Dynavax Technologies (DVAX) saw some insider buying recently (see details below). The insider buying though doesn't come as a surprise. DVAX shares remain undervalued despite a major catalyst in the near future. If the company’s Hep B vaccine is approved, DVAX could see significant upside. I believe this is a good time to enter DVAX ahead of the important catalyst.

Merrimack Pharmaceuticals (MACK) announced a newly presented analysis of the Phase 3 NAPOLI-1 data. The data shows shows patients treated with ONIVYDE® (irinotecan liposome injection), also known as "nal-IRI," in combination with fluorouracil (5-FU) and leucovorin, maintain similar baseline quality of life at 12 weeks despite the addition of a second chemotherapeutic agent when compared to 5-FU and leucovorin alone. These findings were presented in an oral session by Dr. Richard Hubner, an investigator on the NAPOLI-1 trial and a Consultant Medical Oncologist at Christie NHS Foundation Trust, at the European Society for Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

Previously reported Phase 3 NAPOLI-1 data show that the ONIVYDE combination regimen significantly improves overall survival and progression-free survival when compared to 5-FU and leucovorin alone. ONIVYDE in combination with 5-FU and leucovorin was approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease progressed after gemcitabine-based therapy.

Since ONIVYDE’s approval though, MACK shares have struggled. In the last six months, the stock has fallen more than 31%. However, this is mainly due to the negative sentiment on the biotech sector seen at the start of this year. Given the potential of ONIVYDE and MACK’s extensive pipeline, I believe the stock is undervalued.

Shire’s SHP607 Fails in Mid-Stage Study- Shire Plc (SHPG) announced that its investigational protein replacement, SHP607, failed to achieve its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), a rare eye condition. The study did show clinically relevant effects in secondary endpoints related to severe bronchopulmonary dysplasia (BPD) (a chronic lung disease) and severe intraventricular hemorrhage (IVH) (type of brain injury). Results showed a 53% reduction in the incidence of severe BPD and an 89% reduction in those infants who achieved a prespecified target of drug exposure. The incidence of severe IVH was reduced 44% (64% in infants who achieved the target drug exposure). Another secondary endpoint, time to discharge from neonatal intensive care, was not met.

ArQule Reports Encouraging Data for ARQ 087- ArQule (ARQL) announced that an ongoing Phase 1/2 trial evaluating its dual kinase inhibitor ARQ 087 in intrahepatic cholangiocarcinoma showed evidence of effect, measured by objective response rate and disease control rate, in patients with mutations in the fibroblast growth factor receptor 2 (FGFR2) gene. The results were presented a the ESMO 18th World Congress on Gastrointestinal Cancer in Barcelona. 14 of the 21 patients in the study dosed with ARQ 087 were FGFR2 mutation-positive. 12 of the 14 were evaluable. In this group of 12, the objective response rate was 25% (n=3/12) (three partial responders) and the disease control rate was 75% (n=9/12) (three partial responders + six with stable disease). Three patients progressed after treatment. The study is expected to be completed in the current quarter.

Ampio Plunges as Late Stage Study Evaluating Amnion Fails- Ampio Pharmaceuticals (AMPE) shares dropped more than 60% on Thursday after the company announced that a Phase 3 trial evaluating Amnion failed to beat placebo (saline injection). Ampion an intra-articular injection for the potential treatment of pain associated with osteoarthritis (OA) of the knee. Ampion had also failed a Phase 3 study in OA of the knee in 2015. The company said that it will meet with the FDA to discuss all of its data.

Intra-Cellular Completes Enrollment Target in Second Phase 3 Study of Lead Product Candidate- Intra-Cellular Therapeutics (ITCI) announced that it has completed enrollment  in its second Phase 3 clinical trial, ITI-007-302, assessing lead product candidate ITI-007 for the treatment of schizophrenia. The primary endpoint of the study is the change from baseline to day 42 as measured by Positive and Negative Syndrome Scale (PANSS) total score.

Array BioPharma Submits NDA for Lead Product Candidate- Array BioPharma (ARRY) announced the filing of New Drug Application (NDA) with the FDA seeking approval of lead product candidate binimetinib for the treatment NRAS mutation-positive melanoma. The principal data supporting the application was generated in the Phase 3 NEMO study which showed an improvement in progression-free survival versus the chemo agent dacarbazine.

Arena Announces Workforce Reduction- Arena Pharmaceuticals (ARNA) announced that it is cutting 73% of its workforce in order to reduce its operating expenses. The job cuts will mainly affect ARNA’s esearch, manufacturing and G&A areas. he downsizing will be completed by the end of August. ARNA expects to record a $6.1M charge in Q2 for severance-related costs. It expects annualized cash expenses for personnel to drop ~$17M and other related expenses by $6M - 8M. Further cost control measures will be instituted in the near future, including headcount reductions at its Swiss manufacturing site.

Mylan Offers Concessions to Get Nod for Meda Acquisition- Mylan (MYL) has offered concessions in order to get an approval from European Union (EU) competition regulators for its acquisition of Meda, Reuters, citing the European Commission (EC) has reported. The EC will take the view of rivals and consumers before taking a decision on whether to accept MYL’s offer and clear the transaction.

Concordia International (CXRX) announced that the FDA has approved its new Photofrin 630 PDT Laser.

No patents to report.

Opko Health (OPK) announced that it has signed an agreement to acquire Transition Therapeutics (TTHI) for ~6.4M shares of OPKO common stock. Based on the average price of OPKO shares over the five days preceding the signing of the contract, the transaction is valued at ~$60M or $1.55 per TTHI share. The deal is expected to close in the second half of this year.

Bristol-Myers Squibb (BMY) announced an exclusive clinical collaboration agreement with  PsiOxus Therapeutics, a privately held company. The collaboration seeks to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ Enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with BMY's Opdivo (nivolumab), to treat a range of tumor types in late-stage cancer patients. According to the terms of the collaboration agreement, BMY will make a one-time upfront payment of $10M to PsiOxus, and the parties will share development costs. PsiOxus will be responsible for conducting the Phase 1 study with patient recruitment expected to start in the third quarter.

ZIOPHARM Oncology (ZIOP) and Intrexon (XON) have amended their Exclusive Channel Collaborations in oncology and graft-versus-host disease. According to the amended agreement, the operating profits payable (royalty) to Intrexon have been reduced from 50% to 20%. In exchange for the reduction, ZIOP will issue $120M (100K shares) of a new class of preferred to stock to XON that will pay a monthly dividend of 1% in additional preferred shares.

Stellar Biotechnologies (SBOT) announced a direct placement of 1,687,500 shares of common stock and unregistered five-year warrants to purchase up to 1,265,625 shares of common (one warrant = 0.75 of a share of stock) at $4.50. The combined price for one share of stock and one warrant is $4.00. Net proceeds from the direct placement will fund R&D, operating expenses, capex, working capital and general corporate purposes.

Bio-Path Holdings (BPTH) announced registered direct offering to institutional investors of 5,882,353 shares of common stock and warrants to purchase up to 2,941,177 shares of common sold as units. Each unit consists of one share of common stock and a five-year warrant to purchase one half of a share of common stock at $1.70 per unit. The warrants are exercisable at $2.30 per share of stock. The offering is expected to close on July 5th.

TESARO (TSRO) announced that it has initiated a public offering of $300 million of its common stock. The company has not yet disclosed the price, volume and terms of the offering.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Ampio Pharmaceuticals (AMPE) Janney Montgomery Scott Reiterate Positive N/A N/A
Aurinia Pharmaceuticals (AUPH) HC Wainwright Initiation Buy

$7

N/A
Catalyst Biosciences (CBIO) Rodman & Renshaw Initiation Buy

$3.50

N/A
Clovis Oncology (CLVS) Stifel Nicolaus Reiterate Buy

$30

N/A
Dicerna Pharmaceuticals (DRNA) Chardan Capital Price Target Cut Neutral From $5 to $4 N/A
Dicerna Pharmaceuticals (DRNA) Stifel Nicolaus Price Target Cut Buy From $16 to $13 N/A
Esperion Therapeutics (ESPR) Stifel Nicolaus Downgrade/Price Target Cut From Neutral to Underperform From $23 to $10 N/A
Galena Biopharma (GALE) FBR & Co. Reiterate Buy N/A N/A
InVitae (NVTA) Benchmark Initiation Hold

$8.50

N/A
TESARO (TSRO) Jefferies Group Downgrade/Price Target Raised From Buy to Hold From $53 to $75 N/A
TESARO (TSRO) Leerink Swann Price Target Raised Outperform From $65 to $95 N/A
TESARO (TSRO) Mizuho Reiterate Outperform

$67

N/A
TESARO (TSRO) Wells Fargo Reiterate Outperform

$127

N/A
uniQure (QURE) Piper Jaffray Reiterate Buy N/A N/A

Opko Health (OPK)- Dr. Phillip Frost, CEO & Chairman, bought 12,800 shares at $9.24. The total value of the transaction was $118,304. Dr. Frost now owns 159,868,543 shares of OPK.

Dynavax Technologies (DVAX)- Robert Janssen, Vice President, bought 1,452 shares at $13.68. The total value of the transaction was $19,863. Janssen now owns 6,048 shares of DVAX.

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.

Xencor (XNCR)- Paul A. Foster, Chief Medical Officer, sold 1,183 shares at $17.01. Foster still owns 2,419 shares of XNCR. Edgardo Baracchini Jr., sold 1,250 shares at $15.10. Bararcchini still owns 4,528 shares of XNCR.

Bristol-Myers Squibb (BMY)- Lamberto Andreotti, Director, sold 23,200 shares in two separate transactions. Andreotti sold 13,400 shares at $71.67; and 9,800 shares at $72.79. Andreotti still owns 392,194 shares of BMY.

FibroGen (FGEN)- Thomas B. Neff, CEO, sold 27,000 shares in two separate transactions. Neff sold 13,500 shares at $15.87; and 13,500 shares at $16.17. Neff still owns 3,426,164 shares of FGEN.

Vertex Pharmaceuticals (VRTX)- Joshua S. Boger, Director, sold 5,130 shares at $84.82. The total value of the transaction was $435,107. Boger still owns 268,225 shares of VRTX.

Eli Lilly (LLY)- Lilly Endowment Inc., a 10% owner, sold 220,000 shares at $77.86. The total value of the transaction was approximately $17.13 million. Lilly Endowment still owns 126,870,804 shares of LLY.

Biotie Therapies (BITI) announced changes in its management team. The Company has appointed Antero Kallio, M.D., as the new CEO and Kristian Rantala as CFO effective July 1. Also, Timo Veromaa, President and CEO; David Cook, CFO and Stephen Bandak, CMO are leaving the company. BITI was acquired by Acorda Therapeutics (ACOR) earlier this year.

NYSE- Intrexon (XON) shares were among the major movers on the NYSE. The stock closed 3.26% lower.

NASDAQ- Syros Pharmaceuticals (SYRS) shares were among the major gainers on the NASDAQ. The stock closed 45.20% higher. CoLucid Pharmaceuticals (CLCD) ended the day 15.23% higher. Vascular Biogenics (VBLT) ended the day 11.08% higher. OraSure Technologies (OSUR) shares were among the major losers on the NASDAQ. The stock closed 18.53% lower. Pacira Pharmaceuticals (PCRX) shares ended the day 11.26% lower. Mirna Therapeutics (MRTX) ended the day 10.13% lower.

NYSEMKT- Provectus Biopharmaceuticals (PVCT) shares were among the major movers on the NYSEMKT. The stock closed 7.25% higher.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock ended the day 6.11% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
AMAG Pharmaceuticals (AMAG)

21.1%

-3.1%

8

Amgen (AMGN)

1%

-1.5%

3

Amicus Therapeutics (FOLD)

17.5%

2.2%

8

Amphastar Pharmaceuticals (AMPH)

5.8%

-15.3%

6

Anacor Pharmaceuticals (ANAC)

13.1%

16.3%

2

Anavex Life Sciences (AVXL)

9.5%

-14.3%

9

ANI Pharmaceuticals (ANIP)

14.4%

7.5%

6

Anika Therapeutics (ANIK)

11.2%

-4.8%

14

Antares Pharma (ATRS)

6.6%

4.5%

13

Anthera Pharmaceuticals (ANTH)

13.5%

-1%

9