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The Daily Biotech Pulse: NASH Disappointment For Gilead, Xeris To Offer Shares

Shanthi Rexaline

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 Feb. 11)

  • Boston Scientific Corporation (NYSE: BSX)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Harpoon Therapeutics Inc (NASDAQ: HARP)
  • Outlook Therapeutics, Inc. (NASDAQ: OTLK)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 11)

  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Pulmatrix Inc (NASDAQ: PULM)

Stock In Focus Gilead's NASH Drug Disappoints In Phase 3 Trial

Gilead Sciences, Inc. (NASDAQ: GILD) announced its Phase 3 STELLAR-4 study that evaluated the safety and efficacy of selonsertib in patients with compensated cirrhosis due to NASH did not meet the prespecified week 48 primary endpoint of an equal to or more than 1-stage histologic improvement in fibrosis without worsening NASH.

The stock fell 2.41 percent to $65.99 in after-hours trading.

FDA Accepts For Review Pfizer's Kidney Cancer Drug

Pfizer Inc. (NYSE: PFE) and MERCK KGAA/S ADR (OTC: MKKGY) unit EMD Serono said the FDA has accepted for priority review the sBLA for Bavencio in combination of Inlyta for patients with renal cell carcinoma. The PDUFA date has been set for June.

Separately, Pfizer and Astellas Pharma released results of a late-stage study dubbed ARCHES that evaluated its Xtandi plus androgen deprivation therapy, or ADT, for treating men with metastatic hormone-sensitive prostate cancer, or mHSPC, met the primary endpoint of significantly reducing the risk of radiographic progression or death by 61 percent versus ADT alone.

Bristol-Myers Squibb's Kidney Cancer Drug Combo Shows Long-term Survival Benefits

Bristol-Myers Squibb Co (NYSE: BMY)'s released new results from the Phase 3 CHECKMATE-214 study that showed its Opdivo plus low-dose Yervoy continued to demonstrate long-term survival benefits in patients with previously untreated advanced renal cell carcinoma.

See Also: FDA Panel Reviews Johnson & Johnson's Treatment-Resistant Depression Candidate: What To Expect

Nektar's Cancer Drug Shows Reduced Response Rate In Bladder Cancer

Abstract submitted by Nektar Therapeutics (NASDAQ: NKTR) for presentation at the ASCO Genitourinary Cancers Symposium showed that data from the PIVOT-02 Phase 1/2 Study that evaluated its NKTR-214 in combination with Bristol-Myers Squibb's Opdivo for metastatic urothelial cancer, produced a 48 percent overall response rate compared to a 60 percent response rate reported in June. The company will present detailed results at the symposium Feb. 15.

The stock fell 5.65 percent to $43.73 in after-hours trading.

Pacific Biosciences Q4 Results Miss Estimates

Pacific Biosciences of California (NASDAQ: PACB), which has agreed to be acquired by Illumina, Inc. (NASDAQ: ILMN), reported Q4 revenues of $19.53 million, lower than $24.94 million in the year-ago quarter. The net loss widened from 21 cents to 18 cents. The results trailed expectations. The merger is expected to be completed to mid 2019.

Xeris To Offer 5M Shares In A Follow-On Offering

Xeris Pharmaceuticals Inc (NASDAQ: XERS) said it has filed a registration statement on Form S-1 for its proposed offering of 5 million shares. All the shares offered will be sold by the company. The company said it intends to use the net proceeds from the offering to support the expected launch of Gvoke HypoPen and advance other pipeline candidates among other things.

Abeona Confirms Siffert As CEO

Abeona Therapeutics Inc (NASDAQ: ABEO) announced the appointment of Joao Siffert as its CEO, effective immediately. Siffert, who joined Abeona as Head of R&D and chief medical officer in 2018, has been serving as the interim CEO since September.

The stock fell 1.49 percent to $6.60 in after-hours trading.

On The Radar Adcom Meeting

A joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, scheduled for Tuesday, Feb, 12, to deliberate on Johnson & Johnson (NYSE: JNJ) unit Janssen's NDA for Esketamine 28 mg single-use nasal spray device being evaluated for treatment of treatment-resistant depression are due.

Earnings

Exelixis, Inc. (NASDAQ: EXEL)(after the market close)

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