BioMarin price target raised to $145 from $132 at Leerink. Leerink analyst Joseph Schwartz raised his price target to $145 from $132 to reflect new price assumptions for Valrox in hemophilia A following discussions with MEDACorp payor specialists. The analyst reiterates an Outperform rating on the shares.
Monday, May 7, 2018
Spark target upped by Leerink
Spark Therapeutics price target raised to $74 from $55 at Leerink. Leerink analyst Joseph Schwartz raised his price target for Spark Therapeutics to $74 from $55 after adjusting his pricing assumptions for the company’s hemophilia gene therapy – SPK-8011 and SPK-9001. The analyst reiterates a Market Perform rating on the shares.
Edwards target upped by Jefferies
Jefferies ups Edwards Lifesciences target to $155, says story ‘has legs’. After spending a day with management, Jefferies analyst Raj Denhoy raised his price target for Edwards Lifesciences to $155 from $150. The case was again made for why teens transcatheter valve growth is well supported over the short, medium and long term, Denhoy tells investors in a research note titled “Notes from the Road: The EW Story Has Legs.” The TAVR market is proving bigger than forecasts and Edwards’ position is secure, the analyst adds. He keeps a Buy rating on the shares.
Takeda reported near agreement to buy Shire
Takeda Pharmaceutical (TKPYY) is nearing an agreement to acquire Shire (SHPG), and a deal could be announced as early as tomorrow, Manuel Baigorri and Aaron Kirchfeld of Bloomberg reports, citing people familiar with the matter. Shire has been seeking an increase in the cash component of Takeda’s $64B bid, sources told Bloomberg. Shire in premarket trading is trading up 2% to $161.25.
Evolus Phase 3 Europe-Canada Botox Comp Trial Meets Primary Endpoint
Evolus, Inc. (EOLS) (“Evolus”), a medical aesthetics company focused on delivering advanced aesthetic procedures and treatments to physicians and consumers, today announced the presentation of data from the European and Canadian Phase III EVB-003 head-to-head comparative trial demonstrating that its investigational prabotulinumtoxinA 900 kilodalton (kDa) neuromodulator met its primary endpoint of non-inferiority at Day 30 in subjects with moderate to severe glabellar lines, also known as “frown lines,” compared to onabotulinumtoxinA (Botox®).
The results were presented today in a poster titled “A Multicenter Phase III Study Comparing prabotulinumtoxinA and onabotulinumtoxinA for the Treatment of Glabellar Lines” by Dr. Patricia Ogilvie, M.D., dermatologist and Principal Investigator of the study, at the 2018 Aesthetic & Anti-Aging Medicine World Congress (AMWC), being held April 4-7 in Monte-Carlo, Monaco. The results presented at AMWC expand upon the initial results presented at the American Academy of Dermatology (AAD) annual meeting in February 2018.
“Analysis of this study presented at AMWC shows that prabotulinumtoxinA met its primary endpoint in efficacy as well as its secondary endpoints. In particular, the secondary endpoint of subject satisfaction is important because it represents the opinions of consumers who underwent the treatment,” commented Patricia Ogilvie, M.D. “Based on these findings, we believe that prabotulinumtoxinA represents a compelling and innovative option for the aesthetic treatment of glabellar lines.”
“The presentation of this expanded data set from the EVB-003 comparative study is another significant milestone in the prabotulinumtoxinA development program,” Rui Avelar, M.D., Chief Medical Officer of Evolus. “It further expands and supports the growing body of clinical data suggesting that our product candidate has the potential to be efficacious in the treatment of glabellar lines with a favorable safety profile.”
EVB-003 was a 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority study evaluating prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, in subjects who felt their glabellar lines had an important psychological impact. Adults aged 18 or older with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe), who met these criteria were enrolled. Randomization was 5:5:1 to receive a single treatment of 20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo (0.9% saline). The primary efficacy endpoint was measured on Day 30 and a responder was defined as a GLS score of 0 or 1 at maximum frown as assessed by the investigator. A total of 540 subjects were enrolled: 245 received prabotulinumtoxinA; 246 received onabotulinumtoxinA; and 49 received placebo. The study met the primary endpoint of non-inferiority at Day 30 with responder rates of 87.2% in the prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group, and 4.2% in the placebo group. The absolute differences between prabotulinumtoxinA and placebo groups, and between onabotulinumtoxinA and placebo groups were 83.1% and 78.6%, respectively (both p<0.001). The absolute difference between the prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4%; 95% confidence interval or CI (-1.9, 10.8). The lower bound of the 95% CI for the difference was greater than -10.0% therefore non-inferiority of prabotulinumtoxinA versus onabotulinumtoxinA was achieved. The study concluded that a single dose of 20 U prabotulinumtoxinA was non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines. The percentages of subjects experiencing adverse events assessed as study-drug related were 15.5%, 14.6% and 4.1% in the prabotulinumtoxinA, onabotulinumtoxinA and placebo groups, respectively. There were no serious adverse events that were assessed as study-drug related.
Elliott Management makes $6.4B bid to acquire athenahealth
Activist investor Elliott Management is looking to acquire athenahealth in an all-cash offer at about $160 a share, sending shares skyrocketing around 25 percent Monday morning.
Elliott, a New York City-based fund manager, wrote in a seven-page harshly-worded letter to shareholders Monday that it was seeking to acquire the company on an “expedited basis,” saying that they may be able to improve the proposed price with additional diligence.
The offer values the company at $6.4 billion.
“We believe that our proposal represents the best path forward for athenahealth, its shareholders, its employees and its broader mission,” Elliott said in the letter.
Among other things, Elliott said that the company “is not working today and will not work in the future,” namely in the areas of “sales execution, service delivery, product focus, forecasting, executive turnover, capital allocation management discipline and corporate governance.”
An athenahealth spokesperson was not immediately available for comment.
Athenahealth was among the top employers in the state as of last summer, when it told the Business Journal it employed 2,351 people. It since announced layoffs of about 9 percent of its workforce, but did not specify how many Massachusetts workers would be eliminated. The company said that as of Dec. 31, it employed 5,156 people worldwide.
Elliott Management has been involved with athenahealth for the past year, when it acquired 8.9 percent of the company in May 2017. In its letter, the company said it has had extensive private conversations with management and the Board of Directors.
Elliott also bought a stake in another large Massachusetts employer, the technology firm Akamai Corp (Nasdaq: AKAM) in December 2017, and previously helped bring about the same of storage giant EMC Corp. to Dell Technologies as an investor in 2015.
Elliott said in the letter that after doing work to understand the Watertown-based company’s business, it believes that the company has an opportunity to change the health care IT industry.
Yet Elliott said the company isn’t working and hasn’t been able to make strides, despite recent changes at the company, including a massive layoff in October that contributed to $110-115 million in cost cuts. Elliott pointed to the company’s stock price, calling it a “disappointing experience,” and saying it only improved with the presence of Elliott, having increased nearly 40 percent in just the month after it disclosed its initial investment in May 2017.
As of 10:15 a.m. after Elliott confirmed reports that it had offered to buy athenahealth, the company’s stock was trading up 23 percent at $156 a share.
Elliott also criticized the company’s executive turnover, relatively stable operating margin, IT issues, failure to execute on its overall vision, and inability to meet bookings guidance.
“Given athenahealth’s potential, this reality is deeply frustrating, but the fact remains that athenahealth as a public company has not made the changes necessary to enable it to grow as it should and to create the kind of value its shareholders deserve,” the company said.
The letter went on to say that the stock price has underperformed all “relevant benchmarks” for more than five years, and that strategy and execution of operations have “failed to generate returns for shalreholders.”
“As we will address later, this chronic underperformance is driven by athenahealth-specific factors including poor execution, significant management turnover, inefficient allocation of resources and the loss of strategic focus,” Elliott said.
Sunday, May 6, 2018
Biotech week ahead, May 6
After eking out a modest gain in the week ended April 27, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) pulled back this week amid some not-so-encouraging earnings reports and negative regulatory decisions.
Will the lean trot end? Stay tuned to the upcoming week’s developments on the biotech front.
Medical, Health Care And Biotech Conferences
- 2018 Disruptive Growth and Healthcare Conference: May 8-9 in New York City.
- Deutsche Bank 43rd Annual Health Care Conference: May 8-9 at the InterContinental Boston Hotel.
PDUFA Dates
The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)’s NDA for tlando, which is tested for hypogonadism. The PDUFA action date is May 8.
Adcom Schedule
The Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet May 10 to discuss the safety and efficacy of the Akcea Therapeutics Inc (NASDAQ: AKCA)-Ionis Pharmaceuticals Inc (NASDAQ: IONS) combine’s subcutaneously injected volanesoren solution for patients with familial chylomicronemia syndrome.
Earnings
Monday, May 7
- ArQule, Inc. (NASDAQ: ARQL)
- Fulgent Genetics Inc (NASDAQ: FLGT)
- MacroGenics Inc (NASDAQ: MGNX)
- Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
Tuesday, May 8
- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
- Opko Health Inc. (NASDAQ: OPK)
- Aclaris Therapeutics Inc (NASDAQ: ACRS)
- Aerie Pharmaceuticals Inc (NASDAQ: AERI)
- Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
- Amicus Therapeutics, Inc. (NASDAQ: FOLD)
- ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
- Applied Genetic Technologies Corp (NASDAQ: AGTC)
- Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
- BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
- Clovis Oncology Inc (NASDAQ: CLVS)
- Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
- Epizyme Inc (NASDAQ: EPZM)
- Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
- Flexion Therapeutics Inc (NASDAQ: FLXN)
- Haemonetics Corporation (NYSE: HAE)
- Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
- Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
- Kindred Biosciences Inc (NASDAQ: KIN)
- Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
- Loxo Oncology Inc (NASDAQ: LOXO)
- Melinta Therapeutics, Inc. (NASDAQ: MLNT)
- Merrimack Pharmaceuticals Inc (NASDAQ: MAC)
- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
- Ocular Therapeutix Inc (NASDAQ: OCUL)
- Oncomed Pharmaceuticals Inc (NASDAQ: OMED)
- Prothena Corporation PLC (NASDAQ: PRTA)
- Regenxbio Inc (NASDAQ: RGNX)
- Revance Therapeutics Inc (NASDAQ: RVNC)
- Sangamo Therapeutics Inc (NASDAQ: SGMO)
- Supernus Pharmaceuticals Inc (NASDAQ: SUPN)
- Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
- T2 Biosystems Inc (NASDAQ: TTOO)
- Vital Therapies Inc (NASDAQ: VTL)
- Xenon Pharmaceuticals Inc (NASDAQ: XENE)
Wednesday, May 9
- Endocyte, Inc. (NASDAQ: ECYT)
- FibroGen Inc (NASDAQ: FGEN)
- Jounce Therapeutics Inc (NASDAQ: JNCE)
- Neos Therapeutics Inc (NASDAQ: NEOS)
- Mylan NV (NASDAQ: MYL)
- AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
- Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
- Arcadia Biosciences Inc (NASDAQ: RKDA)
- Array Biopharma Inc (NASDAQ: ARRY)
- Audentes Therapeutics Inc (NASDAQ: BOLD)
- Collegium Pharmaceutical Inc (NASDAQ: COLL)
- Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
- Glaukos Corp (NYSE: GKOS)
- Horizon Pharma PLC (NASDAQ: HZNP)
- Inovio Pharmaceuticals Inc (NASDAQ: INO)
- Portola Pharmaceuticals Inc (NASDAQ: PTLA)
- PTC Therapeutics, Inc. (NASDAQ: PTCT)
- Puma Biotechnology Inc (NASDAQ: PBYI)
- Viking Therapeutics Inc (NASDAQ: VKTX)
Thursday, May 10
- Depomed Inc (NASDAQ: DEPO)
- Karyopharm Therapeutics Inc (NASDAQ: KPTI)
- Nektar Therapeutics (NASDAQ: NKTR)
- Athersys, Inc. (NASDAQ: ATHX)
- BioDelivery Sciences International, Inc (NASDAQ: BDSI)
- BioTime, Inc. (NYSE: BTX)
- CareDx Inc (NASDAQ: CDNA)
- Halozyme Therapeutics, Inc. (NASDAQ: HALO)
- Strongbridge Biopharma plc (NASDAQ: SBBP)
- Synergy Pharmaceuticals Inc (NASDAQ: SGYP)
- Catabasis Pharmaceuticals Inc (NASDAQ: CATB)
- RXi Pharmaceuticals Corp (NASDAQ: RXII)
- Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)
- Fibrocell Science Inc (NASDAQ: FCSC)
IPO
Immuno-oncology company Abpro is set to offer 4 million shares. The shares are to be listed on the Nasdaq under the ticker symbol ABP.
Evelo Biosciences, which focuses on therapies that act on the gut-body network, is offering 5.3 million shares. Shares are to be listed on the Nasdaq under the ticker symbol EVLO.
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