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Benzinga's Daily Biotech Pulse: Bellicum CFO Resigns, Roche's Trial Meets Endpoints, Avid Bioservices Turns To Black In Q4

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on July 16)

  • Arcus Biosciences Inc (NYSE: RCUS)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • Novocure Ltd (NASDAQ: NVCR)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)

Down In The Dumps

(Stocks hitting 52-week lows on July 16)

  • Achaogen Inc (NASDAQ: AKAO)
  • Aevi Genomic Medicine Inc (NASDAQ: GNMX)
  • Agenus Inc (NASDAQ: AGEN)(announced the appointment of Dr. Sunil Gupta as VP of Regulatory and Pharmacovigilance and Dr. Anna Wijatyk as the VP of Clinical Development)
  • Arsanis Inc (NASDAQ: ASNS)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • Cytori Therapeutics Inc (NASDAQ: CYTX)
  • Denali Therapeutics Inc (NASDAQ: DNLI)
  • Genocea Biosciences Inc (NASDAQ: GNCA)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)(updated its corporate strategy and outlook following its recent termination of merger agreement with BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
  • Imv Inc (NASDAQ: IMV)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Obalon Therapeutics Inc (NASDAQ: OBLN)
  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)( FBR B Riley downgraded shares from Buy to Neutral)
  • Regulus Therapeutics Inc (NASDAQ: RGLS)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • Titan Medical Inc. (NASDAQ: TMDI)

See Also: The Week Ahead In Biotech: Conferences, Clinical Trial Results, IPOs And More

Stocks In Focus Evolus To Offer 5 Million Shares

Evolus Inc (NASDAQ: EOLS) announced filing of a registration statement on Form S-1 with the SEC and commenced an underwritten public offering of 5 million shares of its common stock. About 2.5 million shares are offered by Evolus and another 2.5 million shares will be offered by a selling shareholder.

The stock slumped 10.86 percent in after-hours trading.

Avid Bioservices Reverses To Profit In Q4

Avid Bioservices Inc (NASDAQ: CDMO), a biologics contract development and manufacturing organization, reported contract manufacturing revenue fell from $17.9 million in Q4 2017 to $17.9 million in Q4 2018, with the decline due to previously announced lower demand from one of the largest customers. The company reversed from a loss of 16 cents per share to a profit of 3 cents per share.

The company said it expects revenues of $51 million to $55 million for FY19. Current revenue backlog climbed 48.2 percent quarter-over-quarter to $57.8 million.

View more earnings on IBB

The stock climbed 3.8 percent to $4.64 in after-hours trading.

Bellicum CFO To Quit

Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) said its CFO Alan Musso would depart, effective Aug. 31, 2018. VP of Finance and Controller Rosemary Williams will serve as the interim principal accounting officer, the company said.

Roche's Flu Drug Meets Primary & Secondary Objectives

Roche Holdings AG Basel ADR (OTC: RHHBY) announced the results of Phase 3 CAPSTONE 2 study, which evaluated its baloxavir marboxil, which showed that the pipeline candidate reduced symptoms in people at high risk of complications from the flu.

Baloxavir marboxil is an oral, single-dose antiviral medication.

Teva Voluntarily Recalls Blood Pressure Drug

Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE: TEVA) said it has initiated a voluntary recall of both single and combination valsartan medicines distributed under the Actavis label in the U.S. The company attributed the recall to the detection of traces of an unexpected impurity found in an active pharmaceutical ingredient, or API, manufactured by Zhejiang Huahai Pharmaceutical.

Valsartan is used for treating hypertension and heart failure as well as for treating left ventricular failure and left ventricular dysfunction following myocardial infraction.

The stock fell about 1 percent to $23.08 in after-hours trading.

Johnson & Johnson Unit Announces Early Stoppage of Chronic Kidney Disease Trial

Johnson & Johnson (NYSE: JNJ)'s Janssen unit said following determination by an Independent Data Monitoring Committee that its Invokana, evaluated in a Phase 3 CREDENCE study versus placebo in combination with the standard of care for patients with chronic kidney disease and type 2 diabetes, demonstrated efficacy, it stopped the study early based on the achievement of pre-specified efficacy criteria.

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