Eleven Biotherapeutics (EBIO) shares are up almost 40% in pre-market trading today. The rally has been sparked after the company announced that the FDA has approved its Investigational New Drug (IND) application for EBI-031 for the treatment of ocular diseases. The company is now entitled to a $22.5M milestone payment from licensee Roche (RHHBY). Despite the rally, EBIO remains well below its 52-week high of $8.

Seres Therapeutics (MCRB) announced that it has commenced a Phase 1b clinical trial assessing its SER-262 in patients with primary Clostridium Difficile Infection (CDI). The trial, expected to enroll ~60 subjects who have experienced a first episode of CDI, will compare the CDI recurrence rate between the SER-262 and placebo groups at up to 8 weeks after dosing.

In a recent report, I had discussed the science behind MCRB’s pipeline. The key value driver for MCRB is of course SER-109, which is being developed CDI. According to Canaccord Genuity’s John Newman, SER-109 could achieve peak sales of $680 million in the U.S. alone. Further, Newman expects ex-U.S. sales to total $280 million. SER-109 could receive royalties of around 10% on these so by 2022, SER-109 could potentially generate $700 million in revenue. Based on the peak sales forecast for SER-109, MCRB certainly looks undervalued. I believe that MCRB is worth watching.

Juno Tumbles as Phase 2 Study of Lead CAR-T Candidate Placed on Hold- Juno Therapeutics (JUNO) shares have plunged in pre-market trading today after the Phase 2 clinical trial, ROCKET, evaluating its lead CAR-T candidate JCAR015 in adult patients with relapsed/refractory B cell acute lymphoblastic leukemia (r/r ALL) has been placed on clinical hold by the FDA after two study participants died last week following the recent addition of chemo agent fludarabine to the pre-conditioning regimen. The company has proposed continuing the study using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested a revised patient informed consent form, a revised investigator brochure, a revised study protocol and a copy of the presentation made to the agency yesterday. Juno intends to submit the information next week.

Pernix Therapeutics Announces Reorganization- Pernix Therapeutics (PTX) announced an initiative o optimize its resources and improve the effectiveness of its sales force. As part of this effort, Pernix has reduced its total full-time work force by ~23%. The key elements of this reorganization plan include: (1) a reduction of 54 sales positions, primarily from the company's Neurology sales team; (2) prioritization and reorganization of sales territories; (3) improvement of the Company’s compensation plan to incentivize the field sales staff; and (4) consolidation of the Neurology and Pain sales forces under one sales management structure to eliminate redundancies. In addition, Pernix is reducing its administrative staff by six positions. The company expects cost savings of approximately $10 million from the reorganization.

AbbVie’s Humira Found to Be Effective in Fingernail Psoriasis- AbbVie (ABBV) announced that it will present initial data from a Phase 3 study of patients with moderate-to-severe fingernail psoriasis demonstrating that nearly half of adult patients treated with HUMIRA (adalimumab) achieved at least a 75% improvement in their symptoms compared to placebo. The results will be presented at Psoriasis 2016 - 5th Congress of the Psoriasis International Network in Paris, France. The study also showed 48.9% of HUMIRA-treated patients achieved Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a 2-point improvement from baseline versus 6.9% for placebo.

Catabasis Commences Open-Label Extension of its MoveDMD Study- Catabasis Pharmaceuticals (CATB) announced that it has initiated the open-label extension of the Phase 2 portion of its MoveDMD study. The study is evaluating CAT-1004 (edasalonexent) for the treatment of Duchenne muscular dystrophy (DMD). The co-primary endpoints are safety/tolerability and muscle composition and inflammation at week 12 as measured by MRI. Top-line results are expected to be announced in the fourth quarter.

Illumina Reaches Settlement with Enzo Biochem- Enzo Biochem (ENZ) and Illumina (ILMN) have settled their patent infringement litigation. As part of the settlement, ILMN will make a payment of $21 million to ENZ.

Nivalis Announces Completion of Patient Enrollment in Mid-Stage Study- Nivalis Therapeutics (NVLS) announced that the last patient has received the first study dose in the Phase 2 clinical trial evaluating N91115 (cavosonstat) for the treatment of patients with cystic fibrosis (CF). The 138 participants have two copies of the F508del mutation and are being treated with Vertex Pharmaceuticals' (VRTX) Orkambi (lumacaftor/ivacaftor). The primary endpoint is the change from baseline to week 12 in lung function determined by FEV1 (forced expiratory volume in one second).

Protalix Commences Mid-Stage Study of AIR DNase in CF- Protalix BioTherapeutics (PLX) announced that the first patient has been dosed in the Phase 2 clinical trial evaluating its AIR DNase (formerly PRX-110) for the treatment of cystic fibrosis (CF). The 28-day switch-over study involves 15 CF patients previously treated with Roche's (OTCQX:RHHBY) Pulmozyme (dornase alfa). The primary endpoint is the change from baseline in lung function as measured by forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Top-line data from the trial is expected to be announced by year end.

Roche (RHHBY) announced that the FDA has approved its cobas HPV test for use with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid, the first test to be so approved. SurePath is one of two fluids commonly used for Pap tests.

No patents to report.

KaloBios (KBIOQ) has emerged from Chapter 11 bankruptcy effective June 30 with $14M in equity financing and the rights to develop antiparasitic drug benznidazole for Chagas disease acquired from privately held Savant Neglected Diseases, LLC. The company had filed for bankruptcy earlier in the year. Benznidazole was formerly marketed by Roche for the treatment of Chagas under the brand names Rochagan and Radanil. KBIOQ has also signed a contract with former CEO Martin Shkreli pertaining to his ownership of the company's common stock that addresses the acquisition, disposition, holding and voting of shares owned. According to the terms of the agreement, for a period of 180 days following June 30, Shkreli may not sell shares to any third party for a price for less than the greater of $2.50 a share or a 10% discount to the prior two-week volume-weighted average price (Market Discount Price). For 180 days following the 61st day after June 30, the company will have the right to buy any and all of  Shkreli's shares at the Market Discount Price. Additionally, hkreli will not have the right to nominate directors to the board and, for a period of 24 months, will be prohibited from purchasing stock or assets of the company, participating in any proposals for a merger, tender offer or other business combination, seeking control of the firm or submitting any proposals to be considered by shareholders.

PTC Therapeutics (PTCT) shares rose sharply on Thursday after the company announced that England’s National Health Service (NHS) will provide access to Translarna for ambulatory patients at least five years old with nonsense mutation Duchenne muscular dystrophy (DMD). The Managed Access Agreement (MAA) will be in effect for five years. Final guidance from NHS advisor NICE should be published in a few weeks.

Alliqua BioMedical (ALQA) announced that it has signed a definitive agreement with BSN Medical for exclusive distribution rights to SORBION SACHET and SORBION SANA primary dressings in the U.S., Canada and Latin America.  According to the terms of the agreement, BSN will pay Alliqua total consideration of up to $4.4M for 100% of the rights owned by Sorbion GmbH & Co KG (now a unit of BSN).

Nivalis Therapeutics (NVLS) has filed a Form S-3 with the U.S. Securities and Exchange Commission (SEC). According to the filing, the company from time to time may offer, issue and sell up to $125 million of any combination of the securities described in the prospectus in one or more offerings.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Achillion Pharmaceuticals (ACHN) JMP Securities Upgrade From Market Perform to Outperform

$13

$7.50

Advaxis (ADXS) FBR & Co. Reiterate Outperform

$34

N/A
Alexion Pharmaceuticals (ALXN) Piper Jaffray Cos. Reiterate Buy N/A N/A
Amarin Corp. (AMRN) Jefferies Group Reiterate Buy

$3.50

N/A
AVEO Pharmaceuticals (AVEO) FBR & Co. Reiterate Outperform

$3

N/A
Gilead Sciences (GILD) Jefferies Group Reiterate Hold

$97

$130

Intrexon (XON) Wunderlich Reiterate Buy

$50

N/A
Medivation (MDVN) BMO Capital Markets Reiterate Market Perform

$50

N/A
Medivation (MDVN) Jefferies Group Reiterate Hold

$56

N/A
Medivation (MDVN) Leerink Swann Reiterate Market Perform

$64

N/A
Shire Plc (SHPG) Shore Capital Reiterate Buy N/A N/A
Ultragenyx Pharmaceutical (RARE) Piper Jaffray Cos. Initiation Overweight

$70

N/A
Vertex Pharmaceuticals (VRTX) Maxim Group Reiterate Hold N/A N/A
Vistagen Therapeutics (VTGN) WallachBeth Capital Initiation Buy

$17

N/A

Nymox Pharmaceutical (NYMX)- James George Robinson, Director, bought 20,000 shares in three separate transactions. Robinson bought 5,000 shares at $3.42; 8,411 shares at $3.28; and 6,589 shares at $3.18. Robinson now owns 2,867,550 shares of NYMX.

Intercept Pharmaceuticals (ICPT)- Barbara Gayle Duncan, Chief Accounting Officer, sold 146 shares at $145.11. Duncan still owns 30,808 shares of ICPT. David Shapiro, CMO and EVO-Development, sold 163 shares at $145.11. Shapiro still owns 48,391 shares of ICPT. Mark Pruzanski, President & CEO, sold 714 shares at $145.11. Pruzanski still owns 547,566 shares of ICPT. Rachel McMinn, Chief Strategy Officer, sold 106 shares at $145.11. McMinn still owns 13,986 shares of ICPT.

Seattle Genetics (SGEN)- Clay B. Siegall, President & CEO, sold 7,618 shares at $40.56. The total value of the transaction was $308,999. Siegall still owns 556,115 shares of SGEN.

MediciNova (MNOV)- Geoffrey O’Brien, Vice President, sold 3,300 shares at $8. The total value of the transaction was $26,400. O’Brien still owns 5,000 shares of MNOV.

ImmuCell (ICCC)- Joseph H. Crabb, VP & Chief Scientific Officer, sold 2,691 shares in two separate transactions. Crabb sold 2,426 shares at $6.59; and 265 shares at $6.54. Crabb still owns 107,046 shares of ICCC.

Akebia Therapeutics (AKBA)- Duane Nash, Director, sold 1,980 shares at $7.48. The total value of the transaction was $14,819. Nash still owns 26,629 shares of AKBA.

Gilead Sciences (GILD)- John F. Milligan, President & CEO, sold 112,000 shares at $84.33. The total value of the transaction was approximately $9.44 million. Milligan still owns 1,058,963 shares of GILD.

No management changes and additions to report.

NYSE- Puma Biotechnology (PBYI) shares were among the major gainers on the NYSE. The stock closed 5.55% higher.

NASDAQ- Ocera Therapeutics (OCRX) shares were among the major gainers on the NASDAQ. The stock closed 23.41% higher. BioMarin Pharmaceutical (BMRN) ended the day 9.10% higher. Achillion Pharmaceuticals (ACHN) ended the day 8.69% higher. Aeglea BioTherapeutics (AGLE) shares were among the major losers on the NASDAQ. The stock closed 13.16% lower. DepoMed (DEPO) ended the day 8.71% lower. Inotek Pharmaceuticals (ITEK) ended the day 6.17% lower.

NYSEMKT- Provectus Biopharmaceuticals (PVCT) shares were among the major movers on the NYSEMKT. The stock closed 2.86% lower.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 4.80% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Aurinia Pharmaceuticals (AUPH)

1.4%

7.6%

7

AVEO Pharmaceuticals (AVEO)

1%

-30.3%

2

AveXis (AVXS)

5.6%

21.9%

4

Aviragen Therapeutics (AVIR)

0.3%

-11.6%

5

AxoGen (AXGN)

1.4%

7.6%

4

Axsome Therapeutics (AXSM)

0.4%

-38.5%

1

Actinium Pharmaceuticals (ATNM)

4.2%

-2.9%

5

Ampio Pharmaceuticals (AMPE)

15.6%

1.7%

25

AmpliPhi Biosciences (APHB)

0.7%

-81.1%

0

Aoxing Pharmaceuticals (AXN)

0.2%

-3%

2