Clovis Oncology (CLVS) shares surged on Tuesday after the company announced that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and who have been treated with least two chemo regimens. The FDA has granted a Priority Review and the PDUFA date has been set on February 23rd, 2017. The stock had seen a sharp pullback after the setback of rociletinib. However, I had noted earlier that the market was ignoring the potential of rucaparib. I believe that based on the potential of just rucaparib, CLVS has significant upside from current levels.

Cempra (CEMP) announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia. The review process is now underway. CEMP has already filed an NDA in the U.S., which is currently under review.

I initiated coverage on CEMP recently, highlighting the fact that the company is a long-term buy. My fair value for CEMP is $45, which implies substantial upside from current levels. I believe CEMP has a favorable risk/reward profile, given that there is no near-term dilution risk.

Janssen Submits Application for Expanded Use of Darzalex- Janssen (JNJ) announced that it has submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of DARZALEX (daratumumab), in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy. The drug is currently approved in the EU as monotherapy in adult patients with relapsed/refractory MM whose prior therapy included a proteasome inhibitor (i.e., VELCADE) and an immunomodulatory agent (i.e., REVLIMID) and experienced disease progression on the last therapy.

CytoDyn Provides Update from Mid-Stage Study of PRO 140- CytoDyn (CYDY) announced that 10 of 11 patients in its Phase 2b extension study of HIV therapeutic candidate PRO 140 have experienced two years of complete viral suppression (plasma HIV-1 RNA <40 copies/mL). Patients in the study received a 350 mg dose of PRO 140 once weekly via subcutaneous injection in place of their HAART (multiple antiretroviral) regimens. In the next two months, nine more patients will reach their two-year benchmarks. Patients in the Phase 2b extension study showed full HIV viral load suppression during a 12-week Phase 2b study in which they receive weekly PRO 140 subcutaneous injections (one 350 mg dose) in place of their HAART regimens.  Forty patients were enrolled in the Phase 2b trial, of which 35 were evaluable and five were excluded for tropism screening failures or protocol violations.

Mylan Under Scrutiny Over Price Hikes- Mylan (MYL) is under scrutiny over hiking price of its EpiPen. Iowa Senator Chuck Grassley has officially requested an explanation from management why it has increased the price of its EpiPen. MYL acquired EpiPen in 2007 and has since raised the price of the injection by around 400%. The news sent MYL shares down sharply on Tuesday.

Stemline Therapeutics (STML) announced that the FDA has granted its lead product candidate SL-401 a Breakthrough Therapy for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive blood cancer. It has Orphan Drug status in Europe for the same indication.

Perrigo (PRGO) announced that the FDA has granted tentative approval to the generic version of Braintree Labs' Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution, used to cleanse the colon prior to a colonoscopy in adult patients.

No patents to report.

CEL-SCI (CVM) announced an agreement with institutional investors for the direct placement of 10 million shares of common stock and five-year warrants to purchase up to 5 million shares at $0.55. Gross proceeds from the offering will be approximately $5 million.

Northwest Biotherapeutics (NWBO) disclosed that it discounted the exercise prices for certain warrant holders as an inducement to raise $1.3 million in new capital. The company offered an exercise price of $0.35 a share for warrants to purchase up to 3,656,817 shares of common stock with original exercise prices of $4.50-$6.00. The company also issued new five-year Series E Warrants to the same warrant holders to purchase up to 3,656,817 shares of common stock at $0.41 per share.

Sophiris Bio (SPHS) announced the pricing of its public offering of 6.5 million shares of common stock and warrants to purchase 4.875 million shares at a combined price of $4. Underwriters to the offering have been granted an option to acquire an additional 975,000 shares of stock and related warrants to purchase up to 731,250 shares. Gross proceeds from the offering are expected to total $26 million.

No IPOs to report.

Sinovac Biotech (SVA) reported a loss of $0.17 per share in its second quarter. The company’s revenue for the quarter was $1.38 million, down 92.5% on a year-over-year basis.

Lannett (LCI) reported earnings of $0.73 per share in its fourth quarter, beating consensus forecast by 14 cents. The company reported revenue of $168.9 million, up 70.1% on a year-over-year basis. Revenue beat consensus forecast by $7.35 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Aerie Pharmaceuticals (AERI) Needham & Company Reiterate Buy

$45

N/A
Aeterna Zentaris (AEZS) Canaccord Genuity Reiterate Buy

$9

N/A
Akebia Therapeutics (AKBA) HC Wainwright Reiterate Buy N/A N/A
Alder Biopharmaceuticals (ALDR) Jefferies Group Reiterate Buy N/A N/A
Amgen (AMGN) Jefferies Group Reiterate Buy N/A

$250

Biogen (BIIB) Jefferies Group Reiterate Buy N/A

$420

Bellicum Pharmaceuticals (BLCM) Jefferies Group Reiterate Buy N/A N/A
Celgene (CELG) Jefferies Group Reiterate Buy N/A

$140

Celgene (CELG) BMO Capital Markets Reiterate Outperform

$141

$140

Concordia Healthcare (CXRX) RBC Capital Markets Reiterate Outperform

$35

N/A
Horizon Pharma (HZNP) Guggenheim Reiterate Buy

$30

N/A
ImmunoCellular Therapeutics (IMUC) Maxim Group Price Target Cut Buy From $3 to $2 N/A
Medivation (MDVN) Maxim Group Downgrade/Price Target Raised From Buy to Hold From $76 to $81.50 N/A
Medivation (MDVN) Canaccord Genuity Price Target Raised Buy From $70 to $82 N/A
Medivation (MDVN) Stifel Nicolaus Downgrade From Buy to Hold N/A N/A
Medivation (MDVN) Credit Suisse Group Downgrade From Outperform to Neutral

$81.50

N/A
Medivation (MDVN) BMO Capital Markets Price Target Raised Market Perform From $67.16 to $81.50 N/A
Intellia Therapeutics (NTLA) Wedbush Reiterate Outperform

$38

N/A
Pfizer (PFE) BMO Capital Markets Reiterate Outperform

$40

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

$54

N/A
Raptor Pharmaceutical Corp. (RPTP) FBR & Co. Reiterate Hold

$10

N/A
Stemline Therapeutics (STML) Wedbush Reiterate Outperform

$15

N/A
United Therapeutics (UTHR) Argus Reiterate Hold N/A N/A

Argos Therapeutics (ARGS)- Pharmstandard International S., a 10% owner, bought 75,474 shares in two separate transactions. Pharmstandard bought 53,524 shares at $4.23; and 21,950 shares at $4.26. Pharmstandard International now owns 12,886,494 shares of ARGS.

Illumina (ILMN)- Robert S. Epstein, Director, sold 300 shares at $170.27. The total value of the transaction was $51,081. Epstein still owns 7,224 shares of ILMN.

Atara Biotherapeutics (ATRA)- Isaac E. Ciechanover, CEO, sold 9,600 shares in two separate transactions. Ciechanover sold 4,800 shares at $22.58; and 4,800 shares at $22.08. Ciechanover still owns 425,778 shares of ATRA.

Theravance Biopharma (TBPH)- Brett K. Haumann, SVP Clinical Development & Chief Medical Officer, sold 9,509 shares at $27.97. The total value of the transaction was $265,967. Haumann still owns 197,391 shares of TBPH.

OncoGenex Pharmaceuticals (OGXI)- John Bencich, CFO, sold 1,380 shares at $0.57. The total value of the transaction was $787. Bencich still owns 9,484 shares of OGXI.

Momenta Pharmaceuticals (MNTA)- Ganesh V. Kaundinya, Senior VP, Research, sold 1049 shares in two separate transactions. Kaundinya sold 822 shares at $12.04; and 227 shares at $12.10. Kaundinya still owns 455,063 shares of MNTA. James M. Roach, Senior VP, Development, sold 1,091 shares in two separate transactions. Roach sold 842 shares at $12.04; and 249 shares at $12.10. Roach still owns 156,472 shares of MNTA. Bruce Leicher, SVP & General Counsel, sold 1,030 shares in two separate transactions. Leicher sold 803 shares at $12.04; and 227 shares at $12.10. Leicher still owns 182,952 shares of MNTA. Richard P. Shea, SVP, CFP, sold 972 shares in two separate transactions. Shea sold 745 shares at $12.04; and 227 shares at $12.10. Shea still owns 132,127 shares of MNTA. Craig A. Wheeler, President, sold 5,880 shares in two separate transactions. Wheeler sold 4,116 shares at $12.04; and 1,764 shares at $12. Wheeler still owns 333,199 shares at MNTA.
Xenon Pharmaceuticals (XENE)- Frank A. Holler, Director, sold 11,938 shares at $7.65. The total value of the transaction was $91,338. Holler still owns 145,869 shares of XENE.

No management changes and additions to report.

NYSE- Puma Biotechnology (PBYI) shares were among the major gainers on the NYSE. The stock closed 3.60% higher.

NASDAQ- Clovis Oncology (CLVS) shares were among the major gainers on the NASDAQ. The stock closed 27.24% higher. Syndax Pharmaceuticals (SNDX) ended the day 14.86% higher. ProQr Therapeutics (PRQR) ended the day 9.19% higher. SCYNEXIS (SCYX) shares were among the major losers on the NASDAQ. The stock closed 5.96% lower. uniQURE (QURE) ended the day 4.95% lower. Mylan (MYL) ended the day 4.76% lower.

NYSEMKT- Provectus Biopharmaceuticals (PVCT) shares were among the major movers on the NYSEMKT. The stock closed 2.29% higher.

OTC- Cellceutix (CTIX) shares were among the major movers on the OTC market. The stock closed 2.17% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
SCYNEXIS (SCYX)

0.7%

-11.8%

1

Seattle Genetics (SGEN)

10%

-5%

20

Selecta Biosciences (SELB)

0.1%

4,916.5%

0

Seres Therapeutics (MCRB)

15.7%

-17.4%

1

Shire Plc (SHPG) -

-28.8%

2

Signal Genetics (SGNL)

0.6%

2%

0

Sinovac Biotech (SVA)

0.9%

8.6%

7

Sophirs Bio (SPHS)

22.4%

2.9%

0

Sorrento Therapeutics (SRNE)

8%

2.5%

30

Spark Therapeutics (ONCE)

16.2%

0.8%

8