TESARO (TSRO) shares surged more than 100% on Wednesday after the company positive results from a Phase 3 clinical trial, NOVA, evaluating its PARP inhibitor niraparib in women with ovarian cancer, including those who are germline BRCA mutation carriers and those who are not germline BRCA carriers but who have homologous recombination deficient (HRD) tumors [as determined by Myriad Genetics' (NASDAQ:MYGN) myChoice HRD test]. TSRO closed at $77.40 on Wednesday. Following the positive results, FBR & Co. raised their price target on TSRO to $93. FBR’s price target still implies an upside of 20% from current levels.

Clovis Oncology (CLVS) shares surged on Wednesday, closing nearly 22% higher. The rally in CLVS shares was sparked after TESARO (TSRO) announced positive results from a late-stage study of its PARP inhibitor, niraparib. CLVS is also developing a PARP inhibitor called rucaparib.

CLVS shares have struggled ever since the rociletinib setback. However, I have noted before, at current levels, the market is not assigning much value to rucaparib, which has significant potential. If approved, rucaparib has the potential to become a blockbuster drug. CLVS’s current valuation, despite the surge on Wednesday, does not reflect this.

Aurinia Pharmaceuticals Completes Analysis of First Seven Patients in AURION Study in LN- Aurinia Pharmaceuticals (AUPH) announced that it has completed an analysis of the first 7 patients to complete 24 weeks in its open-label AURION study. At 24 weeks 57% (n=4/7) of patients continued to be in complete remission as measured by a urinary protein creatinine ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of < 5mg/day.

Galena Tumbles After Late Stage Study of NeuVax Discontinued- Galena BioPharma (GALE) shares dropped more than 80% on Wednesday after the company announced that it has discontinued its Phase 3 PRESENT Study evaluating NeuVax (nelipepimut-S) to prevent breast cancer recurrence in the adjuvant setting. The decision was taken based on recommendation from the Independent Data Monitoring Committee. An interim analysis of 71 qualifying disease-free survival events failed to show a significant effect from treatment with NeuVax. The trial remains blinded. The company says it will host a conference call next week after evaluating the data.

Omeros Announces Completion of Patient Enrollment in Pediatric Trial of OMIDRIA- Omeros Corporation (OMER) announced that it has completed enrollment in the post-marketing pediatric clinical trial that is expected to provide extended market exclusivity of its commercial product OMIDRIA (phenylephrine and ketorolac) 1% / 0.3%. The successful completion of the study will add an additional six months of marketing exclusivity. The FDA has approved OMIDRIA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.

Shire Reports Encouraging Data for SHP465- Shire (SHPG) shares rose more than 5% on Wednesday after the company announced top-line results from a Phase 3 clinical trial called study 306 evaluating its investigational SHP465 for the treatment of symptoms of attention-deficit/ hyperactivity disorder (ADHD) in adults showed a significant treatment benefit compared to placebo. The study met its primary endpoints for both doses (12.5 mg and 37.5 mg) administered once daily. Specifically, SHP465 was superior to placebo as measured by the change from baseline to week 4 in a rating scale called ADHD-RS. It was also superior to placebo on a key secondary endpoint measured by the clinical global impression improvement scale (CGI-I) at week 4. Shire plans to file a Class 2 resubmission of its New Drug Application (NDA) with the FDA by the end of the year. If all goes well, approval should happen in H2 2017. It has been a long haul. The NDA was originally filed in July 2006.

Actinium Initiates Phase 3 SIERRA Trial- Actinium Pharmaceuticals (ATNM) announced that a pivotal Phase 3 clinical trial, SIERRA, for its lead product candidate Iomab-B has been initiated. Iomab-B is intended to be an induction and conditioning agent used to prepare patients with relapsed or refractory acute myeloid leukemia (AML) who are over the age of 55 for a hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT). There are currently no effective treatments for this patient population.

Horizon Submits sNDA for RAVICTI- Horizon Pharma (HZNP) announced that it has submitted a supplemental New Drug Application (sNDA) with the FDA for RAVICTI (glycerol phenylbutyrate) Oral Liquid to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two years of age to two months of age and older. RAVICTI is currently indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

Cara Commences Phase 2/3 Study of Lead Product Candidate- Cara Therapeutics (CARA) announced that it has initiated a Phase 2/3 clinical trial evaluating its lead product candidate CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in dialysis patients. UP is a persistent itch condition associated with chronic kidney failure that affects up to half of patients. There are no approved therapies in the U.S. for the condition. The Phase 2 stage will randomize 160 patients to receive one of three doses of intravenously administered CR845 (0.5 mcg/kg, 1.0 mcg/kg or 1.5 mcg/kg) or placebo three times per week for eight weeks. The Phase 3 stage will randomize up to 240 patients to receive one optimized dose of IV CR845 or placebo three times per week for 12 weeks. Primary and secondary endpoints will include itch intensity and quality-of-life measures associated with pruritus burden.

Johnson & Johnson’s (JNJ) subsidiary Janssen Research & Development announced that the FDA has granted a fourth Breakthrough Therapy Designation (BTD) for Ibrutinib (IMBRUVICA) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. The FDA also granted the therapy Orphan Drug Designation (ODD) for cGVHD. This marks the first time ibrutinib has been granted BTD or ODD for an indication beyond hematologic malignancies

Cascadian Therapeutics (CASC) announced that the FDA has granted a Fast Track status to its lead product candidate ONT-380 for the treatment of advanced HER2+ metastatic breast cancer. The product candidate is currently being evaluated in a Phase 2 clinical trial, in combination with the chemo agent capecitabine and Roche's (RHHBY) Herceptin (trastuzumab), in 180 HER2+ metastatic breast cancer patients with and without brain metastases.

No patents to report.

Merck & Co. (MRK) announced a strategic collaboration and license agreement with Moderna Therapeutics to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and GMP manufacturing capabilities to advance individually tailored cancer vaccines for patients across a spectrum of cancers. The companies believe that the mRNA-based personalized cancer vaccines’ ability to specifically activate an individual patient’s immune system has the potential to be synergistic with checkpoint inhibitor therapies, including Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

Kitov Pharma (KTOV) announced the pricing of its follow-on equity offering. The company has priced its public offering of 2,378,823 Class A units at $3.40 per unit and 1,150,589 Class B units also at $3.40. Each Class A unit consists of one American Depositary Share (ADS) and a listed warrant (symbol: KTOVW") to purchase one ADS at $3.78. Each ADS equals 20 ordinary shares of Kitov. The listed warrants will expire on November 25, 2020. Each Class B unit consists of one non-listed pre-funded warrant to purchase one ADS and one listed warrant to purchase one ADS. The non-listed warrants will be exercisable for 10 years from the date of issuance at an exercise price of $0.01 per ADS.

Onconova Therapeutics (ONTX) announced that it has filed for changes to a planned rights offering for its stockholders. The company has made changes to key dates as well as the price range for the offering. The new record date is July 7, and Onconova will distribute 1.5 non-transferable subscription rights for each share of common stock or participating warrants. Those rights will allow for the purchase of one unit (a share of common stock plus 0.75 of a warrant), and that price per unit is now expected at $5.75-$6.25. The included warrant will allow for the purchase of a share of common stock at 120% of the unit subscription price.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Abbvie (ABBV) Credit Suisse Reiterate Outperform

$67

$80

Acceleron Pharma (XLRN) Morgan Stanley Reiterate Overweight N/A N/A
Advaxis (ADXS) HC Wainwright Reiterate Buy N/A N/A
Aimmune Therapeutics (AIMT) Piper Jaffray Reiterate Overweight

$38

N/A
Alexion Pharmaceuticals (ALXN) Cowen and Company Reiterate Buy N/A N/A
Alexion Pharmaceuticals (ALXN) Morgan Stanley Reiterate Overweight N/A N/A
Allergan (AGN) Bank of America Price Target Raised Buy From $287 to $294 N/A
Allergan (AGN) Morgan Stanley Reiterate Overweight N/A N/A
Amgen (AMGN) Goldman Sachs Reiterate Buy N/A

$250

Amgen (AMGN) Morgan Stanley Reiterate Overweight N/A

$250

Amgen (AMGN) Sanford C. Bernstein Initiation Market Perform

$161

$250

bluebird bio (BLUE) BTIG Research Reiterate Buy

$72

N/A
Biogen (BIIB) Sanford C. Bernstein Initiation Outperform

$282

N/A
Celgene (CELG) Jefferies Group Reiterate Buy

$140

N/A
Clovis Oncology (CLVS) Piper Jaffray Reiterate Hold

$14

N/A
Concordia Healthcare (CXRX) TD Securities Price Target Cut Buy From $45 to $37 N/A
Endo International Plc (ENDP) Deutsche Bank Reiterate Buy

$30

N/A
Endo International Plc (ENDP) JMP Securities Reiterate Buy N/A N/A
Endo International Plc (ENDP) Leerink Swann Reiterate Market Perform

$23

N/A
Endo International Plc (ENDP) Oppenheimer Reiterate Hold N/A N/A
Esperion Therapeutics (ESPR) Barclays Downgrade/Price Target Cut From Overweight to Equal Weight From $28 to $13 N/A
Esperion Therapeutics (ESPR) Chardan Capital Reiterate Hold N/A N/A
Esperion Therapeutics (ESPR) Citigroup Price Target Cut Buy From $36 to $22 N/A
Esperion Therapeutics (ESPR) Credit Suisse Downgrade/Price Target Cut From Neutral to Underperform From $23 to $10 N/A
Esperion Therapeutics (ESPR) JPMorgan Chase & Co. Downgrade/Price Target Cut From Overweight to Neutral From $50 to $15 N/A
Esperion Therapeutics (ESPR) Lake Street Capital Price Target Cut Buy From $80 to $27 N/A
Esperion Therapeutics (ESPR) Needham & Company Reiterate Buy

$25

N/A
Esperion Therapeutics (ESPR) RBC Capital Downgrade/Price Target Cut From Outperform to Sector Perform From $30 to $15 N/A
Galena Biopharma (GALE) Noble Financial Downgrade From Buy to Hold N/A N/A
Galena Biopharma (GALE) Raymond James Downgrade From Outperform to Market Perform N/A N/A
Gilead Sciences (GILD) BMO Capital Markets Reiterate Outperform

$97

$130

Gilead Sciences (GILD) Credit Suisse Reiterate Buy N/A

$130

Gilead Sciences (GILD) Jefferies Group Reiterate Hold

$96

$130

Gilead Sciences (GILD) Leerink Swann Reiterate Outperform

$127

$130

GW Pharmaceuticals (GWPH) Leerink Swann Reiterate Outperform

$130

N/A
Illumina (ILMN) Cantor Fitzgerald Reiterate Hold N/A N/A
Incyte (INCY) Goldman Sachs Reiterate Buy N/A N/A
Intrexon (XON) Stifel Nicolaus Reiterate Buy

$57

N/A
Intra-Cellular Therapies (ITCI) Cowen and Company Reiterate Buy N/A N/A
Lannett Company (LCI) Deutsche Bank Initiation Hold

$26

N/A
Meridian Biosciences (VIVO) Canaccord Genuity Reiterate Hold N/A N/A
Neurocrine Biosciences (NBIX) HC Wainwright Initiation Buy

$80

N/A
Novavax (NVAX) Piper Jaffray Reiterate Overweight

$14

N/A
Omeros (OMER) FBR & Co. Reiterate Outperform N/A N/A
Paratek Pharmaceuticals (PRTK) Cantor Fitzgerald Reiterate Buy N/A

$28

Regeneron Pharmaceuticals (REGN) Sanford C. Bernstein Initiation Outperform

$400

$475

Relypsa (RLYP) BTIG Research Reiterate Buy

$35

$48.20

Seattle Genetics (SGEN) Needham & Company Price Target Raised Buy From $60 $72 N/A
TESARO (TSRO) FBR & Co. Price Target Raised Outperform From $65 to $93 N/A
Valeant Pharmaceuticals International (VRX) Wells Fargo Reiterate Sell N/A N/A
Veracyte (VCYT) Cantor Fitzgerald Reiterate Buy

$13

N/A

CASI Pharmaceuticals (CASI)- Sparkle Byte Ltd., a 10% owner, bought 3,753,855 shares at $1.19. The total value of the transaction was approximately $4.47 million. Sparkle Byte now owns 8,498,765 shares of CASI.

Cyanotech (CYAN)- Meridian OHC Partners, LP, a 10% owner, bought 15,215 shares in two separate transactions. Meridian OHC Partners bought 7,305 shares at $5.19; and 7,910 shares at $5.21. Meridian OHC Partners now owns 749,610 shares of CYAN.

CorMedix (CRMD)- Janet Dillione, Director, bought 3,738 shares at $2.67. The total value of the transaction was $9,980. Dillione now owns 18,738 shares of CRMD.

Agios Pharmaceuticals (AGIO)- Lewis Clayton Cantley Jr., Director, sold 2502 shares in four separate transactions. Cantley sold 627 shares at $40.37; 625 shares at $40.37; 627 shares at $43.38; and 625 shares at $43.38. Cantley still owns 125,318 shares of AGIO.

ARIAD Pharmaceuticals (ARIA)- Hugh M Cole, SVP, Chief Business Officer, sold 6,012 shares at $7.05. The total value of the transaction was $42,385. Cole still owns 29,916 shares of ARIA.

Repligen (RGEN)- Thomas F. Ryan Jr., Director, sold 10,000 shares at $24.59. The total value of the transaction was $245,888. Ryan still owns 17,094 shares of RGEN. ‘

No management changes and additions to report.

NYSE- Intrexon (XON) shares were among the major gainers on the NYSE. The stock closed 6.80% higher. InVitae (NVTA) shares were among the major losers on the NYSE. The stock closed 4.70% lower.

NASDAQ- TESARO (TSRO) shares were among the major gainers on the NASDAQ. The stock closed 108.01% higher. Clovis Oncology (CLVS) ended the day 21.89% higher. Regulus Therapeutics (RGLS) ended the day 12.99% higher. Esperion Therapeutics (ESPR) shares were among the major losers on the NASDAQ. The stock closed 40.30% lower. Intellia Therapeutics (NTLA) ended the day 7.69% lower.

NYSEMKT- Organovo Holdings (ONVO) shares were among the major movers on the NYSEMKT. The stock closed 8.33% higher.

OTC- Cellceutix (CTIX) shares were among the major movers on the OTC market. The stock closed 2.90% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Akers Biosciences (AKER)

0.2%

-35.5%

1

Albany Molecular Research (AMRI)

22.4%

-

28

Alcobra (ADHD)

7.2%

-3.6%

20

Alder Biopharmaceuticals (ALDR)

19.1%

14.9%

11

Aldeyra Therapeutics (ALDX)

0.7%

4.1%

2

Alexion Pharmaceuticals (ALXN)

2.1%

-7.9%

2

Alexza Pharmaceuticals (ALXA) -

-8.3%

5

Alimera Sciences (ALIM)

8%

-3.2%

13

Alliqua Biomedical (ALQA)

1.3%

-17.2%

2

Alnylam Pharmaceuticals (ALNY)

8.5%

3%

8