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The Daily Biotech Pulse: Vascepa Delay Sends Amarin Reeling, Eidos Jumps On Buyout Offer, Nektar's Bitter Q2

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. 8)

  • Aquinox Pharmaceuticals Inc (NASDAQ: AQXP)
  • Avedro Inc (NASDAQ: AVDR)(announced a deal to be bought by Glaukos Corp (NYSE: GKOS)
  • Haemonetics Corporation (NYSE: HAE)
  • Morphosys Ag (NASDAQ: MOR)
  • Natera Inc (NASDAQ: NTRA)(reacted to its second-quarter results)
  • Novocure Ltd (NASDAQ: NVCR)
  • Recro Pharma Inc (NASDAQ: REPH)(reported second-quarter results)
  • West Pharmaceutical Services Inc. (NYSE: WST)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 8)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)(reacted to second-quarter results)
  • BIOLINERX LTD/S ADR (NASDAQ: BLRX)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Clovis Oncology Inc (NASDAQ: CLVS) (announced a debt offering)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC)
  • Guardion Health Sciences Inc (NASDAQ: GHSI)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
  • ICU Medical, Incorporated (NASDAQ: ICUI)(reacted to disappointing second-quarter results)
  • IMMURON LTD/S ADR (NASDAQ: IMRN)
  • OpGen Inc (NASDAQ: OPGN)(reacted to second-quarter results)
  • Precision BioSciences Inc (NASDAQ: DTIL)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)
  • Proteostasis Therapeutics Inc (NASDAQ: PTI)(reacted to second-quarter results)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Wright Medical Group NV (NASDAQ: WMGI)(lowered its full-year guidance)
  • Transenterix Inc (NYSE: TRXC)(second-quarter revenues declined year-over-year)

See Also: Biotech Stock On The Radar: Veru, A Catalyst-Rich Biopharma

Stocks In Focus Amarin Says FDA Schedules Surprise Adcom Meeting For its Fish Oil Pill

Amarin Corporation plc (NASDAQ: AMRN) received a communication from the FDA that it plans an Adcom meeting, tentatively scheduled for November for reviewing the sNDA for Vascepa labeling. The regulatory agency also indicated that the earliest date on which an Adcom could be scheduled is Nov. 14 due to scheduling constraints for such meeting.

The company also said it does not expect the FDA to rule by the originally scheduled PDUFA date of Sept. 28, although the agency did not comment on any delay.

The stock plunged 23.64% to $13.60 in after-hours trading.

BridgeBio Pursues to Buy Out Eidos At 20% Premium

BridgeBio Pharma Inc (NASDAQ: BBIO), a shareholder in Eidos Therapeutics Inc (NASDAQ: EIDX), has filed with the SEC regarding a non-binding proposal the former has made to acquire all outstanding shares that it does not already own in the latter for a fixed exchange ratio of 1.30 shares of its shares for each outstanding share of Eidos.

The stock exchange ratio suggests a valuation of $38.77 per share of Eidos, a premium of 20.1% from Thursday's closing price.

Eidos shares rallied 15.38% to $36.99 in after-hours trading.

Kala Gets Complete Response Letter for its NDA for Dry Eye Disease Drug

Kala Pharmaceuticals Inc (NASDAQ: KALA) received a complete response letter from the FDA regarding its NDA for KPI-121, 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

The FDA said an additional clinical trial will be needed to support a resubmission.

The stock slid 11.96% to $4.05 in after-hours trading.

FDA Extends Avadel's NDA For AV001 By 3 Months

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) said the FDA has extended the PDUFA action date for its NDA for AV001, a sterile injectable product designed for use in the hospital setting, by three months to Dec. 15. The NDA was originally accepted in May under Priority Review program.

View more earnings on IBB

Notwithstanding the setback, the company said it is on track for a commercial launch, as planned, in the first quarter of 2020.

The stock slipped 9.17% to $1.98 in after-hours trading.

Sesen Reports Positive Phase 3 Data for Bladder Cancer Drug

Sesen Bio Inc (NASDAQ: SESN) reported updated preliminary primary and secondary endpoint data from its Phase 3 VISTA trial that supported the strong benefit-risk profile of Vicinium for potential treatment of patients with high-risk, bacillus Calmette-Guerin unresponsive, non-muscle invasive bladder cancer. The company said the updated Phase 3 data will serve as the basis for the anticipated initiation of its BLA submission, planned for the fourth quarter.

The stock gained 7.63% to $1.27 in after-hours trading.

Earnings

Puma Biotechnology Inc (NASDAQ: PBYI)'s second-quarter revenues climbed 6.1% to $53.9 million and the net loss narrowed from $1.17 per share to 97 cents per share.

The stock jumped 22.69% to $11.30 in after-hours trading.

Nektar Therapeutics (NASDAQ: NKTR) reported revenues of $23.3 million, down sharply from $1.088 billion last year. The company reversed to a loss of 63 cents per share from a profit of $5.33 per share. The year-ago revenues included a $1.06 billion licensing revenue from Bristol-Myers Squibb Co (NYSE: BMY).

The stock slumped 29.66% to $20.80 in after-hours trading.

Adamas Pharmaceuticals Inc (NASDAQ: ADMS) reported 68% year-over-year revenue growth to $12.69 million and the net loss narrowed from $1.26 per share to 90 cents per share.

The stock declined 19.61% to $4.92 in after-hours trading.

On The Radar Earnings

  • Avadel Pharma (before the market open)
  • Diplomat Pharmacy Inc (NYSE: DPLO) (before the market open)
  • Melinta Therapeutics Inc (NASDAQ: MLNT (before the market open)
  • Organogenesis Holdings Inc (NASDAQ: ORGO) (before the market open)
  • PLx Pharma Inc (NASDAQ: PLXP) (before the market open)
  • Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) (before the market open)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX) (before the market open)
  • Voyager Therapeutics Inc (NASDAQ: VYGR) (before the market open)

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