Premarket Biotech Digest – $VCEL receives FDA nod, $SRPT sells FDA voucher, $TRVN reports +ve results
$Digest, $VCEL, $SRPT, $TRVN

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Sarepta Therapeutics ($SRPT) announced selling an FDA review voucher to Gilead Sciences. The deal is expected to be worth $125 million. The company had received the rare pediatric disease priority review voucher when the FDA approved its Duchenne muscular dystrophy drug, Exondys51, in September. The voucher may be used for shortening the review period for a subsequent drug, or sell them to other firms.
Sarepta stock has gained over 101 percent in the past 12 months while its year to date gain stands at 3.5 percent.

Vericel Corporation ($VCEL) announced that it has received Fast Track Development Program designation from the FDA for its investigation of ixmyelocel T for reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy.
The company had also recently reported that it has implanted its first patient in the U.S. with MACI (autologous cultured chondrocytes on porcine collagen membrane), a cellular scaffold product indicated to the repair of cartilage defects in the knee with or without bone involvement. It is the first product that uses the process of tissue engineering to grow cartilage cells on a scaffold to gain FDA approval.

 

• Trevena Inc. ($TRVN) reported positive results for its two late stage studies for lead experimental drug oliceridine in patients suffering from acute pain. The intravenous formulation was tested in patients with moderate-to-severe acute pain following bunionectomy and abdominoplasty. In both studies, all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo, as measured by responder rate. The drug also showed dose-related trends of improvements vs. morphine on numerous measures of respiratory safety and gastrointestinal tolerability.
• Cidara Therapeutics ($CDTX) announced discontinuing further development of CD101 Topical. The drug was being developed for treating acute vulvovaginal candidiasis. The study found that the gel and ointment topical formulations of CD101 evaluated in RADIANT were similar in efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole. The company said that it is disappointed that the drug did not demonstrate the highly potent antifungal properties of CD101 against Candida it had shown in preclinical animal models of VVC.

• Roche ($RHHBY) receiving conditional approval from the European Commission (EC) for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with Pfizer's XALKORI (crizotinib). The conditional approval is based on Phase 2 data. Roche is still required to submit Phase 3 results and plans to do so next quarter.

 
• Valeant Pharmaceuticals ($VRX) announced its new collaboration with EyeGate Pharmaceuticals Inc. (EYEG) which involves licensing of exclusive, global commercial and manufacturing rights for EyeGate's EyeGate II Delivery System. The system is being developed for post-operative pain and inflammation in patients who've had ocular surgery. The financial value of the deal has not been disclosed.
• Immunomedics ($IMMU) committed to the Delaware Chancery Court that the company will postpone closing its license agreement with Seattle Genetics until March 10, a week after the March 3 Annual Meeting of Shareholders. The decision has been undertaken in consideration of the company’s ongoing litigation with activist investor venBio Select Advisors LLC over control of the company.

 
• Valeritas ($VLRX) reported its fourth quarter and full year results. The company’s total revenue for the fiscal fourth quarter of 2016 was $4.8 million, a 4% increase from $4.6 million the same period in 2015. Total revenue for the full year 2016 was $19.6 million, an 8% increase from $18.1 million for the full year 2015. Gross profit in the fourth quarter of 2016 was $1.8 million, or 37.1% gross margin, an increase from $1.5 million, or 32.8% gross margin, compared to the fourth quarter of 2015. Total gross profit for the full year 2016 was $6.9 million, or 35.5% gross margin, an increase from $3.9 million, or 21.3% gross margin, for the full year 2015.

• Exactech Inc. ($EXAC) reported that its revenue for 2016 increased 7% to $257.6 million from $241.8 million in 2015. Its diluted earnings per share for the year was $0.01 based on net income of $0.2 million, including the impact of $1.17 in earnings per share charges related to impairment, restructuring and tax valuation allowances, compared to 2015 net income of $14.8 million and diluted earnings per share of $1.04.

Brokerage Action Company Rating Price Target
Mizuho Reiterates Adamas Pharmaceuticals (ADMS)
Buy $26.00
Credit Suisse Group Initiates Anaptysbio (ANAB)
Outperform
JMP Securities Initiates Anaptysbio (ANAB)
Outperform
Stifel Nicolaus Initiates Anaptysbio (ANAB)
Buy $30.00
Wedbush Initiates Anaptysbio (ANAB)
Outperform $28.00
Berenberg Bank Reiterates Astrazeneca PLC (AZN)
Buy
JMP Securities Initiates ChemoCentryx (CCXI)
Outperform
Jefferies Group LLC Reiterates Community Health Systems (CYH)
Hold $8.00
Mizuho Upgrades Community Health Systems (CYH)
Underperform -> Neutral $3.00 -> $7.50
Barrington Research Downgrades DENTSPLY SIRONA (XRAY)
Outperform -> Market Perform
Jefferies Group LLC Reiterates Immune Design Corp. (IMDZ)
Buy
Jefferies Group LLC Reiterates Immunomedics (IMMU)
Buy $7.50
Mizuho Raises Target Jazz Pharmaceuticals PLC (JAZZ)
Buy $127.00 -> $152.00
Cowen and Company Initiates Jounce Theraptc (JNCE)
Outperform
J P Morgan Chase & Co Initiates Jounce Theraptc (JNCE)
Overweight $28.00
Robert W. Baird Initiates Jounce Theraptc (JNCE)
Outperform $30.00
Wells Fargo & Company Initiates Jounce Theraptc (JNCE)
Outperform
Cantor Fitzgerald Reiterates LifePoint Health (LPNT)
Neutral
Mizuho Raises Target LifePoint Health (LPNT)
Neutral $50.00 -> $57.00
Wedbush Initiates Miragen Therapeutics (MGEN)
Outperform
Aegis Reiterates Momenta Pharmaceuticals (MNTA)
Hold $17.00
Rodman & Renshaw Reiterates Strata Skin Sciences (SSKN)
Buy $1.50
Chardan Capital Reiterates Teladoc (TDOC)
Buy
RBC Capital Markets Reiterates Teva Pharmaceutical Industries Ltd (TEVA)
Sector Perform
Jefferies Group LLC Reiterates West Pharmaceutical Services (WST)
Hold $82.00

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