The Daily Biotech Pulse: Cassava Gains On Alzheimer's Presentation, Bristol-Myers Hikes Dividend

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. ACAD(presented positive Phase 3 data for pimavanserin in dementia-related psychosis)
  • Allergan plc AGN
  • Alnylam Pharmaceuticals, Inc. ALNY
  • Applied Therapeutics Inc APLT
  • Aurinia Pharmaceuticals Inc AUPH( reported positive readout for a pivotal trial in volcosporin for lupus nephritis)
  • Bristol-Myers Squibb Co BMY
  • Cassava Sciences Inc SAVA
  • Cue Biopharma Inc CUE
  • Deciphera Pharmaceuticals Inc DCPH
  • DexCom, Inc. DXCM
  • Flexion Therapeutics Inc FLXN
  • GALAPAGOS NV/S ADR GLPG
  • Global Blood Therapeutics Inc GBT
  • Incyte Corporation INCY
  • Merck & Co., Inc. MRK
  • Morphosys Ag MOR
  • NuVasive, Inc. NUVA
  • Oyster Point Pharma Inc OYST
  • PTC Therapeutics, Inc. PTCT
  • Synthorx Inc THOR
  • Vertex Pharmaceuticals Incorporated VRTX
  • Y-mAbs Therapeutics, Inc YMAB
  • Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 5)

  • Akers Biosciences Inc AKER(announced intention to continue evaluation of strategic initiatives and plans to enter into hemp and minor cannabinoid processing industry)
  • Assertio Therapeutics Inc ASRT
  • BIOLINERX LTD/S ADR 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 CAPR
  • Centogene NV CNTG(reacted to its third-quarter results)
  • Citius Pharmaceuticals Inc CTXR
  • Evogene Ltd EVGN
  • Galera Therapeutics Inc GRTX
  • KemPharm Inc KMPH
  • KITOV PHARMA LT/S ADR KTOV
  • Midatech Pharma PLC-ADR MTP
  • Neon Therapeutics Inc NTGN
  • Orgenesis Inc ORGS
  • SAGE Therapeutics Inc SAGE( reported disappointing Phase 3 results for its SAGE-217 in major depressive disorder)
  • Sophiris Bio Inc SPHS
  • Sunesis Pharmaceuticals, Inc. 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 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.

See Also: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Epizyme Rises On Upgrade

Epizyme Inc 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 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 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 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.

Offerings

IVERIC bio Inc 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.

Posted In: BiotechNewsOfferingsTrading Ideas
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