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Results from a Phase 2 study, GOG-0265, evaluating Advaxis’ $ADXS lead product candidate axalimogene filolisbac in patients with persistent/recurrent metastatic carcinoma of the cervix showed a 37.5% overall survival (OS) rate at Month 12 based on 24-subject observations. The drug-maker said this is about 50% better-than-anticipated OS rate of 25%. Details of the trials will be presented at a future medical conference.

Glaxo Files BLA for shingles vaccine in U.S-GlaxoSmithKline $GSK filed a Biologics License Application (BLA) with the FDA, seeking approval of its shingles vaccine, branded as Shingrix, for the prevention of herpes zoster in people aged 50 and above. In the clinical trials, a two-dose regimen of shingrix demonstrated 90% efficacy in participants at least 70 years old and was maintained in those aged 80 and over, considerably better than Merck’s $MRK ZOSTAVAX, which is merely 18% effective in people above 80 years. Regulatory submissions in Europe and Canada will be made before the end of the year, followed by Japan next year.

Marinus to progress with Phase 2 studies with ganaxolone for treating epilepsy-Results from a 36-participant Phase 1 dose-escalation clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Marinus Pharmaceuticals’ $MRNS lead product candidate ganaxolone as an ascending bolus dose or continuous infusion achieved dose levels targeted for efficacy in patients with status epilepticus, an emergency-situation for of epilepsy characterized by prolonged or recurrent grand mal seizures. The data were shown at the 141st Annual Meeting of the American Neurological Association in Baltimore, MD. The Phase 2 clinical trial will start in 2017.

Aduro’s new patient enrollment for LADD clinical trial put on hold-Aduro Biotech $ADRO fell sharply amid heavy trading volume in response to its announcement that the FDA has put a partial clinical hold on its LADD (Listeria-based immunotherapy construct) clinical trials. The action, which halts new subjects enrollment , comes after a  blood culture sample from an indwelling port of a metastatic pancreatic cancer patient with gastrointestinal symptoms tested positive for Listeria, suspected to be product candidate CRS-207. The patient is doing well after treatment with intravenous antibiotics. Subsequent blood cultures have been Listeria-negative.

aTyr Pharma’s Resolaris Fast Tracked-The FDA designated aTyr Pharma’s $LIFE Resolaris for Fast Track review for the treatment of facioscapulohumeral muscular dystrophy (FSHD), an unusual and severe genetic disorder characterized by muscle weakness and wasting. It affects roughly 19,000 Americans every year. There no approved drugs for the ailment. Fast Track designation provides more frequent interactions with the FDA review team and a rolling review of the Biologics License Application (BLA). The company expects to submit results from three Phase 1b/2 studies in December.

The FDA on Monday approved the use of Merck’s $MRK KEYTRUDA (pembrolizumab) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumours have high (at least 50%) PD-L1 expression and no EGFR or ALK mutations.  KEYTRUDA is the foremost PD-1 inhibitor approved for these patients in a first-line setting. The data resulting in an approval was generated in the open-label Phase 3 KEYNOTE-024 clinical trial that showed the superiority of the treatment over chemotherapy as measured by progression-free survival, overall survival, and objective response rate while providing a 50% lower risk of death or cancer progression (hazard ratio: 0.50).

Global Blood Therapeutics $GBT soared in aftermarket hours on Monday amid heavy trading volume in response to its announcement that the FDA has okayed on the design of its pivotal Phase 3 clinical trial, HOPE, evaluating lead product candidate GBT440 for the treatment of adults and adolescents with sickle cell disease(SCD). GBT 440 is an oral, once-a-daily SCD therapy that functions by raising hemoglobin’s affinity for oxygen. Oxygenated hemoglobin does not polymerize which thwarts the characteristic sickling of red blood cells.

No patents to report.

Baxalta $SHPG and CTI BioPharma $CTIC have inked an agreement under which Baxalta will be returning pacritinib to CTI. As per the terms of the deal, Baxalta will pay CTI a one-time cash payment of $10.3 million as reimbursement for certain incurred or anticipated expenses. CTI will repay the $10.3 million upon the first regulatory approval or any pricing/ reimbursement approval of any product containing pacritinib. The original partnership agreement was with Baxter International, started in 2013. Baxalta, now Shire, faced difficulty in developing the drug following mixed-results in a mid-stage myelofibrosis clinical trial and an FDA clinical hold due to certain side effect.

Benitec Biopharma $BNTC entered in an oncology-focused R&D agreement with Nantworks under which the former will lead preclinical evaluation and clinical development of certain assets based on its ddRNAi technology. Specifically, it will lead clinical development of a Phase 2 gene-silencing asset for the treatment of a solid tumor indication and the commencement of a ddRNAi program to develop a second-generation therapeutic for the indication. A formal agreement is expected by the year-end.

Edge Therapeutics $EDGE filed for a Form S-3 with the U.S. Securities and Exchange Commission (SEC). According to the filing, the company may offer and sell from time to time securities described in the prospectus in one or more offerings with an aggregate initial offering price of up to $200 million.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
ACADIA Pharmaceuticals $ACAD Needham & Company Reiterate Buy $49 $94.25
Adaptimmune Therapeutics Plc $ADAP Bank of America Corp. Downgrade From Neutral to Underperform N/A N/A
Aduro Biotech $ADRO Canaccord Genuity Reiterate Outperform $14 N/A
Agios Pharmaceuticalsb $AGIO Needham & Company Initiation Buy $60 N/A
Alnylam Pharmaceuticals $ALNY Piper Jaffray Cos. Reiterate Overweight $106 Under Review
Ariad Pharmaceuticals $ARIA JPMorgan Chase & Co. Downgrade/Price Target Cut From Neutral to Underweight From $9.97 to $7 N/A
Atara Biotherapeutics $ATRA Jefferies Group Initiation Buy $23 N/A
Axovant Sciences $AXON Robert. W Baird Reiterate Outperform $29 N/A
Bristol-Myers Squibb $BMY BMO Capital Markets Price Target Cut N/A $56 N/A
Cempra $CEMP Jefferies Group Price Target Set Buy $40 $32
Check Cap Ltd. $CHEK Maxim Group Price Target Set Buy $6 N/A
CoLucid Pharmaceuticals $CLCD Stifel Nicolaus Price Target Raised Buy From $30 to $40 N/A
Concordia Healthcare $CXRX RBC Capital Markets Reiterate Outperform N/A N/A
Cytori Therapeutics $CYTX Maxim Group Price Target Set Buy $5 N/A
Fulgent Genetics $FLGT Piper Jaffray Cos. Initiation Overweight $13 N/A
Fulgent Genetics $FLGT BTIG Research Initiation Buy $15 N/A
Fulgent Genetics $FLGT Credit Suisse Group Initiation Outperform $13 N/A
Intercept Pharmaceuticals $ICPT Oppenheimer Holdings Price Target Cut Outperform From $250 to $200 N/A
Incyte $INCY RBC Capital Markets Price Target Set Buy $113 N/A
Inovio Pharmaceuticals $INO Stifel Nicolaus Price Target Cut N/A $11 N/A
Ironwood Pharmaceuticals $IRWD Wedbush Price Target Raised Neutral From $10 to $13 N/A
Ocera Therapeutics $OCRX Brean Capital Price Target Set Buy $10 N/A
Perrigo $PRGO RBC Capital Markets Reiterate Sector Perform $92 N/A
Seattle Genetics $SGEN Leerink Swann Reiterate Outperform $62 N/A
Shire Plc $SHPG JPMorgan Chase & Co. Reiterate Overweight N/A N/A
Summit Therapeutics Plc $SMMT Canaccord Genuity Price Target Set Buy $28 N/A
Teva Pharmaceuticals $TEVA Mizuho Downgrade/Price Target Cut From Buy to Neutral From $64 to $45 N/A
Vertex Pharmaceuticals $VRTX HC Wainwright Downgrade/Price Target Cut From Buy to Neutral From $155 to $85 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 1,800 shares at $9.50. The total value of the transaction was $17,091. Dr. Frost now owns 160,241,943 shares of OPK.

Acorda Therapeutics $ACOR- Richard P. Batycky, Chief Technology Officer & Site Head, sold 2,063 shares at $20.30. The total value of the transaction was $41,877. Batycky still owns 45,916 shares of ACOR.

Marinus Pharmaceuticals $MRNS- Anand Mehra, a 10% owner, sold 750,683 shares at $1.39. The total value of the transaction was $1.042 million. Mehra still owns 15,470 shares of MRNS.

Incyte $INCY- Paula J. Swain, EVP, Human Resources, sold 10,000 shares at $90. The total value of the transaction was $900,000. Swain still owns 29,248 shares of INCY.

No management changes and additions to report.

NYSE- Valeant Pharmaceuticals International $VRX shares were among the major movers on the NYSE. The stock closed 1.61% lower.

NASDAQ- Intellia Therapeutics $NTLA shares were among the major gainers on the NASDAQ. The stock closed 9.22% higher. Histogenics $HSGX ended the day 7.14% higher. Ardelyx $ARDX ended the day 5.30% higher. Inovio Pharmaceuticals $INO shares were among the major losers on the NASDAQ. The stock closed 16.39% lower. Flex Pharma $FLKS ended the day 11.17% lower. Ariad Pharmaceuticals $ARIA ended the day 9.73% lower.

NYSEMKT- Asterias Biotherapeutics $AST shares were among the major movers on the NYSEMKT. The stock closed 2.78% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Caladrius Bioscience $CLBS 0.2% 5.5% 1
Calithera Biosciences $CALA 9.1% -8% 9
Cancer Genetics $CGIX 1.4% -6.1% 2
Capricor Therapeutics $CAPR 0.7% -32.6% 1
Cara Therapeutics $CARA 14.8% 37.5% 2
Carbylan Therapeutics $CBYL 1.9% -20.7% 2
CASI Pharmaceuticals $CASI 0.7% 3.7% 2
Catabasis Pharmaceuticals $CATB 5.9% 34.7% 0
Catalyst Biosciences $CBIO 0.9% -15.3% 1
Catalyst Pharmaceuticals $CPRX 2.6% -9.8% 2