Merrimack Pharmaceuticals (MACK) shares have struggled ever since the approval of ONIVYDE in the U.S. On Monday, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use  (CHMP) gave a positive opinion recommending approval of ONIVYDE for the treatment of patients with metastatic pancreatic adenocarcinoma  who have progressed after gemcitabine-based therapy. I believe that MACK remains significantly undervalued. Based on the outlook for ONIVYDE alone, MACK is trading more than 50% below its fair value. With catalysts coming up in early 2017, I believe that MACK is worth a look.

Gilead Sciences (GILD) is down more than 4% following another disappointing quarter for the company’s HCV franchise. It was the HCV franchise that drove GILD in 2014. However, pricing pressures have meant that HCV sales have started to slowdown since 2015.

In the second quarter, Harvoni sales dropped 28.9% on a year-over-year basis to $2.56 billion. Sovaldi sales, meanwhile, rose 5.2% to $1.36 billion.

Gilead lowered its net product sales guidance for 2016. The company now expects net product sales to be between $29.5 billion and $30.5 billion, compared to previous guidance range of $30 billion to $31 billion.

While the disappointment of HCV sales slow down is continuing to hurt GILD shares, I believe the market is continuing to ignore the strength of the HIV franchise. In the second quarter, HIV franchise sales rose to $3.1 billion from $2.7 billion. At current levels, I continue to believe that GILD is significantly undervalued. Even based on the reduced forecasts for 2016 net product sales, GILD only trades at just over 4x sales.

Bellerophon Gets Clearance to Commence Mid-Stage Study of INOpulse- Bellerophon Therapeutics (BLPH) shares edged higher on Monday after the company announced that Belgian health authorities have approved the commencement of an open-label Phase 2 study evaluating INOpulse for the treatment of pulmonary hypertension in patients with chronic obstructive pulmonary disease (PH-COPD). Patient recruiting (10 total) will start this quarter with results expected by year end. BLPH shares rose as much as 35% in pre-market trading on Monday but gave up most of their gains in regular trading to close just under 2% higher.

Tobira’s Lead Product Candidate Fails in Mid-Stage Study- Tobira Therapeutics (TBRA) shares plunged 60% on Monday after the company announced that its lead product candidate cenicriviroc (CVC) failed to achieve its primary endpoint of a two-point reduction in NAFLD Activity Score in a Phase 2b clinical trial, CENTAUR, in patients with non-alcoholic steatohepatitis (NASH). The company did not though that the study showed a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, a secondary endpoint, after one year of treatment (p=0.02). TBRA noted that achieving a two-point reduction in NAFLD Activity Score is not required to support a marketing application. The two endpoints needed are an improvement in fibrosis by at least one stage without worsening of NASH and complete resolution of NASH without worsening of fibrosis.  TBRA plans to meet with regulators later this year to discuss the design of a Phase 3 trial.

Ocular’s Dextenza NDA Rejected- Ocular Therapeutix (OCUL) announced the receipt of a Compete Response Letter (CRL) from the FDA for its New Drug Application (NDA) seeking approval of DEXTENZA (dexamethasone insert) 0.4 mg for intracanalicular use in the treatment of ocular pain following ophthalmic surgery. The CRL cited deficiencies in manufacturing process and controls observed during an on-site inspection of the company's manufacturing facility. The company says the agency did not identify which deficiencies remain open since its last written response to regulator. No safety or efficacy issues related to DEXTENZA are involved.
Clinical Hold on Novartis’ CGF166 Lifted- Novartis (NVS) announced that the FDA has lifted its clinical hold on the company’s Phase 1/2 study evaluating CGF166 in patients with severe-to-profound hearing loss after the Data Safety and Monitoring Board recommended that the trial continue. The FDA stopped the trial in January of this year in accordance with criteria in the study's protocol that required a review of the results. Top-line data should be available in 2017.

Soligenix Obtains Additional Funding- Soligenix (SNGX) announced the receipt of $634,000 in new funding o support the development of OrbeShield (oral beclomethasone 17,21 dipropionate or BDP) as a medical countermeasure for civilian and military use to treat gastrointestinal acute radiation syndrome (GI ARS). The Biomedical Advanced Research and Development Authority (BARDA) chipped in $350K while NIH's National Institute of Allergy and Infectious Diseases (NIAID) contributed $284K. Total funding from the two groups will be as high as $33M if all contract options are exercised ($18M has been committed thus far).

PTC Therapeutics Provides Regulatory Update- PTC Therapeutics (PTCT) provided a regulatory update on its Translarna. The company said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) informed PTCT that its renewal assessment procedure for the Translarna (ataluren) marketing authorization will not be completed by mid-year as expected, although the company believes that the current marketing authorization to remain in effect until a decision is announced by the European Commission (EC). PTCT said that is currently recruiting patients in an open-label 10-subject Phase 2 clinical trial assessing Translarna in boys aged 2 to 5 with DMD.

EPIRUS Files For Bankruptcy- EPIRUS Biopharmaceuticals (EPRS) announced that it has filed for protection under Chapter 7 of the U.S. Bankruptcy Code. In accordance with the provisions, the company's assets will be liquidated and claims paid with the proceeds.

Celgene’s Late-Stage Study of REVLIMID Fails- Celgene (CELG) announced that it will not seek a new indication for Revlimid (lenalidomide) as maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) who responded to first-line rituximab (Roche's Rituxan) plus R-CHOP chemo. The company's decision was based on the results from a randomized Phase 3 study, REMARC, that showed a statistically valid improvement in progression-free survival in the treatment group versus placebo, but no difference in overall survival.

Viking Announces Encouraging Results for VK0214 From Preclinical Studies- Viking Therapeutics (VKTX) shares have surged more than 11% in pre-market trading today after the company announced positive preclinical results for product candidate VK0214 in a rare nervous system disorder called X-linked adrenoleukodystrophy (X-ALD), a disease caused by the deterioration of fatty covering of nerves (myelin) which reduces the ability of the nerves to relay information to the brain. It also damages the outer layer of the adrenal glands which leads to the shortage of certain hormones (adrenocortical insufficiency). It occurs in ~1 in 17,000 births. The results were generated in a proof-of-concept mouse model of X-ALD. VK0214 rapidly reduced plasma very long chain fatty acid (VLCFA) levels by more than 25% compared to controls after six weeks of treatment. VLCFAs are elevated in X-ALD sufferers due to metabolic defects.

AbbeVie (ABBV) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of a 12-week regimen of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 infection with compensated cirrhosis (Child-Pugh A). The currently approved regimen is 24 weeks for these patients. The data supporting the positive opinion was generated in the Phase 3 AGATE-1 study that showed a 97% cure rate (n=57/59) in HCV-4 Child-Pugh A patients treated with VIEKIRAX and RBV for 12.

Meanwhile, the FDA has approved VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets, a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK. The new product is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those patients with compensated cirrhosis (Child-Pugh A). It is used without ribavirin in genotype 1b patients and in combination with twice-daily ribavirin in genotype 1a patients.

Bristol-Myers Squibb (BMY) announced that the EMA’s CHMP adopted a positive opinion recommending approval of its ORENCIA (abatacept) intravenous infusion (IV) and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of patients with highly active and progressive rheumatoid arthritis (RA) not previously treated with methotrexate. If approved, this will be the first biologic in the EU with this indication.

Merck & Co. (MRK) announced that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU. The FDA granted V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA). Meanwhile, the EMA  PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).

Allergan (AGN) announced that the EMA’s CHMP adopted a positive opinion recommending approval of its TRUBERZI (eluxadoline) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

Janssen Biotech’s (JNJ) DARZALEX in combination with REVLIMID has been granted a Breakthrough Therapy by the FDA for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy. DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy.

No patents to report.

AbbVie (ABBV) and Bristol-Myers Squibb (BMY) will collaborate in a Phase 1/2 clinical trial assessing the former's antibody-drug conjugate Rova-T (rovalpituzumab tesirine) and the latter's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) in patients with relapsed extensive-stage small cell lung cancer (SCLC). The objective is to determine if the targeted cell killing and antigen release caused by Rova-T enhances the effect of immunotherapy. Patient recruiting should start later this year.

Apricus Biosciences (APRI) announced that it has expanded its exclusive distribution deal with Swiss firm Ferring Pharmaceuticals related to topical erectile dysfunction cream Vitaros. The new agreement adds 19 countries plus Hong Kong to Ferring's previous territory of Latin America and (recently) the United Kingdom. The existing marketing authorizations will be transferred to Ferring from Sandoz pursuant to the termination of Sandoz's license. According to the new agreement, Apricus is eligible to receive an additional $3.6M in upfront and pre-commercialization payments as well as up to an additional $1.5M in launch-related milestones. It can earn up to $34M in total milestones when the previous distribution agreement is included. Sales-based royalties will be high single-digit to low double-digit.

Kite Pharma (KITE) announced that it has signed a global license agreement with the University of California for technology to advance the development of off-the-shelf allogeneic T-cell therapies from renewable pluripotent stem cells. According to the terms of agreement, Kite has exclusive rights to use the technology to develop and commercialize oncology-focused T-cell products. In connection with the contract, the company has entered into a Sponsored Research Agreement with UCLA to support ongoing preclinical research to optimize the ATO platform. Financial terms of the deal have not been disclosed.

No secondary offerings to report.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Adma Biologics (ADMA) Maxim Group Price Target Cut Buy From $24 to $14 N/A
Adamas Pharmaceuticals (ADMS) Credit Suisse Group Reiterate Buy

$21

N/A
Alnylam Pharmaceuticals (ALNY) Needham & Company Reiterate Buy

$152

$130

Alexion Pharmaceuticals (ALXN) Jefferies Group Price Target Cut Hold From $159 to $140 N/A
Biogen (BIIB) Robert W. Baird Reiterate Neutral

$268

$420

GlaxoSmithKline (GSK) JPMorgan Chase & Co. Reiterate Neutral N/A N/A
Intercept Pharmaceuticals (ICPT) Wedbush Reiterate Outperform

$239

N/A
Keryx Biopharmaceuticals (KERX) FBR & Co. Reiterate Buy

$13

$25

Pfizer (PFE) JPMorgan Chase & Co. Price Target Set Buy

$40

N/A
Pfizer (PFE) Piper Jaffray & Cos. Price Target Set Buy

$54

N/A
Regulus Therapeutics (RGLS) Chardan Capital Price Target Cut Buy From $14.50 to $12

$11.64

Syros Pharmaceuticals (SYRS) Wedbush Initiation Outperform

$18

N/A
Syros Pharmaceuticals (SYRS) Piper Jaffray & Cos. Initiation Overweight

$20

N/A
Syros Pharmaceuticals (SYRS) JMP Securities Initiation Outperform

$22

N/A
Syros Pharmaceuticals (SYRS) Cowen and Company Initiation Outperform N/A N/A
Tobira Therapeutics (TBRA) Cantor Fitzgerald Downgrade Buy

$19

N/A
Teva Pharmaceuticals Industries (TEVA) Mizuho Reiterate Buy N/A N/A
Valeant Pharmaceuticals International (VRX) JPMorgan Chase & Co. Price Target Set Hold

$35

N/A

No insider buys to report.

ARIAD Pharmaceuticals (ARIA)- Timothy P. Clackson, President, R&D, CSO, sold 18,826 shares at $8.11. The total value of the transaction was $148,230. Clackson still owns 248,208 shares of ARIA.

Johnson & Johnson (JNJ)- Ronald A. Kapusta, Controller, CAO, sold 2,935 shares at $125.01. The total value of the transaction was $366,896. Kapusta still owns 25,725 shares of JNJ.

No management changes and additions to report.

NYSE- Opko Health (OPK) shares were among the major movers on the NYSE. The stock closed 0.20% lower.

NASDAQ- Eleven Biotherapeutics (EBIO) shares were among the major gainers on the NASDAQ. The stock closed 14.50% higher. MyoKardia (MYOK) ended the day 8.73% higher. Minerva Neurosciences (NERV) ended the day 7.80% higher. Ocular Therapeutix (OCUL) shares were among the major losers on the NASDAQ. The stock closed 14.51% lower. Aptevo Therapeutics (APVOV) ended the day 14.23% lower. XBiotech (XBIT) ended the day 12.58% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 3.69% lower.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock ended the day 6.14% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Fate Therapeutics (FATE)

0.5%

-57.3%

0

Fibrocell Science (FCSC)

7.1%

-26.2%

2

FibroGen (FGEN)

6.7%

1.1%

6

Five Prime Therapeutics (FPRX)

11.7%

15.5%

5

Flex Pharma (FLKS)

9.6%

27.2%

6

Flexion Therapeutics (FLXN)

9.1%

10.8%

3

Foamix Pharmaceuticals (FOMX)

7.3%

-24.6%

4

Fortress Biotech (FBIO)

15.1%

44.6%

11

Halozyme Therapeutics (HALO)

19.1%

-0.3%

13

Heat Biologics (HTBX)

4.6%

27.8%

1