Premarket Biotech Digest – $PTLA receives FDA approval, $KPTI offers updates, $NVO starts new study

By |June 26th, 2017|Digest|

Idera Pharmaceuticals Inc. ($IDRA) received a positive boost as the FDA designated its Phase 2-stage IMO-2125 an Orphan Drug for the treatment of Stages IIB to IV melanoma. The  Orphan Drug status in the U.S. offers an additional seven-year period of market exclusivity for [...]

Premarket Biotech Digest – $DMPI receives IRB nod, $PFE slapped with CRL, $PRTO strikes new deal

By |June 23rd, 2017|Digest|

VistaGen ($VTGN) stock shot up as the company announced the results  two Phase 1 studies of AV-101, a potential candidate for the non-opioid treatment of neuropathic pain. The data showed AV-101 was safe and well-tolerated.  The company said that the data, along with positive [...]

Corbus moves lead candidate to Phase 3 study, offers good investment deal $CRBP

By |June 22nd, 2017|Monthly Investment Ideas|

Corbus Pharmaceuticals Holdings ($CRBP) is engaged in controversial yet lucrative medical cannabis sector. The company is currently working to develop  anabasum, an endocannabinoid-mimetic drug to treat inflammatory and fibrotic diseases. It recently announced the results from the previously completed Phase 2 clinical study of the lead drug candidate for the [...]

Premarket Biotech Digest – $SHPG receives FDA approval, $EPZM granted orphan drug status, $RXII completes enrollment

By |June 21st, 2017|Digest|

Aimmune Therapeutics ($AIMT) stock showed an uptick as the company announced the update for its late-stage study of peanut allergy candidate AR101. It reported that in a preliminary dataset of 166 European patients who underwent a food challenge to determine eligibility for the Phase [...]

Axsome looks good on multiple catalysts: Fast Track designation eases liquidity concerns

By |June 20th, 2017|Monthly Investment Ideas|

Axsome Therapeutics Inc. ($AXSM) has multiple catalysts coming up in the near future as it has two main drug candidates under Phase 3 testing for multiple conditions. One of its drug candidate recently received the FDA Fast Track designation while the other already has this designation for both the indications. [...]

Premarket Biotech Digest – $LLY announces positive results, $IPSEY reports FDA approval, $AMED to pay settlement

By |June 19th, 2017|Digest|

Sorrento Therapeutics Inc. ($SRNE) kept up its positive trend as the stock gained another 8 percent in its Friday session. The stock received boost from the company’s recent announcement regarding the lawsuits brought by Wildcat Liquid Alpha, LLC. Sorrento reported that all claims against [...]

Premarket Biotech Digest – $HTGM inks new SOW, $ADMP receives FDA approval, $BMY to sell a unit

By |June 16th, 2017|Digest|

Celsion Corporation ($CLSN) stock soared in pre-market trading session as the company announced withdrawing its plan of a stock offering. The company had originally filed on April 5 an S-1 statement with the Securities and Exchange Commission for the sale of shares. The company [...]

Alnylam $ALNY stock to maintain momentum with new patent win

By |June 15th, 2017|Monthly Investment Ideas|

Alnylam Pharmaceuticals Inc. ($ALNY) boosted its patent portfolio with new allowances from USPTO as the regulatory authority issued the notices with regard to patent application 15/483,354 and patent application, 14/943,612. The first patent was acquired by the company from Merck in 2014 and forms a part of the McSwiggen patent [...]

Premarket Biotech Digest – $RDHL initiates two products. $BMY starts recall, $PULM inks new deal

By |June 14th, 2017|Digest|

RedHill Biopharma ($RDHL) stock perked up as the company announced starting two GI-focused products in the U.S. These products are Donnatal, to be used for the adjunctive treatment of irritable bowel syndrome and EnteraGam, designed for the dietary management of chronic diarrhea and loose [...]

Upcoming monitoring system makes iRadimed ($IRMD) a good mid-term investment

By |June 13th, 2017|Monthly Investment Ideas|

iRadimed Corp ($IRMD) recently announced increase in IV pump bookings during the month of March. These pumps are one of the two primary revenue generators for the firm, the other one being an MRI scanner. IV pumps are covered under 510 (k) FDA Premarket license, giving them an almost virtual [...]

Premarket Biotech Digest – $JNJ receives EU nod, $XBIT terminates trial, $PFE amends protocol

By |June 12th, 2017|Digest|

Johnson & Johnson ($JNJ) announced receiving the approval from the regulatory authorities in the EU for its planned $30 billion takeover of Actelion. The approval has come through after the company pledged to spin-off one of the combined firm's two insomnia pipeline programs. Actelion's [...]

Premarket Biotech Digest – $VRX to sell its iNova unit, $MZOR offices raided in Israel, $RHHBY pulls out of licensing deal,

By |June 9th, 2017|Digest|

Sophiris Bio ($SPHS) stock zoomed in the pre-market session as the company announced the dosing of its first patient in its Phase 2b clinical trial assessing topsalysin for the treatment of men with localized prostate cancer. The company intends to enroll 40 patients for [...]

Protalix BioTherapeutics receives FDA approval for expanding use of current manufacturing facilities $PLX

By |June 8th, 2017|Monthly Investment Ideas|

Protalix BioTherapeutics Inc. ($PLX), a biopharmaceutical company, is focused on the development of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system. The company recently announced Phase II Clinical Trial Results for alidornase alfa in Cystic Fibrosis (CF). The new clinical data pertaining to ppFEV1 measurement taken after [...]

Premarket Biotech Digest – $EIGR completes enrollment, $NVO receives EC approval, $INNV in-licenses two products

By |June 7th, 2017|Digest|

Eiger BioPharmaceuticals ($EIGR) announced the completion of enrollment for its Phase 2 multiple-ascending dose study assessing subcutaneous exendin 9-39 for the treatment of post-bariatric surgery patients who are experiencing dangerously low postprandial blood glucose levels. The company intends to present the data on June [...]

Sonoma Pharmaceuticals: Upcoming catalyst presents second opportunity for those who missed the boat earlier $SNOA

By |June 6th, 2017|Monthly Investment Ideas|

Sonoma Pharmaceuticals $SNOA operates in dermatological care segment, which is considered rather low risk area of pharmacology. The company comes with a robust product portfolio as well as an impressive product pipeline, making it an attractive investment target. The valuations of the company are also on the cheaper side, which [...]

Premarket Biotech Digest – $LLY announces positive results, $EXAS initiates recall, $BMY inks new collaboration

By |June 5th, 2017|Digest|

Halozyme Therapeutics Inc. ($HALO) stock perked up as the company announced the updated results from the Phase 2 HALO-202 study assessing its lead product candidate PEGPH20, combined with Celgene's ABRAXANE (nab-paclitaxel) and gemcitabine (AG), in patients with advanced pancreatic cancer showed a treatment benefit. In [...]

Premarket Biotech Digest –$XBIT announces European study results, $PLX gets FDA nod, $THC modifies agreement

By |June 1st, 2017|Digest|

Eleven Biotherapeutics Inc. ($EBIO) announced that its pivotal Phase 3 clinical trial assessing Vicinium in non-muscle invasive bladder cancer exceeded 50% enrollment. The company also said that the trial will proceed without modification as recommended by the independent Data and Safety Monitoring Board.  The [...]

Premarket Biotech Digest – $AVGR announces positive data, $CXRX to be investigated, $CYTX receives BARDA nod,

By |June 1st, 2017|Digest|

Microbot Medical Inc. ($MBOT) announced receiving a new patent from the Canadian Intellectual Property Office. The new patent covers the company’s Self-Cleaning Shunt, specifically an inlet head for use on shunts. Microbot has an  exclusive license to the patent from the Technion - Israel [...]

Premarket Biotech Digest – $ISRG receives 501(k) approval, $ZBH suffers recall, $PFE receives EC nod

By |May 31st, 2017|Digest|

Quidel Corporation ($QDEL) stock showed strong movement as the company announced receiving the FDA’s 501(k) clearance and Clinical Laboratory Improvements Amendments waiver for its Sofia Influenza A+B Fluorescent Immunoassay  to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid, differential detection [...]

Premarket Biotech Digest – $ECYT to provide update, $CLSN reverse splits stock, $MRK receives Ebola drug approval

By |May 30th, 2017|Digest|

Endocyte ($ECYT) reported that it will present updated data on its lead drug candidates EC1456 and EC1169. For EC1456, the results pertain to a  a two-part Phase 1 study, EC1456-01.Part A (dose escalation phase) involves 87 patients with advanced solid tumors while Part B [...]

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