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 Dec. 5)
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)(presented positive Phase 3 data for pimavanserin in dementia-related psychosis)
Allergan plc (NYSE: AGN)
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
Applied Therapeutics Inc (NASDAQ: APLT)
Bristol-Myers Squibb Co (NYSE: BMY)
Cassava Sciences Inc (NASDAQ: SAVA)
Cue Biopharma Inc (NASDAQ: CUE)
Deciphera Pharmaceuticals Inc (NASDAQ: DCPH)
DexCom, Inc. (NASDAQ: DXCM)
Flexion Therapeutics Inc (NASDAQ: FLXN)
GALAPAGOS NV/S ADR (NASDAQ: GLPG)
Global Blood Therapeutics Inc (NASDAQ: GBT)
Incyte Corporation (NASDAQ: INCY)
Merck & Co., Inc. (NYSE: MRK)
Morphosys Ag (NASDAQ: MOR)
NuVasive, Inc. (NASDAQ: NUVA)
Oyster Point Pharma Inc (NASDAQ: OYST)
PTC Therapeutics, Inc. (NASDAQ: PTCT)
Synthorx Inc (NASDAQ: THOR)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)
Zai Lab Ltd (NASDAQ: ZLAB)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Dec. 5)
Akers Biosciences Inc (NASDAQ: AKER)(announced intention to continue evaluation of strategic initiatives and plans to enter into hemp and minor cannabinoid processing industry)
Assertio Therapeutics Inc (NASDAQ: ASRT)
BIOLINERX LTD/S ADR (NASDAQ: BLRX)(announced mid-phase readout of BL-8040 in combination with Merck's Keytruda and chemotherapy in second line patients with metastatic pancreatic cancer)
Capricor Therapeutics Inc (NASDAQ: CAPR)
Centogene NV (NASDAQ: CNTG)(reacted to its third-quarter results)
Citius Pharmaceuticals Inc (NASDAQ: CTXR)
Evogene Ltd (NASDAQ: EVGN)
Galera Therapeutics Inc (NASDAQ: GRTX)
KemPharm Inc (NASDAQ: KMPH)
KITOV PHARMA LT/S ADR (NASDAQ: KTOV)
Midatech Pharma PLC-ADR (NASDAQ: MTP)
Neon Therapeutics Inc (NASDAQ: NTGN)
Orgenesis Inc (NASDAQ: ORGS)
Sophiris Bio Inc (NASDAQ: SPHS)
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)(reacted to Phase 1/2 data on vecabrutinib in patients with B cell blood cancers, made available through abstract meant for ASH presentation)
Theratechnologies Inc (NASDAQ: THTX)
Stocks In Focus Cassava Sciences Presents Positive Mid-stage Readout For Alzheimer's Drug
Cassava presented at the 12th Clinical Trials On Alzheimer's Disease, or CTAD, meeting, additional data from a Phase 2a study of its investigational pipeline asset PTI-125 in Alzheimer's disease, which confirmed its mechanism of action and drug-targeting engagement. The data showed improvements in biomarkers of Alzheimer's disease in plasma and lymphocytes, significant reductions in both nitrated and phosphorylated tau protein, evidence that PTI-125 reversed the shape of altered filamin A in lymphocytes, among other things.
The company said it plans to conclude an ongoing Phase 2b study in 2020.
After hitting a 52-week high in Thursday's regular session, the stock added an incremental 7.78% to $1.94 in after-hours trading.
Epizyme Rises On Upgrade
Epizyme Inc (NASDAQ: EPZM) shares gained some momentum after Morgan Stanley upgraded shares from Equal-Weight to Overweight, and set a price target of $22.
The stock added 4.51% to $15.99 in after-hours trading.
Biohaven Issued Patent With Respect to Prodrug to Treat Genetic Disorder Affecting Movement
Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) said it has been issued U.S. Patent No. 10,485,791 Nov. 26, relating to troriluzole. The company said the patent is related to the composition of matter of troriluzole, a prodrug of a glutamate modulator, as well as other compounds, pharmaceutical compositions and the methods of treating diseases. The company said the patent is not expected to expire until Feb. 26, 2036.
Biohaven is evaluating troriluzole in a Phase 3 study for spinocerebellar ataxia.
Bristol-Myers Squibb Announces 9.8% Dividend Increase
Bristol-Myers Squibb said it has hiked its quarterly dividend by 9.8%, beginning in the first quarter of 2020. The increase takes its quarterly dividend to 45 cents per share. The company noted that the next quarterly dividend is payable Feb. 3, 2020 for shareholders of record as of the close of business Jan. 3, 2020.
Alector's Dementia Drug Gets Fast Track Designation
Alector Inc (NASDAQ: ALEC) said the FDA has granted Fast Track Designation for its investigational therapy AL001 for the treatment of adults with frontotemporal dementia, carrying specific genetic mutations in the granulin gene.
The stock rose 10.88% to $21.50 in after-hours trading.
Y-mAbs' Pediatric Cancer Drug Application Vetted By European Regulator
Y-mAbs said the European Medicines Agency has agreed to its proposed Pediatric Investigation Plan, or PIP, for omburtamab. This followed a positive opinion received from the agency's Pediatric Committee.
Omburtamab is being developed by the company for treating CNS/leptomeningeal metastases from neuroblastoma, as well as a number of additional cancer indications.
An approved PIP is a prerequisite for filing a Marketing Authorization Application for any new medicine in Europe.
Novartis's New Inhaled Dual-Combination Therapy Aces a Late Stage Trial In Asthma Control
Novartis AG (NYSE: NVS) said its pivotal Phase 3 PALLADIUM trial that evaluated a once-daily QMF149, a fixed-dose combination of indacaterol acetate and mometasone furoate, showed that the combo therapy was found superior to mometasone furoate monotherapy at medium and high doses in improving lung function, thus meeting the primary endpoint. It also met the secondary endpoint of asthma control.
QMF149 also showed improvements in lung function when compared to a LABA/ICS standard-of-care, the company added.
IVERIC bio Inc (NASDAQ: ISEE) said it's commencing an underwritten public offering of shares of its common stock. All the shares are being offered by the company.
The stock fell 11.63% to $3.80 in after-hours trading.
On The Radar Clinical Trial Readouts
Alector is scheduled to present at the CTAD meeting, Phase 1 data for AL002, a monoclonal antibody, in Alzheimer's disease.
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