AcelRx Pharmaceuticals (ACRX) announced that it has completed patient enrollment in the two remaining Phase 3 studies of pain med ARX-04, SAP302 and SAP303. SAP302 is a 76-subject, single-arm, open-label study in patients with moderate-to-severe acute pain associated with trauma or injury. The primary endpoint is the time-weighted summed pain intensity difference (SPID) to baseline over the first hour, or SPID1. The company expects to report top-line data from the study in the third quarter.

Lipocine (LPCN) bucked the trend in the broader market on Monday, gaining more than 4.5%. The stock is up another 2.2% in pre-market trading today. This is a big day for LPCN as the FDA is scheduled to make a decision on the New Drug Application (NDA) for LPCN 1021, the company’s lead product candidate. LPCN 1021 is an oral testosterone replacement therapy. If approved, LPCN 1021 could become the standard of care in the TRT therapy market. However, the FDA has been cautious on approving new TRT therapies. This is a binary event so investors should also consider the downside in case of a rejection by the agency.

Regulus Tumbles in Pre-market Trading- Regulus Pharmaceuticals (RGLS) shares have fallen almost 50% in pre-market trading today after the company was verbally notified by the FDA that its Investigational New Drug (IND) application for lead product candidate RG-101 for the treatment of hepatitis C virus (HCV) infection has been placed on clinical hold (prohibiting the recruitment of new patients to clinical studies) after the company reported a second serious adverse event (SAE) of jaundice. The SAE occurred in an HCV patient with end-stage renal disease on dialysis in its ongoing U.S.-based Phase 1 trial 117 days after receiving a single dose of RG-101. Regulus expects to receive a clinical hold letter within the next 30 days. It intends to work closely with agency to promptly investigate and resolve the issue.

In an article earlier today, I noted that it seems unlikely that serious adverse events were treatment related. The sell-off therefore could be an opportunity to enter RGLS.

GW Pharma’s Epidiolex Succeeds in Late-Stage Study- GW Pharmaceuticals (GWPH) shares rose more than 6% on Monday after the company announced positive top-line data from a Phase 3 clinical trial evaluating its lead product candidate, Orphan Drug-tagged Epidiolex (cannabidiol), for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. The study achieved its primary endpoint of a statistically valid reduction in the monthly frequency of drop seizures over the 14-week treatment period compared to placebo (p=0.0135).

Medicine Company’s Carbavance Succeeds in Late-Stage Study- The Medicine Company’s (MDCO) announced that a Phase 3 clinical trial, TANGO 1, evaluating its investigational antibiotic, Fast Track-tagged CARBAVANCE (meropenem-vaborbactam), for the treatment of complicated urinary tract infections (cUTI) met both FDA and EMA pre-specified endpoints, showing an overall success rate of 98.4%, statistically significantly better than piperacillin-tazobactam. The study met the FDA's primary endpoint of overall success rate (98.4% for CARBAVANCE versus 94.0% for piperacillin-tazobactam) and the European Medicines Agency's primary endpoint of microbiological outcome of eradication versus baseline (66.7% for CARBAVANCE compared to 57.7% for piperacillin-tazobactam). Treatment-emergent adverse events (AEs) were similar: 39.0% for CARBAVANCE and 35.5% for piperacillin-tazobactam as were serious AEs: 4.0% and 4.4%, respectively. There were two deaths in each treatment group.

Puma Biotechnology Submits MAA for Neratinib- Puma Biotechnology (PBYI) announced that it has submitted ts Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PB272 (Neratinib). The potential indication is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with Trastuzumab (Herceptin)-based adjuvant therapy. The company has provided data from he ExteNET Phase III study which showed treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009).

Teva Launches Generic Version of Imitrex- Teva Pharmaceutical Industries (TEVA) announced the launch of its generic equivalent of GlaxoSmithKline’s (GSK) Imitrex (sumatriptan succinate) in the U.S. for the treatment of acute migraine, with or without aura, and acute cluster headaches in adults. According to data from IMS, sumatriptan injection sales in the U.S. are ~$183M a year.

Meanwhile, Reuters has reported that Teva is close to divesting assets worth $600 million to Australia’s Mayne Pharma. TEVA has been divesting some of its businesses in order to get a nod from regulators for its $40 billion acquisition of Allergan’s (AGN) generic business.

Emergent BioSolutions Bags BARDA Contract- Emergent BioSolutions (EBS) announced the receipt of a task order from the Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture three GMP-compliant lots of Zika vaccine, which will be used in a Phase 1 clinical trial. BARDA will provide the base vaccine candidate while Emergent will conduct technology transfer of process materials and information, process and analytical method development, execute small-scale production runs and perform cGMP (current Good Manufacturing Practice) cell banking leading to cGMP manufacture of bulk drug substance and final product.

Ionis Pharmaceuticals Reports Encouraging Results for Volanesorsen- Ionis Pharmaceuticals (IONS) announced that a Phase 2 clinical trial evaluating volanesorsen (formerly ISIS-APOCIIIrx) in patients with high plasma triglycerides and type 2 diabetes showed encouraging results, including an improvement in insulin sensitivity. The data have been published in the June edition of the journal Diabetes Care (paper titled: "Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes").

Horizon Pharma Considering Potential Stake Sale- Horizon Pharma (HZNP) has hired Bank of America to help in selling a significant equity stake to an investor, according to Reuters. Reuters, citing people familiar with the matter reported, the stake sale would boost HZNP’s balance sheet. Reuters noted that it is not clear how HZNP would use the proceeds from the sale.

Cytori Therapeutics (CYTX) announced that the Cytori Cell Therapy has been approved for clinical use to treat knee osteoarthritis at the Tokyo Osteoarthritis Clinic under the Japanese 'Act on the Safety of Regenerative Medicine’. CYTX shares rose sharply in pre-market trading but failed to hold on to their gains in regular trading, closing almost 1% lower.

Merck & Co. (MRK) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.

Bristol-Myers Squibb (BMY) announced that the FDA has granted its Opdivo a Breakthrough Therapy designation for the treatment of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after platinum-containing chemo.

No patents to report.

Sanofi (SNY) announced that it has signed a deal with Boehringer Ingelheim (BI) to acquire BI's consumer health business in exchange for its animal health unit plus €4.7B, the difference in the enterprise value of the businesses. Sanofi expects the deal to be EPS neutral in 2017 and accretive thereafter. The transaction should close by year end. SNY will ntegrate BI's consumer business in all countries except China. The combined unit generated ~€4.9B in worldwide sales in 2015.

Eyegate Pharmaceuticals (EYEG) announced a definitive agreement with a single institutional investor to purchase shares of common stock and shares of Series A  Convertible Preferred Stock for ~$3.77M in a registered direct offering. The company agreed to sell an aggregate of 441,000 shares of common stock at a price of $2.25 per share and 2,776.5 shares of Series A Convertible Preferred Stock, at a price of $1,000 per share.  The Series A Convertible Preferred Stock is convertible at any time into ~1.23M shares of common stock at an initial conversion price of $2.25 per share.

Akers Biosciences (AKER) shares soared more than 30% on Monday after the company announced that Cardinal Health unit Aero-Med will distribute its BreathScan OxiChek, a disposable breath test to rapidly determine levels of oxidative stress in the body, an indicator of overall health in a person. Aero-Med has already placed orders for the product. It intends to focus its direct sales efforts on areas with high numbers of anti-aging, functional and integrative health and wellness treatment centers. It will initially target six New England states. Financial terms of the deal were not disclosed.

No secondary offerings to report.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alexion Pharmaceuticals (ALXN) Citigroup Upgrade From Neutral to Buy

$154

N/A
AstraZeneca (AZN) Deutsche Bank Reiterate Buy N/A N/A
Athersys (ATHX) Maxim Group Reiterate Buy N/A N/A
Cytori Therapeutics (CYTX) Maxim Group Reiterate Buy N/A N/A
GW Pharmaceuticals (GWPH) Cowen and Company Reiterate Buy

$135

N/A
GW Pharmaceuticals (GWPH) Janney Montgomery Scott Initiation Sell

$40

N/A
GW Pharmaceuticals (GWPH) Leerink Swann Price Target Raised Buy

$138

N/A
Heron Therapeutics (HRTX) Leerink Swann Reiterate Buy N/A N/A
Karyopharm Therapeutics (KPTI) Leerink Swann Reiterate Buy N/A N/A
Karyopharm Therapeutics (KPTI) Robert W. Baird Initiation Outperform

$16

N/A
Pfizer (PFE) Piper Jaffray Reiterate Overweight

$54

N/A
Retrophin (RTRX) Leerink Swann Reiterate Buy

$27

N/A
Sarepta Therapeutics (SRPT) Robert W. Baird Reiterate Outperform

$23

N/A
Sarepta Therapeutics (SRPT) William Blair Reiterate Market Perform N/A N/A
Valeant Pharmaceuticals International (VRX) RBC Capital Reiterate Sector Perform N/A N/A

Opko Health (OPK)- Dr. Phillip Frost, CEO & Chairman, bought 21,000 shares at $8.88. The total value of the transaction was $186,384. Dr. Frost now owns 159,855,743 shares of OPK.

Valeant Pharmaceuticals International (VRX)- Ross Thomas Sr., Director, bought 4,000 shares at $24.40. The total value of the transaction was $97,600. Thomas now owns 21,882 shares of VRX.

Kite Pharma (KITE)- Cynthia M. Butitta, COO, sold 20,000 shares in two separate transactions. Butitta sold 10,000 shares at $50.15; and 10,000 shares at $51.28. Butitta still owns 95,401 shares of KITE.

Karyopharm Therapeutics (KPTI)- Chione Ltd., a 10% owner, sold 18,824 shares at $8.03. The total value of the transaction was $151,083. Chione Ltd. still owns 8,549,920 shares of KPTI.

Atara Biotherapeutics (ATRA)- Isaac E. Ciechanover, CEO, sold 9,600 shares in two separate transactions. Ciechanover sold 4,800 shares at $21.19; and 4,800 shares at $21.32. Ciechanover still owns 334,711 shares of ATRA.

United Therapeutics (UTHR)- Martine A. Rothblatt, Chairman & CEO, sold 1,312 shares at $104.07. The total value of the transaction was $136,542. Rothblatt still owns 240 shares of UTHR.

No management changes and additions to report.

NYSE- InVitae (NVTA) shares were among the major movers on the NYSE. The stock closed 10% lower. Puma Biotechnology (PBYI) ended the day 9.21% lower.

NASDAQ- Proteon Therapeutics (PRTO) shares were among the major gainers on the NASDAQ. The stock closed 11.67% higher. GW Pharmaceuticals (GWPH) ended the day 6.22% higher. XBiotech (XBIT) ended the day 3.74% higher. Proteostasis Therapeutics (PTI) shares were among the major losers on the NASDAQ. The stock closed 19.06% lower. Syndax Pharmaceuticals (SNDX) ended the day 15.01% lower. Dicerna Pharmaceuticals (DRNA) ended the day 14.56% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major losers on the NYSEMKT. The stock closed 11.97% lower.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 4.59% lower.

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

13.1%

5.4%

13

Acura Pharmaceuticals (ACUR)

0.8%

60.2%

0

Adamas Pharmaceuticals (ADMS)

11.4%

-4.2%

10

Adamis Pharmaceuticals (ADMP)

6.6%

40.7%

1

Adaptimmune Therapeutics (ADAP)

1.4%

-3.5%

5

ADMA Biologics (ADMA) -

11.2%

5

Aduro Biotech (ADRO)

19.3%

14.2%

13

Advavis (ADXS)

25.7%

1.8%

9

Adverum Biotechnologies (ADVM)

3.4%

-12.2%

6

Aegerion Pharmaceuticals (AEGR)

18.1%

-4.6%

3