I initiated coverage on Paratek Pharmaceuticals (PRTK). PRTK offers significant upside from current levels. Even based on conservative estimates, I got a fair value of $28 for the stock, which represents upside of more than 100% from current levels. The full report on PRTK can be read here. Following the recent secondary offering, there is no dilution risk in PRTK in the medium term. The company also has the option of obtaining non-dilutive funding in the future.

Relypsa (RLYP) shares rallied on Tuesday, closing nearly 10% higher. The rally was party due to equities rebounding after the sell-off in the previous two trading sessions. RLYP though was also boosted by the announcement of results of a pre-specified exploratory analysis of the Phase 3 OPAL-HK trial of Veltassa® (patiromer) for oral suspension.

The results were published online by Kidney International, the journal of the International Society of Nephrology. The previously published OPAL-HK study evaluated Veltassa in patients with hyperkalemia (elevated blood potassium levels) and chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors. Results of this newly published analysis found that patients taking Veltassa in the study had significant decreases in systolic and diastolic blood pressure and reduced levels of aldosterone in the blood. Aldosterone is a hormone that plays an important role in the body's regulation of blood pressure and blood potassium levels.

RLYP continues to be in my Conviction buy list. The stock has remained rangebound but I believe that would change once Veltassa gains traction. I am maintaining my $48.20 price target on the stock.

Esperion Tumbles on Update for Lead Product Candidate- Esperion Therapeutics (ESPR) shares plunged more than 26% in after-hours trading on Tuesday after the company provided an update on the clinical development and regulatory path for lead product candidate bempedoic acid, its candidate for lowering "bad" cholesterol in patients intolerant of statins. Investors have been mainly disappointed with the news that the FDA has refused to clarify a regulatory pathway for the LDL-C indication citing potential changes in their view of LDL-C lowering as a surrogate endpoint and the possibility of a shift in the future standard-of-care for statin-intolerant patients with elevated LDL-C. ESPR noted that if lowering LDL-C is no longer a surrogate endpoint for approval, it will still submit a New Drug Application (NDA) for a CV disease risk reduction claim by 2022. This means a significant delay in potential approval in the U.S. However, there some positive news as well. ESPR said that a global pivotal Phase 3 trial to evaluate the safety and efficacy is expected to start in the fourth quarter. A cardiovascular outcomes study is also expected to commence in the fourth quarter. The company believes that the study timelines will support a MAA in Europe in 2019 for patients with elevated LDL-C.

Intra-Cellular Commences Phase 3 Study of Lead Product Candidate- Intra-Cellular Therapeutics (ITCI) announced hat it has initiated a Phase 3 clinical trial evaluating its lead product candidate ITI-007 for the treatment of agitation in patients with dementia, including Alzheimer's disease (AD). The primary endpoint is the treatment effect compared to placebo as measured by a 37-item scale called Cohen-Mansfield Agitation Inventory - Community version (CMAI-C) which measures the ability of a drug to reduce the overall frequency of agitation symptoms, including aggressive behaviors.

BioLineRx Files Regulatory Submissions to Initiate Phase 2a Trial for BL-8040- BioLineRx (BLRX) announced that it has filed regulatory submissions required to initiate a Phase 2a trial assessing BL-8040, in combination with Merck's (MRK) KEYTRUDA (pembrolizumab), for the treatment of pancreatic cancer. The study, called COMBAT, is expected to commence in Q3. The study is designed to evaluate the clinical response, safety and tolerability of the combination as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity in patients with metastatic pancreatic adenocarcinoma.

Cempra Submits Solithromycin MAA- Cempra (CEMP) announced that it has completed submission of its marketing authorization application (MAA) for solithromycin to the European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia (CABP). The MAA is for the intravenous and oral capsule formulations. The submission in Europe follows the completed submissions of two New Drug Applications (NDAs) in the U.S. several months ago.

FDA to Review Egalet’s ARYMO ER NDA on August 4- Egalet (EGLT) announced that a joint meeting between the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will take place on August 4 to review its New Drug Application (NDA) seeking approval of ARYMO ER (morphine sulfate) extended-release tablets, an abuse-deterrent formulation of morphine, for the long-term management of pain. The FDA's action date (PDUFA) is October 14.

Pfizer’s Bococizumab Succeeds in Late Stage Study- Pfizer (PFE) announced successful outcomes in two additional Phase 3 clinical trials assessing its PCSK9 inhibitor bococizumab in patients with high cholesterol. The studies, SPIRE-HR and SPIRE-FH, are the third and fourth of six SPIRE lipid-lowering studies to be completed and demonstrate positive results. SPIRE-HR evaluated bococizumab in 711 adults with primary hyperlipidemia or mixed dyslipidemia at high or very high risk of cardiovascular (CV) events who were receiving a maximally tolerated dose of statin therapy. The primary endpoint was the percent change in LDL-C from baseline to week 12 versus placebo. SPIRE-FH evaluated bococizumab in 370 adults with hereditary high cholesterol, heterozygous familial hypercholesterolemia (FeFH), at high or very risk of CV events who were receiving a maximally tolerated dose of statin therapy. The primary endpoint was the same.

Marinus Reports Top-Line Data from Phase 2 Exploratory Study for Lead Product Candidate- Marinus Pharma (MRNS) announced top-line data from a Phase 2 exploratory study evaluating its lead product candidate, ganaxolone, for the treatment of anxiety and attention in children with Fragile X syndrome (FXS) showed some positive effects despite failing to achieve the primary endpoint.  However, MRNS plans to advance clinical development for the indication. The company believes that the results strongly support the rationale for advancing clinical development.

Coherus BioSciences Reports Encouraging Data for CHS-131- Coherus BioSciences (CHRS) announced that a Phase 2b clinical trial evaluating its CHS-131 n treatment-naive relapsing remitting multiple sclerosis (RRMS) patients has produced encouraging results. Treated patients showed a 50% decrease in the incidence of new contrast-enhancing (CE) lesions over six months compared to placebo. The primary endpoint of the study was the reduction in the cumulative number of (CE) lesions from baseline to week 24 (determined by MRI) versus placebo. Treated patients experienced a statistically valid reduction in CE lesions that was dose dependent. The 3 mg cohort showed a 46.3% reduction (p=0.01).

Roche (RHHBY) subsidiary Genentech announced that the FDA has accepted its Biologics Biologics License Application (BLA) seeking approval of OCREVUS (ocrelizumab) for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis under Priority Review. Its action date is December 28. If approved, OCREVUS will be the first and only treatment indicated for both forms of MS (95% of MS cases).

AstraZeneca (AZN) announced that the European Commission (EC) has approved its Zavicefta (ceftazidime-avibactam) for the treatment of serious Gram-negative bacterial infections requiring hospitalization. The approval includes intravenous use for adult patients suffering from complicated intra-abdominal infections, complicated urinary tract infections (including pyelonephritis), hospital-acquired pneumonia (including ventilator-associated pneumonia) and treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.

Lannett Company (LCI) announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution, 5 mg/5 mL, the therapeutic equivalent to the reference drug, Roxane Laboratories' Diazepam Oral Solution, 5 mg/5 mL. According to IMS, the U.S. wholesale market for the drug is estimated at approximately $4 million.

Teva Pharmaceutical Industries (TEVA) announced that the FDA has accepted for review two New Drug Applications (NDAs) seeking approval of fluticasone propionate/salmeterol, a fixed-dose combination inhaled corticosteroid and long-acting beta agonist delivered via the RespiClick inhaler, and fluticasone propionate as monotherapy, also delivered via RespiClick, for the treatment of adolescents and adults with asthma.

Ultragenyx Pharmaceutical (RARE) announced the receipt of Breakthrough Therapy designation from the FDA for KRN23 for the treatment of X-linked Hypophosphatemia (XLH),  an inherited disorder characterized by bone abnormalities due to chronically low levels of phosphate in the blood. Ultragenyx and Kyowa Hakko Kirin entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.

Gilead Sciences (GILD) announced that the FDA has approved its once-daily fixed-dose combination of sofosbuvir (SOF), a nucleotide analog polymerase inhibitor, and velpatasvir (VEL), a pan-genotypic NS5A inhibitor, for the treatment of adults with chronic genotype 1-6 hepatitis C virus (HCV) infection with and without cirrhosis. It is also approved for use with ribavirin. The single-tablet med will be marketed under the brand name Epclusa.

No patents to report.

No deals and collaborations to report.

No secondary offerings to report.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Adamas Pharmaceuticals (ADMS) Noble Financial Reiterate Buy

$25

N/A
Alkermes (ALKS) Leerink Swann Price Target Cut Outperform From $58 to $54 N/A
Amphastar Pharmaceuticals (AMPH) BMO Capital Markets Initiation Market Perform N/A N/A
Cytori Therapeutics (CYTX) Roth Capital Reiterate Buy

$11

N/A
Emergent Biosolutions (EBS) Singular Research Price Target Cut Buy From $44 to $40 N/A
Eyegate Pharmaceuticals (EYEG) Maxim Group Reiterate Hold N/A N/A
Flexion Therapeutics (FLXN) BMO Capital Markets Initiation Outperform N/A N/A
GW Pharmaceuticals (GWPH) Cantor Fitzgerald Reiterate Buy N/A N/A
GW Pharmaceuticals (GWPH) Goldman Sachs Price Target Cut N/A From $135 to $105 N/A
GW Pharmaceuticals (GWPH) Morgan Stanley Price Target Raised N/A

$152

N/A
Horizon Pharma Plc (HZNP) BMO Capital Markets Initiation Outperform N/A N/A
Impax Laboratories (IPXL) BMO Capital Markets Initiation Market Perform N/A N/A
Infinity Pharmaceuticals (INFI) FBR & Co. Reiterate Market Perform N/A N/A
Infinity Pharmaceuticals (INFI) Wedbush Reiterate Neutral N/A N/A
Jazz Pharmaceuticals (JAZZ) BMO Capital Markets Initiation Outperform N/A N/A
Mallinckrodt (MNK) BMO Capital Markets Initiation Outperform N/A N/A
Marinus Pharmaceuticals (MRNS) Stifel Nicolaus Reiterate Hold N/A N/A
Merck & Co. (MRK) BMO Capital Markets Reiterate Outperform

$62

N/A
Pacira Pharmaceuticals (PCRX) BMO Capital Markets Initiation Underperform N/A N/A
Regulus Therapeutics (RGLS) BMO Capital Markets Downgrade/Price Target Cut From Outperform to Market Perform  From $16 to $4

$11.30

Regulus Therapeutics (RGLS) Chardan Capital Price Target Cut Buy From $20 to $13.50

$11.30

Regulus Therapeutics (RGLS) FBR & Co. Price Target Raised Outperform From $9 to $30

$11.30

Regulus Therapeutics (RGLS) Needham & Company Price Target Cut Buy From $25 to $10

$11.30

Regulus Therapeutics (RGLS) Wedbush Price Target Cut Outperform From $35 to $15

$11.30

SAGE Therapeutics (SAGE) BMO Capital Markets Initiation Outperform N/A N/A
Sanofi (SNY) Citigroup Reiterate Neutral N/A N/A
Shire Plc (SHPG) Goldman Sachs Reiterate Buy N/A N/A
Ultragenyx Pharmaceutical (RARE) Bank of America Initiation Buy

$72

N/A
Ultragenyx Pharmaceutical (RARE) Wedbush Reiterate Outperform

$92

N/A
Valeant Pharmaceuticas International (VRX) BMO Capital Markets Initiation Market Perform N/A N/A
Vascular Biogenics (VBLT) HC Wainwright Initiation Buy

$11

N/A
XBiotech (XBIT) Noble Financial Price Target Raised Buy From $24 to $30 N/A
Xencor (XNCR) Wedbush Reiterate Outperform

$27

N/A
Zynerba Pharmaceuticals (ZYNE) Oppenheimer Reiterate Buy

$29

N/A

Xenon Pharmaceuticals (XENE)- Ian Mortimer, CFO & COO, bought 5,300 shares in two separate transactions. Mortimer bought 1,000 shares at $6.15; and 4,300 shares at $6.23.

Chimerix (CMRX)- Ernest Mario, Director, bought 50,000 shares at $3.70. Mario now owns 381,440 shares of CMRX. Michelle M. Berrey, President & CEO, bought 13,188 shares at $3.69. Berry now owns 258,821 shares of CMRX.

SCYNEXIS (SCYX)- Clarence Patrick Machado, Director, bought 20,000 shares at $2.39. Machado now owns 20,000 shares of SCYX. Eric Francois, CFO, bought 15,000 shares at $2.39. Francois now owns 15,000 shares of SCYX. Marco Taglietti, CEO, bought 100,000 shares at $2.39. Taglietti now owns 225,000 shares of SCYX. Guy MacDonald, Director, bought 40,000 shares at $2.39. MacDonald now owns 40,000 shares of SCYX.

AbbVie (ABBV)- Laura J. Schumacher, Executive Vice President, sold 186,106 shares at $60.03. The total value of the transaction was approximately $11.17 million. Schumacher still owns 194,138 shares of ABBV.

No management changes and additions to report.

NYSE- Axovant Sciences (AXON) shares were among the major gainers on the NYSE. The stock closed 8.63% higher.

NASDAQ- Xencor (XNCR) shares were among the major gainers on the NASDAQ. The stock closed 32.06% higher. Endo International (ENDP) shares ended the day 18.26% higher. Dicerna  Pharmaceuticals (DRNA) ended the day 17.04% higher. Regulus Therapeutics (RGLS) shares were among the major losers on the NASDAQ. The stock closed 49.30% lower. Celyad (CYAD) ended the day 33.33% lower. Pulmatrix (PULM) ended the day 8.41% lower.

NYSEMKT- Organovo Holdings (ONVO) shares were among the major movers on the NYSEMKT. The stock closed 8.39% higher.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock closed 3.88% higher.

Company (Ticker) Short Interest as % of Float % Change Days to Cover
Aeglea BioTherapeutics (AGLE)

0.1%

146.2%

0

Aerie Pharmaceuticals (AERI)

25.9%

-4.8%

20

AEterna Zentaris (AEZS)

8.5%

-1.5%

7

Affimed (AFMD)

9.1%

-4.4%

14

Agenus (AGEN)

10.6%

-3%

8

Agile Therapeutics (AGRX)

3.3%

4.3%

7

Agios Pharmaceuticals (AGIO)

23.4%

13.1%

5

Aimmune Therapeutics (AIMT)

11%

2.2%

10

Akari Therapeutics (AKTX)

0.8%

-4.8%

6

Akebia Therapeutics (AKBA)

7.9%

-4.1%

13