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Exelixis (EXEL) has had an excellent run in the last three months, gaining more than 96%. Last week, EXEL received another positive news. The company along with Ipsen announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx™ (cabozantinib) 20, 40, 60mg for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy and recommended it for marketing authorization.

Michael M. Morrissey, Ph.D., President and CEO, said that the positive CHMP opinion for Cabometryx is a significant milestone for the company. Earlier in the year, the EMA validated Exelixis’ Marketing Authorization Application (MAA) for Cabometyx™ (cabozantinib) as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy. Cabometyx™ (cabozantinib) has also been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

Despite the run in the last three months, I believe there is further upside in EXEL. My fair value on the stock remains at $12.50.

Valeant’s B&L Unit’s Latanoprostene NDA Rejected- Valeant Pharmaceuticals International (VRX) announced that its Bausch + Lomb unit received a Compete Response Letter (CRL) regarding its New Drug Application (NDA) seeking approval of latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The CRL cited deficiencies observed during a Current Good Manufacturing Practice (CGMP) inspection at B+L's manufacturing site in Tampa, FL. The letter did not identify any safety or efficacy issues with the product. VRX plans to meet with the agency as soon as possible to address the matter.

VIVUS Gets Markman Ruling in Patent Case Related to Qsymia- VIVUS (VVUS) announced that a New Jersey district court issued a Markman ruling favoring it in a patent infringement litigation against potential generic competitors Actavis (AGN) and Teva Pharmaceutical Industries (TEVA) related to its Qsymia. In a Markman ruling, also known as a claim construction ruling, the court determines the meaning of disputed patent claims at issue in the litigation.

Amgen Submits BLA for Romosozumab- Amgen (AMGN) announced that it has filed a Biologics License Application (BLA) with the FDA seeking approval of romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.

Gilead Sciences (GILD) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the use of its Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk. The strategy is known as pre-exposure prophylaxis. Truvada has already been approved in 2005 by the EMA for the treatment of HIV-1 infection in adults, in combination with other antiretroviral agents.

No patents to report.

No deals and collaborations to report.

Onconova Therapeutics (ONTX) announced it has adjusted pricing for a rights offering it had announced previously. The company's distributing 1.5 non-transferable subscription rights for each share of common stock or participating warrants. The subscription pricing, previously set for a range of $5.75-$6.25, is now $4.10/unit. Investors who had subscribed previously will receive the adjusted price, and excess payments returned afterward.

No IPOs to report.

No earnings to report.

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

$25

N/A
Biogen (BIIB) Credit Suisse Group Reiterate Hold

$312

$420

Celsion (CLSN) Maxim Group Reiterate Buy

$4

N/A
Galena Biopharma (GALE) FBR & Co. Price Target Cut Outperform From $5 to $2 N/A
Intellipharmaceutics International (IPCI) Maxim Group Reiterate Buy N/A N/A
Kite Pharma (KITE) Mizuho Reiterate Buy

$80

N/A
Progenics Pharmaceuticals (PGNX) Needham & Company Reiterate Buy

$11

$31.50

Progenics Pharmaceuticals (PGNX) Brean Capital Reiterate Buy

$14

$31.50

Relypsa (RLYP) HC Wainwright Downgrade From Buy to Neutral

$32

N/A
Sarepta Therapeutics (SRPT) Needham & Company Price Target Raised Buy From $20 to $26 N/A
Stemline Therapeutics (STML) Jefferies Group Reiterate Buy

$23

N/A

No insider buys to report.

Biogen (BIIB)- George A. Scangos, CEO, sold 157 shares at $280. The total value of the transaction was $43,960. Scangos still owns 54,779 shares of BIIB.

United Therapeutics (UTHR)- Martina A. Rothblatt, Chairman & CEO, sold 1,284 shares at $112.77. The total value of the transaction was $144,791. Rothblatt still owns 140 shares of UTHR.

Prothena Corporation (PRTA)- Arthur W. Homan, Chief Legal Officer, sold 9,375 shares at $52.14. The total value of the transaction was $9,375. Homan does not own any shares of PRTA.

No management changes and additions to report.

NYSE- Puma Biotechnology (PBYI) shares were among the major gainers on the NYSE. The stock closed 20.28% higher. Axovant Sciences (AXON) shares ended the day 6.39% higher. InVitae (NVTA) ended the day 4.13% higher. Valeant Pharmaceuticals International (VRX) shares were among the major losers on the NYSE. The stock closed 6.78% lower.

NASDAQ- Cara Therapeutics (CARA) shares were among the major gainers on the NASDAQ. The stock closed 21.80% higher. Voyager Therapeutics (VYGR) ended the day 9.48% higher. SteadyMed (STDY) ended the day 8.94% higher. Adamas Pharmaceuticals (ADMS) shares were among the major losers on the NASDAQ. The stock closed 4.50% lower. Reata Pharmaceuticals (RETA) ended the day 4.27% lower. Intellia Pharmaceuticals (NTLA) ended the day 4.19% lower.

NYSEMKT- Actinium Pharmaceuticals (ATNM) shares were among the major movers on the NYSEMKT. The stock closed 4.73% higher.

OTC- Cellceutix (CTIX) shares were among the major movers on the OTC market. The stock closed 1.54% higher.

Company (Ticker) Short Interest as % of Float % Change Days to Cover
Eiger Biopharmaceuticals (EIGR)

5.3%

853%

3

Eleven Biotherapeutics (EBIO)

11.9%

8.9%

1

Endocyte (ECYT)

8.9%

-7.4%

15

EPIRUS Biopharmaceuticals (EPRS)

1.8%

30.1%

0

Epizyme (EPZM)

13.6%

20.7%

8

Esperion Therapeutics (ESPR)

26.3%

-2%

3

Evoke Pharma (EVOK)

4%

12.6%

3

Exact Sciences (EXAS)

33%

50.5%

3

Exelixis (EXEL)

23.4%

1.8%

6

Eyegate Pharmaceuticals (EYEG)

1.5%

-4.3%

2