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The Daily Biotech Pulse: Cheery Results For Sage's Depression Drug, UniQure Offering, Axsome Aces Study Of Headache Drug.

Byline: Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Sept. 4)

* Adaptive Biotechnologies Corp (NASDAQ: ADPT)

* Bioanalytical Systems, Inc. (NASDAQ: BASI)

* China Biologic Products Holdings Inc (NASDAQ: CBPO)

* NextCure Inc (NASDAQ: NXTC)

* Novo Nordisk A/S (NYSE:NVO)

* Protagonist Therapeutics Inc (NASDAQ: PTGX)

* West Pharmaceutical Services Inc. (NYSE:WST)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 4)

* Adamis Pharmaceuticals Corp (NASDAQ: ADMP)

* Aerie Pharmaceuticals Inc (NASDAQ: AERI)(announced $250 million worth of convertible senior note offering)

* AngioDynamics, Inc. (NASDAQ: ANGO)

* BioNano Genomics Inc (NASDAQ: BNGO)

* Endologix, Inc. (NASDAQ: ELGX)

* Esperion Therapeutics Inc (NASDAQ: ESPR)

* Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)

* Merit Medical Systems, Inc. (NASDAQ: MMSI)

* Sarepta Therapeutics Inc (NASDAQ: SRPT)

* Seelos Therapeutics Inc (NASDAQ: SEEL)

* Synlogic Inc (NASDAQ: SYBX)

* VBI Vaccines Inc (NASDAQ: VBIV)

See Also: Biotech Stock On The Radar: Ardelyx Gears Up For FDA Decision Day

Stocks In Focus

Sage Publishes Positive Midstage Results For Depression Drug In NEJM

SAGE Therapeutics Inc (NASDAQ: SAGE) announced publication in the New England Journal of Medicine full results from the Phase 2 study that evaluated its SAGE-217 as a treatment for major depressive disorder. SAGE-217, when taken orally once-daily showed a rapid, statistically significant reduction in Hamilton Rating Scale for Depression, or HAM-D, total scores versus placebo beginning the morning following the first dose.

The efficacy was sustained through the primary endpoint of Day 15.

The company also noted that the results published in NEJM included additional data from multiple secondary endpoints, all of which generally favored SAGE-217 at the end of treatment.

The stock gained 3.92% to $169 in after-hours trading.

Axsome's Migraine Drug Found Effective In Early Stage Study

Axsome Therapeutics Inc (NASDAQ: AXSM) said it will present positive results from a Phase 1 pharmacokinetic study of AXS-07 at the 19th Congress of the International Headache Society in Dublin on Friday.

AXS-07 is Axsome's novel, oral, investigational medicine with distinct dual mechanisms of action being developed for the acute treatment of migraine. The results of the early-stage study showed that the investigational asset demonstrated rapid absorption after oral administration, with the MoSEIC meloxicam component also displaying an extended plasma half-life, suggesting the potential for enhanced and sustained efficacy.

The stock was rallying 4.25% to $25.99 in pre-market trading.

Bristol-Myers Squibb's CheckMate-548 Study Fails To Meet One Of The Primary Endpoints

Bristol-Myers Squibb Co (NYSE:BMY) said the Phase 3 CheckMate-548 study that evaluated the addition of Opdivo to the current standard of care, namely temozolomide and radiation therapy, versus the standard of the care alone did not meet one of its primary endooints of progression-free survival in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated.

However, the company noted that the data monitoring committee recommended that the trial continue as planned to allow the other primary endpoint, overall survival, to mature.

The stock was advancing 0.58% to $48.40 in pre-marker trading.

UniQure To Offer $200M Worth Of Shares In Secondary Offering

Gene therapy company Uniqure NV (NASDAQ: QURE) announced the commencement of an underwritten public offering of $200 million worth of shares. All the shares are to be sold by the company.

The stock slumped 12.47% to $49 in after-hours trading.


Aerie announced upsizing of its previously announced debt offering from $250 million to $275 million. The company also priced the offering of notes, which are being sold in a private offering to qualified institutional buyers.

Puma's Breast Cancer Drug Approved in Argentina

Puma Biotechnology Inc (NASDAQ: PBYI), which announced late Tuesday FDA's Orphan Drug Designation for its Nerlynx in breast cancer patients with brain metastases, said the Argentinian drug regulatory agency approved Nerlynx for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed breast cancer, and who complete adjuvant trastuzumab-based therapy less than a year ago.

The approval was granted to Puma's licensing partner Pint Pharma.

The stock rose 1.92% to $10.63 in after-hours trading.

Synlogic CFO Departs

Synlogic announced the departure of its CFO Todd Shegog, effective Sept. 18, who is leaving to pursue another opportunity, as well as the addition of two senior executives. The company appointed Richard Riese as chief medical officer and Michael Slater as head of regulatory affairs.

Synlogic also said it has commenced a search for a new CFO.

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Date:Sep 5, 2019
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