 

Wells Fargo analyst Jim Birchenough initiated coverage of Bellicum with an “outperform” rating and $28-$31 valuation range, citing positive outlook for BLCM is based on the company’s leading position in controllable cell therapies, for use in allogeneic (donor-sourced) transplant, CART therapeutics, and engineered T-cell receptor therapeutics.

 

Rodman & Renshaw analyst Joseph Pantginis initiated coverage of Cytokinetics with a “buy” rating and $25 price target, citing the company has strong clinical data in hand for its two lead assets (omecamtiv mecarbil and tirasemtiv), two pharma partners, strong cash, and has reached a critical execution phase in the company’s history.

 

Aegis analyst Jason Wittes increased his price target of Progenics to $14 from $11, citing expectations of a faster adoption ramp for Azedra.