Cynapsus Therapeutics (CYNA) shares have risen sharply in pre-market trading today. The stock has been pushed higher by the announcement of positive results from its Phase 3 dose titration study, CTH-300, assessing APL-130277 for the treatment of OFF episodes in Parkinson's disease (PD) patients. Data from the first 92 subjects showed a 22-point improvement from baseline to 30 minutes in a PD rating scale called MDS-UPDRS Part III. In addition, 60% of patients showed improvement in motor function between five and 12 minutes after dosing, improvement in motor function was maintained beyond 90 minutes and 83% of patients transitioned from OFF to fully ON. CYNA has had a mixed year so far. The stock has seen a recovery since May and year-to-date, it is up just under 4%.

Evoke Pharma (EVOK) shares dropped more than 70% on Monday after the company reported top-line results from the Phase 3 study of its EVK-001. The trial was evaluating EVK-001 in female patients with symptomatic diabetic gastroparesis. EVK-001 is a novel formulation of Metoclopramide, which has been used as a treatment for gastroparesis for more than three decades. Given that the drug had already been use and Evoke was only developing a nasal delivery formulation, there was a high chance of success. Indeed, that was the reason for my bullish note on EVOK last year. I had calculated a fair value of $10.30 for the stock.

In fact, this is what the market was also expected as ahead of the rally EVOK shares rallied and even crossed my price target of $10.30. The trial results released on Monday came as a surprise. Below is a note from EVOK’s press release.

“Preliminary review of topline data across all study sites revealed similar improvement in the EVK-001 and placebo groups at Week 4 as measured by the total symptom score as well as the individual scores for each of the signs and symptoms, but these results were not consistent across the study sites. Further evaluation of topline data revealed diary data from 28 of 41 of the enrolling sites showed a statistically-significant benefit at Week 4 for EVK‑001 (p=0.006) in contrast to results from the other 13 sites that showed statistically significant benefit for placebo (p=0.002). Once the complete datasets and PK data are available, additional analyses will be conducted to further understand the discrepant results.”

This anomaly means that there is no real hope for EVOK. It is likely that the trial design was flawed and hence the failure. The company can commence a fresh trial following a post-hoc analysis. The problem here is EVOK’s weak cash position. At the end of the first quarter, EVOK only had a little over $6 million in cash. It obviously was banking on positive top-line results to announce a offering. I believe EVOK missed an opportunity when its stock rallied over the past few weeks. The company could have used this to initiate an offering. That would have given it some hope.

What to do with EVOK? It depends on your entry point. I had included EVOK in my Conviction Buy list anticipating a rally ahead of the top-line results. Shares did rally as expected and last week I had recommended one my L4 subscribers to book profit as EVOK hit my price target.

If you entered EVOK at recent highs then the best thing to do right now is hold the stock rather than take a hit. There is a slim hope for EVOK. I say this only because Metoclopramide is an approved drug. In case the entry point was around $5, where EVOK had been trading before the rally, I would suggest exiting the position and taking a loss.

Is EVOK worth at current levels? I believe it is not. As I said, there is only a slim chance of the company succeeding. And given the company’s weak cash position, a dilution is likely in the near future.

Roche’s Phase 3 Study GOYA Fails- Swiss drug maker Roche (RHHBY) announced that a Phase 3 clinical trial evaluating its Gazyva/Gazyvaro (obinutuzumab) plus CHOP chemotherapy in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL) failed to meet its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to MabThera/Rituxan (rituximab) plus CHOP chemo. The company will present the full results from the failed trial at future medical conference. The drug is currently approved in the U.S. for the treatment of chronic lymphocytic leukemia and follicular lymphoma, both in combination with certain types of chemo.

AstraZeneca’s TAGRISSO Succeeds in Late-Stage Study- British drug maker AstraZeneca (AZN) announced that a Phase 3 clinical trial called AURA3, evaluating its TAGRISSO (osimertinib) as second-line treatment in patients with EGFR T790M mutation-positive, locally advanced and metastatic non-small cell lung cancer (NSCLC) met its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The treatment group also showed clinically meaningful increases in objective response rate, disease control rate and duration of response. Complete data will be presented at an upcoming medical conference. TAGRISSO has already been approved by the FDA for the treatment of EGFR T790M-positive NSCLC that has progressed after EGFR-blocking therapy. Under accelerated review, continued approval may be contingent on further confirmatory studies.

ViiV Healthcare Presents 48-Week Data from ARIA Study- ViiV Healthcare presented 48-week data from the Phase IIIb, open-label, international, multi-center ARIA study which showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. Results showed statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both endpoints were met. ViiV Healthcare is a joint venture between GlaxoSmithKline (GSK) and Pfizer (PFE).

Brainstorm Announces Data from Mid-Stage Study of NurOwn- Brainstorm Cell Therapeutics (BCLI) announced data from a Phase 2 study evaluating NurOwn mesenchymal stem cells for the treatment of patients with amyotrophic lateral sclerosis (ALS). Treatment with NurOwn consistently beat placebo, although the difference at most time points (2 weeks - 24 weeks) fell short of statistical significance. Also the treatment effect rapidly diminished over time. The company plans to meet with the FDA to discuss the results. A larger confirmatory study is the next step. BCLI shares dropped more than 9% on Monday but have bounced back in pre-market trading today.

pSivida Announces R&D Consolidation Plan- pSivida (PSDV) announced that it is implementing a site consolidation plan whereby all of its R&D and product development will be conducted at a single location. It intends to close its Malvern, U.K. site and locate all of the functions at its Watertown, Massachusetts facility. The company expects the move to save $900K a year in pre-tax operating expenses starting in the fourth quarter. It will book $680K in charges related to the plan.

Dr. Reddy’s Launches ZEGERID Generic- Indian drug maker Dr. Reddy’s Laboratories (RDY) announced the launch of n FDA-approved Omeprazole and Sodium bicarbonate capsules, 20mg/1100mg and 40mg/1100mg, a therapeutic equivalent generic version of ZEGERID (omeprazole/sodium bicarbonate) capsules in the U.S. According to IMS Health, the Zegerid brand and generic had U.S. sales of ~$307M for the 12-month period ending May 2016.

Bristol-Myers Squibb (BMY) announced that the FDA and the European Medicines Agency (EMA) have accepted for review its market applications seeking approval of Opdivo (nivolumab) for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The FDA's action date (PDUFA) is November 11. The EMA's centralized review process is underway.

Janssen Therapeutics (JNJ) announced that the FDA has approved an expansion to the PREZISTA (darunavir) U.S. package insert to include data from a study investigating the use of PREZISTA during pregnancy and the postpartum period. PREZISTA is indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents.

The FDA has approved Perrigo’s (PRGO) generic version of Zegerid OTC (omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg) for the treatment of frequent heartburn. The product will be sold as a private label brand for retailers.

No patents to report.

Celgene (CELG) announced that it has signed a deal worth up to $2.6 billion with Jounce Therapeutics, a cancer start-up. The partnership will focus on the development of a new generation of drugs that help the body fight against tumors. According to the Financial Times, Jounce will receive an upfront payment of $225 million. CELG will also make a $36 million equity investment in Jounce. The privately-held company is also entitled to $2.3 billion in payments related to several milestones.

No secondary offerings to report.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Akorn (AKRX) Royal Bank of Canada Reiterate Buy N/A N/A
AstraZeneca (AZN) Bank of America Reiterate Buy

$36.65

N/A
Brainstorm Cell Therapeutics (BCLI) Maxim Group Reiterate Buy N/A N/A
Depomed (DEPO) Janney Montgomery Scott Reiterate Buy

$28

$30

Depomed (DEPO) Leerink Swann Reiterate Positive N/A

$30

Evoke Pharma (EVOK) Brean Capital Downgrade From Buy to Hold N/A N/A
Evoke Pharma (EVOK) Rodman & Renshaw Downgrade From Buy to Neutral

$2

N/A
Evoke Pharma (EVOK) Feltl & Co. Downgrade Sell N/A N/A
Evoke Pharma (EVOK) Northland Securities Downgrade From Outperform to Market Perform N/A N/A
GW Pharmaceuticals Plc (GWPH) Bank of America Reiterate Buy

$153

N/A
Incyte (INCY) Leerink Swann Reiterate Buy N/A N/A
Inovio Pharmaceuticals (INO) Piper Jafrray Cos. Reiterate Overweight

$31

N/A
Ionis Pharmaceuticals (IONS) Leerink Swann Price Target Cut Market Perform From $39 to $26 N/A
Juno Therapeutics (JUNO) Maxim Group Reiterate Buy

$80

N/A
Opexa Therapeutics (OPXA) Aegis Price Target Raised N/A

$11

N/A
Peregrine Pharmaceuticals (PPHM) Noble Financial Reiterate Buy

$1.50

N/A
Prothena (PRTA) Royal Bank of Canada Reiterate Outperform

$95

N/A
Parexel International (PRXL) William Blair Downgrade From Outperform to Market Perform N/A N/A
uniQure (QURE) Chardan Capital Reiterate Buy N/A N/A
Ultragenyx Pharmaceuticals (RARE) Robert W. Baird Reiterate Outperform

$85

N/A
Relypsa (RLYP) Brean Capital Reiterate Buy N/A

$48.20

Selecta Biosciences (SELB) Needham & Company Initiation Buy

$28

N/A
Selecta Biosciences (SELB) Stifel Nicolaus Initiation Buy

$23

N/A
Selecta Biosciences (SELB) Canaccord Genuity Initiation Buy

$20

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

$23

N/A
Supernus Pharmaceuticals (SUPN) Piper Jafrray Cos. Downgrade From Overweight to Neutral

$23

N/A
Supernus Pharmaceuticals (SUPN) Northland Securities Downgrade From Outperform to Market Perform N/A N/A
Syros Pharmaceuticals (SYRS) HC Wainwright Initiation Neutral

$10

N/A
Teva Pharmaceutical Industries (TEVA) HSBC Upgrade From Hold to Buy N/A N/A
Teva Pharmaceutical Industries (TEVA) Royal Bank of Canada Reiterate Buy N/A N/A
Teva Pharmaceutical Industries (TEVA) Maxim Group Reiterate Buy N/A N/A
Valeant Pharmaceuticals International (VRX) Canaccord Genuity Reiterate Hold N/A N/A
ZIOPHARM Oncology (ZIOP) Mizuho Reiterate Neutral

$7

N/A

No insider buys to report.

Jazz Pharmaceuticals (JAZZ)- Michael Patrick Miller, SVP, U.S. Commercial, sold 100 shares at $142.43. The total value of the transaction was $14,243. Miller still owns 17,625 shares of JAZZ.

Keryx Biopharmaceuticals (KERX)- Brian Adams, VP and General Counsel, sold 1,083 shares at $7.01. The total value of the transaction was $7,592. Adams still owns 103,320 shares of KERX.

MannKind (MNKD)- Rosabel R. Alinaya, SVP, Principal Accounting Officer, sold 6,294 shares at $1.06. The total value of the transaction was $6,672. Alinaya still owns 131,413 shares of MNKD.

Dermira (DERM)- Christopher M. Griffith, VP Corporate Development & Strategy, sold 1,303 shares at $30.02. The total value of the transaction was $39,116. Griffith still owns 44,654 shares of DERM.

No management changes and additions to report.

NYSE- InVitae (NVTA) shares were among the major losers on the NYSE. The stock ended the day 5.81% lower. Perrigo (PRGO) ended the day 2.35% lower.

NASDAQ- WAVE Life Sciences (WAVE) shares were among the major gainers on the NASDAQ. The stock closed 16.39% higher. Immunogen (IMGN) ended the day 10.51% higher. Marinus Pharmaceuticals (MRNS) ended the day 10.50% higher. Kura Oncology (KURA) shares were among the major losers on the NASDAQ. The stock ended the day 15.41% lower. Syros Pharmaceuticals (SYRS) ended the day 15.20% lower. Supernus Pharmaceuticals (SUPN) ended the day 4.90% lower.

NYSEMKT- Actinium Pharmaceuticals (ATNM) shares were among the major movers on the NYSEMKT. The stock closed 1.18% lower.

OTC- Soligenix (SNGX) shares were among the major movers on the OTC market. The stock closed     3.23% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Clovis Oncology (CLVS)

25%

0.2%

5

Codexis (CDXS)

6.5%

263.1%

4

Coherus Biosciences (CHRS)

16.8%

2.2%

12

Collegium Pharmaceuticals (COLL)

13.6%

25.2%

7

CoLucid Pharmaceuticals (CLCD)

2.8%

31.1%

4

CombiMatrix (CBMX)

9.6%

67.2%

2

Conatus Pharmaceuticals (CNAT)

2.3%

81.5%

3

Concert Pharmaceuticals (CNCE)

3.7%

0.4%

3

Concordia International (CXRX)

29.2%

-1.4%

29

ContraVir Pharmaceuticals (CTRV)

3.5%

-

6