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The Daily Biotech Pulse: FDA Likes Nabriva's Antibiotic, Snubs Sarepta's DMD Drug; Moderna Gets Fast Track Designation For Zika Vaccine

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 Aug. 19)

  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • Avid Bioservices Inc (NASDAQ: CDMO)
  • Bioanalytical Systems, Inc. (NASDAQ: BASI)
  • Cardiovascular Systems Inc (NASDAQ: CSII)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • Medtronic PLC (NYSE: MDT)
  • ResMed Inc. (NYSE: RMD)
  • Novocure Ltd (NASDAQ: NVCR)
  • West Pharmaceutical Services Inc. (NYSE: WST)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 19)

  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)
  • Erytech Pharma SA (NASDAQ: ERYP)
  • KemPharm Inc (NASDAQ: KMPH)
  • Merit Medical Systems, Inc. (NASDAQ: MMSI)

See Also: The Week Ahead In Biotech: FDA Goes Into Overdrive In A Quiet Week

Stocks In Focus Nabriva's Antibiotic Snags FDA Nod For Community-Acquired Pneumonia

Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV), which recently updated its regulatory timeline for its injectable Contepo, announced Monday the FDA approved its NDA for the oral and intravenous formulations of Xenleta, or lefamulin, for the treatment of community-acquired pneumonia in adults.

"Today's approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP," said Ted Schroeder, CEO of Nabriva Therapeutics.

The product is likely to be made available in mid-September.

The stock jumped 21.71% to $2.69 in after-hours trading.

Moderna's Zika Virus Vaccine Accorded Fast Track Designation

Moderna Inc (NASDAQ: MRNA), which develops messenger RNA therapeutics and vaccines, said the FDA has granted Fast Track designation for its investigational Zika vaccine, codenamed mRNA-1893, which is being currently evaluated in a Phase 1 study to prevent Zika vaccine infection in healthy adults.

The stock gained 8.43% to $14.53 in after-hours trading.

Sarepta Receives Complete Response Letter For DMD Drug

Sarepta Therapeutics Inc (NASDAQ: SRPT) said the FDA has issued a complete response letter for its NDA seeking accelerated approval for golodirsen injection for treating Duchenne muscular dystrophy in patients with confirmed mutation amenable to exon 53 skipping.

The company noted that the FDA has raised two concerns, namely risk of infections related to intravenous infusion ports and renal toxicity seen in preclinical models of golodirsen and observed following administration of other antisense oligonucleotides.

View more earnings on SRPT

The company said it will immediately seek a meeting with the FDA to determine the next steps.

The stock plunged 13.30% to $104.31 in after-hours trading.

Synlogic Pulls The Plug On Program Evaluating Its Hyperammonemia Treatment Candidate

Synlogic Inc (NASDAQ: SYBX) announced its decision to discontinue the development of SYNB1020, an early stage clinical product candidate for the treatment of hyperammonemia. The decision to discontinue the program was based on top-line data from an interim analysis of a Phase 1b/2a study in 23 patients with cirrhosis and elevated blood ammonia.

The study, though showing SYNB1020, well tolerated in patients with cirrhosis, did not provide evidence of blood ammonia lowering or changes in other exploratory endpoints relative to placebo.

"Moving forward, we will focus our resources on advancement of SYNB1618 for the treatment of phenylketonuria, SYNB1891 for the treatment of solid tumors and several new programs in early development," the company said.

The stock slipped 9.32% to $4.38 in pre-market trading.

Elanco to Buy Bayer's Animal Health Business For $7.6B

Elanco Animal Health Inc (NYSE: ELAN) announced a deal to buy Bayer AG (OTC: BAYRY)'s animal health business in a transaction valued at $7.6 billion in cash and stock. The deal is expected to close in mid-2020, subject to regulatory approvals and other customary closing conditions.

Clovis Rallies On Disclosure of Increased Stake By D.E. Shaw

Clovis Oncology Inc (NASDAQ: CLVS) shares found some upward momentum after D.E. Shaw announced an increase in its stake in the cancer biotech from 1.7% to 5%

The stock rose 3.70% to $6.17 in after-hours trading.

Earnings On The Radar Earnings

Trinity Biotech plc (NASDAQ: TRIB) (before the market open)
Medtronic PLC (NYSE: MDT) (before the market open)

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