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

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

Stocks In Focus

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

AbbVie Inc 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 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 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 SNY and Denali Therapeutics Inc 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 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 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. ABMD (before the market open)
AMAG Pharmaceuticals, Inc. AMAG (before the market open)
Agios Pharmaceuticals Inc AGIO (before the market open)
Curis, Inc. CRIS (before the market open)
Concert Pharmaceuticals Inc CNCE (before the market open)
Eagle Pharmaceuticals Inc EGRX (before the market open)
Fate Therapeutics Inc FATE (before the market open)
Genocea Biosciences Inc GNCA (before the market open)
Lexicon Pharmaceuticals, Inc. LXRX (before the market open)
Pacira Pharmaceuticals Inc PCRX ) (before the market open)
Syros Pharmaceuticals Inc SYRS (before the market open)
Adamas Pharmaceuticals Inc ADMS (after the market close)
AtriCure Inc. ATRC (after the market close)
CTI BioPharma Corp CTIC(after the market close)
Corcept Therapeutics Incorporated CORT(after the market close)
Conatus Pharmaceuticals Inc CNAT(after the market close)
Cytokinetics, Inc. CYTK(after the market close)
GERN(after the market close)
Emergent Biosolutions Inc EBS (after the market close)
Insulet Corporation PODD (after the market close)
Puma Biotechnology Inc PBYI (after the market close)
Pacific Biosciences of California PACB(after the market close)
NewLink Genetics Corp NLNK (after the market close)
Exelixis, Inc. EXEL (after the market close)
Revance Therapeutics Inc RVNC (after the market close)
Retrophin Inc RTRX (after the market close)
TESARO Inc TSRO (after the market close)
Tandem Diabetes Care Inc 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 ALKS's NDA for buprenorphine and samidorphan sublingual tablets, being evaluated as an adjunctive treatment of major depressive disorder.