The Daily Biotech Pulse: Jounce Jumps On Licensing Deal, Regulus Hit With Partial Clinical Hold, Genomic Health Added to S&P SmallCap Index

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 July 23)

• Akero Therapeutics Inc AKRO
• Mirum Pharmaceuticals Inc MIRM( IPOed June 18)
• Salarius Pharmaceuticals Inc SLRX
• VolitionRX Ltd VNRX

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 23)

• Abbott Laboratories ABT
• Abeona Therapeutics Inc ABEO
• Adamis Pharmaceuticals Corp ADMP
• Advaxis, Inc. ADXS(announced pricing of its 9.2 million common stock offering)
• Aerie Pharmaceuticals Inc AERI
• Apollo Endosurgery Inc APEN(slipped ahead of earnings)
• Applied DNA Sciences Inc APDN
• Autolus Therapeutics Ltd – ADR AUTL
• Bellicum Pharmaceuticals Inc BLCM
• BIOLINERX LTD/S ADR BLRX
• Cancer Genetics Inc CGIX
• Celldex Therapeutics, Inc. CLDX
• China SXT Pharmaceuticals Inc SXTC
• Dynavax Technologies Corporation DVAX
• Eloxx Pharmaceuticals Inc ELOX
• Foamix Pharmaceuticals Ltd FOMX
• Gamida Cell Ltd GMDA
• GENFIT S A/ADR GNFT
• Heat Biologics Inc HTBX
• HTG Molecular Diagnostics Inc HTGM
• Intra-Cellular Therapies Inc ITCI
• Invivo Therapeutics Holdings Corp NVIV
• Jaguar Health Inc JAGX
• Kaleido Biosciences Inc KLDO
• Kindred Biosciences Inc KIN
• Marinus Pharmaceuticals Inc MRNS(announced data from a late-stage study of postpartum depression drug)
• MEI Pharma Inc MEIP )
• Myovant Sciences Ltd MYOV(announced positive late-stage trial results for drug to treat uterine fibroids and heavy menstrual bleeding)
• Neon Therapeutics Inc NTGN
• Neovasc Inc NVCN
• Organogenesis Holdings Inc ORGO
• Psychemedics Corp. PMD
• Strongbridge Biopharma plc SBBP
• Surface Oncology Inc SURF
• Tetraphase Pharmaceuticals Inc TTPH
• TherapeuticsMD Inc TXMD
• Tonix Pharmaceuticals Holding Corp TNXP
• TrovaGene Inc TROV
• Viveve Medical Inc VIVE( announced failed trial results and decision to explore strategic options)
• Wave Life Sciences Ltd WVE
• Xenetic Biosciences Inc XBIO
• Zafgen Inc ZFGN

Stocks In Focus

Jounce Out-Licenses Tumor Drug To Celgene For Up To $530M

Jounce Therapeutics Inc JNCE announced a new licensing agreement with Celgene Corporation CELG under which the former has out-licensed worldwide rights to JTX-8064 to the latter. JTX-8064 is an antibody that targets the anti-Leukocyte Immunoglobulin Like Receptor B2 on macrophages.

The new license agreement provides for Jounce receiving a $50 million non-refundable license fee and potentially up to $480 million in development, regulatory and commercial milestone payments, as well as royalties on potential worldwide sales.

Following a mutual agreement between Celgene and Jounce to terminate their original strategic collaboration agreement, Jounce retained the full worldwide rights to its pipeline beyond JTX-8064, which include vopratelimab, JTX-4014 and all discovery programs.

The stock surged up 32.52% to $5.42 in after-hours trading.

Genomic Health To Join S&P SmallCap 600 Index

Standard & Poor's announced Genomic Health, Inc. GHDX will replace Electronics For Imaging, Inc. EFII in the S&P SmallCap 600 Index prior to the open of trading July 29 as Siris Capital has acquired Electronics For Imaging.

The stock climbed 7.45% to $61 in after-hours trading.

FDA Cancels Adcom Meeting For Intracellular's Schizophrenia Drug

Intra-Cellular Therapies announced the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, which was meant to discuss the company's NDA for lumateperone, its pipeline asset for treating schizophrenia.

The development follows the company submitting additional information to the FDA recently in response to the regulatory agency's information requests relating to non-clinical studies. The review of the additional data could delay the PDUFA date, which is currently scheduled for Sept. 27.

The stock gained 7.45% to $8.80 in after-hours trading.

Seattle Genetics Prices 7.123-Million Common Stock Offering

Seattle Genetics, Inc. SGEN announced pricing of its underwritten public offering of 7.123 million shares at $70 per share. All the shares are sold by the company. The company expects to raise gross proceeds of about $500 million from the offering.

The stock slipped 3.75% to $73.10 in after-hours trading.

Edwards Lifesciences Rallies On Beat-And-Raise Quarter

Edwards Lifesciences Corp EW reported second-quarter sales of $1.1 billion, up 15% year-over-year, and adjusted earnings per share growth of 11% to $1.38. The company raised its 2019 guidance, with the revised guidance in line with estimates.

The stock soared 10.51% to $216 in after-hours trading.

Regulus' Kidney Disease Drug IND Placed On Partial Clinical Hold

Regulus Therapeutics Inc RGLS, which had earlier paused its Phase 1 program evaluating its RGLS4326 in autosomal dominant polycystic kidney disease, or ADPKD, said the FDA has placed its investigational new drug application, or IND, for the candidate on partial hold after reviewing the interim analyses from a new mouse chronic toxicity study and the non-human primate chronic toxicity study submitted by the company to help re-initiate the multiple ascending dose study.

The FDA notified the company regarding additional non-clinical data requirements, including final reports from the chronic toxicity studies in both mice and NHP and satisfactory related analyses to ensure subjects can be safely dosed.

The stock declined 16.67% to 95 cents in after-hours trading.

Pluristem Announces 1-For-10 Reverse Split

Pluristem Therapeutics Inc. PSTI said its board has approved a 1-for-10 reverse split of its common stock. The reverse split will be effective as of market open July 25.

On The Radar

Clinical Trial Readouts

Merck & Co., Inc. MRK is scheduled to release Phase 2b 48-week data for its HIV drug MK-8591 at the IAS 2019 conference.

Earnings

Anika Therapeutics Inc ANIK (before the market open)
Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Boston Scientific Corporation BSX (before the market open)
Integra Lifesciences Holdings Corp IART (before the market open)
The Medicines Company MDCO (before the market open)
Obalon Therapeutics Inc OBLN (before the market open)
LeMaitre Vascular Inc LMAT (after the market close)
Varian Medical Systems, Inc. VAR (after the market close)