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The Daily Biotech Pulse: Melinta Crosses FDA Hurdle But Sees Liquidity Pushback, Positive Readout For Aclaris Wart Drug

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 Oct. 24)

  • AstraZeneca plc (NYSE: AZN) (reacted to a beat-and-raise quarter)
  • Edwards Lifesciences Corp (NYSE: EW)( reported better-than-expected third-quarter results)
  • Frequency Therapeutics Inc (NASDAQ: FREQ) (IPOed Oct. 3)
  • GlaxoSmithKline plc (NYSE: GSK)(FDA approved expanded use of Zejula)
  • Novo Nordisk A/S (NYSE: NVO)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 24)

  • Acorda Therapeutics Inc NASDAQ: ACOR) (announced restructuring plan, including the elimination of 25% of its workforce)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • bluebird bio Inc (NASDAQ: BLUE) (announced resignation of chief strategy officer)
  • Brickell Biotech Inc (NASDAQ: BBI)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • KemPharm Inc (NASDAQ: KMPH)
  • MacroGenics Inc (NASDAQ: MGNX)
  • Midatech Pharma PLC-ADR (NASDAQ: MTP)
  • OpGen Inc (NASDAQ: OPGN) )(announcing pricing of previously-announced underwritten common stock offering)
  • Opko Health Inc. (NASDAQ: OPK)(announced a follow-on offering)
  • Orgenesis Inc (NASDAQ: ORGS)
  • Rexahn Pharmaceuticals, Inc. (NASDAQ: REXN)
  • Titan Medical Inc. (NASDAQ: TMDI)

Stocks In Focus Melinta Gets FDA Nod For Baxdela Label Expansion; Launch to Be Delayed Due to Liquidity Concerns

Melinta Therapeutics Inc (NASDAQ: MLNT) announced FDA approval for Baxdela for the treatment of adult patients with community-acquired bacterial pneumonia, or CABP, caused by designated succeptible bacteria. The approval represents a label expansion for Baxdela, which was originally approved in 2017 for acute bacterial skin and skin structure infections.

However, the company flagged liquidity concerns and said it is delaying the commercial launch of Baxdela for CABP until it gains some insight into its ability to secure additional sources of liquidity.

Melinta is co-developing the drug with Ligand Pharmaceuticals Inc. (NASDAQ: LGND).

Melinta shares tumbled 25.86% to $3.24 in after-hours trading.

See Also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts

Aclaris Aces a Late-stage Study of Treatment For Common Warts

Aclaris Therapeutics Inc (NASDAQ: ACRS) announced positive results from a second Phase 3 study, dubbed THWART-1, of A-101 45% topical solution, an investigational drug for the potential treatment of common warts.

The company said the pipeline asset met the primary and secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts.

In September, the company announced positive results from the first Phase 3 study dubbed THWART-2, sending its shares higher by about 64%.

The company said these data will serve as a basis for an NDA filing.

The stock moved up 18.45% to $1.99 in after-hours trading.

PDL BioPharma Responds to Activist's Call For Review of Strategic Alternatives

Following a letter from its majority shareholder Engine Capital, calling for ceasing of all investment activities and reviewing strategic alternatives, PDL BioPharma Inc (NASDAQ: PDLI) responded with a letter from its chairman Harold Selick, who said the management will meet with the activist once the review by an external financial advisor on certain of the topics raised by Engine Capital is complete.

View more earnings on IBB

In the letter, Selick said at the September board meeting, it has been resolved to engage an external financial advisor for providing an independent perspective.

Anchiano Says Chairman of The Board Hoffman Resigns

ANCHIANO THERAP/S ADR (NASDAQ: ANCN) said Stephen Hoffman, who served as chairman of the board, has stepped down from the board, effective immediately.

Astellas's Xospata Approved In Europe For Blood Cancer With Specific Mutation

ASTELLAS PHARMA/ADR (OTC: ALPMY) said the European Commission has approved its oral once-daily therapy Xospata as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or AML, with a FLT3 mutation. The company noted that Xospata has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation - FLT3 internal tandem duplication and FLT3 tyrosine kinase domain mutation.

Earnings

Gilead Sciences, Inc. (NASDAQ: GILD) reported third-quarter revenues that remained flat at $5.6 billion and non-GAAP earnings per share, or EPS, of $1.75 that exceeded estimates by a penny. The company raised the low-end of its 2019 product sales guidance slightly, while maintaining the upper end.

The stock slipped 1.70% to $64.88 in after-hours trading.

Illumina, Inc. (NASDAQ: ILMN)'s third-quarter revenues rose 6% to $907 million. The non-GAAP income of $1.93 per share was higher than the year-ago's $1.52 per share and the consensus of $1.40 per share. The company issued a strong full-year 2019 guidance

The stock fell 4.52% to $301.24 in after-hours trading, apparently reacting to soft microarray sales, the Investor Business Daily reported, citing Evercore ISI analyst Vijay Kumar.

Anika Therapeutics Inc (NASDAQ: ANIK) reported strong third-quarter revenues growth and an EPS-beat. The company also raised its full-year guidance.

The stock 8.02% to $58.62 in after-hours trading.

ResMed Inc. (NYSE: RMD) reported 16% revenue growth to $681.1 million and a better-than-expected non-GAAP EPS of 93 cents.

The stock rallied 10.39% to $141 in after-hours trading.

On The Radar Clinical Trial Readouts

Abeona Therapeutics Inc (NASDAQ: ABEO) will present at the European Society of Gene and Cell Therapy 27th Annual Congress, Phase 1/2 data on ABO-102 for treating Sanfilippo syndrome type A.

IPOs

Phathom Pharmaceuticals, a biotech company working on in-licensed assets for treating gastrointestinal disorders, priced its upsized offering of 9.56 million shares at $19 per share, at the midpoint of the estimated price range of $18-$20. The company seeks to list its shares on the Nasdaq under the ticker symbol "PHAT."

Cabaletta Bio, which uses chimeric autoantibody receptor, or CAAR, T cells that selectively bind and eliminate B cells that produce disease-causing autoantibodies, priced its upsized 6.8-million share IPO at $11, below the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol "CABA."

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