Join Now - it is FREE

Basic level includes our interactive biotech chatroom, forum, biotech stock screener; you also receive the biotech digest in your email everyday.

[/toggle]

OncoSec Medical $ONCS gained on Tuesday in response to its announcement of encouraging interim results in a mid-stage clinical trial evaluating ImmunoPulse IL-12 and Merck’s $MRK KEYTRUDA (pembrolizumab) in patients with metastatic melanoma. The results from the study will be presented on November 11 at the Society for Immunotherapy of Cancer Annual Meeting in National Harbor, MD.

Enrollment Concluded in Seattle Genetics and Takeda’s late-stage study MTCL treatment -A total of 452 participants got enrolled in a global Phase 3 study, labeled as ECHELON-2, evaluating Seattle Genetics $SGEN and Takeda Pharmaceutical Company’s $TKPHF, $TKPYY ADCETRIS (brentuximab vedotin) in combination with chemotherapy, in treatment naive patients with CD30-positive mature T-cell lymphoma (MTCL). In the study, participants will be randomized 1:1 to receive ADCETRIS plus the chemo regimen CHP (cyclophosphamide, doxorubicin, prednisone) or the chemo regiment CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), the standard-of-care frontline treatment for MTCL. The primary endpoint is progression-free survival.

 Zosano Pharma concludes enrollment in acute migraine treatment study-Zosano Pharma announced conclusion of enrollment in pivotal efficacy study of M207 for acute migraine. The pivotal efficacy study is a multicenter, double-blind, randomized, placebo-controlled study comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack.

Asterias Biotherapeutics’ first AST-OPC1 dose for spinal cord injury administered- The first subject received the highest dose of 20M cells in Asterias Biotherapeutics’ $AST Phase 1/2a Clinical Trial, labeled as SCiSTAR, evaluating AST-OPC1 (oligodendrocyte progenitor cells) in patients with complete cervical spinal cord injury. The purpose of the dose escalation is to build a thorough safety profile before advancing to 2a phase.

 Mylan files marketing application for Herceptin biosimilar- Mylan N.V. $MYL filed a Biologics License Application (BLA) to the FDA, seeking approval of its biosimilar to Roche’s $RHHBY cancer med Herceptin (trastuzumab). This is the company’s maiden BLA filing for a biosimilar in the U.S.

 DBV Tech concludes enrollment in mid-stage clinical trial- Enrollment has been concluded in a Phase 2b study, MILES, evaluating DBV Technologies’ $DBVT Viaskin Milk for the treatment of patients aged between 2 and 17 with IgE-mediated cow’s milk protein allergy (CMPA). For the clinical trial, roughly 176 children have been randomized 1:1:1:1 to receive one of the three doses of Viaskin Milk (150 ug, 300 ug, 500 ug) or placebo for 12 months. The primary endpoint is the response rate at Month 12.

 Osiris Therapeutics announces revised revenue estimates- Osiris Therapeutics $OSIR announced preliminary revenue estimates for FY2014, FY2015, and FY2016. It is expected to soon provide its exact financials, which were marred by errors. The drug-maker said its revenue estimate for 2014 is $46 million to $50 million, $85 million to $90 million for 2015 and $100 million and $110 million for 2016. It added that the estimates are preliminary and subject to change. Earnings estimates were not provided.

No approvals to report.

No patents to report.

Sorrento Therapeutics $SRNE agreed to acquire 72% of the outstanding shares of Scilex Pharmaceuticals for a net purchase price of about $47.6 million in cash and stock. Scilex’s lead product candidate is ZTlido (lidocaine patch 1.8%) under development for the treatment of postherapeutic neuralgia. The company initially filed its new drug application (NDA) with the FDA in July 2015 but got rejected. It had a meeting with the agency in late August and clarified a resubmission pathway. Action date (PDUFA) is expected in H2 2017, subject to everything going smoothly.

No secondary offerings to report.

No IPOs to report.

Taro Pharmaceuticals reported Q3 EPS of $3.00. Revenue was $228.8 million, a growth of 3.5%, Y-o-Y.

Cellular Biomedicine $CBMG reported Q3 EPS of -$0.75. Cash and cash equivalents at the end of quarter were $44.1 million compared to $14.9 million on December 31, 2015.

Adverum Biotechnologies $ADVM reported Q3 EPS of -$0.35, missing the guidance by $0.06. Revenue was $0.4 million, a drop of 57.9%, Y-o-Y, but was in –line with the guidance.

Heron Therapeutics $HRTX reported Q3 EPS of -$1.24, missing the guidance by $0.07. Cash & cash equivalents were $88.91M, at the end of the quarter.

Reprose Therapeutics $RPRX reported Q3 EPS of -$0.17, beating the guidance by $0.01. Revenue was $10K, a growth of 900%, Y-o-Y.

CTI BioPharma $CTIC reported Q3 EPS of -$0.10, missing the guidance by $0.03. Revenue was $4.44 million, a growth of 362.5%, Y-o-Y, and beating the guidance by $0.49 million.

AEterna Zentaris $AEZS reported Q3 EPS of -$0.61, beating the guidance by $0.12. Revenue was $0.3 million, a growth of 76.5%, Y-o-Y, beating the guidance by $0.14 million.

Apricus Biosciences $APRI reported Q3 EPS of -$0.19, beating the guidance by $0.41. Revenue was $4.3 million, a growth of 238.6%, Y-o-Y, and beating the estimate by $2.39 million.

Rockwell Medical $RMTI fell sharply after it reported an 11.1% drop in total sales of 12.8 million for the fiscal third quarter. Net income was ($4.6) million, a drop of 89.9%, Y-o-Y. EPS was $(0.09). Cash flows from operations for the nine months period were at $13 million, an increase of 4.1%. The consensus guidance was a loss per share of ($0.10) on revenue of $15.4 million.

Galectin Therapeutics $GALT reported Q3 EPS of -$0.19, beating the guidance by $0.03. Cash and cash equivalents at the end of the quarter were $16.06 million.

Eiger BioPharmaceuticals $EIGR reported Q3 EPS of -$1.49, missing the guidance by $0.28. Cash and cash equivalents were at $56.3 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
AbbVie $ABBV Citigroup Reiterate Buy N/A $80
AbbVie $ABBV BMO Capital Markets Reiterate Market Perform $63 $80
AbbVie $ABBV Leerink Swann Reiterate Hold N/A N/A
ACADIA Pharmaceuticals $ACAD Leerink Swann Reiterate Hold $29 $94.25
ACADIA Pharmaceuticals $ACAD Bank of America Corp. Upgrade From Neutral to Buy $35 $94.25
Agile Therapeutics $AGRX FBR & Co. Reiterate Buy $16 N/A
Achaogen $AKAO Cowen and Company Reiterate Hold N/A $23
Achaogen $AKAO Wedbush Reiterate Outperform $10 $23
Ardelyx $ARDX Wedbush Reiterate Outperform $24 N/A
Ariad Pharmaceuticals $ARIA Cowen and Company Reiterate Outperform $16 N/A
Aurinia Pharmaceuticals $AUPH HC Wainwright Reiterate Buy $10 $4.30
Axovant Sciences $AXON JMP Securities Reiterate Buy N/A N/A
Axovant Sciences $AXON HC Wainwright Reiterate Buy N/A N/A
BioCryst Pharmaceuticals $BCRX FBR & Co. Reiterate Buy $6 N/A
BioCryst Pharmaceuticals $BCRX HC Wainwright Reiterate Buy N/A N/A
Bristol-Myers Squibb $BMY Citigroup Reiterate Buy N/A N/A
Cara Therapeutics $CARA HC Wainwright Reiterate Buy N/A N/A
Cempra $CEMP Morgan Stanley Downgrade/Price Target Cut From Overweight to Underweight From $35 to $5 Under Review
Cempra $CEMP Robert W. Baird Reiterate Underperform N/A Under Review
Cempra $CEMP RBC Capital Markets Reiterate Buy $27.50 Under Review
Cempra $CEMP WBB Securities Reiterate Buy $40 Under Review
CytoSorbents $CTSO HC Wainwright Reiterate Buy N/A N/A
Concordia Healthcare $CXRX RBC Capital Markets Downgrade From Outperform to Sector Perform N/A N/A
Depomed $DEPO Cantor Fitzgerald Downgrade/Price Target From Buy to Hold From $25 to $23 $30
Depomed $DEPO Mizuho Reiterate Hold $27 $30
Egalet $EGLT Cantor Fitzgerald Reiterate Buy $21 N/A
Eiger Biopharmaceuticals $EIGR Wedbush Price Target Raised Outperform From $34 to $36 N/A
Exelixis $EXEL Cowen and Company Reiterate Outperform N/A $12.50
Fate Therapeutics $FATE Wedbush Price Target Cut Outperform From $8 to $7 N/A
Flexion Therapeutics $FLXN BCS Price Target Cut N/A From $0.65 to $0.02 N/A
Gilead Sciences $GILD Jefferies Group Reiterate Buy N/A $130
Halozyme Therapeutics $HALO Jefferies Group Reiterate Sell $6.75 N/A
Horizon Pharma $HZNP Mizuho Price Target Raised Buy From $29 to $30 N/A
Incyte $INCY Jefferies Group Reiterate Buy N/A N/A
Ionis Pharmaceuticals $IONS BMO Capital Markets Reiterate Buy $48 N/A
Eli Lilly $LLY Citigroup Reiterate Buy N/A N/A
The Medicines Company $MDCO Royal Bank of Canada Price Target Cut Outperform From $48 to $45 $50
The Medicines Company $MDCO Leerink Swann Price Target Cut Outperform From $53 to $50 $50

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 23,100 shares at $9.22. The total value of the transaction was $213,054. Dr. Frost now owns 160,326,043 shares of OPK.

No insider sells to report.

No management changes and additions to report.

NYSE- Puma Biotechnology $PBYI shares were among the major gainers on the NYSE. The stock closed 4% higher. Valeant Pharmaceuticals $VRX shares were among the major losers on the NYSE. The stock closed 21.69% lower.

NASDAQ- Osiris Therapeutics $OSIR shares were among the major gainers on the NASDAQ. The stock closed 23.63% higher. ACADIA Pharmaceuticals $ACAD ended the day 16.75% higher. Celldex Therapeutics $CLDX ended the day 14.89% higher. Rockwell Medical $RMTI shares were among the major losers on the NASDAQ. The stock closed 20.32% lower. Depomed $DEPO ended the day 16.95% lower. Cempra ended the day 13.87% lower.

NYSEMKT- Asterias Biotherapeutics $AST shares were among the major movers on the NYSEMKT. The stock closed 3.17% lower.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 7.58% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
MabVax Therapeutics $MBVX 3.8% 31% 4
Macrocure Ltd. $MCUR 1.7% 132% 0
MacroGenics $MGNX 7.9% 7.1% 12
MannKind $MNKD 30.4% -2% 41
Marinus Pharmaceuticals $MRNS 10.3% 15.6% 3
Marrone Bio Innovations $MBII 4.2% 0.7% 21