Join Now - it is FREE

Basic level includes our interactive biotech chatroom, forum, biotech stock screener; you also receive the biotech digest in your email everyday.


Minerva Neurosciences $NERV announced on Wednesday that its 24-week, open-label extension phase of its Phase 2b clinical trial evaluating lead product candidate MIN-101 for the treatment of patients with negative symptoms of schizophrenia, met with positive results. Data from the core 12-week segment, presented in May, showed a statistically significant improvement in negative symptoms for both the 32 mg and 64 mg doses.

Sarepta’s Insurance Coverage for eteplirsen Hits a Roadblock- The FDA’s contentious decision to approve Sarepta Therapeutics’ $SRPT eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) patients responsive to exon 51 skipping has hit a roadblock due to insurance coverage. Humana said it will cover the $300K cost of therapy only for ambulatory DMD patients. Those who are wheelchair-bound or deteriorate to wheelchair status seems to be out of luck. Anthem will not be covering because it considers eteplirsen experimental notwithstanding the nod from the FDA. Meanwhile, Aetna and Express Scripts plan to conduct a full clinical review of the drug before making their decision on the coverage.

 FDA Issues Draft Guidance for developers of female-desire Treatments- In order to clarify the requisites to approve drugs to treat women with sexual desire dysfunction, the regulatory authority issued a draft guidance for drug developers on Wednesday. The guidance focuses on conditions of low sexual interest, desire and/or arousal that result to distress or interpersonal difficulty in women, including female sexual interest/arousal disorder (FSIAD), hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD).To show drug’s efficacy, the agency maintains its requirement of two randomized pivotal trials. Each study should include at least 24 weeks of blinded treatment to demonstrate the onset and persistence of effect. The agency also recommends a placebo run-in period to gather baseline data and assess the likelihood that the participants will adhere to the proposed dosing regimen.

 Boehringer Ingelheim’s Humira Biosimilar Meets Primary Endpoints-Results from a Phase 3 Clinical Trial demonstrated equivalence between Boehringer Ingelheim’s biosimilar candidate and AbbVie’s $ABBV HUMIRA (adalimumab) in patients with active rheumatoid arthritis (RA). Secondary endpoints were also met during the study. The data will be submitted at future medical conferences. The drug-maker is trying to catch-up with Amgen’s $AMGN Amjevita (adalimumab-atto) which got approved by the FDA last month.

 Aeterna Zentaris Concludes enrollment for study of Macrilen-Aeterna Zentaris $AEZS concluded the enrollment target in its Phase 3 clinical study evaluating Macrilen (macimorelin) as a growth hormone simulation test for assessing adults with growth hormone deficiency (AGHD), an ailment that affects roughly 75K people in the U.S, Canada and Europe, every year. If successful, the company intends to resubmit a New Drug Application (NDA) with the FDA in H1 2017.

AstraZeneca’s Lynparza Shows Positive Development in patients with Ovarian Cancer-Results from a Phase 3 study, SOLO-2, evaluating AstraZeneca’s $AZN LYNPARZA (olaparib) for the maintenance treatment of platinum-resistant, BRCA mutation-positive ovarian cancer demonstrated treatment with 300 mg twice-a-daily as monotherapy extended progression-free survival (PFS) compared to placebo. The results were clinically significant and statistically meaningful. PFS significantly exceeded what was observed in a Phase 2 study, Study 19, in the same profile of patients.

No approvals to report.

No patents to report.

Teva Pharmaceuticals Industries $TEVA extended its existing e-Health alliance with IBM leveraging the IBM Watson Health Cloud. The new contract includes a three-year research partnership to develop cognitive computing technologies that will enable a systemic approach to drug repurposing, an emerging arena focused on discovering new uses for existing medicines.

 Dr. Reddy Laboratories $RDY signed a strategic partnership with Hyderabad, India based Gland Pharma Limited to distribute and market a portfolio of eight planned injectable generic products in the U.S. The regulatory application, Abbreviated New Drug Applications (ANDAs) are either, at present, under review or will be filed soon. IMS Health estimates that the total market for the eight products is about $1 billion. The financial terms of the deal were not disclosed.

No secondary offerings to report.

Myovant Sciences announced the pricing of its upsized IPO. The company offered 14.5 million shares at $15 per share, which is at the high end of its IPO range of $12 per share to $15 per share. The company will list its shares on the NYSE under the ticker symbol MYOV. Myovant Sciences is developing an acquired therapy for endocrine disorders.

Anika Therapeutics Inc. $ANIK, a global integrated orthopedic medicines company, focused on therapeutics based on its proprietary hyaluronic acid (HA) technology, reported its fiscal third quarter results on Wednesday. For the quarter, EPS was $0.59, beating estimates by $0.12. Revenue was $25.8 million, a 9% increase Y-o-Y; but missing forecast by $0.8 million.  “We continued to deliver solid financial results in the third quarter, while expanding globally and advancing our deep and differentiated pipeline to drive sustained growth,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer during the earnings call.

Sangamo Biosciences Inc. $SGMO, reported its fiscal third quarter results on Wednesday and provided an update of recent events and development timelines for its therapeutics programs. For the quarter, EPS was -$0.27, short by $0.02. Revenue was $2.8 million, a drop of 67.3% Y-o-Y, missing estimates by $1.44 million. "The third quarter of 2016 has been a pivotal time for Sangamo, as we worked to focus our efforts and execute on our prioritized therapeutic programs in hemophilia B, hemophilia A, MPS I and MPS II," said Sandy Macrae, M.B., Ch.B., Ph.D., Sangamo's president and chief executive officer, during the conference call.  "I am pleased to announce that the Phase 1/2 clinical trial for SB-FIX, our in vivo genome editing program for hemophilia B, is open. We are also on track to file an IND application for our AAV cDNA Factor 8 gene therapy program for hemophilia A by the end of this year” added the CEO.

PAREXEL $PRXL reported fiscal quarter 1 results on Wednesday. For the quarter, EPS was $0.76, missing guidance by $0.10. Revenue was $500.9 million, a drop of 2.2% Y-o-Y, and missing guidance by $23.89 million. GAAP diluted earnings per share of $0.75, up 66.7%; Gross new business of $930 million. Company guides to GAAP EPS of $3.55-$3.89 and adjusted EPS of $3.71-$4.05 for Fiscal Year 2017. The Board approved new $200 million share repurchase program.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Aduro Biotech $ADRO FBR & Co. Price Target Cut Outperform From $22 to $20 N/A
AMAG Pharmaceuticals $AMAG Needham Company Initiation Buy $40 N/A
Biogen $BIIB Cowen and Company Reiterate Buy $368 N/A
Cempra $CEMP Needham & Company Reiterate Buy $48 N/A
Corbus Pharmaceuticals $CRBP Cantor Fitzgerald Reiterate Buy $17 N/A
Dipexium Pharmaceuticals $DPRX Raymond James Financial Downgrade From Outperform to Market Perform N/A N/A
Eagle Pharmaceuticals $EGRX Mizuho Price Target Cut Buy From $65 to $62 N/A
Global Blood Therapeutics $GBT Cowen and Company Price Target Raised Outperform From $80 to $83 N/A
Gilead Sciences $GILD William Blair Reiterate Outperform N/A $130
GlaxoSmithKline $GSK Beaufort Securities Reiterate Buy N/A N/A
Heron Therapeutics $HRTX Aegis Initiation Buy $41 N/A
Inovio Pharmaceuticals $INO Piper Jaffray Cos. Price Target Cut Overweight From $31 to $13 N/A
Inovio Pharmaceuticals $INO HC Wainwright Reiterate Buy $17 N/A
Mylan $MYL Mizuho Initiation Buy $49 N/A
Progenics Pharmaceuticals $PGNX Aegis Initiation Buy N/A $31.50
Proteon Therapeutics $PRTO Raymond James Financial Upgrade From Outperform to Strong Buy N/A N/A
Sarepta Therapeutics $SRPT Leerink Swann Price Target Raised Market Perform From $50 to $55 N/A
Vertex Pharmaceuticals $VRTX Leerink Swann Price Target Cut Outperform From $112 to $111 N/A
Vertex Pharmaceuticals $VRTX BMO Capital Markets Price Target Raised Market Perform From $87 to $88 N/A
Valeant Pharmaceuticals International $VRX Wells Fargo & Co. Reiterate Underweight $19.50 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 5,600 shares at $9.27. The total value of the transaction was $51,940. Dr. Frost now owns 160,251,143 shares of OPK.

Celgene $CELG- Celgene Corp. D/E, a 10% owner, bought 800,150 shares at $14. The total value of the transaction was $11.20 million. Celgene Corp. D/E now owns 4,834,980 shares of CELG.

Advaxis $ADXS- Gregory T. Mayes, Chief Business Officer, sold 19,162 shares at $8.23. The total value of the transaction was $157,703. Mayes still owns 103,087 shares of ADXS.

No management changes and additions to report.

NYSE- Puma Biotechnology $PBYI shares were among the major movers on the NYSE. The stock closed 3.78% lower.

NASDAQ- Summit Therapeutics $SMMT shares were among the major gainers on the NASDAQ. The stock closed 14.17% higher. ProQR Therapeutics $PRQR ended the day 9.82% higher. Loxo Oncology $LOXO ended the day 8.92% higher. Kura Oncology $KURA shares were among the major losers on the NASDAQ. The stock closed 9.35% lower. Obalon Therapeutics $OBLN shares ended the day 8.85% lower. Abiomed $ABMD ended the day 8.56% lower.

NYSEMKT- Actinium Pharmaceuticals $ATNM shares were among the major movers on the NYSEMKT. The stock closed 7.25% higher.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 6.79% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
DelMar Pharmaceuticals $DMPI 0.4% -35.9% 1
Depomed $DEPO 18.1% -19.7% 6
Derma Sciences $DSCI 0.5% -34.1% 5
Dermira $DERM 9.2% 10.5% 14
Dicerna Pharmaceuticals $DRNA 2.7% -4.3% 2
Dimension Therapeutics $DMTX 2% -26.8% 8
Dipexium Pharmaceuticals $DPRX 10.3% 183.4% 5
Dynavax Technologies $DVAX 28.2% 13% 5