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The Daily Biotech Pulse: AbbVie's Leukemia Drug Trial Meets Endpoint, Denali Strikes Collaboration Deal

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The Daily Biotech Pulse: AbbVie's Leukemia Drug Trial Meets Endpoint, Denali Strikes Collaboration Deal
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Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peak

(Biotech stocks hitting 52-week highs on Nov. 1)

  • Merck & Co., Inc. (NYSE: MRK)(announced FDA approval for its Keytruda-chemotherapy combo for lung cancer)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Veracyte Inc (NASDAQ: VCYT)(reported strong Q3 revenue growth and raised its full-year guidance)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 1)

  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Ardelyx Inc (NASDAQ: ARD)
  • Biocept Inc (NASDAQ: BIOC)
  • Clovis Oncology Inc (NASDAQ: CLVS) (reacted to Q3 results)
  • Dynavax Technologies Corporation (NASDAQ: DVAX)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Fortress Biotech (NASDAQ: FBIO)
  • Forward Pharma A/S (NASDAQ: FWP)
  • Jounce Therapeutics Inc (NASDAQ: JNCE)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • MacroGenics Inc (NASDAQ: MGNX)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Neovasc Inc (NASDAQ: NVCN)
  • Presbia PLC (NASDAQ: LENS)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Radius Health Inc (NASDAQ: RDUS)
  • Ritter Pharmaceuticals Inc (NASDAQ: RTTR) (announced an agreement for $6 million at-market private placement of Series B convertible preferred stock and warrants)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Sutro Biopharma Inc (NASDAQ: STRO)
  • The Medicines Company (NASDAQ: MDCO)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • Unum Therapeutics Inc (NASDAQ: UMRX)

Stocks In Focus

AbbVie Reports Positive Trial Results For Leukemia Drug; Secures EC Approval

AbbVie Inc (NYSE: ABBV) announced positive results for its Phase 3 CLL14 study that evaluated its venetoclax plus obinutuzumab versus the standard care (obinutuzumab plus chlorambucil) in patients with chronic lymphocytic leukemia, or CLL, and coexisting medical conditions who have not received a prior treatment.

The study met its primary endpoint of investigator-assessed progression-free survival, with a 12-month fixed duration of treatment, the company said.

Separately, the company said the European Commission approval of Venclyxto plus Rituximab for treating patients with CLL who have received at least one prior therapy.

The stock rose 1.19 percent to $78.78 in after-hours trading.

Heron Submits NDA For Pain Drug

Heron Therapeutics Inc (NASDAQ: HRTX) said it has submitted a NDA to the FDA for HTX-011, an investigational long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.

The candidate has been granted both Breakthrough Therapy and Fast Track designations.

The stock climbed 8.07 percent to $30 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results, Earnings And IPOs

Synergy Pharma Appoints Spigelman as Chairman

Synergy Pharmaceuticals Inc (NASDAQ: SGYP) announced the appointment of Melvin Spigelman as the Chairman of the Board, effective immediately, as the incumbent Gary Jacob is to depart to pursue other opportunities. Spigelman has been serving as the independent director of Synergy since August 2008.

The stock jumped 12.79 percent to $0.47 in after-hours trading.

Denali To Collaborate With Sanofi For Develop Its Lead Molecules

Sanofi SA (NYSE: SNY) and Denali Therapeutics Inc (NASDAQ: DNLI) announced a collaboration agreement for the development of multiple molecules for treating a range of neurological and systemic inflammatory diseases.

Denali is developing two lead molecules, namely DNL747 and DNL758, with the company planning to study the former in multiple sclerosis, Alzheimer's disease, and amyotrophic lateral sclerosis, and the latter for systemic inflammatory diseases such as rheumatoid arthritis and psoriasis.

The collaboration agreement provides for Sanofi making an upfront cash payment of $125 million to Denali, with future development and commercial milestone payments that could exceed $1 billion.

"Sanofi and Denali will share commercial profits and losses from DNL747 in the U.S. and China equally, while Denali will receive a royalty from Sanofi for other territories for DNL747 and worldwide for DNL758," the companies said.

Earnings

Apricus Biosciences Inc (NASDAQ: APRI) reported a narrower loss for its Q3. The company said it will continue to work with Seelos management in the coming weeks to complete its previously announced merger with Seelos Therapeutics, following the Special Stockholder Meeting. Following the merger, the shares of the merged entity will begin to trade on the Nasdaq under the ticker symbol SEEL.

The stock added 3.75 percent to $0.3517 in after-hours trading.

Novo Nordisk A/S (NYSE: NVO) reported Q3 profits that declined by more than expected, while sales exceeded consensus by a small margin. The company cautioned of intensifying global competition within diabetes care and biopharmaceuticals, as well as pricing pressure within diabetes care.

On The Radar

Earnings

ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (before the market open)
Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open)
Curis, Inc. (NASDAQ: CRIS) (before the market open)
Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the market open)
Eagle Pharmaceuticals Inc (NASDAQ: EGRX) (before the market open)
Fate Therapeutics Inc (NASDAQ: FATE) (before the market open)
Genocea Biosciences Inc (NASDAQ: GNCA) (before the market open)
Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open)
Pacira Pharmaceuticals Inc (NASDAQ: PCRX) ) (before the market open)
Syros Pharmaceuticals Inc (NASDAQ: SYRS) (before the market open)
Adamas Pharmaceuticals Inc (NASDAQ: ADMS) (after the market close)
AtriCure Inc. (NASDAQ: ATRC) (after the market close)
CTI BioPharma Corp (NASDAQ: CTIC)(after the market close)
Corcept Therapeutics Incorporated (NASDAQ: CORT)(after the market close)
Conatus Pharmaceuticals Inc (NASDAQ: CNAT)(after the market close)
Cytokinetics, Inc. (NASDAQ: CYTK)(after the market close)
(Geron Corporation (NASDAQ: GERN)(after the market close)
Emergent Biosolutions Inc (NYSE: EBS) (after the market close)
Insulet Corporation (NASDAQ: PODD) (after the market close)
Puma Biotechnology Inc (NASDAQ: PBYI) (after the market close)
Pacific Biosciences of California (NASDAQ: PACB)(after the market close)
NewLink Genetics Corp (NASDAQ: NLNK) (after the market close)
Exelixis, Inc. (NASDAQ: EXEL) (after the market close)
Revance Therapeutics Inc (NASDAQ: RVNC) (after the market close)
Retrophin Inc (NASDAQ: RTRX) (after the market close)
TESARO Inc (NASDAQ: TSRO) (after the market close)
Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the market close)

Adcom Meeting

A joint committee of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss efficacy, safety and risk-benefit profile of Alkermes Plc (NASDAQ: ALKS)'s NDA for buprenorphine and samidorphan sublingual tablets, being evaluated as an adjunctive treatment of major depressive disorder.

Posted-In: Biotech Earnings News FDA Top Stories Trading Ideas Best of Benzinga

 

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