The Daily Biotech Pulse: Setback For Merck In Breast Cancer Study, Arrowhead to Join S&P SmallCap 600 Index, Ocular's Glaucoma Trial Fails

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 May 20)

• Kaleido Biosciences Inc KLDO

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 20)

• Adamis Pharmaceuticals Corp ADMP
• AIT Therapeutics Inc AITB
• Akcea Therapeutics Inc AKCA
• Alkermes Plc ALKS
• AMAG Pharmaceuticals, Inc AMAG
• Amneal Pharmaceuticals Inc AMRX
• ANCHIANO THERAP/S ADR ANCN
• Aptinyx Inc APTX
• Atara Biotherapeutics Inc ATRA
• Auris Medical Holding Ltd EARS (regained compliance with Nasdaq minimum bid price requirement)
• Bellicum Pharmaceuticals Inc BLCM
• Collegium Pharmaceutical Inc COLL
• DelMar Pharmaceuticals Inc DMPI
• Dynavax Technologies Corporation DVAX
• Emergent Biosolutions Inc EBS
• Heat Biologics Inc HTBX
• Invivo Therapeutics Holdings Corp NVIV
• Mallinckrodt PLC MNK
• Melinta Therapeutics Inc MLNT
• Myriad Genetics, Inc. MYGN
• Nuvectra Corp NVTR
• Obalon Therapeutics Inc OBLN
• Oncolytics Biotech, Inc. ONCY
• OncoSec Medical Inc ONCS(announced 1-for-10 reverse stock split, effective 5 pm ET, May 20)
• Paratek Pharmaceuticals Inc PRTK
• Puma Biotechnology Inc PBYI
• Strongbridge Biopharma plc SBBP
• SurModics, Inc. SRDX
• Theravance Biopharma Inc TBPH(announced additional Phase 3 data and 52-week safety data for Yupelri, approved for the maintenance treatment of chronic obstructive pulmonary disease)
• Tonix Pharmaceuticals Holding Corp TNXP(announced resignation of Donald Landry from the board)
• United Therapeutics Corporation UTHR
• Zomedica Pharmaceuticals Corp ZOM

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

Stock In Focus

Merck's Keytruda Flunks In Breast Cancer Study

Merck & Co., Inc. MRK announced the Phase 3 KEYNOTE-119 trial evaluating its anti-PD-1 therapy Keytruda, as a monotherapy for second- or third-line triple-negative breast cancer did not meet its pre-specified primary endpoint of superior overall survival compared to chemotherapy.

Arrowhead To Join S&P Smallcap 600 Index

S&P Global announced that Arrowhead Pharmaceuticals Inc ARWR will replace Navigators Group Inc NAVG in the S&P SmallCap 600 Index. Navigators is being acquired by Hartford Financial Services Group Inc HIG on or about May 23.

Arrowhead stock rose 6.18 percent to $20.11 in after-hours trading.

Clovis' Ovarian Cancer Drug Had Longer Period Of Quality-adjusted Time

Clovis Oncology Inc CLVS announced new data from the Phase 3 ARIEL3 study that is evaluating its Rubraca in patients with metastatic breast cancer, which showed Rubraca-treated patients had longer periods of quality-adjusted time without clinically relevant symptoms as compared to patients receiving placebo.

Additionally, the company noted that Rubraca maintenance treatment continued to provide significant benefit in progression-free survival when weighted with patients' perceptions of their well being.

The data from post-hoc evaluations were presented at the International Society for Pharmacoeconomics and Outcomes annual meeting in New Orleans.

Rubraca has been approved by the FDA for advanced ovarian cancer, and as a maintenance therapy for recurrent ovarian cancer.

The stock gained 6.05 percent to $17.35 in after-hours trading.

Guardant To Offer 4.5M Shares

Guardant Health Inc GH said it has commenced an underwritten public offering of 4.5 million shares of its common stock. All the shares are to be sold by the company.

The stock fell 4.17 percent to $75.01 in after-hours trading.

Akorn Gains FDA Nod For Generic Version Of Allergic Rhinitis Drug

Akorn, Inc. AKRX said the FDA has approved its generic version of Azelastine hydrochloride nasal spray, 0.1 percent. The company said, citing IQVIA, the product fetched sales of $46 million in the U.S. in the 12 months ended March 2019. The nasal spray is indicated to treat symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

The stock moved up 4.07 percent to $4.35 in after-hours trading.

Ocular's Glaucoma Candidate Fails In Late-stage Study

Ocular Therapeutix Inc OCUL released topline results of a Phase 3 trial that evaluated its glaucoma treatment candidate OTX-TP, which showed that the study did not meet the primary endpoint of statistically superior mean reduction of interocular pressure from the baseline compared with placebo insert treated subjects, at three diurnal time points of 8 am, 10 am and 4 pm, at the end of 2, 6 and 12 weeks following insertion.

However, the study achieved statistical significance in the reduction of intraocular pressure versus placebo at eight of the nine prespecified endpoints.

The company said it plans to discuss the data with the FDA to determine the next steps.

The stock fell 9.20 percent to $3.06 in after-hours trading.

Insmed's Lung Disease Drug Shows Sustained Efficacy In Late-Stage Study; Company To Offer Shares

Insmed Incorporated INSM presented new data from the ongoing Phase 3 CONVERT study of Arikayce in patients with refractory Mycobacterium avium complex, or MAC, lung disease, which showed that the addition of Arikayce to guideline-based therapy, or GBT, was associated with sustained culture conversion through the end of treatment as well as durable culture conversion three months post-treatment compared with GBT alone.

Arikayce is the first and only FDA-approved treatment for refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.

Separately, the company announced a $250 million common stock offering. The company intends to use the net proceeds for the commercialization of Arikayce as well as for its clinical pipeline development, among other things.

The stock slipped 2.74 percent to $27.30 in after-hours trading.

Varian To Buy Cancer Treatment Services For $283M

Varian Medical Systems, Inc. VAR announced an agreement to acquire privately-held Cancer Treatment Services International for $283 million. Cancer Treatment operates the American Oncology Institute in Hyderabad and 10 multidisciplinary—radiation, medical and surgical oncology— cancer centers across the Indian subcontinent as well as a U.S.-based Oncology Solutions division.

Varian expects the deal to close in about two weeks. It expects the deal to be 6 cents per share dilutive on a GAAP basis and 3 cents per share dilutive on a non-GAAP basis for the remainder of 2019. Giving effect to the transaction, Varian lowered its 2019 non-GAAP EPS guidance from $4.60-$4.75 to $4.55-$4.70.

The stock fell 2.90 percent to $126.73 in after-hours trading.