Dynavax Technologies (DVAX) rose sharply on Friday after announcing that its Biologics License Application (BLA) for hep B vaccine HEPLISAV-B is headed for an Advisory Committee meeting on Nov. 16. The PDUFA date for HEPLISAV-B has been set on December 15th.

DVAX’s vaccine combines 1018, a proprietary TLR9 agonist adjuvant, and recombinant hep-B surface antigen. The vaccine has shown earlier protection with fewer doses than currently-licensed vaccines and a safety profile similar to licensed hep-B vaccine.

Dynavax has worldwide commercial rights to HEPLISAV-B. DVAX plans to focus its initial commercialization efforts on the U.S. market. I have valued DVAX based on HEPLISAV-B’s potential in the U.S. alone. The U.S. Hep B vaccine market is estimated at $270 million. GlobalData expects the global Hep B market to cross $1 billion by 2022. The market is estimated at $1.19 billion in 2022. The good news for DVAX though is that most of the growth in vaccine sales is expected to come from the U.S. While the CAGR or compounded annual growth rate for global Hep B market is seen at 2.2%, according to GlobalData, the CAGR for the U.S. market alone is seen at 3.4%. Further, GlobalData expects U.S.’s share of the global market to cross 60%, 61.7% to be precise. So by 2022, DVAX’s focus market i.e. the U.S. could be worth around $650 million.

To value, DVAX, I assumed that HEPLISV-B captures 75% of the market at peak. I calculated the terminal value in 2025. The discount rate was assumed at 8% and the continued growth rate to calculate the terminal value is assumed at 3%. I assumed that the addressable market for DVAX in 2016 in the U.S. is around $350 million and growing at a CAGR of 3%. I assumed a 90% probability of approval, which is the average for drugs under review with the FDA.

Based on these assumptions, I get a fair value for DVAX of $51.32. That is more than two times the current levels.

Egalet Rallies on Positive Vote From FDA Panel- Egalet Corp. (EGLT) shares rallied on Friday after the company received a positive vote from an FDA panel for its abuse-deterrent ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. The panel voted 18-1 to recommend approval of ARYMO ER; the FDA's final decision is scheduled for Oct. 14.

Bristol-Myers Tumbles on Opdivo Setback- Bristol-Myers Squibb (BMY) shares tumbled on Friday after the company announced that CheckMate-026, a Phase 3 trial investigating the use of Opdivo as a therapy, did not meet its primary endpoint of progression-free survival in certain patients with previously untreated advanced non-small cell lung cancer. Opdivo’s failure though boosted Merck & Co. (MRK) shares, which closed more than 10% higher on Friday. MRK rallied as the failure potentially reduces competition for its Keytruda lung cancer drug. In June, a similar trial evaluating the use of KEYTRUDA for the same condition met its primary endpoint. AstraZeneca (AZN) shares also jumped to a 52-week high on Friday before settling lower. According to analysts, the failure of Opdivo increases the potential market opportunity of AZN’s durvalumab and tremelimumab combo. Meanwhile, analysts believe the failed trial could cost BMY as much as $4b billion in lost sales. Following the trial results, Morgan Stanley downgraded Bristol-Myers Squibb to an Equal Weight rating from an Overweight rating. BMY also lowered its price target on the stock from $81 to $63. Morgan Stanley has lowered its 2020 Opdivo revenue estimate for 2020 by more than quarter to $8.1 billion.

Valeant’s Relistor Draws Interest- Valeant Pharmaceuticals International (VRX) and Progenics Pharmaceuticals’ (PGNX) RELITSOR is attracting interest from other drug companies, according to a report by Bloomberg. The FDA had recently approved oral formulation of RELISTOR. The drug is being marketed by VRX and has been developed by PGNX. According to the Bloomberg report, the drug could be valued between $400 million and $500 million.

AbbVie Files Patent Lawsuit Against Amgen- AbbVie (ABBV) has filed a patent infringement lawsuit seeking to block rival Amgen (AMGN) from selling a copy of its arthritis drug, Humira. In the lawsuit, ABBV has alleged that Amgen’s proposed copy would infringe at least 10 ABBV patents, and that the company reserves the right to assert as many as 51 other patents.

No approvals to report.

No patents to report.

No deals and collaborations to report.

No secondary offerings to report.

No IPOs to report.

Egalet (EGLT) reported a loss of $0.97 per share in its second quarter, missing consensus forecast by 15 cents. The company reported revenue of $3.45 million, up 259.4% on a year-over-year basis. Revenue missed consensus forecast by $0.38 million.

Novo Nordisk (NVO) reported earnings of DKK3.92 per share in its second quarter. The company’s revenue for the quarter was DKK27.46 billion, up 1.5% on a year-over-year basis.

GenVec (GNVC) reported a loss of $0.06 per share in its second quarter, beating consensus forecast by 4 cents. The company’s revenue for the quarter was $0.03 million, down 76.9% on a year-over-year basis. Revenue missed consensus forecast by $0.07 million.

Roka Bioscience (ROKA) reported a loss of $0.43 per share in its second quarter. The company’s revenue for the quarter $1.82 million, up 23.8% on a year-over-year basis. Revenue beat consensus forecast by $0.04 million.

CorMedix (CRMD) reported a loss of $0.13 per share in its second quarter, missing consensus forecast by 2 cents. The company’s revenue for the quarter was $0.02 million, down 83.3% on a year-over-year basis.

Aurinia Pharma (AUPH) reported a loss of $0.10 per share in its second quarter. The company ended the quarter with cash and cash equivalents of $12.1 million.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Abeona Therapeutics (ABEO) Rodman & Renshaw Reiterate Buy

$17

N/A
Arbutus Biopharma (ABUS) Wedbush Price Target Raised Reiterate From $13 to $20 N/A
ACADIA Pharmaceuticals (ACAD) Aegis Downgrade From Buy to Hold

$41

$100.40

ACADIA Pharmaceuticals (ACAD) Needham & Company Reiterate Buy N/A

$100.40

AcelRx Pharmaceuticals (ACRX) Stifel Nicolaus Downgrade From Buy to Hold N/A N/A
Aduro Biotech (ADRO) Canaccord Genuity Reiterate Buy

$30

N/A
Advaxis (ADXS) HC Wainwright Reiterate Buy

$23

N/A
Allergan (AGN) JPMorgan Chase & Co. Price Target Set Buy

$325

N/A
Allergan (AGN) Mizuho Price Target Raised Neutral From $232 to $246 N/A
Albany Molecular Research (AMRI) Morgan Stanley Reiterate Buy

$17

N/A
ANI Pharmaceuticals (ANIP) Guggenheim Price Target Raised Buy From $65 to $80 N/A
ANI Pharmaceuticals (ANIP) Oppenheimer Holdings Price Target Raised Outperform From $65 to $71 N/A
Array BioPharma (ARRY) Stifel Nicolaus Price Target Raised Buy From $7 to $8 N/A
Aurinia Pharmaceuticals (AUPH) Canaccord Genuity Price Target Set Buy

$10

N/A
BioCryst Pharmaceuticals (BCRX) JPMorgan Chase & Co. Reiterate Hold N/A N/A
BioCryst Pharmaceuticals (BCRX) HC Wainwright Reiterate Buy N/A N/A
BioCryst Pharmaceuticals (BCRX) Jefferies Group Price Target Raised Hold From $2 to $3 N/A
BioMarin Pharmaceutical (BMRN) Jefferies Group Price Target Raised Buy From $116 to $120 N/A
BioMarin Pharmaceutical (BMRN) Barclays PLC Price Target Raised Overweight From $105 to $125 N/A
BioMarin Pharmaceutical (BMRN) Sfifel Nicolaus Price Target Raised Buy From $107 to $113 N/A
BioMarin Pharmaceutical (BMRN) Piper Jaffray Cos. Price Target Raised Overweight From $107 to $120 N/A
BioMarin Pharmaceutical (BMRN) JPMorgan Chase & Co. Price Target Raised Overweight From $120 to $127 N/A
Bristol-Myers Squibb (BMY) SunTrust Banks Downgrade From Buy to Neutral N/A N/A
Bristol-Myers Squibb (BMY) Morgan Stanley Downgrade/Price Target Cut From Overweight to Equal Weight From $81 to $63 N/A
Bristol-Myers Squibb (BMY) Deutsche Bank Downgrade From Hold to Sell N/A N/A
Blueprint Medicines Corp. (BPMC) Canaccord Genuity Initiation Buy

$26

N/A
Cara Therapeutics (CARA) Cantor Fitzgerald Reiterate Buy N/A N/A
Cara Therapeutics (CARA) Stifel Nicolaus Price Target Cut Buy From $25 to $24 N/A
Celldex Therapeutics (CLDX) Jefferies Group Reiterate Hold N/A N/A
Cellectis SA (CLLS) Jefferies Group Reiterate Buy N/A N/A
Clovis Oncology (CLVS) SunTrust Banks Initiation Buy N/A N/A
Conatus Pharmaceuticals (CNAT) Brean Capital Price Target Set Buy

$7

N/A
Corium International (CORI) FBR & Co. Price Target Set Buy

$18

N/A
Dimension Therapeutics (DMTX) Jefferies Group Reiterate Buy N/A N/A
Dicerna Pharmaceuticals (DRNA) Cowen and Company Reiterate Buy N/A N/A
Endo International Plc (ENDP) Morgan Stanley Price Target Set Hold

$15

N/A
Esperion Therapeutics (ESPR) JPMorgan Chase & Co. Price Target Set Hold

$15

N/A
Five Prime Therapeutics (FPRX) Jefferies Group Price Target Raised Buy From $41 to $60 N/A
Galmed Pharmaceuticals (GLMD) FBR & Co. Price Target Set Buy

$20

$20

Intercept Pharmaceuticals (ICPT) Oppenheimer Holdings Price Target Cut Outperform From $265 to $250 N/A
Intercept Pharmaceuticals (ICPT) Credit Suisse Reiterate Buy

$200

N/A
Intercept Pharmaceuticals (ICPT) Laidlaw Downgrade/Price Target Cut From Buy to Sell From $345 to $105 N/A
Intercept Pharmaceuticals (ICPT) Morgan Stanley Reiterate Sell

$80

N/A
Intercept Pharmaceuticals (ICPT) BMO Capital Markets Price Target Cut Outperform From $219 to $218 N/A
ImmunoGen (IMGN) JPMorgan Chase & Co. Price Target Cut Hold From $9 to $5 N/A
ImmunoGen (IMGN) Jefferies Group Price Target Cut Buy From $13 to $6 N/A
Incyte (INCY) SunTrust Banks Initiation Buy N/A N/A
Inogen (INGN) Stifel Nicolaus Downgrade From Buy to Hold N/A N/A
Inogen (INGN) JPMorgan Chase & Co. Price Target Raised Overweight From $60 to $62 N/A
Ironwood Pharmaceuticals (IRWD) JPMorgan Chase & Co. Price Target Raised Overweight From $15 to $16 N/A
Ironwood Pharmaceuticals (IRWD) Barclays PLC Price Target Raised Equal Weight From $11 to $12 N/A
Intra-Cellular Therapies (ICTI) Cowen and Company Reiterate Buy

$75

N/A
Ligand Pharmaceuticals (LGND) Deutsche Bank Downgrade/Price Target Raised  From Hold to Sell From $104 to $110 N/A
Ligand Pharmaceuticals (LGND) Roth Capital Price Target Raised Buy From $147 to $149 N/A
Lexicon Pharmaceuticals (LXRX) Stifel Nicolaus Price Target Raised Buy From $25 to $26 N/A
Lexicon Pharmaceuticals (LXRX) Wedbush Price Target Raised Outperform From $30 to $31 N/A
Merrimack Pharmaceuticals (MACK) JPMorgan Chase & Co. Price Target Cut Overweight From $9 to $8

$14

Merrimack Pharmaceuticals (MACK) Cowen and Company Downgrade From Outperform to Market Perform N/A

$14

Merrimack Pharmaceuticals (MACK) Brean Capital Price Target Set Buy

$13

$14

The Medicines Company (MDCO) Cowen and Company Reiterate Buy

$45

$50

Momenta Pharmaceuticals (MNTA) JPMorgan Chase & Co. Price Target Cut Overweight From $21 to $15 N/A
Momenta Pharmaceuticals (MNTA) Brean Capital Price Target Set Buy

$19

N/A
Merck & Co. (MRK) BMO Capital Markets Upgrade From Market Perform to Outperform From $62 to $72

$70

Marinus Pharmaceuticals (MRNS) Jefferies Group Reiterate Buy

$2.50

N/A
Neurocrine Biosciences (NBIX) Cowen and Company Reiterate Buy

$65

N/A
Neurocrine Biosciences (NBIX) HC Wainwright Reiterate Buy N/A N/A
Nektar Therapeutics (NKTR) Brean Capital Reiterate Buy

$18

N/A
Nektar Therapeutics (NKTR) Piper Jaffray Cos. Price Target Raised Overweight From $17 to $21 N/A
Intellia Therapeutics (NTLA) Jefferies Group Upgrade From Hold to Buy

$33

N/A
Intellia Therapeutics (NTLA) Leerink Swann Upgrade From Market Perform to Outperform

$32

N/A
Spark Therapeutics (ONCE) Jefferies Group Reiterate Hold N/A N/A
OvaScience (OVAS) JPMorgan Chase & Co. Price Target Cut Neutral From $9 to $8 N/A
Pacira Pharmaceuticals (PCRX) BMO Capital Markets Reiterate Sell

$36

N/A
Pacira Pharmaceuticals (PCRX) Brean Capital Reiterate Hold N/A N/A
Progenics Pharmaceuticals (PGNX) Brean Capital Price Target Set Buy

$14

$31.50

Pieris Pharmaceuticals (PIRS) Roth Capital Reiterate Buy N/A N/A
Parexel International (PRXL) Evercore ISI Price Target Raised Buy From $71 to $78.50 N/A
Parexel International (PRXL) Jefferies Group Price Target Raised Hold From $70 to $72.50 N/A
Parexel International (PRXL) Citigroup Price Target Raised Buy From $74 to $80 N/A
Parexel International (PRXL) Deutsche Bank Price Target Raised Hold From $65 to $71 N/A
PTC Therapeutics (PTCT) JPMorgan Chase & Co. Price Target Cut Neutral From $18 to $17 N/A
PTC Therapeutics (PTCT) Credit Suisse Price Target Set Hold

$6

N/A
PTC Therapeutics (PTCT) Wedbush Reiterate Neutral

$10

N/A
Radius Health (RDUS) Jefferies Group Reiterate Hold N/A

$85

Radius Health (RDUS) JPMorgan Chase & Co. Reiterate Buy N/A

$85

Regeneron Pharmaceuticals (REGN) Cowen and Company Reiterate Hold

$430

$475

Regeneron Pharmaceuticals (REGN) Robert W. Baird Downgrade/Price Target Cut From Outperform to Neutral From $505 to $448

$475

Regeneron Pharmaceuticals (REGN) Canaccord Genuity Reiterate Hold

$450

$475

Regeneron Pharmaceuticals (REGN) Brean Capital Reiterate Buy

$489

$475

Regeneron Pharmaceuticals (REGN) Roth Capital Reiterate Buy

$520

$475

Revance Therapeutics (RVNC) Brean Capital Reiterate Hold N/A N/A
Stemline Therapeutics (STML) Jefferies Group Reiterate Buy N/A N/A
Teva Pharmaceutical Industries (TEVA) Mizuho Reiterate Buy

$75

N/A
Teva Pharmaceutical Industries (TEVA) Oppenheimer Holdings Downgrade From Outperform to Market Perform

$70.29

N/A
TrovaGene (TROV) Piper Jaffray Cos. Price Target Set Hold

$4

N/A
TrovaGene (TROV) Maxim Group Price Target Raised Buy From $9 to $12 N/A
Trevena (TRVN) Cowen and Company Reiterate Buy

$13

N/A
Trevena (TRVN) Jefferies Group Reiterate Buy N/A N/A
Trevena (TRVN) Brean Capital Reiterate Buy

$14

N/A
TESARO (TSRO) Credit Suisse Reiterate Buy N/A N/A
TESARO (TSRO) Wedbush Reiterate Buy N/A N/A
TESARO (TSRO) Jefferies Group Price Target Raised Hold From $75 to $80 N/A
TESARO (TSRO) Mizuho Price Target Cut Buy From $100 to $94 N/A
Tetraphase Pharmaceuticals (TTPH) Wedbush Reiterate Neutral

$4

N/A
Xenon Pharmaceuticals (XENE) Canaccord Genuity Reiterate Buy

$16

N/A
Acceleron Pharma (XLRN) FBR & Co. Reiterate Buy

$63

N/A
Acceleron Pharma (XLRN) Morgan Stanley Reiterate Buy

$58

N/A

No insider buys to report.

Codexis (CDXS)- Vivo Ventures VII, LLC, a 10% owner, sold 80,000 shares in two separate transactions. Vivo Ventures sold 30,000 shares at $4.30; and 50,000 shares at $4.17. Vivo Ventures now owns 117,174 shares of CDXS.

Spark Therapeutics (ONCE)- Anand Mehra, Director, sold 5,064 shares in two separate transactions. Mehra sold 4,612 shares at $60; and 452 shares at $60. Mehra still owns 1,407,237 shares of ONCE.

Exelixis (EXEL)- Gisela Schwab, Pres Product Development & Medical Affairs & CMO, sold 42,338 shares at $11. The total value of the transaction was $465,718. Schwab still owns 132,016 shares of EXEL.

Merck & Co. (MRK)- Kenneth C. Frazier, Chairman, President & CEO, sold 392,000 shares at $61.81. The total value of the transaction was approximately $24.23 million. Frazier still owns 508,877 shares of MRK.

Alkermes (ALKS)- Paul J. Mitchell, Director, sold 2,000 shares at $49.48. The total value of the transaction was $98,966. Mitchell still owns 8,000 shares of ALKS.

Xencor (XNCR)- Paul A. Foster, Chief Medical Officer, sold 5,000 shares at $20.01. The total value of the transaction was $100,050. Foster still owns 2,419 shares of XNCR. John R. Desjarlais, Sr. V.P., Research & CSO, sold 5,905 shares at $20. The total value of the transaction was $118,100. Desjarlais still owns 44,934 shares of XNCR. Edgardo Baracchini Jr., Chief Business Officer, sold 4,528 shares at $20. The total value of the transaction was $90,560. Baracchini does not own any shares of XNCR.

United Therapeutics (UTHR)- Martine A. Rothblatt, Chairman & CEO, sold 1,249 shares at $125.78. The total value of the transaction was $157,101. Rothblatt still owns 140 shares of UTHR.

bluebird (BLUE)- Eric Sullivan, Principal Accounting Officer, sold 416 shares at $59. The total value of the transaction was $24,544. Sullivan still owns 5,641 shares of BLUE.

No management changes and additions to report.

NYSE- Merck & Co. (MRK) shares were among the major gainers on the NYSE. The stock closed 10.41% higher. Bristol-Myers Squibb (BMY) shares were among the major losers on the NYSE. The stock closed 15.99% lower.

NASDAQ- PTC Therapeutics (PTCT) shares were among major gainers on the NASDAQ. The stock closed 27.59% higher. Ocular Therapeutix (OCUL) ended the day 14.92% higher. Intellia Therapeutics (NTLA) ended the day 14.33% higher. Avalanche Biotechnologies (ADVM) shares were among the major losers on the NASDAQ. The stock closed 9.57% lower. Aptevo Therapeutics (APVO) ended the day 8.14% lower. Arbutus Biopharma (ABUS) ended the day 8.01% lower.

NYSEMKT- Palatin Technologies (PTN) shares were among the major movers on the NYSEMKT. The stock closed 5.72% lower.

OTC- Soligenix (SNGX) shares were among the major movers movers on the OTC market. The stock closed 2.44% higher.

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

2.7%

-2%

18

Jazz Pharmaceuticals (JAZZ)

2.4%

10.8%

3

Juniper Pharmaceuticals (JNP)

0.8%

-0.1%

4

Juno Therapeutics (JUNO)

14.2%

13%

2

Johnson & Johnson (JNJ)

0.9%

2%

4

Karyopharm Therapeutics (KPTI)

8.4%

-5.8%

11

KemPharm (KMPH)

4.9%

-12.9%

9

Keryx Biopharmaceuticals (KERX)

16.5%

-3%

16

Kindred Biosciences (KIN)

0.6%

5.5%

6

Kite Pharma (KITE)

18.2%

23.6%

5